EIN Presswire: Breast Cancer Live Feed Press Releases

Hundreds of Lipsticks Contaminated With Lead, Reports New FDA Study

Wed, 08 Feb 2012 16:43:49 +0000

Hundreds of Lipsticks Contaminated With Lead, Reports New FDA Study

PR Newswire

Levels up to twice as high as previously reported; FDA must set safety standard

WASHINGTON, Feb. 8, 2012 /PRNewswire-USNewswire/ -- A new analysis of lead in lipstick conducted by the U.S. Food and Drug Administration reveals that the problem of lead in lipstick is worse and more widespread than previously reported. The recent study found lead in most of the 400 lipsticks tested by the agency, at widely varying levels of up to 7.19 parts per million (ppm) -- more than twice the levels reported in a previous FDA study.

Yesterday, the Campaign for Safe Cosmetics sent FDA a letter asking them to correct misleading statements on their website about the supposed safety of lead in lipstick: http://safecosmetics.org/article.php?id=951. The agency has studied only the levels of lead in lipstick, and has conducted no health studies or safety assessments.

In a recent report, an advisory committee to the U.S. Centers for Disease Control and Prevention said there is no safe level of lead exposure for children and stressed the importance of preventing lead exposure for pregnant women.

"Lead is a proven neurotoxin that can cause learning, language and behavioral problems. Pregnant women are particularly vulnerable to lead exposure, because lead easily crosses the placenta and enters the fetal brain where it can interfere with normal development," explained Sean Palfrey, M.D., a professor of pediatrics and public health at Boston University and the medical director of Boston's Lead Poisoning Prevention Program.

"Lead builds up in the body over time and lead-containing lipstick applied several times a day, every day, can add up to significant exposure levels," said Mark Mitchell, M.D., MPH, policy advisor of the Connecticut Coalition for Environmental Justice and co-chair of the Environmental Health Task Force for the National Medical Association.

"How many millions of women have applied and reapplied lead-containing lipsticks since we first raised concerns about this problem five years ago? How many kids have played with their mom's lipstick?" said Janet Nudelman, interim director of the Campaign for Safe Cosmetics and policy director at the Breast Cancer Fund. "It's time for FDA to set a safety standard for lead in lipstick."

Health advocates are urging FDA to set a maximum limit for lead in lipstick based on the lowest lead levels manufacturers can feasibly achieve.

More information: http://www.SafeCosmetics.org/poisonkiss

SOURCE Campaign for Safe Cosmetics

The Red Devils Angels for Breast Cancer Patients, Stage Feb. Fundraisers for Better Quality-of-Life

Wed, 08 Feb 2012 16:25:08 +0000

The Red Devils Angels for Breast Cancer Patients, Stage Feb. Fundraisers for Better Quality-of-Life

PR Newswire

BALTIMORE, Feb. 8, 2012 /PRNewswire/ -- Breast cancer patients have an angel in the form of The Red Devils, honoring 10 years in 2012 of working to improve the quality-of-life for Maryland patients and their families.

February fundraising events allow the general public to raise dollars for a charity that sends funds – without red tape – directly to the people who need it most.

Two Hunt Valley Towne Centre retailers based off Shawan Road are out front. The month of February, Greetings & Readings of Hunt Valley will showcase The Red Devils 10th anniversary cookbook. Donate $20 or more, get a cookbook. The independent bookseller will track donations on behalf of The Red Devils.

On "Fat Tuesday" February 21 The Greene Turtle Sports Bar and Grille in Hunt Valley celebrates Mardi Gras and the breast cancer cause by donating 20 percent of the day's receipts patrons turn back in. Revelers will enjoy live music with Brian Raphael, a fab happy hour and more. Bring extra cash for $5 Red Devils hair extensions by noted stylist Alberta Santora of Stevenson Village's Capelli Salon and sign up for the $35 annual The Red Devils 5K Run & Stroll on June 10 at Goucher College, the year's biggest fundraiser.

Head to the Dundalk, MD waterfront and Hard Yacht Cafe, 8500 Cove Road, Saturday, February 25 for a "Chili Cook-off" for The Red Devils from 2:00 - 6:00 p.m. Cost is $10 to enter or taste.

Founded in 2002 by the families of two brave young women who succumbed to breast cancer, the Baltimore-based 501 (c) (3) organization works with 38 partner hospitals which refer patients to The Red Devils. Help is not based on finances but the individual toll breast cancer takes.

The Red Devils provide transportation to life-saving treatments; help with drug co-payments; delivering nourishing meals and groceries; therapeutic massages and more. Even out-of-the-box funding is possible, including a surprise birthday party for the sole child of a single mom near life's end or getting a breast cancer patient new eyeglasses.

Funds come from individual and corporate donations as well as grants from groups including The Maryland Affiliate of Susan G. Komen for the Cure.

Call 410-323-0135 or log on to www.thereddevilsmd.org

Media Contact: Liz Chuday, 410-464-1100 or liz@the-red-devils.org

SOURCE The Red Devils

International Medical Imaging Experts Join Efforts to Advance Prostate Cancer Care

Wed, 08 Feb 2012 13:00:00 +0000

International Medical Imaging Experts Join Efforts to Advance Prostate Cancer Care

PR Newswire

American College of Radiology (ACR), AdMeTech Foundation and European Society of Urogenital Radiology (ESUR) Create Standards for High Quality MRI

BOSTON, Feb. 8, 2012 /PRNewswire-USNewswire/ -- ACR, AdMeTech Foundation and ESUR announced today a joint effort to create standards for a high quality prostate MRI and to expedite its transfer of technologies from laboratories to patients. Standards for the Magnetic Resonance Prostate Imaging Reporting and Data System (MR PI-RADS) are modeled after successful efforts in breast cancer care, and are planning to be released in early 2013.

The goal of this international cooperation is to address the central challenge in prostate cancer care recently framed by the U.S. Preventive Services Task Force, American Cancer Society and other groups – improving early detection while reducing unnecessary biopsies and treatment. MR PI-RADS will be based on prostate MRI guidelines developed by ESUR and the work by the AdMeTech Foundation's International Prostate MRI Working Group.

AdMeTech Foundation has been providing international leadership in supporting research, development and testing of high-precision prostate MRI since 1998. AdMeTech's research program has been funded by the Telemedicine and Advanced Technology Research Center, U.S. Army Medical Research, and Materiel Command, Fort Detrick, MD. Dr. Faina Shtern, President of AdMeTech Foundation said, "In the '90s, the American College of Radiology led development of the BI-RADS standardization of breast cancer imaging which transformed women's health. Over the last several years, ESUR led the way in the development of proposed clinical reporting guidelines for prostate MRI. On behalf of AdMeTech Foundation, I would like to thank Dr. Jeffrey Weinreb of ACR and Jelle Barentsz of ESUR for their leadership and partnership in PI-RADS standardization of prostate imaging, which is expected to make a direct and immediate impact on ending the era of blind prostate cancer care and creating the future of the image-guided, least invasive and the most cost-effective diagnosis and treatment."

Dr. Mitchell Schnall, Matthew J. Wilson Professor of Radiology at the University of PA, a pioneer of the prostate-dedicated MRI, one of the original recipients of AdMeTech's research support for high-precision imaging and a Principal Investigator of the American College of Radiology Imaging Network, stated, "Over the last several years, I have been watching growing scientific evidence in support of prostate MRI and its potential to improve patient care in the way which is strongly reminiscent of the research progress we had seen twenty years ago in breast cancer imaging. As a man who lost his father to the complications of prostate cancer and its treatment, I am experiencing a sense of renewed hope for so many men facing the threat of prostate cancer every day."

Prostate cancer is the most common major cancer in the United States and the second most lethal cancer in men. Prostate cancer – diagnosed in as many as 1 in 6 men – has become even more common than breast cancer (striking 1 in 8 women). In spite of the magnitude of the prostate cancer epidemic, prostate cancer has not been recognized as a public health priority, and men do not have accurate diagnostic tools akin to life-saving mammograms.

ABOUT AdMeTech Foundation: A Boston-based non-profit organization providing leadership for ground-breaking programs in research, education and awareness to advance diagnostic tools for improved early detection and treatment of prostate cancer. AdMeTech Foundation gratefully acknowledges the support from the Telemedicine & Advanced Technology Research Center (TATRC). AdMeTech Foundation's International Prostate MRI Working Group's research and development were made possible by grants awarded and managed by the U.S. Army Medical Research & Materiel Command (USAMRMC) and TATRC, at Fort Detrick, MD under Contract Numbers: W81XWH-09-0552; DAMD17-03-2-0055; WX1XWH-11-0077 (www.admetech.org).

ABOUT American College of Radiology: The ACR is a national professional organization serving more than 34,000 radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.

ABOUT ESUR: The European Society of Urogenital Radiology (ESUR) was founded in 1990, to promote high quality science and clinical practice of urogenital radiology. Members of the ESUR are the world leading radiologists in urogenital radiology. This society was especially successful with establishment of guidelines on the safe use of contrast media and on female genital imaging, and recently on standardization of prostate MRI.

SOURCE AdMeTech Foundation

Amgen to Discuss Application for New Use of XGEVA® (denosumab) at FDA Oncologic Drugs Advisory Committee Meeting

Wed, 08 Feb 2012 13:00:00 +0000

Amgen to Discuss Application for New Use of XGEVA® (denosumab) at FDA Oncologic Drugs Advisory Committee Meeting

PR Newswire

THOUSAND OAKS, Calif., Feb. 8, 2012 /PRNewswire/ -- Amgen (NASDAQ: AMGN) will discuss the data from the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases (spread of cancer to the bone) at today's meeting of the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC).

Amgen will discuss results of the pivotal Phase 3 '147 trial, which forms the basis for the proposed new indication. If approved in this expanded indication, XGEVA would become the first therapy licensed to prevent or delay the spread of cancer to bone in men with CRPC. XGEVA is currently approved to prevent skeletal-related events (SREs) in men with advanced prostate cancer that has already spread to the bone.

"The development of bone metastasis is an irreversible, life-changing event for men living with castration-resistant prostate cancer and is associated with significant and progressive morbidity," said Sean Harper, M.D., senior vice president of Global Development and chief medical officer at Amgen. "XGEVA is the first agent to prolong bone metastasis-free survival and addresses this important unmet medical need."

Bone metastases weaken the skeleton and can result in incapacitating complications known as SREs, which include fracture, spinal cord compression, radiation and surgery to bone. An estimated 54,000 patients in the U.S. have CRPC with a high risk of developing bone metastases.

'147 Study Design & Results

Study '147 was a randomized, placebo-controlled, multicenter Phase 3 study comparing the treatment effect of XGEVA to placebo in prolonging bone metastasis-free survival, a measure of the time that patients live without progressing to bone metastases. The study enrolled 1,432 men with CRPC who had no bone metastases at baseline, but were at increased risk based on prostate specific antigen (PSA) criteria. The '147 study enrolled patients with a PSA greater than or equal to 8 ng/mL or PSA doubling time of 10 or less months.

The primary analysis of the overall '147 study population showed that XGEVA significantly reduced the risk for bone metastases or death by 15 percent and increased bone metastasis-free survival, or the time a patient went without developing bone metastasis, by a median of 4.2 months (29.5 versus 25.2 months, respectively; p=0.028). In exploratory analyses of patients with PSA doubling time of 10 months or less (80 percent of the study population), XGEVA prolonged median bone metastasis-free survival time by 6.0 months compared with placebo with a 16 percent reduction in risk. In patients with PSA doubling time of 6 months or less, XGEVA prolonged median bone metastasis-free survival time by 7.2 months compared with placebo with a 23 percent reduction in risk.

Further supporting the clinical relevance of its effects, XGEVA reduced the risk of symptomatic bone metastases by 33 percent and the risk of multiple bone metastases by 24 percent.

Overall survival was similar (HR 1.01; 95 percent CI: 0.85, 1.20; p=0.91) between the XGEVA and placebo groups. The study was not designed to show an overall survival benefit. Patients were taken off treatment once they developed a bone metastasis so they could receive the standard approved treatment for metastatic cancer at the time the study was conducted.

No new safety risks were identified in the study. Adverse events and serious adverse events were relatively similar between the XGEVA and placebo arms. The known risks of hypocalcemia (1.7 percent) and osteonecrosis of the jaw (ONJ) (4.6 percent) were reported with increased frequencies in the XGEVA-treated patients. The yearly rate of ONJ in the XGEVA arm was similar to prior XGEVA trial results. Back pain was the most common adverse event reported in the XGEVA arm of the trial.

About XGEVA

XGEVA is the first-and-only RANK Ligand inhibitor approved by the FDA for the prevention of SREs in patients with bone metastases from solid tumors. XGEVA was initially approved following a six month priority review by the FDA. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is the first novel bone metastases treatment for advanced cancer patients in nearly a decade. Delivered as an every four week 120 mg subcutaneous injection, XGEVA provides a unique option for urologists and oncologists to prevent SREs in patients with bone metastases from solid tumors.

XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.

XGEVA has been studied in over 6,000 patients with cancer. In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the previous standard of care in preventing bone complications. XGEVA is also being investigated for the potential use to delay the onset of bone metastasis in adjuvant breast cancer.

XGEVA Important Safety Information

XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to XGEVA treatment. Monitor calcium levels and administer calcium, magnesium and vitamin D as necessary. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

Osteonecrosis of the jaw (ONJ) can occur in patients receiving XGEVA. Patients who are suspected of having or who develop ONJ while on XGEVA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

The most common adverse reactions in patients receiving XGEVA were fatigue/asthenia, hypophosphatemia and nausea. The most common serious adverse reaction in patients receiving XGEVA was dyspnea. The most common adverse reactions resulting in discontinuation of XGEVA were osteonecrosis and hypocalcemia. Please visit www.amgen.com or www.xgeva.com for full U.S. prescribing information.

XGEVA Regulatory Status

XGEVA has been approved in the U.S., Canada, the European Union (EU), Switzerland, Australia, Russia, Japan and Mexico for the prevention of SREs in patients with bone metastases from solid tumors. XGEVA is not approved to prevent SREs in patients with multiple myeloma.

Amgen has also submitted marketing applications for XGEVA in South Africa, Gulf Cooperation Council countries, Morocco and Egypt. In Japan, Amgen is working with its licensing partner, Daiichi Sankyo Company, Limited. In addition, Amgen and GlaxoSmithKline (GSK) have a collaboration agreement for the commercialization of XGEVA in a number of countries where Amgen does not currently have a commercial presence. In these countries, marketing applications are filed by GSK.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Feb. 8, 2012 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

CONTACT: Amgen, Thousand Oaks
Mary Klem, 805-447-6979 (media)
Arvind Sood, 805-447-1060 (investors)

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

SOURCE Amgen

Sanofi: 2011 Results Benefit from Genzyme Acquisition

Wed, 08 Feb 2012 12:00:00 +0000

Sanofi: 2011 Results Benefit from Genzyme Acquisition

Net Sales and Business EPS(1) up 9.2%(2) in Q4

PR Newswire

PARIS, Feb. 8, 2012 /PRNewswire/ --

(Logo : http://photos.prnewswire.com/prnh/20110616/NY20158LOGO )


	Q4 2011	Change on a reported basis	Change at constant exchange rates	2011	Change on a reported basis	Change at constant exchange rates
Net sales	euro 8,508m	+8.8%	+9.2%	euro 33,389m	+3.2%	+5.3%
Business net income(1)	euro 2,077m	+13.0%	+11.7%	euro 8,795m	-4.6%	-2.7%
Business EPS(1)	euro 1.56	+10.6%	+9.2%	euro 6.65	-5.8%	-3.8%
In order to facilitate an understanding of our operational performance, we comment on our business net income statement. Business net income(1) is a non-GAAP financial measure. The consolidated income statement for 2011 is provided in Appendix 7. A reconciliation of business net income to consolidated net income is provided in Appendix 6. Consolidated net income for 2011 was euro 5,693 million, compared to euro 5,467 million for 2010. Consolidated EPS for 2011 was euro 4.31 versus euro 4.19 for 2010.

Commenting on the Group's performance in 2011, Sanofi Chief Executive Officer, Christopher A. Viehbacher said, "2011 was a key year in transforming Sanofi. We successfully acquired and integrated Genzyme, our growth platforms(3) recorded double-digit growth, we delivered cost savings as planned and submitted filings to regulatory authorities for five new products. Several product exclusivity losses were absorbed and we successfully limited the impact on business EPS. Beyond the remaining patent cliff in 2012, the robust performance of our diversified growth platforms, the reduced exposure to future patent expiries and progress on R&D, position Sanofi for a period of sustainable growth".

2011 Performance

Total sales(4) grew 5.3%(5) to euro 33,389 million. Excluding Genzyme and A/H1N1 sales, sales decreased by 1.2%. euro 2,206 million of sales were lost due to generic competition compared to 2010.
Growth platforms sales increased 10.8% (excluding A/H1N1 sales). Sales of growth platfoms and Genzyme reached euro 21,703 million and accounted for 65% of total sales.
Sales in Emerging Markets(6) grew 10.4% (excluding Genzyme and A/H1N1 sales) to euro 10,133 million.
Diabetes delivered growth of 12.0%. In the fourth quarter, Lantus® sales exceeded euro 1 billion in quarterly sales for the first time.
Vaccines sales were up 7.2% (excluding A/H1N1 sales) to euro 3,469 million.
Genzyme sales (consolidated from April 1, 2011) increased 7.7%(7) to euro 2,395 million. The $700 million targeted cost synergies by 2013 are on track and $230 million were already achieved in 2011.
CHC and Generics recorded another year of impressive growth, up 22.8% and 16.2%, respectively. The Allegra® OTC launch in the U.S. by Chattem was a success with sales of euro 211 million.
Merial sales were up 4.3%, which included growth of 12.4% in Emerging Markets.
Business EPS(1) of euro 6.65 was down 3.8% at CER.
The proposed dividend of euro 2.65 per share corresponds to a payout ratio of 40%.

Outlook

Production recovery is well underway at Genzyme. The Framingham plant recently received important regulatory approvals by both the FDA and EMA for the production of Fabrazyme®.
Five new products were submitted to regulatory authorities since last July. In February, Aubagio™ in the EU and Zaltrap™ in the U.S. were submitted.
As announced last September, the loss of Plavix® and Avapro® exclusivity in the U.S. is anticipated to impact the 2012 business net income by around euro 1.4 billion(2). Taking into account this impact, the performance of growth platforms, contribution from Genzyme and cost control as well as other generic competition should lead to a 2012 business EPS(1) 12% to 15% lower at CER than 2011(8), barring unforeseen adverse events. This objective is in-line with the mid-term plan presented last September for a return to growth over 2012-2015.

(1) See Appendix 10 for definitions of financial indicators; (2) At Constant Exchange Rates; (3) See Appendix 4; (4) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10 for a definition); (5) 2010 includes consolidated Merial sales (euro 1,983 million); (6) See definition in the section, "Net sales by geographic region"; (7) on a constant structure basis and at constant exchange rates; (8) euro 6.65

2011 fourth-quarter and full-year net sales

Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates(1).

In the fourth quarter of 2011, Sanofi generated sales of euro 8,508 million, up 8.8% on a reported basis. Exchange rate movements had a negative effect of 0.4 percentage points. The positive effect from the Japanese yen, the U.S. dollar and the Chinese Yuan was offset by an unfavorable impact from various currencies (notably the Venezuelan Bolivar, Turkish Lira and the Brazilian Real). At constant exchange rates, and including changes in the scope of consolidation (primarily the consolidation of Genzyme), net sales increased by 9.2%.

Sales in 2011 grew 3.2% on a reported basis to euro 33,389 million. Exchange rate movements had an unfavorable effect of 2.1 percentage points. The impact of the depreciation of the U.S. dollar, Venezuelan Bolivar and Turkish Lira against the Euro was mitigated by the favorable effect of the Japanese Yen and Australian dollar. At constant exchange rates, and accounting for changes in the scope of consolidation (primarily the consolidation of Genzyme from April 1), net sales increased by 5.3%. Excluding Genzyme and A/H1N1 sales, 2011 sales decreased by 1.2%.

Growth Platforms (see Appendix 4)

Sales of the Group's growth platforms grew by 7.7% in the fourth quarter. Emerging Markets, Diabetes, Consumer Health Care and Animal Health grew at a double-digit pace in the quarter. The Group's growth platforms together with Genzyme accounted for 66.4% of total consolidated sales in Q4 2011, up from 58.4% in the fourth quarter of 2010. In 2011, the growth platforms and Genzyme comprised 65.0% of total consolidated sales compared with 56.9% in 2010. Full year 2011 sales of growth platforms grew 10.8% excluding A/H1N1 vaccines sales.

Pharmaceuticals

Fourth-quarter sales for the Pharmaceuticals business reached euro 7,220 million, an increase of 10.5%, which reflects the positive contribution (euro 831 million) from Genzyme (consolidated from April 1, 2011) as well as the negative effect of generic competition to Lovenox®, Ambien® CR and Taxotere® in the U.S., Plavix® and Taxotere® in the EU, and the impact of EU austerity measures. Full year 2011 pharmaceuticals sales were euro 27,890 million, an increase of 6.7%.

Flagship Products(9)
(millions of euros)	Q4 2011 net sales	*Change at constant* *exchange rates*	2011 net sales	*Change at constant* *exchange rates*
Lantus®	1,054	+17.8%	3,916	+15.0%
Apidra®	35	-28.6%	190	+9.6%
Plavix®	529	+2.2%	2,040	-2.9%
Lovenox®	498	-13.4%	2,111	-23.4%
Aprovel®	314	-3.4%	1,291	-2.4%
Eloxatin®	325	+119.0%	1,071	+160.9%
Taxotere®	150	-67.5%	922	-57.0%
Multaq®	64	+1.6%	261	+56.4%
Jevtana®	47	+14.6%	188	+135.4%
Cerezyme®	133	-17.4%*	441**	+11.1%*
Myozyme® / Lumizyme®	108	+15.9%*	308**	+27.4%*
Renagel®/Renvela®	143	+9.4%*	415**	+10.2%*
Synvisc®/ Synvisc One®	87	+15.2%*	256**	+14.7%*
* on a constant structure basis and at constant exchange rates;** Sales since April 1st 2011 (1) See Appendix 10 for definitions of financial indicators (9) See Appendix 2 for a geographical split of consolidated net sales by product

Diabetes

The Diabetes business generated sales of euro 1,242 million in the fourth quarter, an increase of 12.5%. Lantus® registered another quarter of strong growth and exceeded euro 1 billion in quarterly sales for the first time. Sales of the product were driven by the U.S. (+16.7% to euro 627 million), Emerging Markets (+30.7% to euro 172 million) and Japan (+18.0% to euro 34 million).

In the U.S, Lantus® SoloSTAR® represented 50.0% of total Lantus® sales in the quarter, versus 40.2% in the fourth quarter of 2010. In China, sales of Lantus® grew by 65.5% reflecting reimbursement coverage in the municipalities of Shanghai (December 2010) and Beijing (July 2011). In Brazil, sales of Lantus® were up 32.0%. In Russia, sales of Lantus® were up 23.5%. Full year 2011 sales of Lantus® reached euro 3,916 million, up 15.0% supported by strong performance in the U.S. (up 14.6% at euro 2,336 million), Emerging Markets (+26.0% at euro 617 million) and Japan (+19.5%).

