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R&D Trends: Depression - Clinical attrition driven by mature market conditions

Thu, 24 May 2012 11:08:27 +0000

R&D Trends: Depression - Clinical attrition driven by mature market conditions

PR Newswire

NEW YORK, May 24, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

R&D Trends: Depression – Clinical attrition driven by mature market conditions

http://www.reportlinker.com/p0799259/RD-Trends-Depression-–-Clinical-attrition-driven-by-mature-market-conditions.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

Several drugs have progressed through the pipeline for depression in recent years, including Pristiq (desvenlafaxine; Pfizer), Oleptro (trazodone extended release; Labopharm), and Viibryd (Forest) in the US, and Valdoxan (agomelatine; Servier/Novartis) in the EU. Despite the heightened competition within the marketplace, an abundance of drugs remain in the pipeline.Understand key dynamics in the R&D pipeline for new depression therapiesBenchmark novel and existing therapies using the target product profile identified by DatamonitorSupport R&D decision making by evaluating antidepressant clinical trial designs that have set a precedentEvaluate the most promising new pharmacological targets in early-stage developmentAccess Datamonitor's prediction of how the treatment landscape may change in the next 20 yearsThere are 46 separate programs across all stages of clinical development for depression, down from 66 in 2007 with a notably high attrition of early-stage projects. Reasons for this include promising new targets failing to yield an effective antidepressant, and big players such as GlaxoSmithKline switching its research focus.Although depleted, the early-stage pipeline still has the potential to change current treatment algorithms, which are dominated by monoamine reuptake inhibitors. Popular approaches include glutamate and neuropeptide receptor modulation. Datamonitor sees the future of treatment in depression as the specific targeting of treatment-resistant patients.Clinical trial design in depression is largely standardized. Although not required, head-to-head trials may allow for a more favorable label and explicit marketing claims. Datamonitor believes that future trials will be designed for regulatory approval in patients with treatment-resistant depression, or for use as an add-on to existing therapies.What are the key trends in the depression pipeline?What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?How will new antidepressant treatments evolve in the next 20 years?

OVERVIEWCatalystSummaryEXECUTIVE SUMMARYStrategic scoping and focusUpdate details: January 2012Datamonitor key findingsRelated reportsCLINICAL PIPELINE OVERVIEWOverview of the depression pipelineDatamonitor has identified 46 separate programs in clinical developmentEmerging features of the depression pipelineChanges in pipeline dynamicsCompanies involved in the depression pipelineDiscontinued pipeline drugs in depression54 distinct depression projects have been discontinued since 2010The vast majority of discontinuations happen either during preclinical testing or Phase II studiesNeuropeptide modulators and monoamine reuptake inhibitors head the list of discontinued projectsTARGET PRODUCT PROFILEComparator therapiesLexapro (escitalopram; Forest/Lundbeck)Target product profile versus current level of attainmentCLINICAL TRIAL DESIGN IN DEPRESSIONClinical trialsCommonly used clinical trial endpoints for depressionTypical trial designTrial length is commonly standardized to a duration of just 8 weeks Comparator trials can provide a compelling argument for using one drug ahead of anotherFuture developments in clinical trial designTreatment-resistant depression clinical trial designAdjunctive therapy clinical trial designINNOVATIVE EARLY-STAGE APPROACHESGlutamate receptor modulationNMDA receptor antagonists and partial agonistsMetabotropic glutamate receptor antagonistsTargeting neuropeptides for depressionBackgroundVasopressin receptor antagonistsNeurokinin receptor antagonistsTHE FUTURE OF TREATMENT IN DEPRESSIONSpecific targeting of treatment-resistant patientsA label for treatment-resistant depression will bypass competition with generic first-line antidepressantsTreatment-resistant depression is characterized by a large target population and substantial unmet needBiomarkers for depressionConsiderable variations in treatment outcomes existBiomarkers may have utility in identifying likely responders and improving treatment outcomesThe commercial appeal of reduced R&D spend and a competitive advantage is a bonusBiomarkers in clinical developmentBIBLIOGRAPHYJournal papersWebsitesDatamonitor reportsAPPENDIXContributing expertsConferences attendedReport methodology

