EIN Presswire: Biotechnology Live Feed Press Releases

New England Biolabs Signs Agreement with Synthetic Genomics Inc. to Launch Gibson Assembly™ Master Mix for Molecular and Synthetic Biology Applications

Tue, 07 Feb 2012 22:00:00 +0000

New England Biolabs Signs Agreement with Synthetic Genomics Inc. to Launch Gibson Assembly™ Master Mix for Molecular and Synthetic Biology Applications

PR Newswire

IPSWICH, Mass. and LA JOLLA, Calif., Feb. 7, 2012 /PRNewswire/ -- New England Biolabs, Inc. (NEB) and Synthetic Genomics, Inc. (SGI) jointly announce that they have entered into a licensing agreement whereby NEB will introduce a master mix based on Gibson Assembly™, a revolutionary technology developed by Dr. Daniel Gibson and his colleagues at the J. Craig Venter Institute (JCVI) as part of a program sponsored by SGI. The financial details of this agreement were not disclosed.

(Logo: http://photos.prnewswire.com/prnh/20090921/NE79207LOGO-b )

Gibson Assembly enables the rapid assembly of multiple DNA fragments using a one-step, isothermal approach. Since its introduction to the life science community in 2009, Gibson Assembly has become a mainstay in the laboratories of many synthetic biologists and is catching on in the wider life science community due to its ease-of-use, robustness and flexibility.

"New England Biolabs is delighted to work with SGI to introduce Gibson Assembly to our customers. As a leader in the discovery and development of cloning tools and technologies, NEB has embraced this approach for building DNA constructs, and believes that it will open new opportunities for the manipulation of complex DNAs," states Richard J. Roberts, Ph.D., Chief Scientific Officer, NEB.

"The Gibson Assembly method is a powerful tool that we believe will enable synthetic biology researchers to make rapid advances leading to new discoveries and products," said J. Craig Venter, Ph.D., Founder and CEO, SGI. "SGI is pleased to work with industry leader NEB in commercializing this product."

The Gibson Assembly Master Mix includes protocols for primer design, and can be used for assembly of multiple DNA fragments, including linearized vector and insert. For more information about the Gibson Assembly Master Mix, visit www.neb.com/gibsonassembly

About New England Biolabs 
Established in the mid 1970's, New England Biolabs, Inc. is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. NEB continues to expand its product offerings into areas related to PCR, gene expression, sample preparation for next generation sequencing, cellular analysis, epigenetics and RNA analysis. Additionally, NEB is focused on strengthening alliances that enable new technologies to reach key market sectors. New England Biolabs is a privately held company, headquartered in Ipswich, MA and has extensive worldwide distribution through a network of exclusive distributors, agents and six subsidiaries located in Canada, China, France, Germany, Japan and the UK. For more information about New England Biolabs visit www.neb.com 

About Synthetic Genomics
SGI, a privately held company founded in 2005, is dedicated to developing and commercializing genomic-driven solutions to address global energy and environment challenges. Advances in synthetic genomics present limitless applications in a variety of product areas, including: energy, chemicals and pharmaceuticals. The company's main research and business programs are currently focused on the following major bioenergy areas: designing advanced biofuels with superior properties compared to ethanol and biodiesel; harnessing photosynthetic organisms to produce value added products directly from sunlight and carbon dioxide; developing new biological solutions to increase production and/or recovery rates of subsurface hydrocarbons and developing high-yielding, more disease resistant and economic feedstocks. For more information go to www.syntheticgenomics.com

Gibson Assembly is a trademark of Synthetic Genomics, Inc.

SOURCE New England Biolabs

Synthetic Genomics, Inc. Announces Agreement with New England Biolabs to Launch Gibson Assembly™ Master Mix Product for Synthetic and Molecular Biology Applications

Tue, 07 Feb 2012 22:00:00 +0000

Synthetic Genomics, Inc. Announces Agreement with New England Biolabs to Launch Gibson Assembly™ Master Mix Product for Synthetic and Molecular Biology Applications

PR Newswire

LA JOLLA, Calif. and IPSWICH, Mass., Feb. 7, 2012 /PRNewswire/ -- Synthetic Genomics, Inc. (SGI), a privately held company commercializing and developing genomic-driven solutions to solve a variety of global needs, and New England Biolabs, Inc. (NEB), today jointly announced that they have entered into a non-exclusive licensing agreement whereby NEB will commercialize the Gibson Assembly™ Master Mix. This product is based on the Gibson Assembly™ method which was developed by Daniel Gibson, Ph.D., and colleagues at the J. Craig Venter Institute (JCVI) as part of a program sponsored by SGI. The financial details of the agreement were not disclosed.

Gibson Assembly uses a one-step, isothermal approach to enable the rapid assembly of multiple DNA fragments. Since its introduction to the life science community in 2009, the Gibson Assembly method has become a mainstay in many synthetic biology laboratories and has attracted interest from both the academic and commercial life sciences community due to its ease-of-use, robustness and flexibility.

The Gibson Assembly Master Mix includes protocols for primer design, and can be used for assembly of multiple DNA fragments, including linearized vector and insert. NEB's Gibson Assembly™ Master Mix can be used by researchers to assemble such synthetic nucleic acids into larger genetic constructs. The Gibson Assembly Master Mix is available for order through the NEB website (www.neb.com).

SGI also recently signed an agreement with Integrated DNA Technologies (IDT) to manufacture, market, and commercialize custom synthetic double-stranded nucleic acids of lengths up to 5 kb using SGI's proprietary technologies.

In May 2010 J. Craig Venter Institute researchers announced the successful construction of the first self-replicating synthetic bacterial cell, work that took years to complete and was enabled only through development of new tools and technologies. One such tool was Gibson Assembly. SGI sponsored this work at JCVI and controls the licensing of the technologies.

Gibson Assembly™ is a trademark of Synthetic Genomics, Inc.

About Synthetic Genomics, Inc.

SGI, a privately held company founded in 2005, is dedicated to developing and commercializing genomic-driven solutions to address a wide range of global challenges. The company is focused on several key research and business programs including: developing algae biofuels in alliance with Exxon Mobil Research and Engineering Company, microbial-enhanced hydrocarbon recovery and conversion through an agreement with BP, new and improved food and nutritional products, and clean water technologies. SGI is also involved in synthetically derived vaccine development through Synthetic Genomic Vaccines Inc. (SGVI), a company co-founded with the J. Craig Venter Institute; and to developing sustainable crops and agricultural products through Agradis Inc., a company co-founded with Plenus S.A. de C.V. For more information go to: www.syntheticgenomics.com.

About New England Biolabs

Established in the mid 1970's, New England Biolabs, Inc. is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. NEB continues to expand its product offerings into areas related to PCR, gene expression, sample preparation for next generation sequencing, cellular analysis, epigenetics and RNA analysis. Additionally, NEB is focused on strengthening alliances that enable new technologies to reach key market sectors. New England Biolabs is a privately held company, headquartered in Ipswich, MA and has extensive worldwide distribution through a network of exclusive distributors, agents and six subsidiaries located in Canada, China, France, Germany, Japan and the UK. For more information about New England Biolabs visit www.neb.com.

SGI Media Contact:
Heather Kowalski, hkowalski@syntheticgenomics.com, 858-361-0466

NEB Media Contact:
Deana Martin, martin@neb.com, 978-380-7464

SOURCE Synthetic Genomics, Inc.

MethylGene to Present at the 14th Annual BIO CEO & Investor Conference

Tue, 07 Feb 2012 21:46:33 +0000

MethylGene Inc. (TSX:MYG) announced today that Mr. Charles Grubsztajn, President and Chief Executive Officer, will present a corporate overview of the Company on Monday, February 13 at 4:30 p.m. EST, at the 14^th Annual BIO CEO & Investor Conference. The event is being held at the The Waldorf=Astoria Hotel in New York, NY.

Mr. Grubsztajn's presentation will be available live via webcast at www.methylgene.com.

About MethylGene

MethylGene Inc. (TSX:MYG) is a clinical-stage biopharmaceutical company that develops novel therapeutics for cancer and infectious disease. The Company's lead product candidates include: MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase 1/2 clinical trials for solid tumor cancers, and MGCD290, a fungal Hos2 inhibitor, for use in combination with fluconazole for fungal infections, which will start randomized Phase 2 trials in the near term. The Company's partners include Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc.

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the results of clinical trials; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD265, MGCD290 or mocetinostat (MGCD0103); the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or mocetinostat, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD265 , MGCD 290 or mocetinostat. Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2010, under the heading "Risk Factors" which you are urged to read and all other documents filed by the Company that can be found at www.sedar.com. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as an update on the date they are made and MethylGene is under no obligation to revise such statements as a result of any event, circumstance or otherwise except in accordance with law.