At the World Diabetes Congress in Dubai last December, new meta-analysis data was presented and added to the wealth of evidence from more than 80,000 patients enrolled in clinical trials and 38 million patient years of treatment exposure to Lantus®. This new meta-analysis on the relationship between diabetes and cancer risk demonstrated no increased risk in patients using Lantus®.

Sanofi is sponsoring a large-scale, methodologically robust epidemiology program as agreed upon with the European Medicines Agency (EMA) and shared with health authorities worldwide. The program includes three large studies including two retrospective cohort studies and one case-control study conducted by independent investigators. The results of the 'Northern European Database Study of Insulin and Cancer Risk' are under review by health authorities and will be presented at scientific conferences in 2012. These results confirm Sanofi's confidence in the safety of Lantus®.

Fourth-quarter sales of the rapid-acting insulin analog Apidra® were euro 35 million, down 28.6%, reflecting a temporary shortage of Apidra® 3mL cartridges, which impacted supplies in some markets. The production of Apidra® 3mL cartridges will return to full capacity in the first half of 2012. Full year 2011 sales of Apidra® reached euro 190 million, an increase of 9.6%.

Sales of Amaryl® were euro 113 million in the fourth quarter, down 8.9% reflecting generic competition in Japan which was partially offset by the growth in Emerging Markets (+8.9% to euro 58 million). Full year 2011 sales of Amaryl® were euro 436 million, down 7.9%.

The Diabetes business generated double digit growth of 12.0% in 2011 to euro 4,684 million.

Oncology

Fourth-quarter sales of Eloxatin® were up 119.0% to euro 325 million due to the further recovery of U.S. sales (euro 260 million, versus euro 79 million in the fourth quarter of 2010). Full year 2011 sales of the product reached euro 1,071 million. In September 2011, the U.S. District Court for the District of New Jersey ruled against Sun Pharmaceuticals in favor of Sanofi U.S. with respect to a contractual dispute arising from the resolution of the Eloxatin® patent litigation. This ruling, under appeal, supports the U.S. market exclusivity of Eloxatin® through August 9, 2012.

As expected, sales of Taxotere® declined significantly (-67.5% to euro 150 million) in the fourth quarter, reflecting generic erosion in the U.S. (sales down 90.4% to euro 14 million) and Western Europe (sales decreased 84.2% to euro 23 million). Full year 2011 sales of Taxotere® were euro 922 million, down 57.0%. In 2011, Taxotere sales generated outside the U.S. and Western Europe totaled euro 490 million.

Jevtana® sales reached euro 47 million in the fourth quarter. Sales in the U.S. and Western Europe reached euro 24 million and euro 18 million, respectively. Full year 2011 sales of Jevtana® were euro 188 million compared to euro 82 million in 2010.

Worldwide presence(1) of Plavix®/Iscover®

In the fourth quarter, the worldwide presence of Plavix® was stable at euro 1,750 million. Sales in the U.S. (consolidated by Bristol-Myers Squibb) were euro 1,159 million, down 2.1%. Over the period, Plavix® reported strong growth in Japan (up 22.7% to euro 208 million) and China (up 23.8% to euro 74 million). Sales in Europe were euro 129 million, down 24.3%, reflecting generic competition. In 2011, the worldwide presence of Plavix® reached euro 6,989 million, an increase of 4.5%. Full year 2011 sales in Japan and China were euro 671 million (up 22.9%) and euro 277 million (up 27.7%), respectively. Full year 2011 consolidated sales of Plavix® in Emerging Markets recorded double digit-growth (up 11.9% to euro 706 million).

Worldwide presence of Plavix®/Iscover®: geographic split
(millions of euros)	Q4 2011	*Change at constant* *exchange rates*	2011	*Change at constant* *exchange rates*
Europe	129	-24.3%	574	-29.8%
United States	1,159	-2.1%	4,758	+7.8%
Other Countries	462	+17.2%	1,657	+13.8%
TOTAL	1,750	*-0.1%*	6,989	*+4.5%*

Worldwide presence(1) of Aprovel®/Avapro®/Karvea®/Avalide®

In the fourth quarter, the worldwide presence of Aprovel® was euro 421 million, down 11.1% reflecting the growing penetration of losartan generics. In 2011, the worldwide presence of Aprovel® totaled euro 1,805 million, a decrease of 11.0%. Full year 2011 consolidated sales of the product in Emerging Markets reached euro 363 million, up 6.7%.

Worldwide presence of Aprovel®/Avapro®/Karvea®: geographic split
(millions of euros)	Q4 2011	*Change at constant* *exchange rates*	2011	*Change at constant* *exchange rates*
Europe	197	-13.4%	824	-13.0%
United States	80	-8.5%	374	-18.8%
Other Countries	144	-9.2%	607	-2.1%
TOTAL	421	*-11.1%*	1,805	*-11.0%*

Other Pharmaceutical Products

Lovenox® sales in the fourth quarter were down 13.4% to euro 498 million, reflecting generic competition in the U.S. (euro 118 million, down 50.2%). In Western Europe and in Emerging Markets, Lovenox® continued to record solid growth (+8.1% to euro 215 million and +19% to euro 140 million, respectively). Full year 2011 sales of Lovenox® reached euro 2,111 million, down 23.4%. Sales generated outside the U.S. grew 9.0% to euro 1,478 million and accounted for 70.0% of total Lovenox® sales. In September 2011, the FDA approved a second competing generic version of enoxaparin. Sanofi commercializes an authorized generic of Lovenox® in the U.S.

Fourth-quarter sales of Multaq® were euro 64 million, of which euro 47 million was generated in the U.S. and euro 15 million in Western Europe. Full year 2011 sales of Multaq® were euro 261 million. In the third quarter of 2011, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), modified the indication for Multaq®. The FDA approved a label update in December 2011 to ensure its use in the appropriate patient population, specifically in patients in sinus rhythm with history of paroxysmal or persistent atrial fibrillation (AF) and reinforcing Warnings and Precautions for use.

Sales of the Ambien® family of products decreased by 18.1% (to euro 137 million) in the fourth quarter, reflecting generic competition to Ambien®CR in the U.S. (Ambien® sales in the U.S. were down 66.7% to euro 18 million). In Japan, Myslee® grew 8.5% to euro 86 million over the quarter. Full year 2011 sales of the Ambien® family were euro 490 million of which euro 82 million were in the U.S. (down 80.6%). In Japan, Myslee® sales increased 9.2% to euro 284 million.

(1) See Appendix 10 for definitions of financial indicators

Allegra® sales in the fourth quarter as a prescription drug were euro 142 million of which euro 116 million (up 11.9%) was generated in Japan. Allegra® moved to the OTC market in the U.S. in March 2011 (sales reported in CHC). Full year 2011 sales of Allegra® as a prescription drug were euro 580 million, 80.2% of which (euro 465 million) were generated in Japan and increased by 22.1% reflecting a strong allergy season. In December 2011, the Japan patent office found two Japanese patents covering Allegra® invalid. This decision was subsequently appealed by Sanofi.

Sales of Copaxone® declined by 31.7% to euro 86 million, reflecting the transfer of the Copaxone® business to Teva in certain countries, notably Germany during the fourth quarter. Full year 2011 sales of the product reached euro 436 million, down 15.4%. All of the remaining Copaxone® business will be transferred to Teva during the first quarter of 2012. Following the transfer, Sanofi will receive a payment of 6% on sales from Teva for a period of two years, on a country-by-country basis.

Genzyme(10)
(millions of euros)	Q4 2011 net sales	*Change on a constant* *structure basis and at* *constant exchange rates*	Net sales since April 1st 2011	*Change on a constant* *structure basis and at* constant exchange rates*
Cerezyme®	133	-17.4%	441	+11.1%*
Myozyme® / Lumizyme®	108	+15.9%	308	+27.4%*
Fabrazyme®	47	+3.7%	109	+9.4%*
Renagel®/Renvela®	143	+9.4%	415	+10.2%*
Synvisc®/ Synvisc One®	87	+15.2%	256	+14.7%*
Total Genzyme	831	+0.8%	2,395	+7.7%*
*April to December 2011 sales compared to April to December 2010 sales

Genzyme sales in the fourth quarter were euro 831 million, an increase of 0.8% over the fourth quarter of 2010. Consolidated sales of Genzyme in 2011 (consolidated since April 1, 2011) reached euro 2,395 million, up 7.7% over the same period of 2010.

Sales of Cerezyme® were euro 133 million in the fourth quarter, a decrease of 17.4%. As communicated last quarter, the reduction in global supply allocations continued to effect sales in the quarter. Consolidated sales of Cerezyme® in 2011 grew 11.1% (to euro 441 million) compared to the same period of 2010, reflecting higher production levels than in 2010. Genzyme continues to expect an improving Cerezyme® supply outlook from February 2012 forward.

Sales of Myozyme®/Lumizyme® were euro 108 million in the fourth-quarter, an increase of 15.9%. Consolidated sales in 2011 were euro 308 million, an increase of 27.4% compared to the same period of 2010 and were driven by continued expansion of Lumizyme® in the U.S. and volume growth across all geographies.

Sales of Fabrazyme® in the fourth quarter were euro 47 million, up 3.7% from the fourth quarter of 2010. Consolidated sales in 2011 reached euro 109 million, an increase of 9.4% compared to the same period of 2010. Growth was driven by stabilized production runs and an increase in product availability. In January 2012, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) approved the Genzyme manufacturing plant in Framingham, for the production of Fabrazyme®. The approval of the Framingham site allows Genzyme to begin the process of returning patients to full dosing levels. Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme® in the first quarter of 2012. Beginning in March, all patients in the U.S. currently on therapy will be returned to full dosing. In addition, the company will begin to transition new patients in the U.S. onto Fabrazyme®, at full dosing levels.

Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned, as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.

(10) Historical Genzyme perimeter; sales growth of Genzyme are stated on a constant structure basis and at constant exchange

Sales of Renvela®/Renagel® were euro 143 million in the fourth quarter, an increase of 9.4%. Growth was driven primarily by the U.S. market which achieved an all-time high in market share of 53.3%. Consolidated sales in 2011 were euro 415 million, up 10.2% compared to the same period of 2010.

Fourth-quarter sales of Synvisc®/Synvisc One® were euro 87 million, up 15.2%. Consolidated sales grew 14.7% (to euro 256 million) compared to the same period of 2010. The solid growth was a result of strong performance of the Synvisc One® franchise in the U.S. and in Japan.

Consumer Health Care

Sales of the Consumer Health Care (CHC) business registered another quarter of double digit growth (up 15.4% to euro 645 million), driven by Allegra® OTC in the U.S. (euro 25 million), the performance of Doliprane® (up 13.8%), Lactacyd® (up 42.1%), Enterogermina® (up 30.0%) and the positive impact from acquisitions (mainly BMP Sunstone in China). The CHC performance was particularly strong in Latin America with sales up 20.4% in the fourth quarter. Full year 2011 sales of CHC grew 22.8% to euro 2,666 million. Allegra® was successfully switched from Rx-to-OTC status in the U.S. in 2011. Sales of Allegra® OTC reached euro 245 million (of which euro 211 million in the U.S.) and the product has become Sanofi's CHC product with highest sales.

In the fourth quarter of 2011, Aventis Pharma Limited (an Indian subsidiary of Sanofi) completed the acquisition of Universal Medicare Private Limited's business of marketing and distribution of branded nutraceutical formulations in India. With this acquisition, Aventis Pharma will advance its sustainable growth strategy in India and facilitate the development of a CHC platform in that country.

Generics

Sales of generics in the fourth quarter reached euro 488 million, an increase of 21.0%, driven by increased authorized generics sales in the U.S. (U.S. sales of generic products were up 107.7% to euro 82 million). Over the period, sales both in Emerging Markets and Western Europe recorded double digit growth, up 11.0% (to euro 291 million) and 14.0% (to euro 106 million) respectively.

Full year 2011 generics sales were up 16.2% to euro 1,746 million, reflecting robust growth in Emerging Markets and recent launches of authorized generics of Taxotere®, Ambien®CR and Lovenox® in the U.S. (U.S. sales of generic products were up 79.4% to euro 177 million). In 2011, sales of generic products in Emerging Markets exceeded euro 1 billion (euro 1,092 million, up 14.0%).

Human Vaccines

Fourth-quarter consolidated sales of Sanofi Pasteur totaled euro 818 million, a decrease of 8.1% reflecting the impact of early supply of seasonal influenza vaccines in the third quarter in the U.S. Excluding influenza vaccines, fourth-quarter consolidated sales were up 24.1%. Full year 2011 consolidated sales for the Human Vaccines business were euro 3,469 million, an increase of 7.2% excluding A/H1N1 influenza vaccines sales booked in 2010, or a decrease of 5.5% including A/H1N1 vaccines sales.

Seasonal influenza vaccines sales were euro 66 million in the fourth quarter compared to euro 285 million in the fourth quarter of 2010, reflecting the early supply in the U.S. in the third quarter 2011. 2011 was a record year for seasonal influenza vaccines with total sales of euro 826 million, an increase of 2.5%, supported by strong Southern Hemisphere seasonal sales. In the U.S., our offering has been further differentiated with the launches of Fluzone® High Dose in 2010 and Fluzone® Intradermal in 2011 which was approved by the FDA in May. Fluzone® Intradermal experienced a limited launch in 2011 focused on the education of patients and healthcare professionals, the first doses were shipped in September.

Polio/Pertussis/Hib vaccines grew 23.4% to euro 325 million in the fourth quarter, driven by another strong performance of Pentaxim® (5-in-1 combination vaccine against diphtheria, tetanus, pertussis, polio and haemophilus influenzae type b) which is primarily sold in Emerging Markets (sales up 42.5% to euro 64 million). Sales of Pentacel® (another 5-in-1 combination vaccine, mainly sold in the U.S.) were up 15.1% (to euro 109 million). Full year 2011 sales of Polio/Pertussis/Hib vaccines totaled euro 1,075 million (up 12.0%), reflecting the performances of Pentaxim® (up 30.2% to euro 238 million), Pentacel® (up 9.1% to euro 332 million) and haemophilus influenzae type b vaccines notably in Japan. Total Hib vaccines sales grew 27.7% to euro 178 million.

Menactra® sales recorded strong double-digit growth (up 43.2%) to euro 93 million in the fourth quarter, led by robust performance in the U.S. where sales were up 53.9% to euro 86 million. U.S. sales benefited from the ACIP (Advisory Committee on Immunization Practices) recommendation of a booster dose for adolescents. Full year 2011 sales of Menactra® were euro 427 million, an increase of 4.3%, including euro 386 million in the U.S., which were up 2.7%.

Fourth-quarter sales of adult boosters grew 16.2% to euro 137 million, led by the performance of Adacel® which sales were up 13.0% to euro 90 million and tetanus/diphtheria vaccines. Full year 2011 sales of adult boosters totaled euro 465 million, an increase of 7.3%, including euro 314 million of Adacel® sales which were up 9.2%.

Travel and other endemic vaccines sales were euro 101 million increasing 10.9% in the fourth quarter and were down 1.6% to euro 370 million in 2011.

Consolidated vaccines sales
(millions of euros)	Q4 2011 net sales	*Change at constant* *exchange rates*	2011 net sales	*Change at constant* *exchange rates*
Influenza Vaccines (incl. Vaxigrip® and Fluzone®)	66	-76.5%	826	-33.2%
of which seasonal vaccines	66	-76.5%	826	+2.5%
of which pandemic vaccines	0	-	0	-100.0%
Polio/Pertussis/Hib Vaccines (incl. Pentacel® and Pentaxim®)	325	+23.4%	1,075	+12.0%
Meningitis/Pneumonia Vaccines (incl. Menactra®)	115	+35.6%	510	+2.3%
Adult Booster Vaccines (incl. Adacel ®)	137	+16.2%	465	+7.3%
Travel and Other Endemics Vaccines	101	+10.9%	370	-1.6%
Other Vaccines	74	+53.4%	223	+37.8%
TOTAL	818	*-8.1%*	3,469	*-5.5%*

Fourth-quarter sales (not consolidated by Sanofi) of Sanofi Pasteur MSD, the joint venture with Merck & Co in Europe were euro 223 million, down 12.7% (on a reported basis). Full year 2011 sales of Sanofi Pasteur MSD reached euro 791 million, down 13.8%, on a reported basis, reflecting a decrease in Gardasil® sales (down 31.1% to euro 181 million) and in flu vaccines sales.

Animal Health

Sales of Merial grew 10.0% to euro 470 million in the fourth quarter, reflecting a recovery of Frontline® family sales despite the entry of generic competition to Frontline® Plus in the U.S. in the third quarter. On June 21, the U.S. District Court for the Middle District of Georgia ruled in favor of Merial holding that sales of PetArmor™ Plus products infringed Merial's patent and barred Cipla and Velcera from making or selling those products in the U.S. A court-ordered seizure of the inventory in the U.S. still in possession of the generic manufacturers went into effect on August 21, 2011. However, the generic products already sold to retailers were not recalled.

Fourth-quarter sales of the companion animals segment were up 9.7% to euro 249 million. Frontline® family products sales were up 16.8% to euro 132 million and recorded double digit growth in all regions. In the U.S., sales of Frontline® family products were up 12.2% (to euro 56 million) reflecting a recovery in Frontline® Plus sales and the July launch of Certifect®, a new combination parasiticide for flea and tick control for dogs.

Fourth-quarter sales of the production animals segment grew 10.4% to euro 221 million reflecting the double digit growth of the Veterinary Public Health segment and the Ruminant segment, which was driven by the launch in the U.S. of the antibiotic Zactran® against bovine respiratory disease.

Full year 2011 sales of Merial were up 4.3% to euro 2,030 million. The companion animals segment recorded sales of euro 1,277 million up 1.8%. Despite generic competition and new competitors in the U.S. and in Western Europe, Frontline® family products sales were up 0.9% to euro 764 million. Sales of the production animals segment increased 8.9% to euro 753 million driven by the robust performance of Ruminant segment (up 11.6%). The Avian segment, which benefited from the success of the vaccine Vaxxitek®, grew 7.8%. In 2011, Emerging Markets sales recorded double digit growth (up 12.4% to euro 507 million) accounting for 25.0% of total Merial sales.

Net sales by geographic region
(millions of euros)	Q4 2011 net sales	*Change at* *constant* *exchange rates*	2011 net sales	*Change at* *constant* *exchange rates*
United States	2,475	+9.8%	9,957	+6.8%
Western Europe*	2,208	-2.6%	9,130	-4.0%
Emerging Markets**	2,649	+18.7%	10,133	+10.1%
of which Eastern Europe and Turkey	667	+10.8%	2,666	+3.7%
of which Asia	634	+18.7%	2,416	+16.6%
of which Latin America	828	+27.2%	3,111	+11.8%
of which Africa	239	+14.3%	949	+9.7%
of which Middle East	237	+14.2%	872	+8.6%
Rest of the world***	1,176	*+12.3%*	4,169	*+13.8%*
of which Japan	840	+17.5%	2,865	+20.2%
TOTAL	8,508	*+9.2%*	33,389	*+5.3%*
* France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark World less the U.S. and Canada, Western Europe, Japan, Australia and New Zealand * Japan, Canada, Australia and New Zealand

Emerging Markets recorded strong double digit growth of 18.7% to euro 2,649 million, or 13.8% excluding Genzyme in the fourth quarter. BRIC (Brazil, Russia, India, China) sales were euro 933 million, up 24.0%, or up 20.2% excluding Genzyme. China recorded sales of euro 270 million, up 30.4% (excluding Genzyme), led by the performance of Plavix®, Lantus®, Aprovel® and the contribution from BMP Sunstone. Brazil sales were euro 398 million, up 14.7% (excluding Genzyme), led by Lantus®, CHC, generics and Vaccines. Sales in Russia reached euro 202 million, an increase of 23.2% excluding Genzyme, driven notably by Lantus®, Lovenox® and Vaccines.

Full-year 2011 sales in Emerging Markets totaled euro 10,133 million, an increase of 10.4% (excluding Genzyme and A/H1N1 vaccines sales of euro 361 million booked in 2010). Full-year sales in BRIC countries reached euro 3,467 million, up 19.8%, (excluding Genzyme and A/H1N1 vaccines sales). Brazil sales in 2011 were euro 1,522 million (up 16.9% excluding Genzyme and A/H1N1 sales). Sales in China in 2011 reached euro 981 million (up 38.5% excluding Genzyme). Russia recorded 2011 sales of euro 732 million, an increase of 7.4% (excluding Genzyme). In 2011, Asia and Latin America continued to deliver strong double digit sales growth of 15.7% and 18.1% respectively (excluding Genzyme and A/H1N1 sales). Full-year sales in Eastern Europe and Turkey were slightly down (- 0.4% excluding Genzyme and A/H1N1 sales) to euro 2,666 million, which were particularly impacted by price cuts and generic competition for Taxotere® in Turkey.

Fourth-quarter sales in the U.S. were euro 2,475 million up 9.8%, or down 8.2% excluding Genzyme (euro 423 million). Sales in the U.S. in the fourth quarter were impacted by generics of Taxotere®, Lovenox®, Ambien®CR and early supply of seasonal flu vaccines, which were partially offset by growth of Lantus® and Eloxatin®. Full-year 2011 sales in the U.S. were euro 9,957 million, up 6.8 % and down 5.7% excluding Genzyme and A/H1N1 sales.

Fourth-quarter sales in Western Europe reached euro 2,208 million, down 2.6% (or down 11.6% excluding Genzyme and A/H1N1 sales), and were impacted by competition for Taxotere® and Plavix®, the transfer of the Copaxone® business to Teva in certain countries, as well as the impact of austerity measures. Full-year 2011 sales in Western Europe reached euro 9,130 million, down 4.0% or down 10.5% excluding Genzyme and A/H1N1 sales.

Japan recorded sales of euro 840 million, up +17.5%, or up 9.4% excluding Genzyme, notably driven by Plavix® (up 22.7%) and Lantus® (up 18.0%). Full-year 2011 sales in Japan were euro 2,865 million, up 20.2%, or up 12.0% excluding Genzyme and were supported by Plavix® (up 22.9% to euro 671 million), Allegra® (up 22.2% to euro 465 million) and Hib vaccine sales.