TABLES

Table: Products in clinical development for depression, January 2012

Table: Depression clinical pipeline, by mode of action and development stage, January 2012

Table: Discontinued pipeline drugs in depression, 2010–12

Table: Discontinued drugs formerly in development for depression, by mode of action and developmental stage, 2010–12

Table: Lexapro (escitalopram; Forest/Lundbeck) – drug profile in depression, 2012

Table: Defining the gold standard for depression: key clinical trial results for Lexapro

Table: Target product profile in major depressive disorder, 2012

Table: Comparison between the HAM-D and MADRS rating scales for depression

Table: Typical Phase III clinical trial design in major depressive disorder

Table: Key facts: Lexapro (escitalopram; Forest/Lundbeck) versus Cymbalta (duloxetine; Eli Lilly) comparator trial in major depressive disorder

Table: Key facts: Symbyax (fluoxetine and olanzapine; Eli Lilly) pivotal Phase III clinical trial

Table: Key facts: Abilify (aripiprazole; Bristol-Myers Squibb/Otsuka) pivotal Phase III clinical trial

Table: Most promising innovative therapeutic approaches in depression, January 2012

FIGURESFigure: Depression clinical pipeline, by developmental stage, January 2012Figure: Depression clinical pipeline, by mode of action, January 2012Figure: Products in clinical development for depression, 2007, 2011, and 2012Figure: Modes of action in the depression pipeline, 2007, 2011, and 2012Figure: Depression pipeline, by developmental stage and company type, January 2012Figure: Big Pharma's involvement in the depression pipeline, January 2012Figure: Discontinued drugs formerly in development for depression, by developmental stage, 2010–12Figure: Modes of action of discontinued pipeline drugs and active pipeline drugs in depression, 2010–12Figure: Head-to-head clinical trial of Lexapro (escitalopram; Forest/Lundbeck) versus Celexa (citalopram; Forest/Lundbeck)Figure: Potential timeline for future depression therapiesFigure: Proportion of patients that display treatment-resistant depression (%) in the seven major markets, 2010Figure: BRITE-MD study of the Antidepressant Treatment Response Index as a functional biomarker for depressionCompanies mentioned Commerzbank AG, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Johnson & Johnson, Kewill plc, Telenor ASA

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Auxilium Pharmaceuticals, Inc. and FCB I LLC File Lawsuit Against Watson for Infringement of Testim® Patents

Thu, 24 May 2012 11:00:00 +0000

Auxilium Pharmaceuticals, Inc. and FCB I LLC File Lawsuit Against Watson for Infringement of Testim® Patents

PR Newswire

MALVERN, Pa., and WILMINGTON, Del., May 24, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") and FCB I LLC ("FCB") announced today that they filed a lawsuit against Watson Laboratories, Inc. (NV); Watson Pharmaceuticals, Inc.; and Watson Pharma, Inc. (collectively, "Watson") for infringement of FCB's ten patents listed in the U.S. Food and Drug Administration's ("FDA's") Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book") as covering Testim^® 1% testosterone gel. The lawsuit was filed in the United States District Court for the District of New Jersey on May 23, 2012.

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO)

Auxilium and FCB filed this lawsuit in response to a notice letter sent by Watson Laboratories, Inc. (NV) regarding its filing with the FDA of Abbreviated New Drug Application ("ANDA") No. 09‑1073 for a generic 1% testosterone gel product. This letter also stated that ANDA No. 09‑1073 contained Paragraph IV certifications, under 21 U.S.C. Section 355(j) of the Federal Food, Drug, and Cosmetic Act, with respect to the nine patents listed in the Orange Book on that date as covering Testim^®: U.S. Patent Nos. 7,320,968; 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; and 8,063,029. On May 15, 2012, a new composition patent covering Testim(U.S. Patent No. 8,178,518) issued. This patent is now also listed in the Orange Book and was included in the patent infringement lawsuit filed against Watson. In total, ten Testim patents are now listed in the Orange Book and are expected to expire on various dates ranging from April 21, 2023 through January 18, 2025. Auxilium and FCB remain committed to protecting their intellectual property rights, including their patent protection for Testim.