Joseph Walewicz
Vice President, Business & Corporate Development
MethylGene Inc.
514-337-3333 ext. 373
ir@methylgene.com
www.methylgene.com
Thomas Fechtner
Vice President
The Trout Group LLC
646-378-2931
tfechtner@troutgroup.com
www.troutgroup.com

Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2011 Financial Results Conference Call on Monday, February 27, 2012

Tue, 07 Feb 2012 21:15:00 +0000

Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2011 Financial Results Conference Call on Monday, February 27, 2012

PR Newswire

EAST BRUNSWICK, N.J., Feb. 7, 2012 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that the Company's fourth quarter and year-end 2011 financial results will be released prior to the open of the market on Monday, February 27, 2012.

David Y. Norton, Interim Chief Executive Officer, Kenneth J. Zuerblis, Executive Vice President and Chief Financial Officer and Louis Ferrari, Executive Vice President, President North American Commercial Operations will host an investment community conference call beginning at 9:00 a.m. Eastern Time on February 27, 2012 to discuss these results and to answer questions.

To participate by telephone, please dial 866-393-1565 (Domestic) or 253-237-1151 (International). The conference ID number is 49538226. The live and archived webcast can be accessed on the investor relations section of the Savient website at www.savient.com. Please log on to Savient's website fifteen minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.

A telephone replay will be available from 12:00 p.m. Eastern Time on February 27, 2012 through 12:00 a.m. Eastern Time on March 7, 2012 by dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering conference ID number 49538226.

ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA® (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University ("Duke") and Mountain View Pharmaceuticals, Inc. ("MVP"). Duke developed the recombinant uricase enzyme and MVP developed the PEGylation technology used in the manufacture of KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents covering the composition, manufacture and methods of use and administration of KRYSTEXXA. Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. For more information, please visit the Company's website at www.savient.com.

SVNT-I

Contact:
Mary Coleman	Carney Noensie
Savient Pharmaceuticals, Inc.	Burns McClellan
(732) 418-9300	(212) 213-0006
information@savient.com	cnoensie@burnsmc.com

SOURCE Savient Pharmaceuticals, Inc.

NuPathe to Present at Upcoming Investor Conferences

Tue, 07 Feb 2012 21:05:00 +0000

NuPathe Inc. (NASDAQ: PATH), an emerging biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced that Jane Hollingsworth, chief executive officer, will present company overviews at two upcoming investor conferences.

On Tuesday, February 14, 2012, NuPathe will present at the 14th Annual BIO CEO & Investor Conference at 3:00 p.m. EST. The conference is being held at The Waldorf Astoria Hotel in New York, NY.

On Wednesday, February 15, 2012, NuPathe will present at the Leerink Swann 2012 Global Healthcare Conference at 4:00 p.m. EST. The conference is also being held at The Waldorf Astoria Hotel in New York, NY.

Live audio webcasts of the presentations will be available via the "Investor Relations" page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time. Replays of the webcasts will also be archived on NuPathe's website for 90 days following the presentation.

About NuPathe
NuPathe Inc. (www.nupathe.com) is an emerging biopharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product candidate, NP101, is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to NP101, NuPathe has two additional proprietary product candidates in preclinical development: NP201 for the continuous symptomatic treatment of Parkinson's disease, which the company plans to partner, and NP202 for the long-term treatment of schizophrenia and bipolar disorder.

Contact Information:

John Woolford
Westwicke Partners, LLC
(443) 213-0506
john.woolford@westwicke.com

Keith A. Goldan
Vice President & Chief Financial Officer
NuPathe Inc.
(484) 567-0130

Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences

Tue, 07 Feb 2012 21:05:00 +0000

Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences

PR Newswire

CAMBRIDGE, Mass., Feb. 7, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc., (NASDAQ: IDIX) announced today that Idenix management will present a corporate overview at the 14th Annual BIO CEO & Investor Conference on February 14, 2012 at 10:00 a.m. ET at the Waldorf Astoria, New York City and at the Leerink Swann 2012 Global Healthcare Conference on February 15, 2012 at 3:00 p.m. ET at the Waldorf Astoria, New York City.

The live and archived webcasts of the company presentations can be accessed under "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 5-10 minutes before each event to ensure a timely connection. The archived replay will be available on the Idenix website for two weeks following the conferences.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with chronic hepatitis C infection. For further information about Idenix, please refer to http://www.idenix.com.

Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Teri Dahlman (617) 995-9807 (investors)

SOURCE Idenix Pharmaceuticals, Inc.

Codexis Reports Fourth Quarter and Full Year 2011 Results

Tue, 07 Feb 2012 21:05:00 +0000

Codexis Reports Fourth Quarter and Full Year 2011 Results

49% Annual Increase in Pharmaceutical Product Sales

CodeXyme™ Cellulase Enzymes and CodeXol™ Detergent Alcohol Product Lines Launched

PR Newswire

REDWOOD CITY, Calif., Feb. 7, 2012 /PRNewswire/ -- Codexis, Inc. (NASDAQ: CDXS), a developer of industrial enzymes to enable the production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced financial results for the fourth quarter and year ended December 31, 2011.

“In 2011, we launched our CodeXyme™ cellulase enzymes and CodeXol™ detergent alcohol product lines,” said Alan Shaw, Ph.D., President and CEO of Codexis, Inc. “In 2012 we are focused on delivering world-class CodeXyme™ cellulase enzymes to our development partners, piloting production of CodeXol™, and delivering continued sales growth in our pharmaceuticals products and services”.

Full Year 2011 Financial Highlights:

Revenue: For fiscal 2011, the company reported revenues of $123.9 million, an increase of $16.8 million or 16% over fiscal 2010 revenue of $107.1 million. Product revenue of $49.0 million increased $16.2 million or 49% over the prior year, driven by increased sales to both generic and innovator pharmaceutical customers. Collaborative R&D revenue of $71.4 million increased $1.2 million from $70.2 million over the prior year.

Operating Expenses: Research and development expenses for fiscal 2011 were $61.0 million, compared to $52.4 million for fiscal 2010. The increase was primarily due to additional headcount and amortization related to intellectual property purchased from Maxygen, Inc. Selling, general and administrative expenses for fiscal 2011 increased to $36.9 million compared to $33.8 million for fiscal 2010, driven by higher stock compensation expense and higher compensation expense due to headcount increases.

Net Loss: Net loss was ($16.6) million, or ($0.46) per share, based on 35.7 million weighted average common shares outstanding for fiscal year 2011. This compares to a net loss of ($8.5) million or ($0.35) per share for fiscal 2010.

Adjusted EBITDA: On a non-GAAP basis, Adjusted EBITDA was $4.3 million for fiscal 2011 compared to $9.9 million for fiscal 2010. Adjusted EBITDA is calculated by adjusting net loss for net interest expense, income taxes, depreciation, amortization, stock-based compensation and preferred stock warrant fair market valuation. A reconciliation of net loss to Adjusted EBITDA is presented below.

Cash: Cash, cash equivalents and marketable securities at December 31, 2011, was $63.8 million compared to $74.1 million at December 31, 2010. The company used ($0.5) million in cash from operations in fiscal 2011.

Fourth Quarter 2011 Financial Highlights:

Revenue: For the fourth quarter of 2011, the company reported revenues of $33.5 million, an increase of $3.7 million or 12% over $29.8 million in the fourth quarter of 2010. Product revenue increased $6.9 million or 80% over the same time period of 2010.

Operating Expenses: Research and development expenses in the fourth quarter of 2011 were $15.5 million, compared to $13.3 million for the fourth quarter of 2010. The increase was primarily due to additional headcount for the development of CodeXol™ Detergent Alcohol. Selling, general and administrative expenses in the fourth quarter of 2011 increased to $9.8 million, compared to $8.6 million over the same time period of 2010, related to use of consultants, legal costs associated with intellectual property patent filing and increased costs related to SOX compliance.

Net Loss: Net loss was ($5.3) million, or ($0.15) per share, based on 36.0 million weighted average common shares outstanding in the fourth quarter of 2011. This compares to a net loss of ($0.5) million or ($0.01) per share during the fourth quarter of 2010.

Adjusted EBITDA: On a non-GAAP basis, Adjusted EBITDA decreased from $4.4 million in the fourth quarter of 2010 to ($0.2) million in the fourth quarter of 2011. Adjusted EBITDA is calculated by adjusting net loss for net interest expense, income taxes, depreciation, amortization, stock-based compensation and preferred stock warrant fair market valuation. A reconciliation of net loss to Adjusted EBITDA is presented below.

Cash: Cash, cash equivalents and marketable securities at December 31, 2011 was $63.8 million compared to $70.6 million at September 30, 2011. The company used ($2.9) million in cash from operations in the fourth quarter.

Outlook

Codexis' statements with regard to its outlook are based on current expectations. The following statements are forward looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full year 2012, Codexis forecasts revenues in line with or exceeding 2011 results. Codexis expects 2012 Adjusted EBITDA will be positive.

Conference Call

Codexis will hold a conference call for investors on February 7, 2012 at 1:30 p.m. PT (4:30 p.m. ET). The conference call dial-in numbers are US: 866-788-0541 or International: 857-350-1679, access code 54501345. A live webcast of the call will also be available from the Investor Relations section of www.codexis.com. A recording of the call will be available by calling US: 888-286-8010 or International: 617-801-6888, access code 84268524 beginning approximately two hours after the call, and will be available for up to thirty days. A webcast replay from today's call will also be available from the Investor Relations section of www.codexis.com approximately two hours after the call and will be available for up to thirty days.