R&D update

Sanofi submitted the following products to regulatory authorities in the U.S. and/or EU since July 2011:

Kynamro™(11) (mipomersen), licensed from Isis Pharmaceuticals Inc., was filed in the EU in July 2011 for the treatment of patients with homozygous familial hypercholesterolemia (hoFH) and severe heterozygous familial hypercholesterolemia (heFH). In the U.S., the submission of the hoFH indication is planned in the first quarter of 2012.
Aubagio™ (teriflunomide) in the EU at the beginning of February 2012 for the treatment of relapsing multiple sclerosis. Teriflunomide was submitted in the U.S. in August 2011.
Visamerin®/Mulsevo® (semuloparin) was submitted in the EU and U.S. in September 2011 for the prevention of Venous Thrombo-Embolism events in cancer patients initiating a chemotherapy regimen.
Lyxumia® (lixisenatide), licensed from Zealand Pharma, was filed in the EU in October of 2011 for the treatment of type 2 diabetes. Submission of lixisenatide in the U.S. is expected in the fourth quarter of 2012.
Zaltrap™ (aflibercept), from the Regeneron partnership, was submitted in second line metastatic colorectal cancer in EU in December 2011 and in the U.S. in early February 2012.

Genzyme is completing the dossier for Lemtrada™ (alemtuzumab(12)) for relapsing remitting multiple sclerosis which will be submitted to the FDA and EMA in the second quarter of 2012.

Additional regulatory milestones were achieved since the beginning of November with the submission to EU authorities of a pediatric indication for Lantus® and the filing of Plavix® in Japan for the treatment of peripheral arterial disease and ST- elevated myocardial infection. Plavix® was also approved in Japan in a new indication, stable angina/old myocardial infarction undergoing PCI (percutaneous coronary interventions).

Since the R&D update on November 3, the evolution of the R&D portfolio has been favourable with additional positive Phase III results for Lemtrada™ (alemtuzumab), Lyxumia® (lixisenatide) and Aubagio® (teriflunomide); the beginning of a Phase III program for a new formulation of insulin glargine and for a JAK-2 inhibitor; the entry into Phase II of 5 compounds.

At the beginning of February, the R&D portfolio comprises 60 NMEs (New Molecular Entities) projects and vaccines in clinical development of which 17 are in Phase III or have been submitted to the health authorities for approval.

Evolution of the late stage portfolio:

In November, Sanofi and Regeneron announced positive preliminary results from the Phase 2 study program in which patients with elevated low-density lipoprotein cholesterol (LDL-C) were treated with SAR236553. This compound is a novel, high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9. Blocking the PCSK9 pathway is a novel mechanism for lowering LDL-C, the leading known risk factor for coronary artery disease. Detailed Phase II data will be presented at the American College of Cardiology congress (ACC) in March. The Phase III program is targeted to start in the second quarter of 2012.

In November, Sanofi and its subsidiary Genzyme announced that the Phase lll CARE-MS ll trial, which compared Lemtrada™ (alemtuzumab) to interferon beta-1a, Rebif®, in patients with relapsing-remitting multiple sclerosis met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability were significantly reduced in multiple sclerosis patients receiving alemtuzumab (Lemtrada™) as compared with Rebif®. Results for both of these co-primary endpoints were highly statistically significant. The full results of CARE-MS II will be presented at a forthcoming scientific meeting.

(11)Zaltrap™, Lemtrada™, Aubagio™, Kynamro™ and Lyxumia® are registered trade names submitted to health authorities for investigational agents

(12) Genzyme is developing alemtuzumab in Multiple Sclerosis in collaboration with Bayer HealthCare

In December, positive topline results were announced for Lyxumia® (lixisenatide) in combination with Lantus® in patients with type 2 diabetes uncontrolled on oral anti-diabetics. In this GetGoal Duo 1 study, lixisenatide achieved its primary efficacy endpoint of significantly reducing HbA1c, with a significant improvement in post-prandial glucose.

Positive top-line results of GetGoal-M evaluating Lyxumia® (lixisenatide) given as a morning or evening dosing as add-on therapy to metformin were presented at the 21st World Diabetes Congress in December.

Today, Sanofi announces positive top line results of the GetGoal-P study. In this study, Lyxumia® (lixisenatide) achieved its primary efficacy endpoint of significantly reducing HbA1c compared with placebo (p<0.0001) with HbA1c in the lixisenatide group decreasing from a mean baseline value of 8.08% to a mean value of 7.06% after 24 weeks.

Lyxumia® (lixisenatide), our new once-daily GLP-1, delivered positive results throughout the GetGoal phase III program.

In December, Genzyme reported top-line results from TENERE, a Phase III clinical trial comparing the effectiveness, safety and tolerability of once-daily oral Aubagio™ (teriflunomide) to interferon beta-1a (Rebif®), an approved injectable therapy, in people with relapsing forms of multiple sclerosis. No statistical superiority was observed between the Rebif® and teriflunomide arms (7mg and 14mg) on risk of treatment failure, the primary composite endpoint of the study. Both the 7mg and 14mg doses of teriflunomide were safe and generally well tolerated.

ENCORE, ENGAGE and EDGE, the Phase III trials evaluating eliglustat, potentially the first oral therapy for Gaucher disease, are fully enrolled.

Three projects entered Phase III:

A new formulation of insulin glargine started Phase III trial. The EDITION I trial compares the new formulation of insulin glargine with Lantus® in patients with type II diabetes on basal plus meal-time insulin. The EDITION II trial compares the new formulation of insulin glargine with Lantus® in patients with type II diabetes with oral anti-diabetic agents. The estimated number of patients enrolled in each study is 800. Recruitment started at the end of 2011.
SAR302503, a JAK-2 inhibitor, entered Phase III in myelofibrosis;
VaxiGrip®, a quadrivalent inactivated influenza vaccine

Five compounds entered Phase II or started additional Phase II:

SAR279356, an anti-PNAG monoclonal antibody in prevention of serious infections;
SAR3419, a monoclonal antibody maytansinoid loaded anti CD19 for the treatment of Diffuse Large B-cell Lymphoma (DLBCL);
SAR113945, an Ikβ kinase inhibitor for the treatment of symptoms of osteoarthritis;
SAR245408/XL147, an oral PI3K inhibitor for breast cancer. This compound is already in Phase II for endometrial cancer;
SAR256212/MM-121, a monoclonal antibody anti-ErbB3 for non-small cell lung cancer. This compound is already in Phase II for breast cancer.

Two projects in Phase I (SAR101099 – an urotensin II receptor antagonist evaluated in diabetes nephropathy and SAR103168 – a Multi-Kinase Inhibitor in oncology), three projects in Phase II (FOV2302 – a plasma kallikrein inhibitor evaluated in ophthalmology, a recombinant human TSH modified for Goiter, and ataluren- a transcription modulator evaluated in cystic fibrosis) and one project in Phase III (prochymal – a mesenchymal stem cell evaluated for graft-versus-host disease) have been discontinued.

In December, Regeneron announced top-line results of the Phase II, AFFIRM trial that studied Zaltrap® (aflibercept) in combination with the modified FOLFOX6 regimen in first-line therapy for metastatic colorectal cancer. The results showed that in patients who received Zaltrap® in combination with modified FOLFOX6, the Progression Free Survival rate at one year (the primary endpoint of the study) was similar to that seen in the standard therapy arm for patients who received modified FOLFOX6 alone.

Fourth-quarter financial results

Business Net Income(1)

Sanofi net sales in the fourth quarter reached euro 8,508 million, up 8.8% on a reported basis (up 9.2% at constant exchange rates), reflecting the performance of growth platforms, the acquisition of Genzyme (euro 831 million), the impact from EU austerity measures, and the loss of euro 387 million of sales due to generic competition. Other revenues were down 1.0% to euro 415 million, reflecting the slight decrease in Plavix® sales in the U.S. (-2.1%) and a positive dollar effect. At constant exchange rates, other revenues were down 1.9%.

Gross profit was up 7.5% (or up 7.3% at constant exchange rates) to euro 6,202 million. The ratio of cost of sales to net sales reached 32.0%, an increase of 0.4 percentage points due to the impact of generic competition.

Research and development expenses increased 10.7% (or 10.5% at constant exchange rates) to euro 1,293 million. Excluding Genzyme, R&D expenses decreased 1.7% at constant exchange rates. The ratio of R&D expenses to net sales was 15.2%, up 0.3 percentage point versus the fourth quarter of 2010.

Selling and general expenses were euro 2,221 million, an increase of 0.9% (or up 1.0% at constant exchange rates). Excluding Genzyme, SG&A expenses were down 9.2% at constant exchange rates. The ratio of selling and general expenses to net sales decreased 2.0 percentage points to 26.1%, reflecting tight cost control and start of Genzyme synergies.

Other current operating income net of expenses was stable at -euro 59 million.

The share of profits from associates reached euro 256 million, an increase of 1.2% (stable at constant exchange rates). The share of after-tax profits from the territories managed by BMS under the Plavix® and Avapro® alliance was euro 258 million, up 4.9%.

Net income attributable to non-controlling interests was euro 57 million (up 3.6%) of which euro 49 million was the profits paid to BMS from territories managed by Sanofi.

Business operating income increased 11.3% (up 10.0% at constant exchange rates) to euro 2,828 million. The ratio of business operating income to net sales reached 33.2%, 0.7 percentage points higher than in the fourth quarter of 2010.

Net financial expenses were euro 113 million, compared to euro 95 million. This line included an impairment of euro 18 million recognized on Greek bonds valued at mark-to-market and a gain linked to revaluation at fair value of Yves Rocher stake.

The effective tax rate was 25.4%, compared to 27.0% in the fourth quarter of 2010, reflecting the positive effect of the Advance Pricing Agreement concluded between France and the U.S. in December 2011 on 2011 intercompany flows.

Business net income(1) was euro 2,077 million, up 11.7% at constant exchange rates or 13.0% on a reported basis.

In Q4 2011, Business earnings per share(1) (EPS) was euro 1.56, up 9.2% at constant exchange rates, or up 10.6% on a reported basis. The average number of shares outstanding increased to 1,330.0 million this quarter versus 1,304.9 million in Q4 2010.

(1) See Appendix 10 for definitions of financial indicators, and Appendix 6 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi

2011 financial results

Business Net Income(1)

In 2011, Sanofi net sales reached euro 33,389 million, an increase of 3.2% on a reported basis and 5.3% at constant exchange rates reflecting the performance of growth platforms, the consolidation of Genzyme from April 1, the impact from EU austerity measures, and the loss of euro 2,206 million of sales due to generic competition. Other revenues were stable at euro 1,669 million, or increased 4.0% at constant exchange rates.

Gross profit was euro 24,632 million, down 0.4% or up 1.9% at constant exchange rates. The ratio of cost of sales was 31.2%, 2.4 percentage points higher, reflecting the impact of generic competition and the lack of A/H1N1 vacines sales.

Research and development expenses reached euro 4,811 million, up 5.6% (or 7.4% at constant exchange rates) and included euro 419 million of R&D expenses from Genzyme. Excluding Genzyme, R&D expenses were down 2.4% at constant exchange rates reflecting transforming initiatives. The ratio of R&D expenses to net sales was 14.4%, 0.3 percentage points higher than in 2010.

Selling and general expenses totaled euro 8,536 million, an increase of 4.5% or 6.7% at constant exchange rates. Excluding Genzyme, SG&A expenses were down 2.6% at constant exchange rates as transforming initiatives more than offset launch costs for Jevtana® in the EU, and Allegra® OTC in the U.S. and greater promotional effort behind Lantus® in the U.S. The ratio of selling and general expenses to net sales was 25.6%, 0.4 percentage points higher than in 2010.

Other current operating income net of expenses was euro 4 million versus euro 77 million in 2010, which included a euro 87 million payment received from Teva on sales of Copaxone® in North America (these payments ceased at the end of Q1 2010) and acquisition expenses related to Genzyme (euro 65 million in 2011).

The share of profits from associates reached euro 1,102 million, up 6.4% compared to 2010. The share of after-tax profits from the territories managed by BMS under the Plavix® and Avapro® alliance was euro 1,070 million, up 9.2%.

Net income attributable to non-controlling interests reached euro 247 million, down 3.9%. The profits paid to BMS from territories managed by Sanofi were euro 225 million, down 5.5 %, reflecting competition from clopidogrel generics in Europe.

Business operating income reached euro 12,144 million, a decrease of 3.9% at constant exchange rates, or down 5.6% on a reported basis. The ratio of business operating income to net sales was 36.4%, 3.3 percentage points lower than 2010.

Net financial expenses reached euro 412 million versus euro 362 million in 2010. Net financial expenses included an impairment of euro 49 million recognized on Greek bonds valued at mark-to-market. The average cost of gross debt was 2.6% in 2011.

The effective tax rate decreased 1.0 percentage point to 27.0% compared to 2010.

Business net income(1) reached euro 8,795 million, a decrease of 2.7% at constant exchange rates, or a decrease of 4.6% on a reported basis.

In 2011, Business earnings per share(1) (EPS) was euro 6.65, a decrease of 3.8% at constant exchange rates, or a decrease of 5.8% on a reported basis. The average number of shares outstanding increased to 1,321.7 million in 2011 versus 1,305.3 million in 2010.

(1) See Appendix 10 for definitions of financial indicators, and Appendix 6 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi

From business net income to consolidated net income (see Appendix 6)

In 2011, the main reconciling items between business net income and consolidated net income attributable to equity holders of Sanofi were:

A euro 3,314 million amortization charge against intangible assets arising on the application of purchase accounting to acquired companies (primarily Aventis: euro 1,788 million, Genzyme: euro 709 million and Merial euro 353 million) and to acquired intangible assets (licenses/products: euro 178 million). The fourth quarter amortization charge against intangible assets was euro 809 million (primarily Aventis: euro 369 million, Genzyme euro 233 million and Merial euro 94 million), euro 40 million of which related to acquired intangible assets (licenses/products). This item has no cash impact on the Group.
An impairment loss against intangible assets of euro 142 million (including euro 66 million in the fourth quarter notably for a project from Genzyme in Phase II for Goiter). This item has no cash impact on the Group.
An income of euro 15 million reflecting a decrease in the fair value of contingent considerations related to the CVRs (euro 211 million of which a charge of euro 41 million booked in Q4), an increase in the fair value of contingent considerations related to TargeGen business combination (euro 69 million of which euro 21 million booked in Q4), and Bayer contingent considerations (euro 127 million of which euro 90 million booked in Q4).
A charge of euro 476 million arising from the workdown of inventories of acquired companies (mainly due to Genzyme) remeasured at fair value due to the application of purchase accounting to acquisitions, of which euro 72 million in the fourth quarter. This item has no cash impact on the Group. This charge impacted the consolidated gross margin.
euro 1,314 million of restructuring costs (including euro 777 million in the fourth quarter) mainly related to continuing transformation of R&D, Operations in the U.S. and Europe and Industrial Affairs in Europe.
Damages of euro 210 million were awarded to Sanofi as part of a Plavix® patent litigation against Apotex. On October 18, 2011, in the damages phase of the Plavix® patent infringement case against Apotex, the U.S. Court of Appeals upheld the damages award, and Sanofi is to receive payment of $273 million in February 2012.
A non-recurring amortization charge of euro 519 million booked in the first quarter of 2011 due to the change of plan for Merial assets that were previously classified as held for sale or exchange in accordance with IFRS5. This charge corresponds to the depreciation and amortization of Merial assets that would have been recognized for the period from September 18, 2009 to December 31, 2010, had these assets not been classified as held for sale or exchange. This item has no cash impact on the Group.
A euro 1,905 million tax effect arising from the items listed above, comprising euro 1,178 million generated by amortization charged against intangible assets, euro 191 million by the non-recurring amortization charge on Merial assets, euro 143 million by the workdown of inventories of acquired companies and euro 399 million linked to restructuring costs. The fourth-quarter tax effect from the items listed above was euro 476 million, including euro 265 million of deferred taxes generated by amortization charged against intangible assets, euro 23 million by the workdown of inventories of acquired companies and euro 225 million linked to restructuring costs (see Appendix 6).
A euro 577 million non-recurring tax effect related to the impact of Franco-American APA on prior period and an adjustment of deferred taxes liabilities linked to revaluation of intangible assets following legislation changes.
In "Share of profits/losses from associates", a charge of euro 32 million (of which euro 11 million in Q4 2011), net of tax, mainly relating to the share of amortization of intangible assets. This item has no cash impact on the Group.

Strong cash flow from operating activities in 2011

Net cash generated by operating activities after changes in working capital and before restructuring costs was euro 10,002 million, a decrease of 7.3% compared to 2010. This amount largely provided finance for capital expenditures (euro 1,644 million), the dividend paid by Sanofi (euro 1,372 million), repurchasing of shares (euro 1,074 million), and restructuring costs (euro 707 million). The acquisitions and partnerships made during the period (euro 14,079 million) were mainly Genzyme (euro 13,528 million) and BMP Sunstone (euro 377 million) and the disposals (euro 359 million) were mainly Dermik (euro 321 million). As a consequence, net debt increased from euro 1,577 million at December 31, 2010 to euro 10,859 million (debt of euro 14,983 million, net of euro 4,124 million cash and cash equivalents) at December 31, 2011.

The Board meeting which signed off the financial statements for the year ended December 31, 2011 was held on February 7, 2012. Audit procedures on the consolidated financial statements are complete. The audit opinion will be issued by the statutory auditors once they have finalized the specific verifications and other procedures required for the purposes of filing the French-language "document de reference" and the Form 20-F with the market authorities.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Appendices

List of appendices

Appendix 1: 2011 fourth-quarter and 2011 consolidated net sales by product
Appendix 2: 2011 fourth-quarter and 2011 consolidated net sales by geographic region and product
Appendix 3: Consolidated net sales by business segment
Appendix 4: Net sales of Growth Platforms
Appendix 5: 2011 fourth-quarter and 2011 business net income statements
Appendix 6: Reconciliation of business net income to net income attributable to equity holders of Sanofi
Appendix 7: 2011 fourth-quarter and 2011 consolidated income statements
Appendix 8: Change in net debt
Appendix 9: Simplified consolidated balance sheet
Appendix 10: Definitions

Appendix 1: 2011 fourth-quarter and 2011 consolidated net sales by product Pharmaceuticals
(euro million)	Q4 2011 net sales	*Change at constant* *exchange rates*	*Change on a* *reported basis*


Lantus®	1,054	17.8%	17.9%
Apidra®	35	-28.6%	-28.6%
Insuman®	36	0.0%	2.9%
Amaryl®	113	-8.9%	-8.1%
*Total Diabetes*	*1,242*	*12.5%*	*12.8%*
Lovenox®	498	-13.4%	-14.4%
Plavix®	529	2.2%	4.8%
Taxotere®	150	-67.5%	-67.1%
Aprovel®	314	-3.4%	-3.4%
Eloxatin®	325	119.0%	121.1%
Multaq®	64	1.6%	1.6%
Jevtana®	47	14.6%	14.6%
Stilnox®/Ambien®/Ambien CR®/Myslee®	137	-18.1%	-14.4%
Allegra®	142	-10.5%	-6.6%
Copaxone®	86	-31.7%	-31.7%
Tritace®	88	-4.2%	-8.3%
Depakine®	101	7.4%	6.3%
Xatral®	37	-46.5%	-47.9%
Actonel®	37	-32.1%	-33.9%
Nasacort®	18	-55.8%	-58.1%
Other Products	1,441	*-1.9%*	*-3.5%*
Consumer Health Care	645	*15.4%*	*12.8%*
Generics	488	*21.0%*	*16.2%*
Genzyme	831	ns	ns
Total Pharmaceuticals	7,220	*10.5%*	*11.0%*
Vaccines	818	*-8.1%*	*-8.1%*
Animal Health	470	*10.0%*	*9.8%*
Total	8,508	*9.2%*	*8.8%*

Vaccines
(euro million)	Q4 2011 net sales	*Change at constant* *exchange rates*	*Change on a* *reported basis*


Polio/Pertussis/Hib Vaccines	325	23.4%	22.6%
Influenza Vaccines	66	-76.5%	-76.8%
Méningitis/Pneumonia Vaccines	115	35.6%	36.9%
Adult Booster Vaccines	137	16.2%	17.1%
Travel and Other Endemics Vaccines	101	10.9%	9.8%
Other Vaccines	74	53.4%	57.4%
Total vaccines	818	*-8.1%*	*-8.1%*

Animal Health
(euro million)	Q4 2011 net sales	*Change at constant* *exchange rates*	*Change on a* *reported basis*


Frontline® and other fipronil products	132	+16.8%	16.8%
Vaccines	190	+9.1%	8.0%
Avermectin	86	+13.2%	13.2%
Other	62	-3.2%	-1.6%
Total	470	*10.0%*	*9.8%*

Pharmaceuticals
(euro million)	2011 net sales	*Change at constant* *exchange rates*	*Change on a* *reported basis*


Lantus®	3,916	15.0%	11.6%
Apidra®	190	9.6%	7.3%
Insuman®	132	-0.8%	-0.8%
Amaryl®	436	-7.9%	-8.8%
*Total Diabetes*	*4,684*	*12.0%*	*9.0%*
Lovenox®	2,111	-23.4%	-24.8%
Plavix®	2,040	-2.9%	-2.1%
Taxotere®	922	-57.0%	-56.6%
Aprovel®	1,291	-2.4%	-2.7%
Eloxatin®	1,071	160.9%	150.8%
Multaq®	261	56.4%	51.7%
Jevtana®	188	135.4%	129.3%
Stilnox®/Ambien®/Ambien CR®/Myslee®	490	-41.4%	-40.2%
Allegra®	580	-8.6%	-4.4%
Copaxone®	436	-15.4%	-15.0%
Tritace®	375	-6.3%	-8.5%
Depakine®	388	5.4%	4.3%
Xatral®	200	-30.7%	-32.4%
Actonel®	167	-29.8%	-29.8%
Nasacort®	106	-41.8%	-43.9%
Other Products	5,773	*-3.4%*	*-4.8%*
Consumer Health Care	2,666	*22.8%*	*20.3%*
Generics	1,746	*16.2%*	*13.8%*
Genzyme*	2,395	ns	ns
Total Pharmaceuticals	27,890	*6.7%*	*4.9%*
Vaccines	3,469	*-5.5%*	*-8.9%*
Animal Health	2,030	*4.3%*	*2.4%*
Total	33,389	*5.3%*	*3.2%*
*Net sales since April 1st 2011

Vaccines
(euro million)	2011 net sales	*Change at constant* *exchange rates*	*Change on a* *reported basis*


Polio/Pertussis/Hib Vaccines	1,075	12.0%	9.2%
Influenza Vaccines*	826	-33.2%	-36.3%
Méningitis/Pneumonia Vaccines	510	2.3%	-3.2%
Adult Booster Vaccines	465	7.3%	3.6%
Travel and Other Endemics Vaccines	370	-1.6%	-3.1%
Other Vaccines	223	37.8%	31.9%
Total vaccines	3,469	*-5.5%*	*-8.9%*
*Seasonal and pandemic influenza Vaccines

Animal Health
(euro million)	2011 net sales	*Change at constant* *exchange rates*	*Change on a* *reported basis*


Frontline® and other fipronil products	764	0.9%	-1.3%
Vaccines	662	7.2%	5.6%
Avermectin	372	6.5%	4.8%
Other	232	4.4%	2.2%
Total	2,030	*4.3%*	*2.4%*

Appendix 2: 2011 fourth-quarter and 2011 consolidated net sales by geographic region and product