Under the Hatch-Waxman Act, as a result of the patent infringement lawsuit filed against Watson, final FDA approval of Watson's ANDA for its proposed generic version of Testim will be stayed until at least the earlier of 30 months from the date Watson's notice letter was received (i.e., October 13, 2014) or final resolution of the pending patent infringement lawsuit. Should Watson receive tentative approval from the FDA for its generic version of Testim before one of those events occurs, it would not be permitted to launch its generic product in the U.S. Watson will also not be able to launch a generic version of Testim in the U.S. until it receives the necessary final approval of its ANDA from the FDA, which includes proving to the FDA that Watson's proposed generic product is comparable to Testim in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

About Auxilium

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets Testim^® 1% (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX^® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord. GlaxoSmithKline LLC is expected to co-promote Testim with Auxilium in the U.S. beginning in the third quarter of 2012. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Pfizer has marketing rights for XIAPEX^® (the EU tradename for collagenase clostridium histolyticum) in 46 countries in Eurasia; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie's disease, phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.

About FCB

FCB I LLC is an indirect, majority-owned subsidiary of Xstelos Holdings, Inc. (OTC Pink Sheets: XTLS.PK).

AUXILIUM SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which discuss matters that are not facts, and may include words to indicate their uncertain nature such as "believe," "expect," anticipate," "intend," "plan," "should," "could," "estimate," "project," "will," and "target." Our forward-looking statements convey management's expectations, beliefs, plans and objectives regarding future performance of Auxilium and are based upon preliminary information and management assumptions. No specific assurances can be given with respect to: whether Auxilium will succeed in its efforts in defense of the patents covering Testim, including enforcement of its intellectual property rights and approved labeling, whether Watson will be subject to a 30-month stay of its efforts to launch a generic competitor to Testim, the timing of any such launch by Watson or the expected duration of any patent covering Testim. While the Company may elect to update the forward-looking statements made in this news release in the future, the Company specifically disclaims any obligation to do so. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration, and those risks discussed in our reports on file with the Securities and Exchange Commission (the "SEC"). Our SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "For Investors - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.

FCB SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on FCB's parent companies' current estimates and assumptions and, as such, involve uncertainty and risk. Forward-looking statements include the information concerning FCB and its parent companies' possible or assumed future results of operations and also include those preceded or followed by the words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "should," "plans," "targets" and/or similar expressions. These statements relate to future events or future financial performance and involve known and unknown risks, uncertainties and other factors that could cause FCB or its parent companies' actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others, competition from existing products or new products that may emerge, regulatory difficulties relating to products that have already received regulatory approval, potential product liability claims, dependency on third-party manufacturers to supply or manufacture products, ability to establish or maintain collaborations, licensing or other arrangements, Xstelos' ability and third parties' abilities to protect intellectual property rights, limitation on the ability to utilize net operating losses, compliance with obligations under intellectual property licenses with third parties, ability to successfully invest for future growth, and those risks discussed in Xstelos' reports on file with the SEC. The forward-looking statements are not guarantees of future performance, events or circumstances, and actual results may differ materially from those contemplated by these forward-looking statements. For these reasons, one should not place undue reliance on any forward-looking statements. Xstelos' SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov.

Auxilium Contacts:
James E. Fickenscher / CFO	William Q. Sargent, Jr. / V.P., IR
Auxilium Pharmaceuticals, Inc.	Auxilium Pharmaceuticals, Inc.
(484) 321-5900	(484) 321-5900
jfickenscher@auxilium.com	wsargent@auxilium.com

FCB Contacts:
Jonathan M. Couchman, President
FCB I LLC
(603) 658-6100 x502

SOURCE Auxilium Pharmaceuticals, Inc.