About Codexis, Inc.

Codexis is an industrial biotechnology company developing enzymes for the production of high value sustainable chemicals, clean fuels, cost effective pharmaceutical processes and renewable bioindustrial ingredients to make industry more efficient, productive and profitable. Partners and customers include global leaders such as Shell, Merck and Pfizer. For more information, see www.codexis.com.

Forward-Looking Statements

This press release contains forward-looking statements relating to Codexis' forecast for 2012 revenue and Adjusted EBITDA, and Codexis’ ability to deliver CodeXyme™ cellulase enzymes to its development partners in 2012, pilot production of CodeXol™ in 2012, and deliver sales growth in its pharmaceuticals products and services in 2012. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control and that could materially affect actual results. Factors that could materially affect actual results include the risks that our operating results may fluctuate in the future, that we have a history of net losses and that we may be unable to successfully commercialize our technology in biofuels. Additional factors that could materially affect actual results can be found in Codexis' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2011, including under the caption "Risk Factors." Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Codexis, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In Thousands, Except Per Share Amounts)

		Three Months Ended			Year Ended
		December 31,			December 31,
		2011	2010	% change	2011	2010	% change
	Revenues:
	Product	$ 15,493	$ 8,586	80%	$ 49,021	$ 32,835	49%
	Collaborative research and development	17,296	20,746	-17%	71,368	70,196	2%
	Government grants	705	479	47%	3,476	4,073	-15%

	Total revenues	33,494	29,811	12%	123,865	107,104	16%

	Costs and operating expenses:
	Cost of product revenues	13,067	8,126	61%	41,781	27,982	49%
	Gross margin $	2,426	460	427%	7,240	4,853	49%
	Gross margin %	16%	5%		15%	15%

	Research and development	15,548	13,349	16%	61,049	52,405	16%
	Selling, general and administrative	9,782	8,649	13%	36,942	33,841	9%
					.	.
	Total costs and operating expenses	38,397	30,124	27%	139,772	114,228	22%

	Loss from operations	(4,903)	(313)	1466%	(15,907)	(7,124)	123%

	Interest income	77	31	148%	273	166	64%
	Interest expense and other, net	(297)	(153)	94%	(675)	(1,199)	-44%

	Loss before provision for income taxes	(5,123)	(435)	1078%	(16,309)	(8,157)	100%

	Provision for income taxes	174	60	190%	241	384	-37%
	Net loss	$ (5,297)	$ (495)	970%	$ (16,550)	$ (8,541)	94%

	Net loss per share of common stock,
	basic and diluted	$ (0.15)	$ (0.01)		$ (0.46)	$ (0.35)

	Weighted average common shares used in computing net loss per share of common stock, basic and diluted	35,965	34,452		35,674	24,594

Codexis, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In Thousands)

	December 31,	December 31,
	2011	2010
Assets
Current assets:
Cash and cash equivalents	$ 25,762	$ 72,396
Marketable securities	27,720	-
Accounts receivable, net	18,917	15,333
Inventories	4,488	2,817
Prepaid expenses and other current assets	2,345	1,646
Total current assets	79,232	92,192

Restricted cash	1,511	1,466
Non-current marketable securities	10,348	1,650
Property and equipment, net	24,176	21,452
Intangible assets, net	16,442	20,158
Goodwill	3,241	3,241
Other non-current assets	972	1,141
Total assets	$ 135,922	$ 141,300

Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$ 10,364	$ 9,208
Accrued compensation	6,785	8,107
Other accrued liabilities	7,354	5,630
Deferred revenues	3,789	4,539
Total current liabilities	28,292	27,484

Deferred revenues, net of current portion	1,485	5,074
Other long-term liabilities	3,455	1,381
Total liabilities	33,232	33,939

Stockholders' equity:
Common stock	4	4
Additional paid-in capital	287,792	275,540
Accumulated other comprehensive income (loss)	(407)	(34)
Accumulated deficit	(184,699)	(168,149)
Total stockholders' equity	102,690	107,361
Total liabilities, and stockholders' equity	$ 135,922	$ 141,300

Codexis, Inc.
Condensed Consolidated Statements of Cash Flow
(Unaudited)
(In Thousands)

	Year Ended
	December 31,
	2011		2010
Operating activities:
Net loss	$ (16,550)		$ (8,541)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of intangible assets	3,716		1,063
Depreciation and amortization of property and equipment	7,755		7,246
Revaluation of redeemable convertible preferred stock warrant liability	-	0	677
Loss (gain) on disposal of property and equipment	49		148
Gain from extinguishment of asset retirement obligation	(124)		-
Extinguishment of royalty payable	-		461
Stock-based compensation	9,431		8,737
Accretion of asset retirement obligation	39		146
Amortization of debt discount	-		26
Accretion (amortization) of premium/discount on marketable securities	771		511
Changes in operating assets and liabilities:
Accounts receivable	(3,583)		(8,087)
Inventories	(1,671)		98
Prepaid expenses and other current assets	(682)		13
Other assets	513		2,814
Accounts payable	1,156		(2,105)
Accrued compensation	(1,322)		1,589
Other accrued liabilities	4,351		(6,048)
Deferred revenues	(4,339)		(15,131)
Net cash used in operating activities	(490)		(16,383)

Investing activities:
Increase in restricted cash	(45)		(735)
Purchase of property and equipment	(10,736)		(6,990)
Purchase of marketable securities	(52,564)		(49,051)
Purchase of Maxygen patent portfolio			(20,705)
Proceeds from sale of marketable securities	6,037		1,605
Proceeds from maturities of marketable securities	8,500		70,695
Proceeds from disposal of property and equipment			15
Net cash used in investing activities	(48,808)		(5,166)

Financing activities:
Principal payments on financing obligations	-		(8,026)
Payments in preparation for initial public offering	-		(3,870)
Proceeds from issuance of common stock on IPO, net of underwriting discounts	-	-	72,541
Proceeds from exercises of stock options	2,579		1,594
Net cash provided by financing activities	2,579		62,239

Effect of exchange rate changes on cash and cash equivalents	85		(79)

Net increase (decrease) in cash and cash equivalents	(46,634)		40,611
Cash and cash equivalents:
Beginning of the period	72,396		31,785
End of the period	25,762		72,396

Marketable securities at the end of period	38,068		1,650

Cash, cash equivalents and marketable securities	$ 63,830		$ 74,046


Reclassification of preferred stock warrant from liability to additional paid-in capital			$ 2,686
Conversion of preferred stock to common stock and additional paid-in capital			$ 179,672

Reconciliation of GAAP to Non-GAAP Financial Information

In this press release, in addition to GAAP financial results, we present Adjusted EBITDA because we believe it assists investors and analysts in comparing our performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance. In addition, we use Adjusted EBITDA to evaluate the effectiveness of our business strategies.

A reconciliation of GAAP net loss to Adjusted EBITDA is included in the table below.

Codexis, Inc.
Reconciliation of GAAP Net Loss to Adjusted EBITDA
(Unaudited)
(In Thousands)

	Three Months Ended		Year Ended
	December 31,		December 31,
Calculation of Adjusted EBITDA	2011	2010	2011	2010
Net loss	$(5,297)	$ (495)	$(16,550)	$(8,541)
Adjustments:
Minus: Interest income	(77)	(31)	(273)	(166)
Plus: Interest expense	-	5	-	529
Plus: Income taxes	174	60	241	384
Plus: Depreciation and amortization	3,006	2,609	11,471	8,309
Plus: Stock-based compensation	2,038	2,271	9,431	8,737
Plus: Preferred stock warrant fair market valuation adjustment	-	-	-	677

Adjusted EBITDA	$ (156)	$4,419	$ 4,320	$ 9,929

Adjusted EBITDA has limitations as an analytical tool. Some of these limitations are:

Adjusted EBITDA does not reflect our cash expenditures, or future requirements, for capital expenditures or contractual commitments;
Adjusted EBITDA does not reflect changes in, or cash requirements for, our working capital needs;
Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and Adjusted EBITDA does not reflect any cash requirements for such replacements; and
Non-cash compensation is and will remain a key element of our overall long-term incentive compensation package, although we exclude it as an expense when evaluating our ongoing operating performance for a particular period.

Because of these limitations, Adjusted EBITDA should not be considered in isolation or as a substitute for performance measures calculated in accordance with GAAP. We compensate for these limitations by relying primarily on our GAAP results and using Adjusted EBITDA only supplementally.

Contacts:
Investors: Jay Sarwar, ir@codexis.com, 650-421-8331
Media: Lyn Christenson, lyn.christenson@codexis.com, 650-421-8144 or Saskia Sidenfaden, ssidenfaden@mww.com, 212-827-3771.

SOURCE Codexis, Inc.