Pharmaceuticals
Q4 2011 net sales (euro million)	Western Europe	*Change* *at CER*	United States	*Change* *at CER*	Emerging Markets	*Change* *at CER*	Rest of the World	*Change* *at CER*



Lantus®	186	8.1%	627	16.7%	172	30.7%	69	26.9%
Apidra®	12	-36.8%	12	-18.8%	5	-44.4%	6	0.0%
Insuman®	27	-3.6%	0	-	8	28.6%	1	-
Amaryl®	7	-30.0%	1	0.0%	58	8.9%	47	-23.2%
*Total Diabetes*	*236*	*3.1%*	*640*	*15.6%*	*243*	*21.5%*	*123*	*0.0%*
Lovenox®	215	8.1%	118	-50.2%	140	19.0%	25	-4.0%
Plavix®	90	-32.3%	35*	-30.6%	183	18.7%	221	23.8%
Taxotere®	23	-84.2%	14	-90.4%	64	-29.3%	49	-27.4%
Aprovel®	178	-11.1%	11*	22.2%	87	1.1%	38	29.6%
Eloxatine®	7	-41.7%	260	225.3%	41	-2.4%	17	21.4%
Multaq®	15	-26.3%	47	9.5%	2	100.0%	0	100.0%
Jevtana®	18	-	24	-41.5%	5	-	0	-
Stilnox®/Ambien®/Ambien CR®/Myslee®	13	0.0%	18	-66.7%	17	11.8%	89	6.6%
Allegra®	2	0.0%	-1	-103.2%	25	22.7%	116	11.3%
Copaxone®	81	-33.6%	0	-	0	-	5	25.0%
Tritace®	40	-10.9%	0	-	42	4.5%	6	-16.7%
Depakine®	37	0.0%	0	-	58	13.0%	6	0.0%
Xatral®	13	-13.3%	6	-83.8%	17	0.0%	1	0.0%
Actonel®	11	-47.8%	0	-	17	-9.5%	9	-41.7%
Nasacort®	6	0.0%	5	-82.8%	6	0.0%	1	0.0%
Consumer Health Care	156	*3.3%*	107	*23.3%*	324	*22.7%*	58	*0.0%*
Generics	106	*14.0%*	82	*107.7%*	291	*11.0%*	9	*28.6%*
Others	586	*-10.9%*	108	*-25.0%*	548	*15.6%*	199	*0.0%*
Genzyme	210	-	423	-	115	-	83	-
Total Pharmaceuticals	2,043	*-2.9%*	1,897	*19.2%*	2,225	*19.3%*	1,055	*14.8%*
*Sales of active ingredient to the American entity managed by BMS

Vaccines
Q4 2011 net sales (euro million)	Western Europe	*Change at* *CER*	United States	*Change at* *CER*	Emerging Markets	*Change at* *CER*	Rest of the World	*Change at* *CER*



Polio/Pertussis/Hib Vaccines	8	-27.3%	143	10.9%	141	52.6%	33	3.2%
Influenza Vaccines*	-1	-107.1%	25	-88.1%	40	-36.5%	2	-33.3%
Méningitis/Pneumonia Vaccines	1	0.0%	87	53.6%	23	-4.2%	4	30.6%
Adult Booster Vaccines	21	61.5%	99	8.8%	11	83.3%	6	-28.6%
Travel and Other Endemics Vaccines	6	100.0%	20	11.1%	57	9.4%	18	0.0%
Other Vaccines	4	-50.0%	60	71.4%	4	150.0%	6	1.6%
Total vaccines	39	*-20.8%*	434	*-18.7%*	276	*16.0%*	69	*-2.9%*

Animal Health
Q4 2011 net sales (euro million)	Western Europe	*Change at* *CER*	United States	*Change at* *CER*	Emerging Markets	*Change at* *CER*	Rest of the World	*Change at* *CER*



Frontline® and other fipronil products	30	20.0%	56	12.2%	24	14.3%	22	27.8%
Vaccines	54	14.6%	33	0.0%	98	12.4%	5	-33.3%
Avermectin	17	13.3%	31	28.0%	17	13.3%	21	-4.8%
Other	25	-11.1%	24	15.0%	9	50.0%	4	-75.0%
Total	126	*9.6%*	144	*12.6%*	148	*15.0%*	52	*-7.5%*

Pharmaceuticals
2011 net sales (euro million)	Western Europe	*Change at* *CER*	United States	*Change at* *CER*	Emerging Markets	*Change at* *CER*	Rest of the World	*Change at* *CER*



Lantus®	730	6.4%	2,336	14.6%	617	26.0%	233	22.3%
Apidra®	68	0.0%	65	11.3%	37	8.6%	20	58.3%
Insuman®	103	-4.6%	0	-	29	20.0%	0	-
Amaryl®	32	-23.8%	4	-33.3%	228	8.6%	172	-21.6%
*Total Diabète*	*943*	*4.3%*	*2,405*	*14.4%*	*911*	*20.1%*	*425*	*0.5%*
Lovenox®	833	6.4%	633	-54.3%	551	14.0%	94	3.5%
Plavix®	414	-35.6%	196*	-8.0%	706	11.9%	724	18.6%
Taxotere®	189	-73.6%	243	-69.2%	294	-24.6%	196	-20.2%
Aprovel®	753	-9.1%	49*	25.6%	363	6.7%	126	8.6%
Eloxatin®	38	-19.6%	806	393.0%	162	9.3%	65	10.2%
Multaq®	66	66.7%	184	50.8%	7	250.0%	4	33.3%
Jevtana®	44	-	131	65.9%	13	-	0	-
Stilnox®/Ambien®/Ambien CR®/Myslee®	53	-3.6%	82	-80.6%	65	-1.5%	290	8.3%
Allegra®	13	-18.8%	3	-98.6%	99	19.3%	465	22.2%
Copaxone®	415	-14.1%	0	-	0	-100.0%	21	11.1%
Tritace®	170	-10.1%	0	-	181	0.0%	24	-23.3%
Depakine®	145	-2.0%	0	-	227	11.5%	16	-6.7%
Xatral®	58	-12.1%	75	-49.7%	63	-7.1%	4	-20.0%
Actonel®	54	-48.1%	0	-	78	-12.9%	35	-22.0%
Nasacort®	25	-10.7%	54	-57.7%	23	0.0%	4	-20.0%
Consumer Health Care	651	*3.2%*	549	*80.0%*	1,225	*20.8%*	241	*5.1%*
Generics	443	*9.4%*	177	*79.4%*	1,092	*14.0%*	34	*-20.0%*
Others	2,417	*-8.9%*	497	*-19.9%*	2,106	*7.4%*	753	*1.4%*
Genzyme**	621	-	1,180	-	347	-	247	-
Total Pharmaceuticals	8,345	*-3.9%*	7,264	*8.5%*	8,513	*15.0%*	3,768	*14.0%*
*Sales of active ingredient to the American entity managed by BMS; ** Net sales since April 1st 2011

Vaccines
2011 net sales (euro million)	Western Europe	*Change at* *CER*	United States	*Change at* *CER*	Emerging Markets	*Change at* *CER*	Rest of the World	*Change at* *CER*



Polio/Pertussis/Hib Vaccines	36	-41.0%	463	2.8%	457	21.9%	119	66.7%
Influenza Vaccines*	77	-39.8%	435	-11.2%	296	-51.1%	18	-21.7%
Méningitis/Pneumonia Vaccines	3	-40.0%	390	2.7%	104	4.0%	13	-6.6%
Adult Booster Vaccines	76	40.7%	339	3.5%	30	-9.1%	20	11.8%
Travel and Other Endemics Vaccines	24	33.3%	89	17.5%	210	-9.4%	47	-8.2%
Other Vaccines	15	-12.5%	176	45.3%	16	13.3%	16	58.7%
Total vaccines	231	*-18.4%*	1,892	*2.5%*	1,113	*-18.1%*	233	*24.2%*
*Seasonal and pandemic influenza Vaccines

Animal Health
2011 net sales (euro million)	Western Europe	*Change at* *CER*	United States	*Change at* *CER*	Emerging Markets	*Change at* *CER*	Rest of the World	*Change at* *CER*



Frontline® and other fipronil products	206	4.5%	411	-2.1%	86	8.8%	61	0.0%
Vaccines	195	2.6%	126	2.3%	325	14.2%	16	-21.1%
Avermectin	64	8.5%	177	2.8%	60	8.9%	71	13.6%
Other	89	-6.4%	87	24.3%	36	11.8%	20	-24.0%
Total	554	*2.4%*	801	*2.1%*	507	*12.4%*	168	*-1.2%*

Appendix 3: Consolidated net sales by business segment

Net sales (euro million)	Q4 2011	Q4 2010	2011	2010
Pharmaceuticals	7,220	6,505	27,890	26,576
Vaccines	818	890	3,469	3,808
Merial	470	428	2,030	1,983
Merial	470	428	2,030	1,983
Total	8,508	7,823	33,389	32,267

Appendix 4: Net sales of Growth Platforms


(euro million)	Q4 2011	*Change at constant* *exchange rates*	2011	*Change at constant* *exchange rates*
Emerging Markets(1/2)	2,649	+18.7%	10,133	+10.1%
Emerging Markets excluding Diabetes, Vaccines, CHC, animal health and new products	1,536	+10.1%	6,010	+6.6%
Diabetes	1,242	+12.5%	4,684	+12.0%
Vaccines	818	-8.1%	3,469	-5.5%
Consumer Health Care (CHC)	645	+15.4%	2,666	+22.8%
Animal Health	470	+10.0%	2,030	+4.3%
New products(3)	111	+6.7%	449	+81.9%
Total Growth Platforms	4,822	+7.7%	19,308	+8.1%*
(1) World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand. (2) Include Diabetes, Vaccines, Consumer Health Care, animal health and new products sales generated in Emerging Markets; (3) Multaq® and Jevtana® * Excluding A/H1N1 sales, growth platforms sales increased 10.8%.

Appendix 5: Business net income statement

Fourth quarter 2011

Pharmaceuticals

Vaccines

Animal health(1)

Other

Group Total

Millions of euros

Q4 2011

Q4 2010

% change

Q4 2011

Q4 2010

% change

Q4 2011

Q4 2010

% change

Q4 2011

Q4 2010

Q4 2011

Q4 2010

% change

Net sales

7,220

6,505

11.0%

818

890

(8.1%)

470

428

9.8%

8,508

7,823

8.8%

Other revenues

400

408

(2.0%)

100.0%

415

419

(1.0%)

Cost of sales

(2,201)

(1,942)

13.3%

(352)

(368)

(4.3%)

(168)

(162)

3.7%

(2,721)

(2,472)

10.1%

As % of net sales

(30.5%)

(29.9%)

(43.1%)

(41.3%)

(35.7%)

(37.9%)

(32,0%)

(31.6%)

Gross profit

5,419

4,971

9.0%

473

529

(10.6%)

310

270

14.8%

6,202

5,770

7.5%

As % of net sales

75.1%

76.4%

57.8%

59.4%

66.0%

63.1%

72.9%

73.8%

Research and development expenses

(1,107)

(987)

12.2%

(146)

(139)

5.0%

(40)

(42)

(4.8%)

(1,293)

(1,168)

10.7%

As % of net sales

(15.3%)

(15.2%)

(17.8%)

(15.6%)

(8.5%)

(9.8%)

(15.2%)

(14.9%)

Selling and general expenses

(1,935)

(1,882)

2.8%

(138)

(175)

(21.1%)

(148)

(145)

2.1%

(2,221)

(2,202)

0.9%

As % of net sales

(26.8%)

(28.9%)

(16.9%)

(19.7%)

(31.4%)

(33.9%)

(26.1%)

(28.1%)

Other current operating income/expenses

(54)

(45)

(1)

(6)

(8)

(13)

(59)

(58)

Share of profit/loss of associates*

260

251

(4)

256

253

Net income attributable to non-controlling interests

(55)

(2)

(57)

(55)

Business operating income

2,528

2,253

12.2%

184

223

(17.5%)

124

61.0%

(8)

(13)

2,828

2,540

11.3%

As % of net sales

35.0%

34.6%

22.5%

25.1%

26.4%

18.0%

33.2%

32.5%

Financial income and expenses

(113)

(95)

Income tax expense

(638)

(607)

Tax rate**

25.4%

27.0%

Business net income

2,077

1,838

13.0%

As % of net sales

24.4%

23.5%

Business earnings per share*** (in euros)

1.56

1.41

10.6%

* Net of tax

** Determined on the basis of Business income before tax, associates, and non-controlling interests

*** Based on an average number of shares outstanding of 1,330 million in the fourth quarter of 2011 and 1,304.9 million in the third quarter of 2010

(1) In 2010: the results of operations of the Merial business previously presented as "held-for-exchange" were reclassified and included in income from continuing operations

in accordance with IFRS5 § 36, following the announcement to maintain Merial and Intervet/Schering-Plough as two separate organizations.

Full-year 2011

Pharmaceuticals

Vaccines

Animal health(1)

Other

Group Total

Millions of euros

FY 2011

FY 2010

% change

FY 2011

FY 2010

% change

FY 2011

FY 2010

% change

FY 2011

FY 2010

FY 2011

FY 2010

% change

Net sales

27,890

26,576

4.9%

3,469

3,808

(8.9%)

2,030

1,983

2.4%

33,389

32,367

3.2%

Other revenues

1,622

1,623

(0.1%)

(10.7%)

22.2%

1,669

Cost of sales

(8,368)

(7,316)

14.4%

(1,404)

(1,371)

2.4%

(654)

(615)

6.3%

(10,426)

(9,302)

12.1%

As % of net sales

(30.0%)

(27.5%)

(40.5%)

(36.0%)

(32.2%)

(31.0%)

(31.2%)

(28.8%)

Gross profit

21,144

20,883

1.2%

2,090

2,465

(15.2%)

1,398

1,386

0.9%

24,632

24,734

(0.4%)

As % of net sales

75.8%

78.6%

60.2%

64.7%

68.9%

69.9%

73.8%

76.4%

Research and development expenses

(4,101)

(3,884)

5.6%

(564)

(517)

9.1%

(146)

(155)

(5.8%)

(4,811)

(4,556)

5.6%

As % of net sales

(14.7%)

(14.6%)

(16.3%)

(13.6%)

(7.2%)

(7.8%)

(14.4%)

(14.1%)

Selling and general expenses

(7,376)

(6,962)

5.9%

(542)

(603)

(10.1%)

(617)

(604)

2.2%

(1)

(2)

(8,536)

(8,171)

4.5%

As % of net sales

(26.4%)

(26.2%)

(15.6%)

(15.8%)

(30.4%)

(30.5%)

(25.6%)

(25.2%)

Other current operating income/expenses

(13)

177

(7)

(6)

(108)

Share of profit/loss of associates*

1,088

1,009

1,102

1,036

Net income attributable to non-controlling interests

(246)

(258)

(1)

(247)

(257)

Business operating income

10,496

10,965

(4.3%)

985

1,379

(28.6%)

627

621

1.0%

(102)

12,144

12,863

(5.6%)

As % of net sales

37.6%

41.3%

28.4%

36.2%

30.9%

31.3%

36.4%

39.7%

Financial income and expenses

(412)

(362)

Income tax expense

(2,937)

(3,286)

Tax rate**

27.0%

28.0%

Business net income

8,795

9,215

(4.6%)

As % of net sales

26.3%

28.5%

Business earnings per share*** (in euros)

6.65

7.06

(5.8%)

* Net of tax

** Determined on the basis of Business income before tax, associates, and non-controlling interests

*** Based on an average number of shares outstanding of 1,321.7 million 2011 and 1,305.3 million in 2010

(1) In 2010: the results of operations of the Merial business previously presented as "held-for-exchange" were reclassified and included in income from continuing operations

in accordance with IFRS5 § 36, following the announcement to maintain Merial and Intervet/Schering-Plough as two separate organizations

Appendix 6: Reconciliation of Business net income to Net income attributable to equity holders of sanofi


Millions of euros	Q4 2011	Q4 2010(1)	% change
Business net income	2,077	1,838	13.0%
Amortization of intangible assets(2)	(809)	(848)
Impairment of intangible assets	(66)	(154)
Fair value remeasurement of contingent consideration liabilities	(152)
Expenses arising from the impact of acquisitions on inventories	(72)	(6)
Restructuring costs	(777)	(892)
Other gains and losses, and litigation (3)	190	(138)
Discontinuation of depreciation of PP&E* (IFRS5)		19
Tax effect of items listed above:	476	653
Amortization of intangible assets	265	265
Impairment of intangible assets	15	50
Fair value remeasurement of contingent consideration liabilities	24
Expenses arising on the workdown of acquired inventories	23	1
Restructuring costs	225	299
Other gains and losses, and litigation	(76)	46
Discontinuation of depreciation of PP&E (IFRS5)		(8)
Other tax items (4)	577
Share of items listed above attributable to non-controlling interests	6	1
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures	(11)	(36)
Net income attributable to equity holders of sanofi	1,439	437	229.3%
Consolidated earnings per share(5) (in euros)	1.08	0.33	227.3%
(1) the results of operations of the Merial business previously presented as "held-for-exchange" were reclassified and included in income from continuing operations in accordance with IFRS5 § 36, following the announcement to maintain Merial and Intervet/Schering-Plough as two separate organizations. (2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: euro 769 million in the fourth quarter of 2011 and euro 795 million in the fourth quarter of 2010. (3) Of which euro 210 million of income related to the award received by Sanofi in reparation of damages on the Plavix patent litigation. (4) In 2011, related to Advance Price Agreement impact for euro 349 million and euro 228 million reflecting a decrease in deferred taxes liabilities linked to revaluation of intangible assets following legislation changes. (5) Based on an average number of shares outstanding of 1,330 million in the fourth quarter of 2011 and 1,304.9 million in the fourth quarter of 2010. * Property, Plant and Equipment.

See the section, "From business net income to consolidated net income," for comments on the reconciliation of business net income to consolidated net income


Millions of euros	FY 2011	FY 2010(1)	% change
Business net income	8,795	9,215	(4.6%)
Amortization of intangible assets(2)	(3,314)	(3,529)
Impairment of intangible assets	(142)	(433)
Fair value remeasurement of contingent consideration liabilities	15
Expenses arising from the impact of acquisitions on inventories	(476)	(142)
Restructuring costs	(1,314)	(1,384)
Other gains and losses, and litigation(3)	(327)	(138)
Discontinuation of depreciation of PP&E* (IFRS5)		77
Tax effect of items listed above:	1,905	1,856
Amortization of intangible assets	1,178	1,183
Impairment of intangible assets	37	143
Fair value remeasurement of contingent consideration liabilities	34
Expenses arising on the workdown of acquired inventories	143	44
Restructuring costs	399	466
Other gains and losses, and litigation	114	46
Discontinuation of depreciation of PP&E (IFRS5)		(26)
Other tax items (4)	577
Share of items listed above attributable to non-controlling interests	6	3
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures	(32)	(58)
Net income attributable to equity holders of Sanofi	5,693	5,467	4.1%
Consolidated earnings per share(5) (in euros)	4.31	4.19	2.9%
(1) the results of operations of the Merial business previously presented as "held-for-exchange" were reclassified and included in income from continuing operations in accordance with IFRS5 § 36, following the announcement to maintain Merial and Intervet/Schering-Plough as two separate organizations. (2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: euro 3,136 million in 2011 and euro 3,327 million in 2010. (3) Of which in 2011: related to the "Catch up" in respect of 2009 and 2010 depreciation and amortization expense on PP&E* and intangible assets of Merial, previously classified as "Assets held for sale or exchange" (euro 519 million) and euro 210 million of income related to the award received by Sanofi in reparation of damages on the Plavix patent litigation. (4) In 2011, related to Advance Price Agreement impact for euro 349 million and euro 228 million reflecting a decrease in deferred taxes liabilities linked to revaluation of intangible assets following legislation changes. (5) Based on an average number of shares outstanding of 1,321.7 million in 2011 and 1,305.3 million in 2010. * Property, Plant and Equipment.

Appendix 7: Consolidated income statements


Millions of euros	Q4 2011	Q4 2010(1)	FY 2011	FY 2010(1)
Net sales	8,508	7,823	33,389	32,367
Other revenues	415	419	1,669	1,669
Cost of sales	(2,793)	(2,469)	(10,902)	(9,398)
Gross profit	6,130	5,773	24,156	24,638
Research and development expenses	(1,293)	(1,167)	(4,811)	(4,547)
Selling and general expenses	(2,221)	(2,193)	(8,536)	(8,149)
Other operating income	38	30	319	369
Other operating expenses	(97)	(88)	(315)	(292)
Amortization of intangible assets	(809)	(848)	(3314)	(3,529)
Impairment of intangible assets	(66)	(154)	(142)	(433)
Fair value remeasurement of contingent consideration liabilities	(152)		15
Restructuring costs	(777)	(892)	(1,314)	(1,384)
Other gains and losses, and litigation	190	(138)	(327)	(138)
Operating income	943	323	5,731	6,535
Financial expenses	(165)	(138)	(552)	(468)
Financial income	52	43	140	106
Income before tax and associates and joint ventures	830	228	5,319	6,173
Income tax expenses	415	46	(455)	(1,430)
Share of profit/loss of associates and joint ventures	245	217	1,070	978
Net income	1,490	491	5,934	5,721
Net income attributable to non-controlling interests	51	54	241	254
Net income attributable to equity holders of sanofi	1,439	437	5,693	5,467
Average number of shares outstanding (million)	1,330	1,304.9	1,321.7	1,305.3
Earnings per share (in euros)	1.08	0.33	4.31	4.19
(1) The results of operations of the Merial business previously presented as "held-for-exchange" were reclassified and included in income from continuing operations in accordance with IFRS5 § 36, following the announcement to maintain Merial and Intervet/Schering-Plough as two separate organizations.