Innovative public-private collaboration launches to tackle antibiotic research

Thu, 24 May 2012 08:10:00 +0000

Issued: Thursday 24 May 2012, London UK New €224m (£180m) funding to enable development of antibiotics for bacterial infections and drive unprecedented information sharing

GlaxoSmithKline and AstraZeneca today welcomed the launch of a pioneering approach to antibiotic research in Europe that will see pharmaceutical and biotechnology companies working alongside public partners to tackle the rising threat from antibiotic resistance and address some of the key barriers to the development of effective antibiotics.

The objective of the proposed research programme is to improve the underlying scientific understanding of antibiotic resistance, design and implement efficient clinical trials and take novel drug candidates through clinical development. The programme is part of the European Commission’s Action Plan against the rising threats from Antimicrobial Resistance , launched in November last year.

Set against a backdrop of emerging resistant bacteria and with the pipeline of future antibiotics described by the World Health Organization (WHO) as “virtually dry”, this innovative research programme, NewDrugs4BadBugs , intends to boost the currently faltering discovery and development of new antibiotics.

Supported by theInnovative Medicines Initiative (IMI), Europe’s largest public-private initiative, the research programme’s first projects will be funded by a joint budget of up to €223.7million – €109million provided by IMI and €114.7million in kind contributions from the pharmaceutical and biotechnology companies involved. GlaxoSmithKline , AstraZeneca , Janssen , Sanofi and Basilea Pharmaceutica will work alongside public research organisations and scientific experts to address several aspects of resistance and stimulate new antibiotic research. Further projects within the programme, with additional funding, are expected to launch later in the year.

Antibiotic resistance is increasingly becoming a worldwide health threat. Many of the medical advances in recent years, such as chemotherapy for cancer treatment and organ transplantation, depend on effective antibiotics. Despite this need and the continued emergence of bacteria resistant to existing drugs, research has diminished over the past 15 years and few companies remain active in this area. This is due to the scientific difficulties in finding new agents that successfully target bacteria, regulatory complexities and a lack of the commercial incentives needed to encourage investment in this area and to fund future R&D.

Patrick Vallance, President, Pharmaceuticals R&D at GlaxoSmithKline, said : “The rise of infections such as MRSA is well known, but today marks a chance to reverse the threat. This announcement signals a new model of collaboration and a willingness to change and adapt to seek different solutions. GSK has a legacy in the development of new antibiotics going back 40 years and we remain active in this field of research. We can bring our scientific innovation and expertise to this novel collaboration which, in combination with the different skills and resources provided by other partners, provides a real opportunity to address the needs of patients today and prepare for the potential threats of tomorrow.”

Martin Mackay, President, R&D, at AstraZeneca, said : “The steady rise of drug-resistant bacteria is an imminent and urgent threat to public health, and without a reliable arsenal of effective antibiotics, modern medical care is not possible. Bacteria develop resistance as fast, or faster, than we can develop treatments and a combination of scientific, regulatory, and financial challenges have impeded new antibiotic development.

“It is time to tackle this issue in a different way, sharing information and expertise among public and private partners – collaboration of this type is critical if we are to speed up the discovery of these medicines to improve patient health.”

The proposed research programme will initially focus on three key areas:

Progressing development of pipeline antibiotics

This funding will support new research that will progress potential antibiotics already under investigation through clinical trials and improve the design of future clinical trials.

GlaxoSmithKline’s investigational antibiotic, GSK1322322, targeting multi-drug resistant respiratory and skin infections including MRSA (m ethicillin resistant Staphylococcus aureus ) and currently in Phase II development, will be included in the research programme. Pending the results of ongoing work, these will be joined slightly later by AstraZeneca’s MEDI4893, a novel investigational monoclonal antibody in early stage development that targets a toxin released by Staphylococcus aureus and AZD9773, an investigational treatment for severe sepsis and septic shock, conditions triggered by uncontrolled bacterial infection.