Life Technologies Announces Fourth Quarter and Fiscal Year 2011 Results

Tue, 07 Feb 2012 21:01:00 +0000

Life Technologies Announces Fourth Quarter and Fiscal Year 2011 Results

- Fourth quarter revenue increased 4 percent to $970 million; GAAP earnings per share (EPS) increased to $0.69, or $1.06 on a non-GAAP basis, an increase of 18 percent

- 2011 revenue increased 4 percent to $3.7 billion; GAAP EPS increased to $2.23, or $3.73 on a non-GAAP basis, an increase of 5 percent

- 2011 free cash flow totaled $710 million

- 2012 outlook of non-GAAP organic revenue growth of 2 to 4 percent over 2011; Non-GAAP EPS guidance range of $3.90 to $4.05

PR Newswire

CARLSBAD, Calif., Feb. 7, 2012 /PRNewswire/ -- Life Technologies Corporation (NASDAQ: LIFE) today announced results for the quarter and full year ended December 31, 2011 and provided financial guidance for 2012.

(Logo: http://photos.prnewswire.com/prnh/20110216/MM49339LOGO)

"I am pleased with our performance in the fourth quarter and throughout 2011, even as we faced a number of challenges, including macroeconomic headwinds and constrained spending by some of our customers," said Gregory T. Lucier, Chairman and Chief Executive Officer of Life Technologies. "Overcoming these obstacles, we delivered top line growth, reduced our operating costs to meet the slower growth environment and expanded our operating margins an impressive 110 basis points, all of which we leveraged to deliver bottom line growth for the twelfth consecutive year. We finished the year with strong free cash flow of $710 million."

"Looking ahead to 2012, we expect growth in our game-changing Ion Torrent franchise, expansion in end markets and geographies and continued operational efficiencies to drive organic revenue growth of 2 to 4 percent over 2011 results and adjusted non-GAAP EPS in a range of $3.90 to $4.05."

Life Technologies reported results compared to quarter and year ended December 31, 2010.

Analysis of Fourth Quarter 2011 and Fiscal Year 2011 Results

Fourth quarter non-GAAP 2011 revenue increased 4 percent, or 3 percent excluding the impact from currency, with particularly strong growth in sales of Ion Torrent and Forensics. Full year non-GAAP 2011 revenue increased 4 percent, or 3 percent excluding the impact from currency, driven by increased sales of Ion Torrent, BioProduction and Forensics. The increase in both periods was partially offset by a decrease in sales of SOLiD products.
Non-GAAP gross margin in the fourth quarter increased 20 basis points to 64.8 percent, driven primarily by realized price and increased manufacturing productivity, which were partially offset by product mix and the termination of a supply agreement. Full year non-GAAP gross margin was 65.3 percent, a decrease of 150 basis points, due to currency hedging losses, upgrades to our SOLiD 5500 and Ion Torrent sales, which were partially offset by realized price and manufacturing productivity.
Non-GAAP operating margin increased 470 basis points to 31 percent in the fourth quarter, representing an all time high for the Company. Full year operating margin increased 40 basis points to 29.1 percent and, excluding currency, expanded 110 basis points. The increase in both periods resulted from a reduction in operating expenses including cost savings initiatives, a portion of which was offset by expenses related to developing Ion Torrent.
The non-GAAP tax rate was 26.8 percent for the fourth quarter and 27.3 percent for the full year.
Fourth quarter non-GAAP EPS increased 18 percent to $1.06. Full year non-GAAP EPS increased 5 percent to $3.73.
Diluted weighted shares outstanding were 184.5 million in the fourth quarter.
Cash flow from operating activities for the fourth quarter was $316 million. Fourth quarter capital expenditures were $34 million and resulting free cash flow was $282 million. The company ended the quarter with $882 million in cash and short-term investments.

Business Highlights:

Genetic Systems division non-GAAP revenue increased 13 percent to $278 million in the fourth quarter, or 11 percent excluding the impact from currency. Growth in the current year quarter was driven by increased sales of Ion Torrent and double digit growth in Forensics, which was partially offset by reduced sales of SOLiD products. Full year non-GAAP revenue increased 8 percent to $1 billion, or 7 percent excluding the impact from currency. Growth for the full year period was driven by increased sales of Ion Torrent franchise, growth in Forensics and Capillary Electrophoresis, all of which was partially offset by lower growth in SOLiD products.
Molecular Biology Systems division non-GAAP revenue decreased 1 percent to $441 million in the fourth quarter, or 2 percent excluding the impact of currency. The decline in the current year quarter resulted from a decline in qPCR royalties and continued lower spending by academic customers. Full year non-GAAP revenue was $1.7 billion, flat compared to the prior year period, and decreased 2 percent excluding the impact of currency. The decrease for the full year was the result of lower qPCR royalties, slower funding which drove lower PCR sales and a disruption in China sales as the company transitioned certain dealer networks to direct sales during the second quarter of 2011.
Cell Systems division non-GAAP revenue increased 3 percent to $244 million in the fourth quarter, or 1 percent excluding the impact of currency, compared to a strong fourth quarter of 2010. Growth in the fourth quarter was driven by increased sales of cell culture products and by increased sales in BioProduction. Full year non-GAAP revenue increased 7 percent to $969 million, or 6 percent excluding the impact of currency. Full year growth was driven by increased BioProduction sales and sales across our cell consumables businesses.
Regional organic growth rates for the quarter were as follows: the Americas was flat, Europe grew 4 percent, Asia Pacific grew 10 percent and Japan grew 4 percent. Full year growth rates were as follows: the Americas was 2%, Europe grew 3 percent, Asia Pacific 9 percent, and Japan declined 3 percent.
Revenue from orders transacted through Life Technologies' eCommerce channels grew approximately 8 percent during the quarter and approximately 12 percent for the full year. Over 50 percent of all transactions globally are processed using eCommerce platforms.

Changes in Reporting

The company plans to modify its reporting to better align with changes it has made in its internal organization. These changes have no impact on results of operations, financial condition or cash flows of the Company as a whole.

The company currently reports revenues for three divisions: Molecular Biology Systems, Genetic Systems and Cell Systems. Starting in the first quarter of 2012, the company will report revenues for the following three business groups: Research Consumables, Genetic Analysis and Applied Sciences. These changes will be finalized during and effective for the first quarter of 2012 and the company will provide revised financial data reflecting these changes prior to reporting its first quarter results in April 2012.

Fiscal Year 2012 Outlook

Subject to the risk factors detailed in the Safe Harbor Statement section of this release, the company provided its expectations for fiscal year 2012 financial performance. The company expects organic revenue growth of 2 to 4 percent over 2011 revenues of $3.7 billion and non-GAAP earnings per share to be in a range of $3.90 to $4.05. The guidance includes a revenue headwind of approximately $26 million, or 0.7 percent, and a benefit to non-GAAP EPS of approximately $0.02 from currency. The currency impact consists of a negative effect from changes in currency exchange rates based on December 2011 month end rates, partially offset by a benefit from not having the hedge losses that occurred in 2011. The company will provide further detail on its business outlook during the webcast today.

Webcast Details

The company will discuss its financial and business results as well as its business outlook on its webcast at 4:30 PM ET today. This webcast will contain forward-looking information. The webcast will include a discussion of "non-GAAP financial measures" as that term is defined in Regulation G. For actual results, the most directly comparable GAAP financial measures and information reconciling these non-GAAP financial measures to the company's financial results determined in accordance with GAAP, as well as other material financial and statistical information to be discussed on the webcast will be posted at the company's Investor Relations Web site at https://ir.lifetechnologies.com. The webcast can be accessed through the investor relations page of the Life Technologies' website at https://ir.lifetechnologies.com/events.cfm. A replay of the webcast will be available on the company's website through Tuesday, February 28, 2012.

About Life Technologies

Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific and medical advancements that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance the fields of discovery and translational research, molecular medicine, stem cell-based therapies, food safety and animal health, and 21st century forensics. The company manufactures both molecular diagnostic and research use only products. Life Technologies' industry-leading brands are found in nearly every life sciences lab in the world and include innovative instrument systems under the Applied Biosystems and Ion Torrent names, as well as, the broadest range of reagents with its Invitrogen, GIBCO, Ambion, Molecular Probes and TaqMan® products. Life Technologies had sales of $3.7 billion in 2011, employs approximately 10,400 people, has a presence in approximately 160 countries, and possesses one of the largest intellectual property estates in the life sciences industry, with approximately 4,000 patents and exclusive licenses. For more information on how we are making a difference, please visit our website: www.lifetechnologies.com.

Safe Harbor Statement

Certain statements contained in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, and Life Technologies intend that such forward-looking statements be subject to the safe harbor created thereby. Forward-looking statements may be identified by words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "will," or words of similar meaning and include, but are not limited to, statements about the expected future business and financial performance of the company. Such forward-looking statements include, but are not limited to, statements relating to financial projections, including revenue and pro forma EPS projections; success of acquired businesses, including cost and revenue synergies; development and increased flow of new products; leveraging technology and personnel; advanced opportunities and efficiencies; opportunities for growth; expectations of prospective new standards, new delivery platforms, and new selling specialization and effectiveness; and corporate strategy and performance. A number of the matters discussed in this press release and presentation that are not historical or current facts deal with potential future circumstances and developments, including future research and development plans. The discussion of such matters is qualified by the inherent risks and uncertainties surrounding future expectations generally and other factors that could cause actual results to differ materially from future results expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: volatility of the financial markets; and the risks that are described from time to time in Life Technologies' reports filed with the SEC. This press release and presentation speaks only as of its date, and the company disclaims any duty to update the information herein.