Appendix 8: Change in net debt


Millions of euros	FY 2011	FY 2010
Business net income	8,795	9,215
Depreciation, amortization and impairment of property, plant and equipment and intangible assets	1,156	1,080
Net gains and losses on disposals of non-current assets, net of tax	(52)	(111)
Other non cash items	579	550
Operating cash flow before changes in working capital (1)	10,478	10,734
Changes in working capital (1)	(476)	57
Acquisitions of property, plant and equipment and software	(1,644)	(1,349)
Free cash flow (1)	8,358	9,442
Acquisitions of intangibles, excluding software	(138)	(313)
Acquisitions of investments, including assumed debt(2)	(14,079)	(2,121)
Restructuring costs paid	(707)	(892)
Proceeds from disposals of property, plant and equipment, intangibles, and other non-current assets, net of tax	359	111
Issuance of sanofi shares	70	18
Dividends paid to sanofi shareholders	(1,372)	(3,131)
Acquisition of treasury shares	(1,074)	(321)
Disposals of treasury shares, net of tax	3	57
Other items(3)	(702)	(299)
Change in net debt	(9,282)	2,551
(1) Excluding restructuring costs (2) In 2011: (euro 13,528 million) related to Genzyme acquisition (3) In 2011: of which foreign exchange effect on net debt (euro 754 million)

Appendix 9: Simplified consolidated balance sheets


ASSETS euro million	12/31/2011	12/31/2010	LIABILITIES & EQUITY euro million	12/31/2011	12/31/2010
Property, plant and equipment	10,750	8,155	Equity attributable to equity-holders of sanofi	56,219	53,097
Intangible assets (including goodwill)	61,718	44,411	Equity attributable to non-controlling interests	170	191
Non-current financial assets, investments in associates, and deferred tax assets	6,839	5,619	Total equity	56,389	53,288
			Long-term debt	12,499	6,695
			Non-current liabilities related to business combinations and to non-controlling interests	1,336	388
Non-current assets	79,307	58,185	Provisions and other non-current liabilities	10,346	9,326
			Deferred tax liabilities	6,011	3,808
Inventories, accounts receivable and other current assets	16,667	13,578	Non-current liabilities	30,192	20,217
Cash and cash equivalents	4,124	6,465	Accounts payable and other current liabilities	10,404	8,424
			Current liabilities related to business combinations and to non-controlling interests	220	98
			Short-term debt and current portion of long-term debt	2,940	1,565
Current assets	20,791	20,043	Current liabilities	13,564	10,087
Assets held for sale or exchange	67	7,036	Liabilities related to assets held for sale or exchange	20	1,672
Total ASSETS	100,165	85,264	Total LIABILITIES & EQUITY	100,165	85,264

Appendix 10: Definitions

Re-presentation of Merial results

In accordance with IFRS 5.36 and as Merial has ceased to be qualified as held for sale or exchange in Q1/2011, the results of Merial classified as held for sale or exchange in previously-issued financial statements have been reclassified and included in income from continuing operations for all periods presented.

Definitions of non-GAAP financial indicators

Net sales at constant exchange rates

When we refer to changes in our net sales "at constant exchange rates", this means that we exclude the effect of changes in exchange rates.

We eliminate the effect of exchange rates by recalculating net sales for the relevant period at the exchange rates used for the previous period.

Reconciliation of reported net sales to net sales at constant exchange rates for the fourth quarter of 2011 and 2011


(millions of euros)	Q4 2011	2011
Net sales	8,508	33,389
Effect of exchange rates	(34)	(704)
Net sales at constant exchange rates	8,542	34,093

Net sales on a constant structure basis

We eliminate the effect of changes in structure by restating prior-period net sales as follows:

by including sales from the acquired entity or product rights for a portion of the prior period equal to the portion of the current period during which we owned them, based on sales information we receive from the party from whom we make the acquisition;
similarly, by excluding sales in the relevant portion of the prior period when we have sold an entity or rights to a product;
for a change in consolidation method, by recalculating the prior period on the basis of the method used for the current period.

Worldwide presence of Plavix®/Iscover®, Avapro®/Aprovel®

When we refer to the "worldwide presence" of a product, we mean our consolidated net sales of that product, minus sales of the product to our alliance partners plus non-consolidated sales made through our alliances with Bristol-Myers Squibb on Plavix®/Iscover® (clopidogrel bisulfate) and Aprovel®/Avapro®/Karvea® (irbesartan), based on information provided to us by our alliance partner.

Business net income

Sanofi publishes a key non-GAAP indicator in response to the application of IFRS 8. This indicator "Business net income", replaced "adjusted net income excluding selected items".

Business net income is defined as net income attributable to equity holders of Sanofi excluding:

amortization of intangible assets,
impairment of intangible assets,
fair value remeasurement of contingent consideration liabilities related to business combinations,
other impacts associated with acquisitions (including impacts of acquisitions on associates),
restructuring costs *,
other gains and losses (including gains and losses on disposals of non-current assets*),
costs or provisions associated with litigation*,
tax effects related to the items listed above as well as effects of major tax disputes,

*Reported in the line items Restructuring costs and Gains and losses on disposals, and litigation, which are defined in Note B.20. to our consolidated financial statements.

Sanofi : www.sanofi.com

Media Relations: (+) 33 1 53 77 46 46 - E-mail : MR@sanofi.com

Investor Relations : (+) 33 1 53 77 45 45 - E-mail : IR@sanofi.com

SOURCE Sanofi

Biomarkers Market (Discovery Technologies, Applications & Indications) - Global Trends, Opportunities & Forecasts (2011 - 2020)

Wed, 08 Feb 2012 09:48:36 +0000

Biomarkers Market (Discovery Technologies, Applications & Indications) - Global Trends, Opportunities & Forecasts (2011 - 2020)

PR Newswire

NEW YORK, Feb. 8, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Biomarkers Market (Discovery Technologies, Applications & Indications) – Global Trends, Opportunities & Forecasts (2011 – 2020)

http://www.reportlinker.com/p0769003/Biomarkers-Market-Discovery-Technologies-Applications--Indications-–-Global-Trends-Opportunities--Forecasts-2011-–-2020.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Genomics

Biomarkers Market (Discovery Technologies, Applications & Indications) – Global Trends, Opportunities & Forecasts (2011 – 2020)

A biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic response to a therapeutic intervention. Biomarkers are classified in different ways based on different parameters such as on the basis of their application, their characteristics and on their usage in decision making in early drug development. With drug development facing challenges from ever increasing cost of developing drugs and rise in the failure rate for drugs in phase II and III clinical trials, biomarkers are being employed on large scale by pharmaceutical companies to overcome these challenges. Also the advent of personalized medicine and companion diagnostics is witnessing a strong presence of use of biomarkers and holds to be a big opportunity for the overall biomarker market.

The global biomarker market is also growing due to emergence of several new companies, providing advanced technology platforms in areas such as bioinformatics, genomics, metabolomics, transcriptomics, proteomics, and pharmacogenomics. Scientific progress in these areas likely to be a key driver for further biomarker research to improve sample throughputs, enhance detection levels, and generate multiple biomarker panels with increased utility in diagnostics, preclinical research, clinical trials and product commercialization.

This report studies the global biomarker market divided into global discovery technologies market, global application market across major indications which is given as a different segment; Global biomarker indication market over the forecast period (2011-2020). The global biomarker market is valued at $13.16 billion in 2011 growing at a steady pace of CAGR 14.40% to reach $25.79 billion by 2016. The biomarker discovery technology market is the major contributor of this market followed by the application market. Oncology is seen to be the largest indication in terms of revenue but cardiology is the fastest growing indication with a CAGR of 16.24% from 2011 to 2016. North America is leading the market followed by Europe and Asia is the fastest growing region due to high adoption rate of high throughput technologies for biomarker discovery and rapid growth of IT industry in this region.

Players are implementing various growth strategies in the market to gain competitive edge. New products launch, agreements and collaborations, partnerships, joint ventures, mergers and acquisitions, were some of the major strategies adopted by the players during the study period between January 2009 and December 2011. Our research indicates that agreements, partnerships, collaborations, and new joint ventures form a major growth strategy in the Global Biomarker Market accounting for a 42% share in this market.

Scope of the report

This Biomarkers Market research report categorizes on the basis of discovery technologies and application market across major indications; forecasting revenues and analyzing trends in each of the following submarkets:

The report categorizes the global biomarker market as follows:

Discovery technologies (Omics technologies comprising genomics, proteomics, metabolomics, transcriptomics and epigenomics; imaging technologies comprising PET, SPECT, CT, MRI, ultrasound, and bioinformatics)

Services market (Assay production and development, biomarker testing, and biomarker validation)

Applications market (drug development and discovery, personalized medicine, and molecular diagnostics)

Indications (Oncology, cardiology, neurology, and others)

On the basis of geography:

North America

Europe

Asia

ROW

In addition to market data on the submarkets of the global biomarker market, each section of the report will identify and analyze the market trends, opportunities, and the factors driving or inhibiting market growth. The report will also draw a competitive landscape, in which it will profile 40 key market players.

TABLE OF CONTENTS

1 INTRODUCTION

1.1 KEY TAKE-AWAYS

1.2 REPORT DESCRIPTION

1.3 STAKEHOLDERS

1.4 RESEARCH METHODOLOGY

1.4.1 MARKET SIZE

1.4.2 KEY DATA POINTS FROM SECONDARY SOURCES

1.4.3 ASSUMPTIONS

2 EXECUTIVE SUMMARY

3 MARKET OVERVIEW

3.1 DEFINITION OF BIOMARKERS

3.2 BIOMARKERS & ITS TYPES

3.3 BIOMARKERS MARKET

3.3.1 MARKET SEGMENTATION

3.3.2 CHALLENGES & OPPORTUNITIES

3.3.2.1 Challenges

3.3.2.1.1 Variability

3.3.2.1.2 Ethical considerations & acceptability

3.3.2.2 Opportunities

3.3.2.2.1 Personalized medicine

3.3.2.2.2 Companion diagnostics

3.3.3 DRIVERS & RESTRAINTS

3.3.3.1 Drivers

3.3.3.1.1 High demand boosts the growth of the biomarker market globally

3.3.3.1.2 Strategic collaborations lead to increasing applications in the market

3.3.3.1.3 Technological advances contribute to growth

3.3.3.1.4 The rising prevalence of the disease forms

3.3.3.1.5 FDA support for biomarker development

3.3.3.2 Restraints

3.3.3.2.1 Low capital investment & cost-benefit hinders growth of biomarkers

3.3.3.2.2 Biomarkers not a profitable market for small organizations

3.3.3.2.3 Sample collection & storage

3.3.3.2.4 Limited biomarker validation

3.3.3.2.5 Need for new R&D models with greater precision & flexibility

4 GLOBAL BIOMARKER MARKET, BY DISCOVERY TECHNOLOGIES 4.1 INTRODUCTION 4.2 IMAGING TECHNOLOGIES FOR BIOMARKER DISCOVERY 4.2.1 POSITRON EMISSION TOMOGRAPHY (PET) 4.2.2 SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY(SPECT) 4.2.3 ULTRASOUND 4.2.4 MAGNETIC RESONANCE IMAGING (MRI) 4.2.5 COMPUTED TOMOGRAPHY (CT) 4.3 OMICS TECHNOLOGIES FOR BIOMARKER DISCOVERY 4.3.1 PROTEOMICS 4.3.1.1 Mass spectrometry 4.3.1.1.1 MALDI mass spectrometry 4.3.1.1.2 Imaging mass spectrometry 4.3.1.2 2D Gel Electrophoresis 4.3.1.3 Protein microarray technology 4.3.1.4 Antibody array technology 4.3.1.5 Peptide array technology 4.3.2 GENOMICS 4.3.2.1 Whole genome sequencing 4.3.2.2 Genotyping 4.3.2.3 Epigenetics 4.3.3 TRANSCRIPTOMICS 4.3.3.1 Microarrays 4.3.3.2 Gene expression profiling 4.3.4 METABOLOMICS 4.3.4.1 Capillary electrophoresis 4.3.4.2 Mass spectrometry based kits 4.3.4.3 Nuclear Magnetic Resonance(NMR) 4.4 BIOINFORMATICS 4.4.1 CLUSTER ANALYSIS 4.4.2 STATISTICAL ANALYSIS 4.4.3 CELL SIGNAL PATHWAYS 4.4.4 COMPUTER AIDED DESIGN 4.4.5 DATA MINING 4.4.6 PROTEIN INTERACTION MAPS

5 SERVICES MARKET OF BIOMARKERS

5.1 INTRODUCTION

5.2 CLINICAL

5.2.1 SAMPLE PREPARATION

5.2.2 ASSAY DEVELOPMENT

5.2.3 BIOMARKER VALIDATION & TESTING

5.2.3.1 Feasibility Studies and choice of assay & biomarker

5.2.3.2 Long lead time required for Biomarker Assay preparation

5.3 BIOINFORMATICS

5.3.1 FUNCTIONAL GENOMICS & PROTEOMICS DRIVE THE DEMAND FOR BIOINFORMATICS

6 BIOMARKER APPLICATION MARKET 6.1 INTRODUCTION 6.2 DRUG DISCOVERY & DEVELOPMENT 6.2.1 CLINICAL TRIALS 6.2.1.1 Preclinical Development 6.2.1.2 Phase I drug development 6.2.1.3 Phase II drug development 6.2.1.4 Phase III drug development 6.2.1.5 Phase IV drug development 6.3 PERSONALIZED MEDICINE 6.4 MOLECULAR DIAGNOSTICS 6.4.1 MOLECULAR DIAGNOSTICS IS A DYNAMIC & RAPIDLY BROADENING MARKET 6.4.2 TRENDS IN THE DIAGNOSTICS MARKET 6.4.3 CHALLENGES 6.4.3.1 Nucleic acids pose a challenge to the molecular diagnostics field 6.4.3.2 Molecular diagnostics market lacks a collaborated effort 6.4.4 DRIVER 6.4.4.1 Increase in the incidence of diseases spurs the growth of the diagnostics market 6.4.5 RESTRAINT 6.4.5.1 The "interest-information" restricts growth of molecular diagnostics 6.4.6 MOLECULAR DIAGNOSTICS IN MAJOR INDICATIONS 6.4.6.1 Oncology 6.4.6.2 Cardiology 6.4.6.3 Neurology 6.4.6.4 Other treatment areas 6.4.7 BIOMARKERS IN DIAGNOSTICS 6.4.8 BENEFITS OF MOLECULAR DIAGNOSTICS

7 BIOMARKER INDICATION MARKET

7.1 INTRODUCTION

7.2 ONCOLOGY BIOMARKER MARKET

7.2.1 ONCOLOGY BIOMARKER DISCOVERY MARKET

7.2.1.1 Genomics

7.2.1.2 Proteomics

7.2.1.3 Metabolomics

7.2.1.4 Transcriptomics

7.2.1.5 Other Omics

7.2.1.6 Imaging

7.2.2 DRUG DISCOVERY & DEVELOPMENT

7.2.3 CANCER TYPES

7.2.3.1 Ovarian Cancer

7.2.3.2 Breast Cancer

7.2.3.3 Bladder Cancer

7.2.3.4 Cervical Cancer

7.2.3.5 Prostate Cancer

7.2.3.6 Lung Cancer

7.2.3.7 Colorectal Cancer

7.3 CARDIOLOGY BIOMARKERS MARKET

7.3.1 CARDIOLOGY BIOMARKER DISCOVERY MARKET

7.3.1.1 Genomics

7.3.1.2 Proteomics

7.3.1.3 Metabolomics

7.3.1.4 Transcriptomics

7.3.1.5 Imaging

7.3.1.6 Bioinformatics

7.3.2 DRUG DISCOVERY & DEVELOPMENT

7.3.3 CARDIAC MARKERS, BY DISEASE TYPES

7.3.3.1 Acute Coronary Syndrome

7.3.3.2 Coronary artery disease

7.3.3.3 Stroke

7.3.4 CARDIOLOGY BIOMARKERS USED IN THE MARKET

7.4 NEUROLOGY BIOMARKER MARKET

7.4.1 NEUROLOGY BIOMARKER DISCOVERY MARKET

7.4.1.1 Omics technologies

7.4.1.2 Imaging Technologies

7.4.2 DRUG DISCOVERY & DEVELOPMENT

7.4.3 DISEASE TYPES

7.4.3.1 Alzheimer's disease

7.4.3.2 Parkinson's disease

7.4.3.3 Multiple sclerosis

7.4.3.4 Schizophrenia

7.4.3.5 Amyotrophic Lateral Sclerosis

7.4.3.6 Epilepsy

7.5 OTHER INDICATIONS BIOMARKER MARKET

7.5.1 OTHER INDICATION BIOMARKER DISCOVERY MARKET

7.5.1.1 Omics technologies

7.5.1.2 Imaging technologies

7.5.2 DRUG DISCOVERY & DEVELOPMENT

7.6 DISEASE TYPES

7.6.1 HIV

7.6.1.1 Immunological & Virological Markers in HIV Infection

7.7 RENAL FAILURE

7.8 ARTHRITIS

7.9 TUBERCULOSIS

7.10 DIABETES

8 GEOGRAPHICAL ANALYSIS 8.1 INTRODUCTION 8.2 NORTH AMERICA 8.3 EUROPE 8.4 ASIA 8.5 ROW

9 COMPETITIVE LANDSCAPE

9.1 KEY STRATEGIES

9.2 MERGERS & ACQUISITIONS

9.3 AGREEMENTS, PARTNERSHIPS, COLLABORATIONS & JOINT VENTURES

9.4 NEW PRODUCTS LAUNCH

9.5 OTHER DEVELOPMENTS

10 COMPANY PROFILES 10.1 ABBOTT LABORATORIES 10.1.1 OVERVIEW 10.1.2 FINANCIALS 10.1.3 PRODUCTS & SERVICES 10.1.4 STRATEGY 10.1.5 DEVELOPMENTS 10.2 ABCODIA LTD 10.2.1 OVERVIEW 10.2.2 FINANCIALS 10.2.3 PRODUCTS & SERVICES 10.2.4 STRATEGY 10.2.5 DEVELOPMENTS 10.3 AFFYMETRIX INC 10.3.1 OVERVIEW 10.3.2 FINANCIALS 10.3.3 PRODUCTS & SERVICES 10.3.4 STRATEGY 10.3.5 DEVELOPMENTS 10.4 AGILENT TECHNOLOGIES INC 10.4.1 OVERVIEW 10.4.2 FINANCIALS 10.4.3 PRODUCTS & SERVICES 10.4.4 STRATEGY 10.4.5 DEVELOPMENTS 10.5 AMGEN INC 10.5.1 OVERVIEW 10.5.2 FINANCIALS 10.5.3 PRODUCTS & SERVICES 10.5.4 STRATEGY 10.5.5 DEVELOPMENT 10.6 ASTRAZENECA PLC 10.6.1 OVERVIEW 10.6.2 FINANCIALS 10.6.3 PRODUCTS & SERVICES 10.6.4 STRATEGY 10.6.5 DEVELOPMENTS 10.7 AUGUREX LIFE SCIENCES CORP 10.7.1 OVERVIEW 10.7.2 FINANCIALS 10.7.3 PRODUCTS & SERVICES 10.7.4 STRATEGY 10.7.5 DEVELOPMENTS 10.8 AUSHON BIOSYSTEMS INC 10.8.1 OVERVIEW 10.8.2 FINANCIALS 10.8.3 PRODUCTS & SERVICES 10.8.4 STRATEGY 10.8.5 DEVELOPMENTS 10.9 BAYER AG 10.9.1 OVERVIEW 10.9.2 FINANCIALS 10.9.3 PRODUCTS & SERVICES 10.9.4 STRATEGY 10.9.5 DEVELOPMENTS 10.10 BECKMAN COULTER INC 10.10.1 OVERVIEW 10.10.2 FINANCIALS 10.10.3 PRODUCTS & SERVICES 10.10.4 STRATEGY 10.10.5 DEVELOPMENTS 10.11 BGI 10.11.1 OVERVIEW 10.11.2 FINANCIALS 10.11.3 PRODUCTS & SERVICES 10.11.4 STRATEGY 10.11.5 DEVELOPMENTS 10.12 BIOCRATES LIFE SCIENCES AG 10.12.1 OVERVIEW 10.12.2 FINANCIALS 10.12.3 PRODUCTS & SERVICES 10.12.4 STRATEGY 10.12.5 DEVELOPMENTS 10.13 BIOMARKER STRATEGIES 10.13.1 OVERVIEW 10.13.2 FINANCIALS 10.13.3 PRODUCTS & SERVICES 10.13.4 STRATEGY 10.13.5 DEVELOPMENTS 10.14 BIOSYSTEMS INTERNATIONAL 10.14.1 OVERVIEW 10.14.2 FINANCIALS 10.14.3 PRODUCTS & SERVICES 10.14.4 STRATEGY 10.14.5 DEVELOPMENTS 10.15 BRISTOL-MYERS SQUIBB 10.15.1 OVERVIEW 10.15.2 FINANCIALS 10.15.3 PRODUCTS & SERVICES 10.15.4 STRATEGY 10.15.5 DEVELOPMENTS 10.16 CRESCENDO BIOSCIENCE 10.16.1 OVERVIEW 10.16.2 FINANCIALS 10.16.3 PRODUCTS & SERVICES 10.16.4 STRATEGY 10.16.5 DEVELOPMENTS 10.17 EISAI CO. LTD. 10.17.1 OVERVIEW 10.17.2 FINANCIALS 10.17.3 PRODUCTS & SERVICES 10.17.4 STRATEGY 10.17.5 DEVELOPMENTS 10.18 EPIONTIS GMBH 10.18.1 OVERVIEW 10.18.2 FINANCIALS 10.18.3 PRODUCTS & SERVICES 10.18.4 DEVELOPMENTS 10.19 EPISTEM HOLDINGS PLC 10.19.1 OVERVIEW 10.19.2 FINANCIALS 10.19.3 PRODUCTS & SERVICES 10.19.4 STRATEGY 10.19.5 DEVELOPMENTS 10.20 EUROGENTEC S.A. 10.20.1 OVERVIEW 10.20.2 FINANCIALS 10.20.3 PRODUCTS & SERVICES 10.20.4 STRATEGY 10.20.5 DEVELOPMENTS 10.21 EVOTEC AG 10.21.1 OVERVIEW 10.21.2 FINANCIALS 10.21.3 PRODUCTS & SERVICES 10.21.4 STRATEGY 10.21.5 DEVELOPMENTS 10.22 GLAXOSMITHKLINE PLC 10.22.1 OVERVIEW 10.22.2 FINANCIALS 10.22.3 PRODUCTS & SERVICES 10.22.4 STRATEGY 10.22.5 DEVELOPMENTS 10.23 IPSEN 10.23.1 OVERVIEW 10.23.2 FINANCIALS 10.23.3 PRODUCTS & SERVICES 10.23.4 STRATEGY 10.23.5 DEVELOPMENTS 10.24 JOHNSON & JOHNSON 10.24.1 OVERVIEW 10.24.2 FINANCIALS 10.24.3 PRODUCTS & SERVICES 10.24.4 STRATEGY 10.24.5 DEVELOPMENTS 10.25 MERCK & CO. 10.25.1 OVERVIEW 10.25.2 FINANCIALS 10.25.3 PRODUCTS & SERVICES 10.25.4 STRATEGY 10.25.5 DEVELOPMENTS 10.26 MICROMEDIC TECHNOLOGIES LTD 10.26.1 OVERVIEW 10.26.2 PRODUCTS & SERVICES 10.26.3 STRATEGY 10.26.4 DEVELOPMENTS 10.27 MYRIAD GENETICS INC 10.27.1 OVERVIEW 10.27.2 FINANCIALS 10.27.3 PRODUCTS & SERVICES 10.27.4 STRATEGY 10.27.5 DEVELOPMENTS 10.28 NEXTGEN SCIENCES INC 10.28.1 OVERVIEW 10.28.2 FINANCIALS 10.28.3 PRODUCTS & SERVICES 10.28.4 STRATEGY 10.28.5 DEVELOPMENTS 10.29 NOVARTIS INTERNATIONAL AG 10.29.1 OVERVIEW 10.29.2 FINANCIALS 10.29.3 PRODUCTS & SERVICES 10.29.4 STRATEGY 10.29.5 DEVELOPMENTS 10.30 OCIMUM BIOSOLUTIONS LTD 10.30.1 OVERVIEW 10.30.2 FINANCIALS 10.30.3 PRODUCTS & SERVICES 10.30.4 STRATEGY 10.30.5 DEVELOPMENTS 10.31 PFIZER INC 10.31.1 OVERVIEW 10.31.2 FINANCIALS 10.31.3 PRODUCTS & SERVICES 10.31.4 STRATEGY 10.31.5 DEVELOPMENTS 10.32 PRONOTA NV 10.32.1 OVERVIEW 10.32.2 FINANCIALS 10.32.3 PRODUCTS & SERVICES 10.32.4 STRATEGY 10.32.5 DEVELOPMENTS 10.33 QUINTILES TRANSNATIONAL CORPORATION 10.33.1 OVERVIEW 10.33.2 FINANCIALS 10.33.3 PRODUCTS & SERVICES 10.33.4 STRATEGY 10.33.5 DEVELOPMENTS 10.34 QIAGEN NV 10.34.1 OVERVIEW 10.34.2 FINANCIALS 10.34.3 PRODUCTS & SERVICES 10.34.4 STRATEGY 10.34.5 DEVELOPMENTS 10.35 QUINTILES TRANSNATIONAL CORPORATION 10.35.1 OVERVIEW 10.35.2 FINANCIALS 10.35.3 PRODUCTS & SERVICES 10.35.4 STRATEGY 10.35.5 DEVELOPMENTS 10.36 ROCHE DIAGNOSTICS LIMITED 10.36.1 OVERVIEW 10.36.2 FINANCIALS 10.36.3 PRODUCTS & SERVICES 10.36.4 STRATEGY 10.36.5 DEVELOPMENT 10.37 SANOFI-AVENTIS 10.37.1 OVERVIEW 10.37.2 FINANCIALS 10.37.3 PRODUCTS & SERVICES 10.37.4 STRATEGY 10.37.5 DEVELOPMENT 10.38 SIEMENS HEALTHCARE 10.38.1 OVERVIEW 10.38.2 FINANCIALS 10.38.3 PRODUCTS & SERVICES 10.38.4 STRATEGY 10.38.5 DEVELOPMENTS 10.39 TRANS-HIT BIOMARKERS INC 10.39.1 OVERVIEW 10.39.2 FINANCIALS 10.39.3 PRODUCTS & SERVICES 10.39.4 STRATEGY 10.39.5 DEVELOPMENTS 10.40 PACIFIC BIOMARKERS INC 10.40.1 OVERVIEW 10.40.2 FINANCIALS 10.40.3 PRODUCTS & SERVICES 10.40.4 STRATEGY 10.40.5 DEVELOPMENTS 10.41 CAPRION PROTEOMICS INC. 10.41.1 OVERVIEW 10.41.2 FINANCIALS 10.41.3 PRODUCTS & SERVICES 10.41.4 STRATEGY 10.41.5 DEVELOPMENTS 10.42 PROTEOME SCIENCES PLC 10.42.1 OVERVIEW 10.42.2 FINANCIALS 10.42.3 PRODUCTS & SERVICES 10.42.4 STRATEGY 10.42.5 DEVELOPMENTS 10.43 VERMILLION INC 10.43.1 OVERVIEW 10.43.2 FINANCIALS 10.43.3 PRODUCTS & SERVICES 10.43.4 STRATEGY 10.43.5 DEVELOPMENTS