Information sharing

The collaboration will be underpinned by an unprecedented level of data and knowledge sharing. It is hoped that developing a platform to enable the sharing of knowledge and resources across multiple groups will improve the chances of success in developing the next generation of antibiotics.

A new information hub will allow the sharing of knowledge and data between participants and across the wider antibiotic research community to enable the field to learn from antibiotic development successes and failures and gain a shared and improved understanding of the science behind antibiotic resistance. This will minimise duplication of effort and reduce inefficiencies in future R&D, supporting antibiotic research through the life of the programme and beyond.

Participants will share information on the design of clinical trials and the data generated, to support development of novel trials in the future that will increase efficiency of antibiotic research. A clinical trial network will be established to evaluate antibiotics currently in development, enabling experts in clinical antibiotic research to work alongside the scientists developing future medicines.

Continuing research and discovering new antibiotics

Tackling infections caused by Gram negative bacteria is a very difficult challenge, owing to the particular defence mechanisms they employ. There are few treatment options available and currently limited ongoing development activities in this area. This research programme aims to find more approaches to the design of antibiotics that could be effective against Gram negative bacteria, increase understanding of their defence mechanisms and use this knowledge to support future drug discovery efforts.

Key to the success of NewDrugs4BadBugs will be the involvement of multiple public partners from across Europe. Public institutions and research organisations, clinical investigators and scientific experts are being encouraged to learn more about the proposed research programme through a series of events. Full details can be found at www.imi.europa.eu .

Antibody Drugs: Technologies and Global Markets

Wed, 23 May 2012 11:04:07 +0000

Antibody Drugs: Technologies and Global Markets

PR Newswire

NEW YORK, May 23, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Antibody Drugs: Technologies and Global Markets

http://www.reportlinker.com/p0801344/Antibody-Drugs-Technologies-and-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

INTRODUCTION

STUDY GOALS AND OBJECTIVES

The aim of this report is to provide a range of information—from detailed analysis through industry trends—to quantify and qualify the rapidly growing market for therapeutic monoclonal antibody (mAb) drugs. Forecasts and trends are gleaned from industry sources, analyst reports, and company forecasts, as well as from assessment of available and emerging technologies.

The report develops forecasts for sales of the mAb market by individual antibody, by therapeutic antibody target (epidermal growth factor receptor [EGFR], cluster of differentiation [CD] 20, tumor necrosis factor [TNF] alpha, etc.), and by major disease applications from 2011 through 2016. Additionally, we examine strategies employed by biopharmaceutical firms to develop and market products in this explosive market sector.

Our main objective is to present a comprehensive analysis of the current market for therapeutic mAb disease-modifying products and to forecast this market's future direction through 2016.

REASONS FOR DOING THE STUDY

Therapeutic mAbs represent the largest and one of the fastest-growing classes of biopharmaceutical products by sales in the U.S. and throughout the world. Of the top 20 drugs by sales throughout the world today, five are mAbs.

During our forecast period from 2011 through 2016, eight new mAbs are forecast to enter the market, and sales of therapeutic mAbs are estimated to grow from approximately $43 billion in 2010 to nearly $58 billion in 2016. Sales of humanized and fully human antibodies for autoimmune/inflammatory diseases such as rheumatoid arthritis, ulcerative colitis, and multiple sclerosis are forecast to experience the fastest sales growth.

This period of dynamic growth for humanized and fully human antibodies plus the continued rollout of antibody-drug conjugates (ADCs), also called immunoconjugates, is expected to result in stagnating sales of chimeric antibodies from 2011 through 2016.

INTENDED AUDIENCE

This study will be of interest to those working in the biotechnology and pharmaceutical industries and related life science, drug discovery, and diagnostic test manufacturing companies, as well as all those interested or actively working in drug research.