Non-GAAP Measurements

This press release includes certain financial information which constitutes "non-GAAP financial measures" as defined by the SEC. The GAAP measures which are most directly comparable to these measures, as well as a reconciliation of these measures with the most directly comparable GAAP measures, can be found at on the Investor Relations portion of the company's website at www.lifetechnologies.com.

Investor and Financial Contact:

Carol Cox
Investor Relations
(760) 603-7208
ir@lifetech.com

LIFE TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
AND RECONCILIATION OF NON-GAAP ADJUSTMENTS(1)

				For the three months				For the three months
(in thousands, except per share data)				ended December 31, 2011				ended December 31, 2010
(unaudited)
				GAAP	Adjustments		Non-GAAP	GAAP	Adjustments		Non-GAAP
Revenues				$ 1,010,445	$ (40,106)	(2)	$ 970,339	$ 932,337	$ 1,301	(2)	$ 933,638
Cost of revenues				345,305	(3,855)	(3)	$ 341,450	330,940	(104)	(3)	330,836
Purchased intangibles amortization				82,201	(82,201)	(4)	-	83,401	(83,401)	(4)	-
			Gross profit	582,939	45,950		628,889	517,996	84,806		602,802
Gross margin				57.7%			64.8%	55.6%			64.6%
Operating expenses:
	Selling, general and administrative			249,535	(5,864)	(5)	243,671	270,001	(11,200)	(5)	258,801
	Research and development			90,201	(5,587)	(5)	84,614	108,711	(10,119)	(5)	98,592
	Business consolidation costs			18,856	(18,856)	(6)	-	27,025	(27,025)	(6)	-
		Total operating expenses		358,592	(30,307)		328,285	405,737	(48,344)		357,393
			Operating income	224,347	76,257		300,604	112,259	133,150		245,409
Operating margin				22.2%			31.0%	12.0%			26.3%
	Interest income			972			972	678			678
	Interest expense			(38,162)	6,649	(7)	(31,513)	(36,289)	8,617	(7)	(27,672)
	Other income (expense), net			(2,933)	-		(2,933)	385	(559)	(8)	(174)
		Total other income (expense), net		(40,123)	6,649		(33,474)	(35,226)	8,058		(27,168)
Income from operations before provision for
income taxes				184,224	82,906		267,130	77,033	141,208		218,241
Income tax provision				(56,871)	(14,814)	(9)	(71,685)	(6,465)	(39,466)	(9)	(45,931)
			Net income	127,353	68,092		195,445	70,568	101,742		172,310
			Net loss attributable to non-controlling interests	-	-		-	113	(98)	(10)	15
			Net income attributable to controlling interest	$ 127,353	$ 68,092		$ 195,445	$ 70,681	$ 101,644		$ 172,325

Effective tax rate				30.9%			26.8%	8.4%			21.0%
Add back interest expense for subordinated
debt, net of tax				584	(551)	(11)	33	-			-
Numerator for diluted earnings
per share				$ 127,937	$ 67,541		$ 195,478	$ 70,681	$ 101,644		$ 172,325

Earnings per common share:
	Basic earnings per share attributable to controlling interest			$ 0.71			$ 1.10	$ 0.38			$ 0.93

	Diluted earnings per share attributable to controlling interest			$ 0.69			$ 1.06	$ 0.37			$ 0.90

Weighted average shares used in per share calculation:
	Basic			178,304			178,304	186,046			186,046
	Diluted			184,544			184,544	191,227			191,227


(1)		The Company reports Non-GAAP results which exclude costs that are not indicative of the profitability or cash flows of the Company’s ongoing or future operations. Such costs include restructuring charges, business transformation expenses, amortization and depreciation of deferred revenue, intangibles assets, and fixed assets, revaluation charges for inventories, contingent consideration liabilities, and asset impairments, and in process research and development expenses incurred as a result of business combinations, as well as the impact from the divestiture and discontinuance of product lines. The Company also excludes noncash interest expense associated with convertible debt bifurcation and noncash charges associated with non-controlling interests. In addition, the Company excludes one-time costs including the early repayment of debt and the associated impacts, and the impact of certain settlements in order to provide a supplemental comparison of the results of operations.

(2)		Adjust for royalty revenue recognized upon a historical and current licensing settlement of $38.8 million and revenue related to credit usage on returns of a discontinued product of $1.8 million, offset with fair value amortization of purchased deferred revenue of $0.5 million for the three months ended December 31, 2011. Add back fair value amortization of purchased deferred revenue of $1.3 million for the three months ended December 31, 2010.

(3)		Add back royalty fees and expenses of $4.5 million related to the historical portion of the settlement of a licensing dispute, offset with contingent consideration revaluation of $0.6 million for the three months ended December 31, 2011. Add back noncash charges for purchase accounting inventory revaluations cost of $0.1 million for the three months ended December 31, 2010.

(4)		Add back amortization of purchased intangibles.

(5)		Add back $10.0 million for expenses and an asset impairment partially offset by recovery of expenses related to the historical portion of the settlement of a licensing dispute and depreciation of purchase accounting property, plant, and equipment revaluations of $1.5 million for the three months ended December 31, 2011. Add back depreciation of purchase accounting property, plant, and equipment revaluations of $2.4 million and accelerated compensation expenses related to business acquisitions of $18.9 million for the three months ended December 31, 2010.

(6)		Add back business consolidation costs.

(7)		Add back charges related to noncash interest expense as a result of the provision adopted in accordance with the ASC Topic of Debt with Conversion and Other Options of $5.1 million and $7.1 million for the three months ended December 31, 2011 and 2010, respectively. Adjust for imputed finance charges of $1.5 million associated with contingent consideration on business acquisitions for each of the three months ended December 31, 2011 and 2010.

(8)		Adjust for a discontinuance gain recognized on cash flow hedge of $0.6 million for the three months ended December 31, 2010.

(9)		Non-GAAP tax differs from GAAP tax expense due to the exclusion of the aforementioned business combination related charges, non cash charges, and one-time costs which are not indicative of the profitability or cash flows of the Company’s ongoing or future operations. These deductions produce a GAAP only tax benefit which is added back for Non-GAAP presentation.

(10)		Add back noncash charges for purchase accounting inventory revaluations and depreciation of purchase accounting property, plant, and equipment revaluations attributable to non-controlling interest, net of tax benefit.

(11)		Eliminate noncash interest charges from diluted earnings per share calculation, as the noncash interest is excluded from the calculation of Non-GAAP net income.

LIFE TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
AND RECONCILIATION OF NON-GAAP ADJUSTMENTS(1)

				For the year ended				For the year ended
(in thousands, except per share data)				December 31, 2011				December 31, 2010
(unaudited)
				GAAP	Adjustments		Non-GAAP	GAAP	Adjustments		Non-GAAP
Revenues				$ 3,775,672	$ (34,995)	(2)	$ 3,740,677	$ 3,588,094	$ 6,746	(2)	$ 3,594,840
Cost of revenues				1,301,145	(4,394)	(3)	$ 1,296,751	1,188,199	5,360	(3)	1,193,559
Purchased intangibles amortization				308,728	(308,728)	(4)	-	293,754	(293,754)	(4)	-
			Gross profit	2,165,799	278,127		2,443,926	2,106,141	295,140		2,401,281
Gross margin				57.4%			65.3%	58.7%			66.8%
Operating expenses:
	Selling, general and administrative			1,008,973	(10,776)	(5)	998,197	1,023,179	(17,096)	(5)	1,006,083
	Research and development			377,924	(21,561)	(5)	356,363	375,465	(12,208)	(5)	363,257
	Purchased in-process research and development			-	-		-	1,650	(1,650)	(4)	-
	Business consolidation costs			75,324	(75,324)	(6)	-	93,450	(93,450)	(6)	-
		Total operating expenses		1,462,221	(107,661)		1,354,560	1,493,744	(124,404)		1,369,340
			Operating income	703,578	385,788		1,089,366	612,397	419,544		1,031,941
Operating margin				18.6%			29.1%	17.1%			28.7%
	Interest income			3,932	-		3,932	4,266	-		4,266
	Interest expense			(162,073)	30,779	(7)	(131,294)	(152,322)	39,582	(7)	(112,740)
	Loss on early retirement of debt			-	-		-	(54,185)	54,185	(8)	-
	Gain on divestiture of equity investments			-	-		-	37,260	(37,260)	(9)	-
	Other income (expense), net			(10,913)	-		(10,913)	(5,864)	5,500	(10)	(364)
		Total other income (expense), net		(169,054)	30,779		(138,275)	(170,845)	62,007		(108,838)
Income from operations before provision for
income taxes				534,524	416,567		951,091	441,552	481,551		923,103
Income tax provision				(122,405)	(137,424)	(11)	(259,829)	(63,694)	(182,994)	(11)	(246,688)
			Net income	412,119	279,143		691,262	377,858	298,557		676,415
			Net loss attributable to non-controlling interests	658	(308)	(12)	350	437	(290)	(12)	147
			Net income attributable to controlling interest	$ 412,777	$ 278,835		$ 691,612	$ 378,295	$ 298,267		$ 676,562