LIST OF TABLES

TABLE 1 GLOBAL BIOMARKER MARKET REVENUE, BY SEGMENTS, 2009 – 2020 ($MILLION) TABLE 2 GLOBAL BIOMARKER MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 3 GLOBAL BIOMARKER DISCOVERY MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 4 BIOMARKER DISCOVERY TECHNOLOGIES MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 5 GLOBAL BIOMARKER DISCOVERY MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 6 BIOMARKER IMAGING TECHNOLOGIES MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 7 GLOBAL BIOMARKER DISCOVERY MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 8 GLOBAL BIOMARKER OMICS TECHNOLOGIES MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 9 BIOMARKER OMICS TECHNOLOGIES MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 10 GLOBAL PROTEOMICS BIOMARKER MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 11 GLOBAL GENOMICS BIOMARKER MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 12 GLOBAL TRANSCRIPTOMICS BIOMARKER MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 13 GLOBAL METABOLOMICS BIOMARKER MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 14 GLOBAL BIOMARKER BIOINFORMATICS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 15 BIOMARKER BIOINFORMATICS MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 16 GLOBAL BIOMARKER MARKET, BY APPLICATIONS, 2009 – 2020 ($MILLION) TABLE 17 GLOBAL BIOMARKER APPLICATION MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 18 BIOMARKER APPLICATION MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 19 GLOBAL BIOMARKER DRUG DISCOVERY & DEVELOPMENT PROCESS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 20 BIOMARKER DRUG DISCOVERY & DEVELOPMENT PROCESS MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 21 GLOBAL BIOMARKER APPLICATION MARKET, BY PHASES IN DRUG DISCOVERY & DEVELOPMENT PROCESS, 2009 – 2020 ($MILLION) TABLE 22 GLOBAL BIOMARKER PRECLINICAL STUDY MARKET, BY VARIOUS INDICATIONS, 2009 – 2020 ($MILLION) TABLE 23 GLOBAL BIOMARKER PHASE I MARKET, BY PHASES IN VARIOUS INDICATIONS, 2009 – 2020 ($MILLION) TABLE 24 GLOBAL BIOMARKER PHASE II MARKET, BY PHASES IN VARIOUS INDICATIONS, 2009 – 2020 ($MILLION) TABLE 25 GLOBAL BIOMARKER PHASE III MARKET, BY PHASES IN VARIOUS INDICATIONS, 2009 – 2020 ($MILLION) TABLE 26 GLOBAL BIOMARKER PHASE IV MARKET, BY PHASES IN VARIOUS INDICATIONS, 2009 – 2020 ($MILLION) TABLE 27 PERSONALIZED MEDICINE(PM) USING BIOMARKERS IN CURRENT DRUG LABELS TABLE 28 GLOBAL BIOMARKER PERSONALIZED MEDICINE MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 29 BIOMARKER PERSONALIZED MEDICINE MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 30 GLOBAL MOLECULAR DIAGNOSTICS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 31 MOLECULAR DIAGNOSTICS MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 32 GLOBAL BIOMARKER MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 33 GLOBAL ONCOLOGY BIOMARKER MARKET, BY SEGMENTS, 2009 – 2020 ($MILLION) TABLE 34 GLOBAL ONCOLOGY BIOMARKER MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 35 GLOBAL ONCOLOGY BIOMARKER MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 36 GLOBAL ONCOLOGY BIOMARKER MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 37 GLOBAL ONCOLOGY BIOMARKER MARKET, BY PHASES, 2009 – 2020 ($MILLION) TABLE 38 GLOBAL ONCOLOGY BIOMARKER MARKET, BY CANCER TYPES, 2009 – 2020 ($MILLION) TABLE 39 ONCOLOGY BIOMARKER MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 40 GLOBAL CARDIOLOGY BIOMARKERS MARKET REVENUE, BY SEGMENTS, 2009 – 2020 ($MILLION) TABLE 41 GLOBAL CARDIOLOGY BIOMARKERS MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 42 GLOBAL CARDIOLOGY BIOMARKER MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 43 GLOBAL CARDIOLOGY BIOMARKER MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 44 GLOBAL CARDIOLOGY BIOMARKER MARKET, BY PHASES, 2009 – 2020 ($MILLION) TABLE 45 GLOBAL CARDIOLOGY MARKERS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 46 COMMONLY USED CARDIAC BIOMARKER TESTS TABLE 47 BIOMARKER TESTS USED FOR PROGNOSIS TABLE 48 CARDIAC MARKERS MARKET REVENUE, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 49 GLOBAL NEUROLOGY BIOMARKER MARKET, BY SEGMENTS, 2009 – 2020 ($MILLION) TABLE 50 GLOBAL NEUROLOGY BIOMARKER MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 51 GLOBAL NEUROLOGY BIOMARKER MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 52 GLOBAL NEUROLOGY BIOMARKER MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 53 GLOBAL NEUROLOGY BIOMARKER MARKET, BY PHASES, 2009 – 2020 ($MILLION) TABLE 54 GLOBAL NEUROLOGY BIOMARKER MARKET, BY DISEASE TYPES, 2009– 2020 ($MILLION) TABLE 55 NEUROLOGY BIOMARKER MARKET, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 56 GLOBAL OTHER INDICATIONS BIOMARKER MARKET, BY SEGMENTS, 2009 – 2020 ($MILLION) TABLE 57 GLOBAL OTHER INDICATIONS BIOMARKER MARKET REVENUE, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 58 GLOBAL OTHER INDICATION BIOMARKER MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 59 GLOBAL OTHER INDICATION BIOMARKER MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 60 GLOBAL OTHER INDICATION BIOMARKER MARKET, BY PHASES, 2009 – 2020 ($MILLION) TABLE 61 GLOBAL OTHER INDICATIONS BIOMARKER MARKET, BY TYPES, 2009 – 2020 ($MILLION) TABLE 62 HIV BIOMARKERS TABLE 63 RENAL BIOMARKERS TABLE 64 OTHER INDICATIONS MARKET REVENUE, BY GEOGRAPHY, 2009 – 2020 ($MILLION) TABLE 65 BIOMARKERS MARKET REVENUE, BY GEOGRAPHY, 2009 – 2020 ($BILLION) TABLE 66 NORTH AMERICA: BIOMARKERS MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 67 NORTH AMERICA: BIOMARKERS MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 68 NORTH AMERICA: BIOMARKERS MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 69 NORTH AMERICA: BIOMARKERS MARKET, BY APPLICATIONS, 2009 – 2020 ($MILLION) TABLE 70 NORTH AMERICA: BIOMARKERS MARKET, BY DRUG DISCOVERY & DEVELOPMENT, 2009 – 2020 ($MILLION) TABLE 71 NORTH AMERICA: BIOMARKERS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 72 NORTH AMERICA: ONCOLOGY BIOMARKERS MARKET, BY CANCER TYPES, 2009 – 2020 ($MILLION) TABLE 73 NORTH AMERICA: CARDIOLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 74 NORTH AMERICA: NEUROLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 75 NORTH AMERICA: OTHER INDICATIONS BIOMARKERS MARKET, BY TYPES, 2009 – 2020 ($MILLION) TABLE 76 EUROPE: BIOMARKERS MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 77 EUROPE: BIOMARKERS MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 78 EUROPE: BIOMARKERS MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 79 EUROPE: BIOMARKERS MARKET, BY APPLICATIONS, 2009 – 2020 ($MILLION) TABLE 80 EUROPE: BIOMARKERS MARKET, BY DRUG DISCOVERY & DEVELOPMENT, 2009 – 2020 ($MILLION) TABLE 81 EUROPE: BIOMARKERS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 82 EUROPE: ONCOLOGY BIOMARKERS MARKET, BY CANCER TYPES, 2009 – 2020 ($MILLION) TABLE 83 EUROPE: CARDIOLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 84 EUROPE: NEUROLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 85 EUROPE: OTHER INDICATIONS BIOMARKERS MARKET, BY TYPES, 2009 – 2020 ($MILLION) TABLE 86 ASIA: BIOMARKERS MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 87 ASIA: BIOMARKERS MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 88 ASIA: BIOMARKERS MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 89 ASIA: BIOMARKERS MARKET, BY APPLICATIONS, 2009 – 2020 ($MILLION) TABLE 90 ASIA: BIOMARKERS MARKET, BY DRUG DISCOVERY & DEVELOPMENT, 2009 – 2020 ($MILLION) TABLE 91 ASIA: BIOMARKERS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 92 ASIA: ONCOLOGY BIOMARKERS MARKET, BY CANCER TYPES, 2009 – 2020 ($MILLION) TABLE 93 ASIA: CARDIOLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 94 ASIA: NEUROLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 95 ASIA: OTHER INDICATIONS BIOMARKERS MARKET, BY TYPES, 2009 – 2020 ($MILLION) TABLE 96 ROW: BIOMARKERS MARKET, BY DISCOVERY TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 97 ROW: BIOMARKERS MARKET, BY OMICS TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 98 ROW: BIOMARKERS MARKET, BY IMAGING TECHNOLOGIES, 2009 – 2020 ($MILLION) TABLE 99 ROW: BIOMARKERS MARKET, BY APPLICATIONS, 2009 – 2020 ($MILLION) TABLE 100 ROW: BIOMARKERS MARKET, BY DRUG DISCOVERY & DEVELOPMENT, 2009 – 2020 ($MILLION) TABLE 101 ROW: BIOMARKERS MARKET, BY INDICATIONS, 2009 – 2020 ($MILLION) TABLE 102 ROW: ONCOLOGY BIOMARKERS MARKET, BY CANCER TYPES, 2009 – 2020 ($MILLION) TABLE 103 ROW: CARDIOLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 104 ROW: NEUROLOGY BIOMARKERS MARKET, BY DISEASE TYPES, 2009 – 2020 ($MILLION) TABLE 105 ROW: OTHER INDICATIONS BIOMARKERS MARKET, BY TYPES, 2009 – 2020 ($MILLION) TABLE 106 MERGERS & ACQUISITIONS (JANUARY 2009 – DECEMBER 2011) TABLE 107 AGREEMENTS, PARTNERSHIPS, COLLABORATIONS & JOINT VENTURES (JANUARY 2009 – DECEMBER 2011) TABLE 108 NEW PRODUCTS LAUNCH (JANUARY 2009 – DECEMBER 2011) TABLE 109 OTHER DEVELOPMENTS (JANUARY 2009 – DECEMBER 2011) TABLE 110 ABBOTT LABORATORIES: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 111 ABBOTT LABORATORIES: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 112 ABBOTT LABORATORIES: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 113 AFFYMETRIX INC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 114 AFFYMETRIX INC: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 115 AFFYMETRIX INC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 116 AGILENT TECHNOLOGIES INC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 117 AGILENT TECHNOLOGIES INC: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 118 AGILENT TECHNOLOGIES INC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 119 AMGEN INC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 120 AMGEN INC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 121 ASTRAZENECA PLC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 122 ASTRAZENECA PLC: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 123 ASTRAZENECA PLC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 124 BAYER AG: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 125 BAYER AG: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 126 BAYER AG: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 127 BECKMAN COULTER INC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 128 BECKMAN COULTER INC: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 129 BECKMAN COULTER INC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 130 BRISTOL-MYERS SQUIBB: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 131 BRISTOL-MYERS SQUIBB: TOTAL REVENUES, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 132 BRISTOL-MYERS SQUIBB: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 133 EISAI CO. LTD: TOTAL REVENUE AND R&D EXPENSES, 2009 – 2011 ($MILLION) TABLE 134 EISAI CO. LTD: TOTAL REVENUES, BY SEGMENTS, 2009 – 2011 ($MILLION) TABLE 135 EISAI CO. LTD: REVENUE, BY GEOGRAPHY, 2009 – 2011 ($MILLION) TABLE 136 EPISTEM HOLDINGS PLC: TOTAL REVENUE AND R&D EXPENSES, 2009 – 2011 ($MILLION) TABLE 137 EPISTEM HOLDINGS PLC: TOTAL REVENUE, BY SEGMENTS, 2009 – 2011 ($MILLION) TABLE 138 EPISTEM HOLDINGS PLC: REVENUE, BY GEOGRAPHY, 2009 – 2011 ($MILLION) TABLE 139 EVOTEC AG: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 140 EVOTEC AG: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 141 GLAXOSMITHKLINE PLC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2011 ($MILLION) TABLE 142 GLAXOSMITHKLINE PLC: TOTAL REVENUE, BY SEGMENTS, 2008 – 2011 ($MILLION) TABLE 143 GLAXOSMITHKLINE PLC: REVENUE FOR PHARMACEUTICAL SEGMENT, BY GEOGRAPHY, 2008 – 2011 ($MILLION) TABLE 144 IPSEN: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 145 IPSEN: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 146 IPSEN: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 147 JOHNSON & JOHNSON: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 148 JOHNSON & JOHNSON: TOTAL REVENUE, BY SEGMENTS, 2008 -2010 ($MILLION) TABLE 149 MEDICAL DEVICES & DIAGNOSTICS SEGMENT REVENUE, 2008 – 2010 ($MILLION) TABLE 150 JOHNSON & JOHNSON: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 151 MERCK & CO: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 152 MERCK & CO: TOTAL REVENUES, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 153 MERCK & CO: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 154 MYRIAD GENETICS INC: TOTAL REVENUE AND R&D EXPENSES, 2009 – 2011 ($MILLION) TABLE 155 MYRIAD GENETICS INC: TOTAL REVENUE, BY SEGMENTS, 2009 – 2011 ($MILLION) TABLE 156 NEXTGEN GROUP PLC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 157 NEXTGEN GROUP PLC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 158 NOVARTIS INTERNATIONAL AG: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 159 NOVARTIS INTERNATIONAL AG: TOTAL REVENUES, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 160 NOVARTIS INTERNATIONAL AG: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 161 PFIZER INC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 162 PFIZER INC: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 163 PFIZER INC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 164 QIAGEN N.V: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 165 QIAGEN N.V.: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 166 QIAGEN N.V.: GEOGRAPHIC REVENUES, 2008 – 2010 ($MILLION) TABLE 167 ROCHE: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 168 ROCHE: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 169 SANOFI-AVENTIS: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 170 SANOFI-AVENTIS: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 171 SANOFI-AVENTIS: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 172 SIEMENS: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 173 SIEMENS: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION) TABLE 174 SIEMENS: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 175 PROTEOME SCIENCES PLC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 176 PROTEOME SCIENCES PLC: REVENUE, BY GEOGRAPHY, 2008 – 2010 ($MILLION) TABLE 177 VERMILLION INC: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION) TABLE 178 VERMILLION INC: TOTAL REVENUE, BY SEGMENTS, 2008 – 2010 ($MILLION)

LIST OF FIGURES

FIGURE 1 OVERVIEW OF BIOMARKERS MARKET FIGURE 2 LIFE CYCLE OF A BIOMARKER FIGURE 3 BIOMARKER MARKET FIGURE 4 LEVEL OF IMPACT OF CHALLENGES FIGURE 5 BIOMARKER DISCOVERY PROCESS FIGURE 6 BIOMARKER DISCOVERY MARKET, 2011 FIGURE 7 OMICS TECHNOLOGIES & THE CENTRAL DOGMA FIGURE 8 BIOMARKER DISCOVERY MARKET, BY OMICS TECHNOLOGIES, 2011 FIGURE 9 THE CENTRAL ROLE OF MASS SPECTROMETRY IN PROTEOMICS FIGURE 10 BIOMARKER DISCOVERY USING 2-D DIGE & MS FIGURE 11 TRANSCRIPTOMICS BIOMARKER DISCOVERY FIGURE 12 BIOINFORMATICS MICROARRAY TOOLS FIGURE 13 CLUSTER ANALYSIS OF OMICS DATA FOR BIOMARKER DISCOVERY FIGURE 14 BIOMARKER SERVICES MARKET, BY SEGMENTS (%) FIGURE 15 FLOW OF CLINICAL BIOMARKER SERVICES FIGURE 16 DRUG DISCOVERY & DEVELOPMENT PROCESS FIGURE 17 BIOMARKER DISCOVERY, BY INDICATIONS, 2011 FIGURE 18 KEY GROWTH STRATEGIES (JANUARY 2009 – DECEMBER 2011)

To order this report:Genomics Industry: Biomarkers Market (Discovery Technologies, Applications & Indications) – Global Trends, Opportunities & Forecasts (2011 – 2020)

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Nicolas Bombourg
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Email: nbo@reportlinker.com
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SOURCE Reportlinker

Failure to Communicate by Distracted Doctors Leads to Medical Mistakes

Wed, 08 Feb 2012 08:10:48 +0000

Many medical malpractice claims involve a breakdown in communication between diagnosticians and treating physicians.

February 08, 2012 /24-7PressRelease/ -- Complex systems are prone to communication breakdowns, unless there is a concerted effort to properly share necessary information. Unfortunately, the failure to communicate is all too prevalent in the delivery of medical care.

Dr. Peter Pronovost, a leading patient-safety experts at Johns Hopkins University, estimates diagnostic errors are responsible for the deaths of 40,000 to 80,000 hospitalized patients every year. That is a shockingly high number.

With so many errors being made, injured people naturally turn to the legal system seeking proper compensation. And indeed, a recent study by the State University of New York (SUNY) Downstate Medical Center in Brooklyn found medical malpractice related to diagnostic errors is on the rise.

Hospital Errors in Communication Lead to Poor Care

Many medical malpractice claims involve a breakdown in communication between diagnosticians and treating physicians. These breakdowns include both doctors and patients failing to receive results of tests, as well as delays in sharing the findings of tests.

Who hasn't been in a doctor's office as they scurry from examining room to examining room? The time pressure of seeing as many patients as possible a day makes simple mistakes in communicating -- and on the other side, receiving and digesting -- important information more likely.

In other words, many medical specialists do not only often fail to communicate properly with patients. There is also often a communication gap between doctors themselves, when they fail to close the loop on conveying the results of diagnostic tests. As a result, claims for medical malpractice increased by an estimated $4.7 million annually between 1991 and 2009.

Why are there so many communication breakdowns in the practice of medicine today? It's not enough to say that modern medicine has become exceedingly complex, thereby multiplying the chance for communication errors to occur. Nor is it sufficient to say that doctors are practicing too much defensive medicine, ordering tests that aren't really needed.

The reality is that, far too often, doctors and other medical staff lose sight of the importance of good patient care. Good care means ordering only those diagnostic tests that are truly needed and following through on those. Healthcare providers have it in their power to close the communication loop, and they need to do a better job of doing so.

In some health systems, this process is already underway. For example, the Veterans Health Administration has begun developing programs for following up on lab results that are abnormal. Electronic medical records may help in implementing programs like these in New York and around the country.

Malpractice and Failure to Diagnose

Insurance companies, hospitals, and self-styled proponents of "tort reform" like to argue that fear of lawsuits results in too many tests. It should be noted, however, that ordering too few tests is also an issue and can lead to misdiagnosis or failure to diagnose cancer.

Missed diagnoses most often include various types of cancer, infection, fractures and myocardial infarctions or heart attacks. Healthcare providers need to work on "closing the loop" through checklists and other safeguards so that lab results do not get lost. Primary care doctors and specialists also need to make sure to actually communicate with each other, so that patient care is paramount.

Article provided by Pearlman, Apat, Futterman, Sirotkin & Seinfeld, LLP

Visit us at www.queensnewyorklawyers.com

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A.C. Moore Arts & Crafts Raises $123,000+ for American Cancer Society® Via Its "Crafting a Better World" Program

Tue, 07 Feb 2012 22:02:33 +0000

A.C. Moore Arts & Crafts Raises $123,000+ for American Cancer Society® Via Its "Crafting a Better World" Program

A.C. Moore Associates and Customers Raise Funds at All Stores

PR Newswire

BERLIN, N.J., Feb, 7, 2012 /PRNewswire/ -- A.C. Moore Arts and Crafts has raised $123,340 for the American Cancer Society during a recent register campaign at all 133 A.C. Moore (www.acmoore.com) stores.