Both individuals looking for a comprehensive listing of mAbs in human clinical-stage development and individuals looking at how the mAb drug marketplace is expected to change (in terms of sales and technology) in the coming years will find this report extremely useful.

SCOPE OF REPORT

This report analyzes and assesses therapeutic applications of mAbs in human medicine. Covered in this report are mAbs exclusively, including the combination of mAbs when they are attached to a cytotoxic agent such as with ADCs.

Excluded from this report are diagnostic uses of mAbs (such as for imaging purposes) and therapeutic antibodies for veterinary use. Also excluded are research applications of mAbs.

The scope of the study is global. The "Overview" section provides a discussion of the importance and advantages of antibody-based products, valuation of antibody product sales, patent issues and differences in applicability of mAbs products versus polyclonal antibodies (pAbs), and other competing agents such as small molecule therapeutics.

The "Technology and Technical Issues" section discusses new directions in antibody research, the types of antibodies used as therapeutics, the challenges in antibody production, and other approaches—in particular transgenic sources—of antibody production.

The "Products" section provides a synopsis of more than 60 mAb drugs, including those currently marketed and those in late-stage development. Comparative product and sales analyses are provided for individual products. Tables include current and forecasted sales by individual product, sales by target and technology (for mAb-based drugs), as well as global market size and growth estimates for therapeutic mAbs.

The "Applications" section provides an overview of the leading indications for available and emerging antibody-based therapeutics. These include selected indications for autoimmune diseases (specifically rheumatoid arthritis, psoriasis, and Crohn's disease), cancer indications (specifically the most common solid tumor types, leukemias, and lymphomas) cardiovascular diseases, infectious diseases, ophthalmic indications, and respiratory diseases.

The "Industry Structure" section provides an overview of the antibody industry as well as a discussion of the pending huge impact of genomics and the emergence of biotechnology firms into the mainstream market.

The "Company Profiles" section emphasizes companies that lead the biotechnology and pharmaceutical industry in the research and development of antibody drugs and the innovative products that those companies have launched or have in development.

INFORMATION SOURCES

The information in this report was derived from the review of more than 200 biotechnology and pharmaceutical companies developing mAbs and the review of journal articles related to mAb therapeutics. Sources of information include PubMed, ClinicalTrials.gov, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and company presentations and annual reports.

TABLE OF CONTENTS

CHAPTER ONE: INTRODUCTION 1

STUDY GOALS AND OBJECTIVES . 1

REASONS FOR DOING THE STUDY 1

INTENDED AUDIENCE 2

SCOPE OF REPORT 2

INFORMATION SOURCES . 3

ANALYST CREDENTIALS 3

RELATED REPORTS . 3

BCC ON-LINE SERVICES . 4

DISCLAIMER . 4

CHAPTER TWO: SUMMARY 5

SUMMARY TABLE GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES, THROUGH 2016 ($ MILLIONS) 5

SUMMARY FIGURE GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES, 2009-2016 ($ MILLIONS) . 6

CHAPTER THREE: OVERVIEW 7

DEFINITIONS 7

DEFINITIONS (CONTINUED) . 8

THE IMPORTANCE OF ANTIBODY DRUGS AND DIAGNOSTICS . 9

THE IMPORTANCE OF ANTIBODY … (CONTINUED) 10

INTELLECTUAL PROPERTY ISSUES AND PATENT LICENSING 11

THE HISTORY OF THE COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS . 11

TABLE 1 TIMELINE TO COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS . 11