Effective tax rate				22.9%			27.3%	14.4%			26.7%
Add back interest expense for subordinated
debt, net of tax				1,300	(1,169)	(13)	131	171			171
Numerator for diluted earnings
per share				$ 414,077	$ 277,666		$ 691,743	$ 378,466	$ 298,267		$ 676,733

Earnings per common share:
	Basic earnings per share attributable to controlling interest			$ 2.30			$ 3.86	$ 2.06			$ 3.69

	Diluted earnings per share attributable to controlling interest			$ 2.23			$ 3.73	$ 1.99			$ 3.55

Weighted average shares used in per share calculation:
	Basic			179,390			179,390	183,398			183,398
	Diluted			185,595			185,595	190,591			190,591


(1)		The Company reports Non-GAAP results which excludes costs that are not indicative of the profitability or cash flows of the Company’s ongoing or future operations. Such costs are restructuring cost, business transformation expenses, amortization and depreciation of deferred revenue, intangibles assets, and fixed assets, and revaluation charges for inventories, contingent consideration liabilities, asset impairments, and in process research and development expenses, incurred as a result of business combinations as well as the impact from the divestiture and discontinuance of product lines. The Company also excludes noncash interest expense associated with convertible debt bifurcation and noncash charges associated with non-controlling interests. In addition, the Company excludes one-time costs including the early repayment of debt and the associated impacts, and the impact of certain settlements in order to provide a supplemental comparison of the results of operations.

(2)		Adjust for royalty revenue recognized upon a historical and current licensing settlement of $38.8 million, offset with fair value amortization of purchased deferred revenue of $2.9 million and add back revenue related to returns of a discontinued product of $0.9 million for the year ended December 31, 2011. Add back fair value amortization of purchased deferred revenue of $6.7 million for the year ended December 31, 2010.

(3)		Add back royalty fees and expenses of $4.5 million related to the historical portion of the settlement of a licensing dispute, charges for inventory reserves related to a discontinued product of $2.1 million, and $0.5 million of purchase accounting related cost of revenue revaluation, offset by contingent consideration revaluation of $2.7 million for the year ended December 31, 2011. Add back noncash charges for purchase accounting inventory revaluation cost of $0.9 million, offset with contingent consideration revaluation of $6.3 million for the year ended December 31, 2010.

(4)		Add back amortization of purchased intangibles and write off of purchased in-process research and development.

(5)		Add back contingent consideration revaluation of $13.7 million, depreciation of purchase accounting property, plant, and equipment revaluations of $7.1 million, $10.0 million for expenses and an asset impairment partially offset by recovery of expenses related to the historical portion of the settlement of a licensing dispute, and accelerated compensation expense related to business acquisitions of $1.5 million for the year ended December 31, 2011. Add back depreciation of purchase accounting property, plant, and equipment revaluations of $10.4 million and accelerated compensation expense related to business acquisitions of $18.9 million for the year ended December 31, 2010.

(6)		Add back business consolidation costs.

(7)		Add back charges related to noncash interest expense as a result of the provision adopted in accordance with the ASC Topic of Debt with Conversion and Other Options of $24.6 million and $38.0 million for the years ended December 31, 2011 and 2010, respectively. Adjust for imputed finance charges of $6.2 million and $1.5 million associated with contingent consideration on business acquisitions for the years ended December 31, 2011 and 2010, respectively.

(8)		Add back loss on early retirement of debt.

(9)		Adjust for gain on divestiture of equity investments.

(10)		Adjust for gain on impaired security recovery of $7.1 million, a discontinuance gain on cash flow hedge of $0.6 million and gain on foreign currency related to joint venture divestiture of $1.0 million offset by loss on discontinuance of cash flow hedge of $12.9 million and joint venture purchase accounting adjustment of $1.2 million for the year ended December 31, 2010.

(11)		Non-GAAP tax differs from GAAP tax expense due to the exclusion of the aforementioned business combination related charges, non cash charges, and one-time costs which are not indicative of the profitability or cash flows of the Company’s ongoing or future operations. These deductions produce a GAAP only tax benefit which is added back for Non-GAAP presentation.

(12)		Add back noncash charges for purchase accounting inventory revaluations and depreciation of purchase accounting property, plant, and equipment revaluations attributable to non-controlling interest, net of tax benefit.

(13)		Eliminate noncash interest charges from diluted earnings per share calculation, as the noncash interest is excluded from the calculation of Non-GAAP net income.

LIFE TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS



		For the year
		ended December 31,
(in thousands)(unaudited)		2011	2010
Net income		$ 412,119	$ 377,858
	Add back amortization and
	share-based compensation	394,326	386,621
	Add back depreciation	123,578	122,978
	Balance sheet changes	(82,781)	(101,435)
	Other noncash adjustments	(38,107)	(46,933)
Net cash provided by operating activities		809,135	739,089
	Capital expenditures	(99,293)	(124,817)
Free cash flow		709,842	614,272
Net cash provided by (used in) investing activities		(52,591)	5,013
Net cash used in financing activities		(627,268)	(407,808)
Effect of exchange rate changes on cash		(4,790)	5,505
Net increase in cash and cash equivalents		$ 25,193	$ 216,982

LIFE TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS



		December 31,	December 31,
(in thousands)		2011	2010
ASSETS		(unaudited)
Current assets:
	Cash and short-term investments	$ 881,994	$ 854,801
	Trade accounts receivable, net of allowance for doubtful accounts	636,998	587,456
	Inventories	377,866	323,318
	Prepaid expenses and other current assets	175,222	280,950
	Total current assets	2,072,080	2,046,525

Long-term assets		7,094,346	7,439,674
	Total assets	$ 9,166,426	$ 9,486,199

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
	Current portion of long-term debt	$ 450,839	$ 347,749
	Accounts payable, accrued expenses and other current liabilities	989,645	798,636
	Total current liabilities	1,440,484	1,146,385


Long-term debt		2,297,653	2,727,624
Other long-term liabilities		794,778	1,174,161
Equity		4,633,511	4,438,029
	Total liabilities and equity	$ 9,166,426	$ 9,486,199

SOURCE Life Technologies Corporation

CoLucid Founder Passes Away

Tue, 07 Feb 2012 20:38:31 +0000

CoLucid Founder Passes Away

PR Newswire

DURHAM, N.C., Feb. 7, 2012 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, mourns the passing of its founder, James F. White, Ph.D. on February 3rd, after a lengthy illness. Jim co-founded CoLucid in 2005 with Art Pappas to develop lasmiditan, a first in class therapy for acute migraine. Jim assembled an experienced management team and Scientific Advisory Board to progress lasmiditan through clinical development to become a Phase 3-ready compound. Prior to CoLucid, Jim served as Chief Operating Officer and Vice President, Research for Hypnion, Inc., where he developed a novel therapy for sleep disorders, resulting in Hypnion's acquisition by Eli Lilly & Co. in 2006. Jim was also a co-founder of Dynogen Inc. and a scientific adviser to other biotech companies. During a 22-year career with Eli Lilly, he held key positions including Head of Toxicology, Head of Central Nervous System, Gastrointestinal & Genitourinary Disease Research, and had responsibility for strategy and business development for the Neuroscience Global Business Unit. Jim received his B.S. in Chemistry and M.S. and Ph.D. in Pharmacology/Toxicology from Purdue University. He was honored as a Distinguished Alumnus in 2003.

Jim leaves behind his wife, Linda, their son, Jarrett, and a large group of professional colleagues who knew him as their friend. He will be greatly missed by all.

Visitation will be held Thursday, February 9th, from 4 – 8 PM at the Dee Funeral Home in Concord, MA, with services at Trinity Episcopal Church, Concord, MA at 2 PM Friday, February 10th. Burial will be in Greenfield, Indiana, with a memorial service in Indianapolis at a later date.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company's pipeline includes lasmiditan, a novel treatment for migraine, and a conjugated stigmine platform that has generated a series of preclinical candidates for wake promotion (COL-204), chronic pain, Alzheimer's disease and psychiatric disorders. For more information, please visit CoLucid at www.colucid.com.

SOURCE CoLucid Pharmaceuticals, Inc.

Save Your Skin Foundation Applauds Health Canada's Decision to Approve Yervoy(TM) for Advanced Melanoma

Tue, 07 Feb 2012 19:59:19 +0000

New Treatment is First and Only to Extend Survival for Canadians With Deadliest Form of Skin Cancer

Health Canada has announced its approval of Yervoyâ¢ (ipilimumab) to treat metastatic, or advanced, melanoma. It is the first new treatment for the disease in more than a decade, and is the only medicine proven to significantly extend the lives of patients living with the disease. Melanoma is the deadliest form of skin cancer and one of the fastest growing cancers in Canada.