(Photo: http://photos.prnewswire.com/prnh/20120207/CG49428)

The East coast retailer teamed with the American Cancer Society Making Strides Against Breast Cancer® program created to celebrate breast cancer survivors, educate people about how to reduce their breast cancer risk or find the disease early, and raise funds to end breast cancer. The fundraising program is part of A.C. Moore's "Crafting a Better World Program" which helps local communities. Since its launch in 2010, the program has raised more than $750,000 for not-for-profit organizations that provide services in the communities in which A.C. Moore stores operate.

"Our Crafting a Better World program underscores our commitment to improving the communities where our associates and customers live and work, and support of the American Cancer Society resonated strongly with our customer base, " says Pepe Piperno, Chairman of the Board of A.C. Moore. "We look forward to our 2012 campaign and to helping bring services to those with breast cancer and to helping save lives from the disease."

All 133 A.C. Moore stores participated in the campaign with the top contributions collected from stores in: Wilmington, DE, Lancaster, PA, Clifton, NJ, White Marsh, Md., Moorestown, NJ and Huntington, WV. As part of A.C. Moore's ongoing commitment to local customers, anyone who visited any A.C. Moore store during the campaign was able to donate to the Making Strides Against Breast Cancer program at check out. Special crafting events were also held during the campaign period.

"We are grateful for the efforts of A.C. Moore in the fight against breast cancer," said Terry Music, chief mission delivery officer for the American Cancer Society. "Making Strides enables the American Cancer Society to make strides to end breast cancer and save lives by helping people stay well, helping people get well, by finding cures and fighting back against the disease."

Funds raised through the Making Strides program help the American Cancer Society save lives and create more birthdays by helping people stay well by taking steps to reduce breast cancer risk or find it early; helping people get well by providing information and support during and after a breast cancer diagnosis; by finding cures through investment in groundbreaking breast cancer research; and by fighting back by encouraging lawmakers to pass laws to help defeat breast cancer and by rallying communities worldwide to join the fight.

About A.C. Moore
With 133 stores along the East Coast, A.C. Moore Arts & Crafts, Inc. brings families together for fun through creativity. For more info visit http://www.acmoore.com/, www.facebook.com/acmoore, twitter.com/officialacmoore and www.youtube.com/user/officialacmoore.

SOURCE A.C. Moore

Walk for Warmth - Warming Hearts and Homes in Michigan

Tue, 07 Feb 2012 21:31:55 +0000

Walk for Warmth - Warming Hearts and Homes in Michigan

PR Newswire

CAAs, Utilities, Neighbors Join in Energy Assistance Fund Raisers

LANSING, Mich., Feb. 7, 2012 /PRNewswire-USNewswire/ -- In late February, when most Michiganders prefer to stay indoors, you might notice large groups of young and not so young walkers, traipsing through the streets of your community. Chances are they are taking part in a "Walk for Warmth" fundraiser, sponsored by their local Community Action Agency to raise money to help low income neighbors keep the heat and lights on through our cold, dark winters.

(Photo: http://photos.prnewswire.com/prnh/20120207/DC49390)

There are 30 Community Action Agencies (CAAs) in Michigan, operating in each of the 83 counties. Many sponsor a "Walk for Warmth" or similar fundraiser to support their mission of helping low income families achieve higher levels of economic self-sufficiency. When a household has to spend 25-35 percent of its monthly income for energy, compared to less than 10 percent in more affluent homes, other needs are likely to go unmet. Or they are simply unable to pay their bills, risking dangerous shutoffs and driving them deeper into debt.

The need for help is greater than ever. In recent months, Michigan has seen state and federal support for heating assistance programs wane like a weak winter sun. The federal Low Income Home Energy Assistance Program (LIHEAP) is slated for a 50% cut in FY 2012, and the state's Low Income Energy Efficiency Fund has been replaced by the Vulnerable Household Warmth Fund at 65% of former funding levels. In 2010, 1.2 million Michigan households were eligible for LIHEAP assistance and it's unlikely that number has gone down.

CAAs have long been centers where folks facing hard times could go to get help paying their utility bills and making their homes more energy efficient through the Weatherization Assistance Program and other resources. About 20 years ago, agencies began to supplement the funds they received from state and federal sources with their own fundraising events, eventually creating today's "Walk for Warmth." With drastic cuts being made to LIHEAP and our state assistance programs, private funds to address the need are more important than ever.

That's where events like "Walk for Warmth" come in. The concept is much like other efforts to raise money for worthy causes: "Race for the Cure" for breast cancer awareness, Easter Seals' "Walk with Me" to combat birth defects, are two examples. Participants collect pledges for donations upon completion of the walk or simply make a donation in their own names.

CAAs also enlist corporate sponsors in the effort, many of which contribute cash and in kind donations. Among the leading supporters have been the state's utility companies. DTE, Consumers Energy, and others energy companies provide marketing support and employee volunteers. Working with its hometown CAA in Jackson, for example, Consumers Energy has vowed to match all employee and retiree contribution to any "Walk for Warmth" in the state.

The "Walks" themselves are designed to be fun and are combined with other activities to generate interest. EightCAP, the CAA serving Gratiot, Ionia, Isabella, and Montcalm counties adds a chili cook-off competition to spice up its event. Dickinson-Iron Community Services Agency in the UP offers up a Nordic twist with its cross-country themed "Ski for Warmth." Many agencies recruit local politicians and celebrities to participate—radio disc jockeys and television personalities are great at spreading the word and increasing awareness of the need for funding a vital program.

The number of participants and the amount of money raised by the "Walk for Warmth" events are impressive. Oakland Livingston Human Service Agency expects nearly 1500 residents and 30 sponsors to take part and to collect $180,000 in cash and in kind contributions through its two "Walk" events this year. Collections in the area of $50,000 are not uncommon even among the smaller CAAs. And, as each agency will tell you, the money raised stays in the community and is used only to pay utility bills or for deliverable fuels such as propone and fuel oil for neighbors in need. No "Walk for Warmth" money is used for administrative costs or other unrelated purposes.

Most "Walk for Warmth" events in Michigan are being held in February and March. A complete listing can be found at www.mcaaa.org/events page at MCAAA.org to find out who's holding a Walk in your area and contact your local CAA to find out how to get involved. Participating in a "Walk for Warmth" is like chopping your own firewood: you'll be warmed by it twice—once by the exercise and once more by the feeling in your heart when you've helped a neighbor in need.

Contact: Mike Shalley, +1-517-321-7500, mshalley@mcaaa.org

SOURCE Michigan Community Action Agency Association

Aethlon Medical to Present Hepatitis C (HCV) Treatment Technology at the 32nd Annual Dialysis Conference

Tue, 07 Feb 2012 13:15:00 +0000

Aethlon Medical to Present Hepatitis C (HCV) Treatment Technology at the 32nd Annual Dialysis Conference

PR Newswire

SAN DIEGO, Feb. 7, 2012 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that a presentation of the Aethlon Hemopurifier® to treat Hepatitis C virus (HCV) and other infectious disease conditions will occur at the upcoming 32^nd Annual Dialysis Conference to be held on February 26-28 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. The presentation, which will be given by Aethlon President Rod Kenley, is scheduled to begin at 9:20 am CST on February 28^th.

(Photo: http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b)

The Hemopurifier® is a first-in-class medical device that provides rapid real-time clearance of circulating HCV as well as immunosuppressive proteins shed by the virus. The goal of therapy is to improve benefit, dose, duration and tolerability of current and future drug therapies without introducing drug toxicity and interaction risks. Included among the Hemopurifier® treatment opportunities in HCV are the estimated 300,000 infected dialysis patients that currently live with the virus. As a result of their health-compromised end-stage renal condition, dialysis patients are often unable to tolerate HCV drug therapy dosing and duration, resulting in suboptimal treatment outcomes. To optimize outcomes, Hemopurifier® therapy would be combined with reduced dose drug therapy and conveniently administered during regular dialysis, which is scheduled three times per week with each treatment lasting four hours. In regards to the size of the overall HCV treatment opportunity, it is estimated that approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S.

On February 1, 2012, Aethlon reported that intermittent administration of Hemopurifier® therapy in just the first three days of standard of care peginterferon+ribavirin (PR) drug therapy resulted in immediate and rapid virologic responses in genotype-1 infected HCV patients not on dialysis. An immediate virologic response (IVR) represents a 2-log or 100 fold reduction of HCV RNA at day-7 of therapy and rapid virologic response (RVR) is defined as undetectable HCV RNA at day-30 of the 48-week PR regimen. Average HCV RNA reduction during the three day Hemopurifier® + PR treatment window was 98.79%. In previous studies of HCV-infected dialysis patients, average per treatment reductions of HCV RNA exceeded 50% when Hemopurifier® therapy was included in series with four-hour dialysis sessions in patients not receiving HCV drug therapy.

Aethlon also anticipates that Hemopurifier® therapy could benefit emerging all-antiviral drug cocktails, which face the challenge of overcoming the rate at which viruses attain drug resistance through rapid mutation. The development of drug-resistant strains can occur quickly owing to the extraordinarily high rate of HCV replication. The clearance of circulating hepatitis C virions, including mutant strains, would inhibit the continued replication of drug-resistant viruses and decrease the likelihood of early onset resistance to emerging all-antiviral strategies.

The Extract-1 Study Protocol

The results reported by Aethlon on February 1^st, represent interim data from the first three patients treated with Hemopurifier® therapy under the Extract-1 study protocol, which was initiated in the fall of 2011. Under the Extract-1 study protocol, hard-to-treat genotype 1 HCV patients are enrolled to receive three 6-hour applications of Hemopurifier® therapy during the first three days of standard of care PR therapy. On day one of the Extract-1 protocol, PR therapy is initiated within one hour of first Hemopurifer® therapy completion. Hemopurifier® therapy is then administered again once daily for the next two days in combination with PR therapy. During the Hemopurifier® treatment periods, patients are free to watch movies, read books, and perform other tasks in the comfort of a clinic setting.

Clinical Endpoint Assessments

The aim of the Extract-1 study protocol is to assess the safety and clinical impact of intermittent Hemopurifier® therapy when combined with the first three days of peginterferon+ribavirin (PR) standard-of-care. To date, Hemopurifier® therapy in Extract-1 treated patients has been well tolerated and without device-related adverse events during the Hemopurifier® + PR treatment period. At present, the reported data of the Extract-1 study is not statistically significant and should be considered preliminary. Changes in HCV RNA levels are measured with the Roche Cobas TaqMan assay, which has a quantification limit of 15 IU per milliliter (iu/ml). In addition to measuring changes in HCV RNA, the Extract-1 study protocol will quantify the amount of HCV captured within Hemopurifier® treatment cartridges. The goal of PR treatment is to establish a sustained virologic response (SVR), defined as undetectable HCV RNA 24 weeks after completion of therapy. Primary clinical endpoints of the Extract-1 study measure the impact of Hemopurifier® therapy during the initial phase of PR therapy. Each clinical endpoint is based on changes in HCV RNA from baseline viral load measurements taken prior to Hemopurifier® + PR therapy initiation. These endpoints include:

Day Three (3): the change in HCV RNA from baseline to the end of the Hemopurifier® + PR treatment phase;

Day Seven (7): the change in HCV RNA 7 days from initial baseline. A drop of HCV RNA greater than 2 logs at day 7 is known as an Immediate Virologic Response (IVR). Based on the landmark IDEAL Study of 3,070 HCV genotype-1 patients receiving PR therapy, IVR achievement correlates with 90+% SVR rates, yet is observed in less than 5% of patients;

Day 30: the change in HCV RNA 30 days from initial baseline. Undetectable HCV RNA at day 30 is known as a Rapid Virologic Response (RVR). Based on the IDEAL Study, RVR achievement correlates with an SVR likelihood of 86.2%, which is observed in only 10.35% of patients.

Day 3 Results

Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured on day 3, representing a 3.49 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 99.96% of the overall HCV RNA reduction reported at day-30.

Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 31,550 IU/ml when measured on day 3, representing a 0.80 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 84.21% of the overall HCV RNA reduction reported at day-30.

Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to 54,900 IU/ml when measured on day 3, representing a 1.38 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 95.90% of the overall HCV RNA reduction reported at day-30.

Day 7 Results

On average, the treated patients achieved 2.24 log HCV RNA reduction from baseline at day-7, which is beyond the 2 log reduction that defines the IVR criteria achieved in less than 5% of PR treated patients.

Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 234 IU/ml when measured on day 7, representing a 4.39 log reduction.

Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 17,300 IU/ml when measured on day 7, representing a 1.06 log reduction.

Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to 24,400 IU/ml when measured on day 7, representing a 1.74 log reduction.

Day 30 Results

Two of the three patients achieved a RVR at day 30, which is normally achieved in only 10.35% of patients receiving PR therapy, yet correlates with a 86.2% SVR versus a 30.4% SVR in patients who fail to achieve a RVR. Based on the IDEAL study, it would normally require the enrollment of approximately 20 PR treated patients to accomplish 2 RVR outcomes. It should also be noted that patient E-1.02 missed RVR achievement by 25 iu/ml.

Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to undetectable (<15 IU/ml) when measured on day 30, representing a 5.58 log reduction.

Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 40 IU/ml when measured on day 30, representing a 3.69 log reduction.

Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to undetectable (<15 IU/ml) when measured on day 30, representing a 4.95 log reduction.

Beyond high SVR rates, RVR achievement also provides HCV infected individuals the opportunity to reduce PR duration from 48 to 24 weeks (6-month reduction) in RVR patients that maintain undetectable HCV RNA through week 12 of PR therapy. RVR patients are also unlikely to discontinue PR therapy as a result of a non-virological response, which represents the primary reason why 46% of PR therapy patients don't complete their treatment regimen.

RVR achievement also plays a pivotal role in curbing treatment relapse, defined as undetectable HCV RNA at PR completion that again becomes detectable in the 24-week window after therapy completion. As reflected in the IDEAL study, the time to first undetectable HCV RNA correlates with the incidence of treatment relapse. Approximately 50% of patients who achieve complete HCV suppression for the first time by week 24 of therapy suffer from treatment relapse, while less than 10% of RVR patients relapse from therapy.

The Extract-1 study is being conducted at Medanta, The Medicity Institute (Medicity), a $360 million multi-specialty medical institute recently established to be a premier center for medical tourism in India. The principal investigator of the study is Vijay Kher, M.D., Chairman of the Department of Nephrology at the Medanta Kidney & Urology Institute. Dr. Kher previously served as the principal investigator of Hemopurifier® therapy studies conducted at the Apollo and Fortis hospitals in Delhi, India.

Based on the initial Extract-1 study outcomes, Aethlon will seek permission to open up the treatment study to HCV infected individuals who reside outside of India. The company also plans to expand its GMP manufacturing capabilities and upon quantification of HCV capture within Hemopurifier® treatment cartridges, will resubmit an Investigational Device Exemption (IDE) that will request FDA permission to initiate treatment studies in the U.S. The Company is also interested in collaborative clinical opportunities aimed at determining the synergistic effects of Hemopurifier® therapy combined with non-interferon based drug regimens.

About Aethlon Medical

The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.

Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability to recruit genotype-1 hepatitis C infected patients, including dialysis patients, positive results at the conclusion of the Extract-1 study, the ability to attain permission and to attract patients outside of India, the company's ability to expand its GMP manufacturing capabilities, the Company's ability to attain clinical collaborations to determine the Hemopurifier's® effect with non-interferon based drug regimens, there is no assurance that FDA will approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.

Contacts:

James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com

Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com

John P. Salvador
Director, Communications
858.459.7800 x307
jps@aethlonmedical.com

SOURCE Aethlon Medical, Inc.

Bionovo Announces Findings of Bezielle™ Anticancer Properties and Active Principles

Tue, 07 Feb 2012 13:00:00 +0000

Bionovo Announces Findings of Bezielle™ Anticancer Properties and Active Principles

Studies are published in the Journal of the Public Library of Science One

PR Newswire

EMERYVILLE, Calif., Feb. 7, 2012 /PRNewswire/ -- Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced the publication of two studies that characterize the anticancer properties of its drug Bezielle, and that identify the active principles of the drug. The two papers are published in the Journal of the Public Library of Science One.

(Logo: http://photos.prnewswire.com/prnh/20111110/SF04662LOGO)

"There are various strategies to exploit the differences between normal cells and cancer cells that may allow the selective killing of tumor cells," said Dr. Emma Shtivelman, Director of Cancer Biology at Bionovo. "Bezielle takes advantage of a crucial inherent difference in how cancer cells produce energy for survival and rapid replication. Treatment with Bezielle inhibits cancer cells capacity to produce energy, and induces selective cancer cell death. The distinguishing feature of Bezielle is its ability to shut down both major cellular energy-producing pathways in cancer cells. The analysis of the active chemical components of Bezielle reveals important interactions of this drug with the metabolic pathways."

Bezielle has been evaluated in two early stage clinical trials in women with advanced and metastatic breast cancer, and has shown promising efficacy and excellent safety. Bionovo scientists have shown previously that Bezielle is highly selective toward cancer cells and has little cytotoxic activity towards normal cells. The new studies show that the selectivity of Bezielle is based on the inherent differences in the metabolic properties of cancer versus normal cells. Cell energy producing pathways are utilized and regulated differently in tumor cells that are frequently dependent on glycolysis for survival (known as the Warburg effect). They are efficiently targeted by Bezielle to induce energetic collapse and cell death. The normal cells are spared by Bezielle due to their reliance on mitochondrial energy production. In addition to the mechanistic analysis of Bezielle, the new studies provide a chemical analysis of the active compounds within Bezielle that are responsible for the anti-cancer activity of this drug.

"The two current publications continue to show the promise that Bezielle can provide to cancer patients. We hope to be able to initiate the Phase 2 clinical trials, lead by MD Anderson Cancer Center in Houston, Texas, in the near future," said Dr. Isaac Cohen, Chairman and CEO of Bionovo. "Cancer patients should have an oral, non-toxic drug with a unique mechanism of action as an option for cancer treatment."

Bezielle (BZL101)

Bezielle is an oral drug designed for the treatment of advanced breast cancer with a novel mechanism of action. Bezielle targets diseased cells while leaving normal cells healthy and intact. Normal cells depend primarily on the citric acid cycle (>85%) and very little on glycolysis (<7%) for energy production. Cancer cells depend largely on glycolysis (>85%) for energy production. Bezielle stops the production cycle of energy in cancer cells by inhibiting glycolysis. This leads to DNA damage and cell death in cancer cells while normal cells remain unharmed.

There are currently no effective therapeutic cures for advanced breast cancer and treatment is primarily aimed at palliation of symptoms as well as improving overall survival. Over 200,000 women in the United States are diagnosed with breast cancer each year and breast cancer is the second leading cause of cancer death in women. Although survival after breast cancer treatment is improving, there are still over 40,000 deaths per year due to the disease in the Unites States alone.

Bionovo, Inc.

Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit http://www.bionovo.com.

Forward Looking Statements

This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.

SOURCE Bionovo, Inc.

Abraxane (Breast Cancer) - Analysis and Forecasts to 2020

Tue, 07 Feb 2012 10:16:52 +0000

Abraxane (Breast Cancer) - Analysis and Forecasts to 2020

PR Newswire

NEW YORK, Feb. 7, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Abraxane (Breast Cancer) – Analysis and Forecasts to 2020

http://www.reportlinker.com/p0657216/Abraxane-Breast-Cancer-–-Analysis-and-Forecasts-to-2020.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

Abraxane (Breast Cancer) – Analysis and Forecasts to 2020

Summary

GlobalData's pharmaceuticals report, "Abraxane (Breast Cancer) – Analysis and Forecasts to 2020" provides Abraxane sales forecasts for US, EU5 and Japan. In addition, it covers detailed clinical assessment of the drug, factors impacting drug sales, competitive landscape, and analysis of sales performance during the forecast period (2005-2017). The report also includes information on Breast Cancer market. This report is built using data and information sourced from GlobalData's proprietary databases, primary and secondary research using Company's corporate website, SEC filings, investor presentations and featured press releases, both from company and industry-specific third party sources, put together with in-house analysis, by GlobalData's team of industry experts.Scope

- Therapy area profile including patient population for the US, EU5 and Japan (seven major markets)

- Analysis and review of Abraxane including sales data

- Qualitative and quantitative assessment of market space

- Analysis of the trends, drivers and restraints shaping and defining the markets

- In-depth analysis of Abraxane including efficacy, safety, pricing, competition and other details which influence its sales potential

- Detailed sales forecasts from 2005-2017 for Abraxane in the seven major markets

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return

- Stay ahead of competition by understanding the changing competitive landscape

- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

- Make more informed business decisions from insightful and in-depth analysis of the drug's performance

- Examine the historical sales performance of a drug in seven major markets

- Obtain sales forecast for currently marketed/pipeline drug for 2011-2020 for all seven major markets

1 Table of Contents1 Table of Contents 21.1 List of Tables 31.2 List of Figures 42 Intro duction 52.1 Breast Cancer Market 52.2 Epidemiology 52.3 Etiology and Risk Factors 72.3.1 Age and Gender 72.3.2 Genetic Inheritance 72.3.3 Hormone Replacement Therapy 72.3.4 Radiation 72.3.5 Obesity 72.3.6 Alcohol Consumption 72.3.7 Late Child Birth 72.3.8 Use of Birth Control Pills 72.4 GlobalData Report Guidance 83 Breast Cancer: Market Characterization 93.1 Breast Cancer Market 93.2 Breast Cancer Market Forecasts and CAGR 93.3 Drivers of Breast Cancer Market 103.3.1 Breast Cancer: Most Frequent Cancer in Women 103.3.2 Increasing Breast Cancer Incidence Rate 103.3.3 Decreasing Breast Cancer Mortality Rate 123.3.4 High Survival Rates of Breast Cancer 144 Staging of Breast Cancer: Introduction 154.1 Distribution of Patients by Stages 154.1.1 Stages 155 Predictive Biomarker in the Treatment of Breast Cancer 176 Treatment Options of Breast Cancer 196.1 Stage 0 Breast Cancer 196.2 Early Stage Breast Cancer (Excluding Stage 0) 206.3 Metastatic Breast Cancer (MBC) 226.3.1 Endocrine Treatment: Adjuvant, First Line and Second Line 226.3.2 Cytotoxic Chemotherapy 246.3.3 Management of Patients with HER-2 Positive Patients 267 Abraxane 287.1 Introduction 287.2 Mechanism of Action 287.3 Clinical Studies 287.4 Approval History of Abraxane 297.5 Factors Affecting Sales of Abraxane 297.5.1 No Premedication Required to Prevent Solvent-Related Hypersensitivity 297.5.2 Patent Expiry of Abraxane 297.5.3 Competition from Generics 297.6 Drug Evaluation 307.6.1 Drug Risk Benefit Score 307.6.2 Intensity of Competition 307.7 Sales Forecast 317.7.1 Target Patient Pool of Abraxane 317.7.2 Dosing 317.7.3 Market Penetration 317.7.4 Annual Cost of Therapy 327.7.5 Sales Projections of Abraxane 328 Appendix 418.1 Market Definitions 418.2 Abbreviations 418.3 Research Methodology 418.3.1 Coverage 418.3.2 Secondary Research 428.3.3 Forecasting 428.3.4 Number of Patients Approved to Take the Drug 428.3.5 Net Penetration of Drug 438.3.6 Net Annual Dosing 438.3.7 Annual Cost of Therapy 438.4 Drug Sales Estimates Model 438.5 Contact Us 438.6 Disclaimer 448.7 Sources 44