"Health Canada's approval of Yervoy provides hope for Canadians fighting to live longer," says Kathy Barnard, Founder of the Save Your Skin Foundation. "It's heartbreaking to see so many Canadians losing their battle with melanoma and, given that most patients with advanced melanoma survive less than a year, time is critical. I hope all Canadians who need it, will have access to Yervoy as soon as possible, giving them a chance to survive this disease."

This news hits a personal note for Barnard, who is fighting her own battle with melanoma. In 2003 Barnard was first diagnosed, and by 2005 stage IV malignant melanoma had spread. Tumors were found in her left lung, kidney, liver, and adrenal gland. In 2007 through a clinical study Barnard was treated with Yervoy and has been disease free since.

"I was extremely fortunate to have had access to this medication," says Barnard. "Awareness and access to new treatments is critical. It's the reason I'm alive today." One of the key objectives of Save Your Skin is to create timely and national awareness of available treatment options.

In its late stages, the average life expectancy for melanoma is just six months, with a one-year survival rate of only 25 percent, making metastatic melanoma one of the most aggressive forms of cancer and one of the deadliest forms of skin cancer. An estimated 5,500 Canadians will be diagnosed with melanoma this year and 950 will die from it. Melanoma is responsible for 75 percent of the deaths associated with skin cancer.

The Kaplan-Meier survival rate with Yervoy at both one and two years was almost double when measured against patients treated with gp100 cancer vaccine. Survival was 46 per cent at one year and 24 percent at 2 years for Yervoy, versus 25 percent at one year and 14 percent at two years for gp100. Yervoy also showed long-term survival with some patients living three or four years beyond treatment.

Yervoy provides advanced melanoma suffers with an important new treatment option and a real hope for long-term survival.

About Melanoma in Canada

Every year, thousands of Canadians are diagnosed with Melanoma, with the incidence of the disease increasing faster than that of any other cancer. Melanoma is a deadly form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. One in 74 men and 1 in 90 women are expected to develop melanoma during their lifetime; 1 in 284 men and 1 in 486 women will die of it. Melanoma is clearly visible on the skin, and 90 per cent of melanomas are caused by exposure to UV light, including tanning beds.

About Yervoyâ¢

Yervoy (3 mg/kg) is indicated for the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease.

Yervoy is a recombinant; human monoclonal antibody, and the first approved cancer immunotherapy for melanoma to target the CTLA-4 (cytotoxic T lymphocyte-associated antigen-4), which plays a role in suppressing normal immune function.

About the Save Your Skin Foundation

The Save Your Skin Foundation is a Canadian not-for-profit foundation. Through events and other initiatives, the Foundation focuses on: raising funds for education and awareness, providing emotional and financial support to those dealing with melanoma and non-melanoma skin cancers, and on supporting the ongoing research and treatment of skin cancer - especially melanoma.

Donations go towards providing critical and timely treatments, as well as ongoing education, research, and awareness initiatives.

For additional information please visit www.saveyourskin.ca or contact Birgit Simon at 604-734-4223.

Karran Finlay Marketing
Birgit Simon
Media Liaison
604-734-4223
bsimon@karranfinlaymarketing.com
www.saveyourskin.ca
For medical information about Yervoy,
please contact BMS Canada medical
information line at 1-800-463-6267

SeraCare Life Sciences to Report First Quarter Fiscal Year 2012 Financial Results on February 10, 2012

Tue, 07 Feb 2012 19:14:11 +0000

SeraCare Life Sciences to Report First Quarter Fiscal Year 2012 Financial Results on February 10, 2012

PR Newswire

MILFORD, Mass., Feb. 7, 2012 /PRNewswire/ -- SeraCare Life Sciences, Inc. (NASDAQ: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today announced that it expects to release first quarter fiscal year 2012 financial results before the U.S. financial markets open on Friday, February 10, 2012. SeraCare executives expect to host a conference call at 8:30 a.m. ET on the same day to review first quarter results.

(Logo: http://photos.prnewswire.com/prnh/20110324/NE70714LOGO )

Conference Call Information:

The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investor Center, Events" section of the SeraCare Life Sciences website at www.seracare.com. The call can also be accessed by dialing (866) 804-6927 (within the United States) or (857) 350-1673 (outside the United States). The passcode for participants is 11801041.

A replay of the call will be available approximately two hours after the live call concludes through February 17, 2012. To access the replay, dial (888) 286-8010 (within the United States) or (617) 801-6888 (outside the United States). The passcode is 89716522. The webcast will also be archived on the Company's website.

About SeraCare Life Sciences, Inc.:

SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics. The Company's innovative portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking and contract research services. SeraCare's quality systems, scientific expertise and state-of-the-art facilities support its customers in meeting the stringent requirements of the highly regulated life sciences industry. For more information visit www.seracare.com.

Contacts:

Gregory A. Gould
Interim President and Chief Executive Officer and Chief Financial Officer
SeraCare Life Sciences, Inc.
508-244-6400

Sarah Cavanaugh
MacDougall Biomedical Communications
781-235-3060

SOURCE SeraCare Life Sciences, Inc.

Spherix Announces Closing of Registered Direct Offering of $1.15 Million in Common Stock and Warrants

Tue, 07 Feb 2012 18:53:58 +0000

Spherix Announces Closing of Registered Direct Offering of $1.15 Million in Common Stock and Warrants

PR Newswire

BETHESDA, Md., Feb. 7, 2012 /PRNewswire/ -- Spherix Incorporated (NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the closing of previously announced agreements to sell $1.15 million of shares of its common stock together with warrants to purchase additional shares of its common stock in a registered direct offering to institutional investors. Spherix has issued an aggregate of 1,064,815 shares of common stock at a price of $1.08 per share along with warrants to purchase an additional 212,963 shares of common stock at an exercise price of $1.40 per share. The warrants are exercisable 6 months after issuance and terminate 66 months after the date of issuance.

The Company intends to use the net proceeds from the offering to continue the development of SPX-106T, for general development and commercialization efforts, including the possibility of obtaining by license or acquisition other clinical stage compounds/orphan drugs, as well as for general corporate purposes.

"We are pleased to have completed this transaction, the proceeds of which will help fund additional studies to investigate SPX-106T," commented Dr. Claire L. Kruger, CEO of Spherix. "In addition, we are continuing with our strategy to diversify the product pipeline to add value to the Company."

Rodman & Renshaw, LLC, a wholly-owned subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM), acted as the exclusive placement agent for the offering.

The common stock and warrants are being offered by Spherix pursuant to an effective registration statement on Form S-3 filed with the Securities and Exchange Commission (SEC). A prospectus supplement relating to the offering described above was filed with the SEC on February 6, 2012.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities may only be offered by means of a prospectus. Copies of the prospectus supplement and related prospectus can be obtained directly from Rodman & Renshaw, LLC at info@rodm.com or (212) 356-0549, or by mail at 1251 Avenue of the Americas, 20th floor, New York, NY 10020, or from the SEC's website at www.sec.gov.

About Spherix

Spherix Incorporated was launched in 1967 as a scientific research company under the name Biospherics Research. The Company now leverages its scientific and technical expertise and experience through its two subsidiaries – Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is dedicated to developing and licensing/marketing proprietary therapeutic products for treatment of diabetes, metabolic syndrome and atherosclerosis. Biospherics is actively seeking a pharmaceutical partner to continue the development of its Phase 3 compound for the treatment of diabetes, D-tagatose, while exploring new drugs and combinations for treatment of high triglycerides, a risk factor for atherosclerosis, myocardial infarction, and stroke. Spherix's Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products and industrial chemicals and pesticides. For more information, please visit www.spherix.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of D-tagatose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop D-tagatose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

SOURCE Spherix Incorporated

DURECT to Present at the BIO CEO & Investor Conference

Tue, 07 Feb 2012 17:03:44 +0000

DURECT to Present at the BIO CEO & Investor Conference

PR Newswire

CUPERTINO, Calif., Feb. 7, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that Matt Hogan (Chief Financial Officer) will be presenting at the BIO CEO & Investor Conference on Tuesday, February 14 at 10:30 a.m. Eastern Time. The conference is being held at the Waldorf-Astoria Hotel in New York City.

(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

A live audio webcast of the presentation will be available by accessing http://www.veracast.com/webcasts/bio/ceoinvestor2012/61206433.cfm. A live audio webcast of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.

About DURECT Corporation

DURECT is a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR®, and TRANSDUR®-Sufentanil. DURECT's proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. For more information, please visit www.durect.com.

NOTE: POSIDUR™, SABER™, ORADUR®, TRANSDUR®, ELADUR™ and DURIN® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

SOURCE DURECT Corporation

ORLive Program Highlights Penile Implantation Techniques

Tue, 07 Feb 2012 17:02:00 +0000

For men struggling to find a dependable treatment for erectile dysfunction, penile implant surgery is a safe and popular option. Advancements in surgical techniques have enhanced the lives of men living with ED. Learn more about improved patient outcomes in penile implant surgery, and hear from a patient and his wife about their overall satisfaction with the procedure.