List of Tables

Table 1: Breast Cancer, Incidences and Mortality, By Country, 2008-2030 5Table 2: Five-Year Relative Survival Rates, 2005, By Stages 14Table 3: Efficacy Results of Phase III trial of Abraxane 29Table 4: Approval History of Abraxane 29Table 5: Drug Risk Benefit Score of Abraxane 30Table 6: Abraxane, Breast Cancer, Global, Annual Cost of Therapy ($), 2011 32Table 7: Abraxane, Breast Cancer, Global Sales Estimates ($m), 2005–2020 33Table 8: Abraxane, Breast Cancer, The US, Sales Estimates ($m), 2005–2020 33Table 9: Abraxane, Breast Cancer, the UK, Sales Estimates ($m), 2009–2020 34Table 10: Abraxane, Breast Cancer, France, Sales Estimates ($m), 2009–2020 35Table 11: Abraxane, Breast Cancer, Germany, Sales Estimates ($m), 2009–2020 36Table 12: Abraxane, Breast Cancer, Italy, Sales Estimates ($m), 2009–2020 37Table 13: Abraxane, Breast Cancer, Spain, Sales Estimates ($m), 2009–2020 38Table 14: Abraxane, Breast Cancer, Japan, Sales Estimates ($m), 2010–2020 39

List of Figures

Figure 1: Distribution by Incidence and Mortality, Most Commonly Diagnosed Cancers, Worldwide, 2010 6Figure 2: Breast Cancer, Global, Market Size Forecasts ($bn), 2010–2020 9Figure 3: Incidence per 100,000, Breast Cancer, Selected Countries, 1975-2005 10Figure 4: Incidence per 100,000, Breast Cancer, Selected Countries, 1975-2005 11Figure 5: Breast Cancer, Incidence, Worldwide, 2008-2030 11Figure 6: All Cancers, Incidence, Worldwide, 2008-2030 12Figure 7: Mortality per 100,000, Breast Cancer, Selected Countries, 1975-2005 12Figure 8: Breast Cancer, Mortality, Worldwide, 2008-2030 13Figure 9: All Cancers, Mortality, Worldwide, 2008-2030 13Figure 10: Broad Classification of Breast Cancer, By Type 15Figure 11: Classification of Non-Invasive Breast Cancer, By CIS 15Figure 12: Classification of Invasive Breast Cancer, By Stages 16Figure 13: Classification of Invasive Breast Cancer, By Treatment 16Figure 14: Current Molecular Biomarkers used in the Clinical Management of Breast Cancer 17Figure 15: Breast Cancer Intrinsic Sub Types used for Deciding Treatment Options for MBC 18Figure 16: Breast Cancer Types in Decreasing Order of their Aggressiveness 18Figure 17: Treatment Options, DCIS Breast Cancer 19Figure 18: Treatment Options, LCIS Breast Cancer 20Figure 19: Classification of Stages I, II and IIIA 20Figure 20: Treatment Options, Stages I, II and IIIA (HR Positive and Premenopausal Breast Cancer) 21Figure 21: Treatment Options, Stages I, II and IIIA (HR Negative, Pre and Postmenopausal Breast Cancer) 21Figure 22: Treatment Options, Stages I, II and IIIA (HR Positive Postmenopausal Breast Cancer) 22Figure 23: Adjuvant Therapy for HR Positive, HER2 Negative Metastatic Breast Cancer 23Figure 24: Hormonal Therapy in Adjuvant Setting in HR Positive, HER2 Negative MBC 23Figure 25: Adjuvant and First Line Therapy for HR Negative, HER2 Negative Metastatic Breast Cancer 25Figure 26: Treatment Options, HR Negative and HER2 Positive Metastatic Breast Cancer 26Figure 27: Drug Model Diagram of Abraxane 31Figure 28: Abraxane, Breast Cancer, Global, Sales Estimates ($m), 2005–2020 32Figure 29: Abraxane, Breast Cancer, the US, Sales Estimates ($m), 2005–2020 33Figure 30: Abraxane, Breast Cancer, the UK, Sales Estimates ($m), 2009–2020 34Figure 31: Abraxane, Breast Cancer, France, Sales Estimates ($m), 2009–2020 35Figure 32: Abraxane, Breast Cancer, Germany, Sales Estimates ($m), 2009–2020 36Figure 33: Abraxane, Breast Cancer, Italy, Sales Estimates ($m), 2009–2020 37Figure 34: Abraxane, Breast Cancer, Spain, Sales Estimates ($m), 2009–2020 38Figure 35: Abraxane, Breast Cancer, Japan, Sales Estimates ($m), 2010–2020 39Figure 36: Abraxane, Breast Cancer, Global, Sales Distribution by Country (%), 2020 40Figure 37: Patients Approved for the Drug 42

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CONTACT
Nicolas Bombourg
Reportlinker
Email: nbo@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626

SOURCE Reportlinker

Genomic Health Announces Formation of New Genetics Subsidiary

Mon, 06 Feb 2012 21:02:00 +0000

Genomic Health Announces Formation of New Genetics Subsidiary

New Venture to Focus on Integrating Clinically Relevant Genetic Information from the Human Genome into Routine Medical Practice

Randy Scott to Lead Subsidiary, Kim Popovits to Assume Role of Chairman of Genomic Health, Julian Baker Named Lead Independent Director of Genomic Health

PR Newswire

REDWOOD CITY, Calif., Feb. 6, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced plans to establish a wholly owned subsidiary with the goal of improving the quality of diagnosis, communication and support for millions of patients and their families faced with common and rare genetic conditions. The subsidiary is expected to be established by March 1, 2012 and provide its first commercial service in 2013. The new venture will be led by Randy Scott, who in his role as Executive Chairman for the past three years has focused on commercial applications of next generation sequencing.

The new subsidiary will focus on accelerating the integration of the human genome into medical practice with an emphasis on bioinformatics and clinical utility. Dr. Scott will be CEO of the new subsidiary and remain a Genomic Health Board member and Kim Popovits, President and Chief Executive Officer, will assume the additional role of Chairman of the Board effective March 1, 2012. In a related action, Julian Baker has been named as Lead Independent Director.

"As the cost of DNA sequencing continues to drop, new medical applications with the potential to impact millions of people are rapidly emerging," said Randy Scott, Executive Chairman of Genomic Health. "We are at a unique turning point in medicine and believe the investment we have made over the past several years in the development of a robust next generation sequencing platform and the capabilities we have established in building a successful cancer genomic business make this the ideal time to expand into both common and rare genetic conditions and expect this new start-up to be a significant long-term contributor to the company's growth."

Genomic Health plans to invest up to $20 million in the new subsidiary over the next two years and has incorporated this into its 2012 financial outlook provided in its separate earnings release issued today. The new venture will focus on commercial applications of the human genome and plans to leverage Genomic Health's research and development as well as third party R&D efforts.

"With our ability to leverage Genomic Health's established commercial infrastructure, clinical laboratory, research and development, and information technology platform, we believe we are uniquely positioned to lead the translation of individual genomic sequencing into real world medical practice by making this investment to expand our business," said Kim Popovits, President and Chief Executive Officer. "Randy has the vision and entrepreneurial track record to lead this exciting new endeavor as we continue our mission to deliver future growth and better outcomes for physicians, patients and payers through Genomic Health."

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a global cancer company focused on the development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to the predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multigame expression test developed for the assessment of risk of recurrence in patients with stage II disease. As of December 31, 2011, more than 10,000 physicians in over 65 countries had ordered more than 265,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and www.mybreastcancertreatment.org.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's plans to establish and invest in a subsidiary focused on clinical and commercial applications of genetics; our expectations regarding the potential for clinical and commercial applications of genetic information; our plans to make genomic services available in 2013; our expectations regarding the subsidiary's future contributions to our long term profit expectations; our expectations regarding the cost of DNA sequencing; our belief regarding our ability to leverage our global infrastructure in cancer to integrate the human genome more broadly into medical practice; our 2012 financial guidance; the focus and attributes of the company's product pipeline; the ability of the company to develop additional tests in the future; and the ability of any potential tests the company may develop to optimize cancer treatment. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our ability to successfully launch a new business in the field of genetics; our ability to develop and commercialize new services or tests and the timing thereof; unanticipated costs or delays in our efforts; the applicability of initial next generation sequencing studies to future results; the risk that the opportunity that we envision for genetics may not exist; the risk that the cost of DNA sequencing may not evolve as we expect; our ability to compete against third parties; the risks and uncertainties associated with the regulation of our tests by the FDA and other agencies abroad; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the period ended September 30, 2011. These forward- looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

SOURCE Genomic Health, Inc.

Genomic Health Announces Year-End 2011 Financial Results, Provides 2012 Financial Outlook

Mon, 06 Feb 2012 21:01:00 +0000

Genomic Health Announces Year-End 2011 Financial Results, Provides 2012 Financial Outlook

- Full-Year Product Revenue Increased 17 Percent Compared with 2010 -

- Delivered Net Income of $7.8 Million -

- Launched Oncotype DX® DCIS Score and MMR Testing -

- Conference Call Today at 4:30 p.m. ET -

PR Newswire

REDWOOD CITY, Calif., Feb. 6, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results and business progress for the year ended December 31, 2011.

Total revenue for the year ended December 31, 2011 increased to $206.1 million, compared with $178.1 million in 2010, an increase of 16 percent. Product revenue was $204.8 million, compared with $174.9 million in 2010, an increase of 17 percent. Contract revenue comprised the balance of total revenue for each of these periods.

Net income was $7.8 million for the year ended December 31, 2011, compared with $4.3 million in 2010. Basic and diluted net income per share applicable to common stockholders was $0.27 and $0.26, respectively in 2011, compared with $0.15 and $0.14 per share, respectively, in 2010.

Total revenue for the fourth quarter of 2011 increased to $53.4 million, compared with $47.1 million in the fourth quarter of 2010. Product revenue was $53.2 million in the fourth quarter of 2011, compared with $46.3 million for the fourth quarter of 2010, an increase of 15 percent. Net income in the fourth quarter of 2011 was $2.6 million, compared with $1.7 million in the fourth quarter of 2010. Basic and diluted net income per share applicable to common stockholders was $0.09 and $0.08, respectively, for the fourth quarter of 2011, compared with $0.06 per share in the fourth quarter of 2010.

"In 2011, we increased our financial strength and generated $7.8 million in profit while making important progress across our commercial and pipeline programs," said Kim Popovits, President and Chief Executive Officer of Genomic Health. "As we look ahead, we remain focused on providing solutions that deliver better outcomes for cancer patients worldwide by continuing to expand our Oncotype DX^® services to include prostate cancer and by accelerating the development of next generation genomic and genetic services."

In a separate press release issued today the company announced plans to establish a wholly owned genetics subsidiary with the intention of making clinically relevant genetic information available to physicians and patients beginning in 2013. Genomic Health plans to invest up to $20 million in the new subsidiary over the next two years and has incorporated this into its 2012 financial outlook provided below.

Additional Year-End and Fourth Quarter 2011 Financial Results

Total operating expenses for the year ended December 31, 2011 were $197.9 million, including cost of product revenues of $33.8 million, compared with total operating expenses for the comparable period in 2010 of $174.2 million, including cost of product revenues of $34.6 million. Included in operating expenses for the year ended December 31, 2011 were non-cash charges of $19.0 million, including $11.7 million of stock-based compensation expense and $7.3 million of depreciation and amortization expenses, compared with non-cash charges for the same period in 2010 of $17.5 million, including $10.3 million of stock-based compensation expense and $7.2 million of depreciation and amortization expenses.

Cash and cash equivalents and short-term investments at December 31, 2011 were $100.5 million, compared with $76.8 million at December 31, 2010, an increase of $23.7 million.

Total operating expenses for the fourth quarter of 2011 were $50.7 million, including cost of product revenues of $7.4 million, compared with total operating expenses for the comparable period in 2010 of $45.8 million, including cost of product revenues of $8.7 million. Included in operating expenses for the fourth quarter of 2011 were non-cash charges of $4.7 million, including $2.9 million of stock-based compensation expense and $1.8 million of depreciation and amortization expenses, compared with non-cash charges for the same period in 2010 of $4.2 million, including $2.3 million of stock-based compensation expense and $1.9 million of depreciation and amortization expenses.

More than 66,600 Oncotype DX test results were delivered for the year ended December 31, 2011, an increase of 16 percent, compared with more than 57,270 test results delivered in 2010. In the fourth quarter of 2011, more than 17,080 Oncotype DX test results were delivered, an increase of 13 percent, compared with more than 15,180 test results delivered in the same period in 2010.

2012 Financial Outlook

The company is providing the following financial guidance for the full year ending December 31, 2012:

Total revenue of $230 to $240 million
Oncotype DX test results delivered of 75,000 to 77,000
Full-year net income of $5 to $8 million before an incremental loss of up to $8 million in new subsidiary

"In 2012, we plan to further strengthen our cancer genomics business by making key investments aimed at driving top-line revenue growth with positive cash from operations," said Dean Schorno, Chief Financial Officer of Genomic Health. "Over the next several years, we plan to aggressively invest in what we believe are significant opportunities presented by our growing worldwide business, the recent launch of our breast cancer DCIS Score, our prostate cancer program and next generation products."

Recent Business Highlights:

Oncotype DX Breast Cancer Commercial Progress

Began providing the Oncotype DX DCIS Score to physicians and patients worldwide.
Established node-positive reimbursement for an additional eight million U.S. lives through policies or arrangements with BCBS Michigan, Tufts Associated Health Maintenance Organization, Presbyterian Health Plan, BCBS South Carolina HMO and Priority Health.
Established Medicaid reimbursement for node-negative breast cancer in Minnesota, Michigan, Vermont and Oregon.
The British Columbia Breast Tumour Group recommended the Ministry of Health begin paying for Oncotype DX for node-negative breast cancer patients in British Columbia, Canada.
Secured reimbursement coverage with a leading German Sick fund for patients participating in a study conducted by the West German Study Group.
NCIC researchers in Canada began enrolling node-positive patients in the NCI-sponsored RxPONDER trial, which requires the Oncotype DX Recurrence Score® for study entry.
Established distribution agreements to provide Oncotype DX in Hungary, Romania and Peru.

Oncotype DX Colon Cancer Commercial Progress

The Journal of Clinical Oncology published results from the landmark QUASAR clinical validation study, which demonstrated that the Oncotype DX colon cancer test predicts recurrence risk in stage II colon cancer patients following surgery.
Began providing mismatch repair (MMR) testing for recurrence risk that allows physicians to identify the approximately 15 percent of stage II colon cancer patients with MMR-deficient tumors, who have low recurrence risk and thus may be more appropriately considered for observation following surgery.
Presented results of the first clinical decision making study of the Oncotype DX colon cancer test at the Gastrointestinal (GI) Cancers Symposium, demonstrating a 29 percent change in treatment recommendations.
Established reimbursement for an additional 3.8 million U.S. lives through policies or arrangements with Wellmark BCBS of Iowa, Wellmark BCBS of South Dakota, Wisconsin Physicians Service Insurance Corporation, Preferred One and AvMed.

Product Pipeline, Peer-Reviewed Publications and Medical Meeting Presentations

Initiated large clinical validation study of prostate cancer test.
Accelerated next generation sequencing (NGS) program in development to be used in clinical studies later this year.
Presented 16 Oncotype DX studies at the San Antonio Breast Cancer Symposium (SABCS) in December, including:
- Complete results from the study of Oncotype DX in patients with DCIS.
- Multiple international studies on changing treatment decisions and/or cost effectiveness of Oncotype DX in the United Kingdom, Germany, France, Ireland, Israel, Canada, Hungary, Japan, Singapore, Australia, and Venezuela.
- Positive results from the first clinical outcomes study for biomarker discovery using NGS for whole transcriptome profiling of fixed tumor specimens.
Presented results from a large clinical study in prostate cancer at the Genitourinary (GU) Cancer Symposium evaluating the relationship of microRNAs, a novel class of biomarkers, to clinical outcomes for patients with early stage prostate cancer.

Conference Call Details

To access the live conference call on February 6 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada or +1(224) 357-2389 internationally. Please dial in approximately ten minutes prior to the start of the call. A telephone replay will be available beginning approximately two hours after the call through February 13, and may be accessed by dialing (855) 859-2056 from the United States and Canada or +1(404) 537-3406 internationally. The replay passcode is 45978166.

To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company's Web site at http://investor.genomichealth.com. Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a global cancer company focused on the development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to the predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. As of December 31, 2011, more than 10,000 physicians in over 65 countries had ordered more than 265,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and www.mybreastcancertreatment.org.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's 2011 fourth quarter and annual results; 2012 financial guidance, including the company's expectations regarding the number of test results delivered, total revenue and net income before investments; our plans to focus on continuing to expand our Oncotype DX services and to accelerate our next generation product development, and the focus of new product development; our expectations regarding the business of a subsidiary to be formed; our belief regarding our ability to leverage our global infrastructure in cancer to integrate the human genome more broadly into medical practice; our plans to make investments aimed at driving top-line revenue growth with positive cash from operations; our plans to invest in our business and the amounts and areas of investments; the focus and attributes of the company's product pipeline; the ability of the company to develop additional tests in the future; and the ability of any potential tests the company may develop to optimize cancer treatment. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the results of clinical and developmental studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and the timing thereof; unanticipated costs or delays in research and development efforts; the applicability of initial next generation sequencing studies to future results; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop, both domestically and abroad; our ability to compete against third parties; the risks and uncertainties associated with the regulation of our tests by the FDA and other agencies abroad; the results of our year end audit; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the period ended September 30, 2011. These forward- looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

Genomic Health, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)

	For the Three Months Ended		For the Twelve Months Ended
	December 31,		December 31,
	2011	2010	2011	2010
	(Unaudited)		(Unaudited)

REVENUES:
Product revenues	$ 53,155	$ 46,317	$ 204,766	$ 174,870
Contract revenues	242	799	1,345	3,231
Total revenues	53,397	47,116	206,111	178,101

OPERATING EXPENSES:
Cost of product revenues	7,352	8,707	33,832	34,634
Research and development	10,282	9,272	39,864	33,225
Selling and marketing	22,393	18,536	83,613	71,405
General and administrative	10,638	9,278	40,543	34,913
Total operating expenses	50,665	45,793	197,852	174,177

Income from operations	2,732	1,323	8,259	3,924

Interest income	4	58	221	232
Other income (expense), net	(14)	(18)	(205)	(4)

Income before income taxes	2,722	1,363	8,275	4,152

Income tax expense (benefit)	163	(322)	429	(136)

Net income	$ 2,559	$ 1,685	$ 7,846	$ 4,288

Basic net income per share	$ 0.09	$ 0.06	$ 0.27	$ 0.15
Diluted net income per share	$ 0.08	$ 0.06	$ 0.26	$ 0.14

Shares used to compute basic net income per share	29,644	28,910	29,395	28,815
Shares used to compute diluted net income per share	31,062	29,763	30,754	29,653

Genomic Health, Inc.
Condensed Consolidated Balance Sheets
(in thousands)

	As of	As of
	December 31, 2011	December 31, 2010
	(Unaudited)	(Unaudited)
Cash and cash equivalents	$ 32,869	$ 31,183
Short-term investments	67,605	45,635
Accounts receivable, net	21,077	14,306
Prepaid expenses and other current assets	7,444	6,541
Total current assets	128,995	97,665

Property and equipment, net	9,443	10,345
Restricted cash	107	608
Other assets	4,453	2,243
Total assets	$ 142,998	$ 110,861

Accounts payable	$ 7,025	$ 3,968
Accrued expenses and other current liabilities	17,265	16,305
Deferred revenues	2,060	2,821
Other liabilities	1,289	1,657
Stockholders’ equity	115,359	86,110
Total liabilities and stockholders’ equity	$ 142,998	$ 110,861


The condensed consolidated balance sheet at December 31, 2010 has been derived from the
audited consolidated financial statements at that date included in the Company's Form 10-K
for the fiscal year ended December 31, 2010.

SOURCE Genomic Health, Inc.

Survival Rate of Cancer Patients in Korea Ranked in the Top in the World

Mon, 06 Feb 2012 15:17:52 +0000

Survival Rate of Cancer Patients in Korea Ranked in the Top in the World

PR Newswire

SEOUL, South Korea, Feb. 6, 2012 /PRNewswire-Asia/ -- As the whole world battles against cancer, the survival rate of cancer patients in Korea has shown a great improvement. Cancer is still the number one cause of death in Korea, but about half of Korean cancer patients have, in recent times, managed to survive for more than ten years, which illustrates that world class cancer treatments are available in Korea.

The Korean government recently announced that the survival rate of Korean cancer patients had improved from 59.5% in 2008 to 62.0% in 2009, while the cancer mortality rate showed a 19% decrease in 2006 and a 21% decrease in 2008. In addition, the 2011 Health Care Quality Indicators released by OECD member countries indicated that Korea excelled in the treatment of uterine cancer and that its survival rate for stomach cancer, 65.3%, well surpassed those of the USA (26%), Europe (24.9%), Japan (62.1%) and Canada (22%). In addition, the survival rate from thyroid cancer in Korea is 99.7% while that of breast cancer is 90.6%.

Similarly, Korean Ministry of Health & Welfare carried out an interim assessment of the '10-Year Plan to Conquer Cancer' and found out that the plan had exceeded its initial objective in 2011. Thus, the Ministry upgraded the survival rate target by 2015 from 54% to 67% following the deliberation by the National Cancer Management Committee. Cancer survival rate refers to the percentage of people able to survive five years after being diagnosed with and treated for cancer. It actually means the complete recovery rate.

Such excellent survival rates for Korean cancer patients have been due to the continuous efforts of the government to manage cancer and advance the medical technology. Korea has been building its reputation in robot-assisted surgery, a cutting edge cancer treatment technology, which has every year attracted many medical experts from Japan, Taiwan and many other countries to the National Cancer Center to learn the robot-assisted surgical techniques.

Proton therapy at the National Cancer Center is one of the most renowned cancer treatment techniques in Korea. Proton therapy is a type of particle therapy that uses hydrogen ions, which are 1800 times heavier than electrons. Protons accelerated by a cyclotron irradiate a human body containing cancerous tumors in order to destroy the DNA contained by these tumors.

For more information:
Please contact Yang Ji-young of the Korea Health Development Institute's Global Healthcare Business Department at+82-43-713-8248 or kknmk0612@gmail.com.

SOURCE Korea Health Development Institute