Join urological surgeons Irwin Goldstein, MD, J. Francois Eid, MD, Paul Perito, MD, and Andrew Kramer, MD, as they discuss penile implant surgery topics including: Growing Adoption and Benefits of the "No Touch Technique," Ongoing Development with the "Perito Minimally Invasive Penile Implant" Approach, and The Importance of Training for the Young Prosthetic Urologist. Viewers are welcome to email in questions they have for the surgeons when they view the program and questions will be answered confidentially.

"Evolution in Penile Implantation Technique & Patient Outcomes" is now available on-demand at ORLive.com.

Learn more about this and future web events at www.ORLive.com. You can sign up for our weekly e-newsletter and follow us on Facebook and Twitter. Plus, to see numerous health videos from a wide-range of specialties, check out our YouTube Channel.

About BroadcastMed, Inc.

BroadcastMed is an online medical broadcasting company. We help the World's leading hospitals and medical device companies create and deliver trusted educational content to physicians. Our clients rely on us to deliver measurable results by expanding their reach through the BroadcastMed syndication network which includes ORLive.com, ranked among the top three online destinations for physicians.

CONTACT:
Todd Leddy
Marketing & Promotions Manager
Email Contact

Siemens Forms New Companion Diagnostics Partnerships with ViiV Healthcare and Tocagen

Tue, 07 Feb 2012 16:33:24 +0000

Siemens Forms New Companion Diagnostics Partnerships with ViiV Healthcare and Tocagen

Siemens' move into the companion diagnostics market targets the development of novel diagnostics tests for physicians treating HIV and brain cancer

PR Newswire

RESEARCH TRIANGLE PARK, N.C., SAN DIEGO and TARRYTOWN, N.Y., Feb. 7, 2012 /PRNewswire/ -- Siemens Healthcare Diagnostics announces two new companion diagnostics partnerships with pharmaceutical companies ViiV Healthcare and Tocagen — marking a major step for Siemens (NYSE: SI) into this important and fast-growing segment of the in vitro diagnostics (IVD) market. Both partnerships intend to leverage the clinical trial and commercialization options within Siemens' CLIA laboratory, as well as Siemens' established IVD clinical and regulatory expertise.

(Logo: http://photos.prnewswire.com/prnh/20070904/SIEMENSLOGO )

Siemens' partnership with ViiV Healthcare will focus on clinical trials related to Celsentri/Selzentry® (maraviroc) — ViiV Healthcare's novel CCR5 co-receptor antagonist for the treatment of CCR5-tropic HIV — followed by potential commercialization of a diagnostics test to assist in patient selection prior to physician treatment decisions, subject to FDA approval. According to the World Health Organization, 33.3 million people worldwide were living with HIV as of 2009. That same year, 2.6 million new infections were reported and 1.8 million people worldwide died of AIDS-related illnesses.

The Siemens - Tocagen relationship will begin with diagnostic tests to support clinical trials related to Tocagen's unique viral gene therapy (Toca 511 & Toca FC) under investigation for the treatment of primary brain cancer, followed by potential commercialization of diagnostic tests for therapy monitoring, subject to FDA approval. According to the American Cancer Society, primary brain and central nervous system cancers are expected to account for 22,910 new cases and 13,700 deaths in 2012. Additionally, the National Institutes of Health estimates that 10-30% of all adults with cancer will develop brain metastases.

Widely considered a major step towards the vision of personalized healthcare, companion diagnostics are clinical tests linked to a specific drug or therapy intended to assist physicians in making treatment decisions for their patients. The technology and science behind the field allows pharmaceutical drug developers to identify subpopulations of patients more or less likely to respond favorably to a particular drug or therapy, and those more or less likely to experience unfavorable side effects.(1)The companion diagnostics market, worth an estimated $1.5 billion annually, is reportedly the fastest growing segment in the IVD industry, due largely to demand for safer, higher quality drugs.(2)

Complementing a move into next-generation sequencing, Siemens' companion diagnostics business will establish relationships with pharmaceutical companies to offer clinical trial expertise as well as diagnostic test development and commercialization. The company's CLIA-certified clinical lab in Berkeley, California is capable of offering a broad range of nucleic acids and immunoassay tests, as well as developing new test approaches as required.

"Siemens' presence in the emerging companion diagnostics market enables us to leverage our innovation capabilities and deep clinical knowledge to help improve pharmaceutical drug safety and effectiveness," said Michael Reitermann, CEO, Siemens Healthcare Diagnostics. "More so, it helps align Siemens with new classes of therapies tailored to the individual that hold the promise of improving patient care and delivering on the goal of personalized medicine."

ViiV Healthcare previously announced the start of the Phase III MODERN Study [Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen], also known as A4001095, comparing its CCR5-inhibitor, Celsentri/Selzentry® (maraviroc), to emtricitabine/tenofovir (Truvada®), both in combination with darunavir/ritonavir. The 96-week trial will evaluate a two-drug versus three-drug once-daily regimen for the treatment of antiretroviral-naive patients infected with CCR5-tropic HIV-1.

In addition, MODERN is the first large Phase III trial that will compare the performance of a genotypic test with a phenotypic test in identifying patients appropriate for use of Celsentri/Selzentry®. Patients will be randomised to undergo screening with either the genotypic or phenotypic test. Genotypic tropism testing in the MODERN study is provided by Siemens Healthcare Diagnostics as part of this partnership and phenotypic testing (Trofile®) by Monogram Biosciences. Subject to FDA approval, Siemens Healthcare Diagnostics may commercialize their genotypic tropism diagnostic test.

"Our partnership with Siemens Healthcare Diagnostics is a valuable part of our commitment to addressing patient needs through developing innovative treatment approaches," said Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. "Celsentri/Selzentry is an important treatment option for people living with CCR5-tropic HIV and we continue to support the evolution of tropism testing to provide physicians with accurate, accessible and affordable companion diagnostics."

Tocagen is enrolling patients in its clinical trials of Toca 511 (vocimagene amiretrorepvec), for injection & Toca FC (flucytosine), extended-release tablets. These multicenter, open-label studies(3) are in patients with recurrent high-grade glioma, such as those with glioblastoma multiforme (GBM, Grade 4), who have had prior surgery and chemoradiation. Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a cytosine deaminase (CD) gene selectively to cancer cells. After allowing time for the administered Toca 511 to spread through the tumor, those cancer cells expressing the CD gene may convert the antibiotic flucytosine into the anti-cancer drug 5-fluorouracil (5-FU). In these studies, patients receive multiple cycles of oral Toca FC. Tocagen plans to work with Siemens Healthcare Diagnostics on the assays used during these clinical studies. Subject to FDA approval, Siemens may commercialize diagnostic tests capable of monitoring patient levels of Toca 511 and Toca FC.

"We believe that developing the necessary diagnostic tests with the right diagnostic partner is an important component for the successful commercialization of Toca 511 & Toca FC," said Harry E. Gruber, CEO, Tocagen Inc. "Siemens' capabilities in developing commercial viral assays in addition to their market presence in the diagnostics space make them an excellent complement to Tocagen's focus on the development and commercialization of viral gene transfer products to treat advanced cancer."

These partnerships reflect Siemens' efforts to expand its healthcare global presence by leveraging the power of in vivo and in vitro diagnostics to impact therapeutics – one goal of the recently launched Siemens Agenda 2013, a new two-year global initiative to further strengthen the innovative power and competitiveness of the Siemens Healthcare Sector.

(1) http://www.dddmag.com/article-Companion-Prospecting-91211.aspx (accessed on 10/6/11)
(2) http://www.prnewswire.com/news-releases/companion-diagnostics-world-market-outlook-2011-2021-130615878.html, http://www.visiongain.com (accessed on 10/6/11)
(3) http://clinicaltrials.gov/ct2/results?term=tocagen

ViiV Healthcare is a global specialist HIV company established by GlaxoSmithKline (LSE: GSK.L) and Pfizer (NYSE: PFE) to deliver advances in treatment and care for people living with HIV. Our aim is to take a deeper and broader interest in HIV/AIDS than any company has done before, and take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit: www.viivhealthcare.com.

Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of gene transfer products for the treatment of cancer. Tocagen is initially focusing on treatments for patients with advanced cancer for whom no adequate treatments currently exist. Toca 511 & Toca FC, the company's lead investigational combination product candidate, is being evaluated in clinical trials in patients with recurrent high grade glioma (such as glioblastoma multiforme). Tocagen has received grant support from leading brain cancer foundations including, Accelerate Brain Cancer Cure (ABC2), the American Brain Tumor Association (ABTA), and the National Brain Tumor Society (NBTS). For more information about Tocagen or Toca 511 please visit: www.tocagen.com.

The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2011 (to September 30), the Sector posted revenue of 12.5 billion euros and profit of around 1.3 billion euros. For further information please visit: www.siemens.com/healthcare.

SOURCE Siemens Healthcare Diagnostics