ADVANTAGES OF MONOCLONAL ANTIBODY DRUGS 12

WHY DO MONOCLONAL ANTIBODY PRODUCTS HAVE SO MANY APPLICATIONS COMPARED WITH POLYCLONAL ANTIBODY PRODUCTS? 13

VALUATION OF ANTIBODY PRODUCT SALES . 14

CHAPTER FOUR: TECHNOLOGY AND TECHNICAL ISSUES . 15

OVERVIEW . 15

OVERVIEW (CONTINUED) . 16

TABLE 2 MONOCLONAL ANTIBODIES VERSUS SMALL MOLECULE DRUGS . 17

TABLE 2 (CONTINUED) . 18

TABLE 3 MONOCLONAL ANTIBODIES VERSUS POLYCLONAL ANTIBODIES . 18

THE HAMA PROBLEM AND ITS RESOLUTION . 19

PHAGE DISPLAY AND POLYSOME DISPLAY 20

PHAGE DISPLAY AND POLYSOME … (CONTINUED) 21

DIRECTED EVOLUTION 22

ANTIBODY CLASSES 22

TABLE 4 ANTIBODY TYPES AND DESCRIPTIONS . 23

ANTIBODY FORMS IN PRODUCTS 23

TABLE 5 GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES BY ANTIBODY TECHNOLOGY TYPE, THROUGH 2016 ($ MILLIONS) . 24

TABLE 6 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY

ANTIBODY FORM (NUMBER/%) 25

TABLE 7 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY TECHNOLOGY FORM AND STAGE OF DEVELOPMENT 25

TABLE 8 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY TARGET . 26

ABTIDES 26

ANTIBODY-DRUG CONJUGATES / IMMUNOCONJUGATES 26

ANTISERUMS . 27

BISPECIFIC ANTIBODIES 28

CAMOUFLAGED ANTIBODIES 28

CHIMERIC ANTIBODIES 29

HUMANIZED ANTIBODIES 29

Humanized Antibodies (Continued) . 30

FULLY HUMAN ANTIBODIES 31

PROGENITOR STEM CELLS . 32

SINGLE-CHAIN ANTIBODIES 32

SYNTHETIC ANTIBODIES 33

SOURCES OF MONCLONAL ANTIBODIES ON THE MARKET 34

TABLE 9 MARKETED MONOCLONAL ANTIBODY PRODUCTS AND THEIR SOURCES 34

TABLE 9 (CONTINUED) . 35

TABLE 9 (CONTINUED) . 36

THE SPECIAL CASE OF ENBREL. 36

ANTIBODY TECHNOLOGIES IN DEVELOPMENT 37

AFFIBODIES . 37

DOMAIN ANTIBODIES 37

NANOBODIES . 38

TABLE 10 MONOCLONAL ANTIBODIES IN PHASE 3 DEVELOPMENT 39

TABLE 10 (CONTINUED) . 40

TABLE 11 MONOCLONAL ANTIBODIES IN PHASE 2 DEVELOPMENT 40

TABLE 11 (CONTINUED) . 41

TABLE 11 (CONTINUED) . 42

TABLE 11 (CONTINUED) . 43

TABLE 11 (CONTINUED) . 44

TABLE 11 (CONTINUED) . 45

TABLE 11 (CONTINUED) . 46

TABLE 11 (CONTINUED) 47

TABLE 12 MONOCLONAL ANTIBODIES IN PHASE 1 DEVELOPMENT 47

TABLE 12 (CONTINUED) 48

TABLE 12 (CONTINUED) . 49

TABLE 12 (CONTINUED) . 50

TABLE 12 (CONTINUED) . 51

TABLE 12 (CONTINUED) . 52

NEW DIRECTIONS IN ANTIBODY RESEARCH 53

THE MARKET OPPORTUNITY FOR TRANSGENIC PRODUCTION OF ANTIBODY PRODUCTS 53

THE MARKET OPPORTUNITY FOR …(CONTINUED) 54

THE HIGH COST OF PRODUCING ANTIBODIES AND OTHER PROTEIN DRUGS . 55

THE GROWING CRISIS IN MEETING PRODUCTION DEMANDS FOR PROTEIN DRUGS 56

THE TRANSGENIC ADVANTAGE . 56

TRADITIONAL PRODUCTION METHODS 57

MICROBIAL FERMENTATION . 58

MAMMALIAN CELL CULTURE 58

THE ENBREL SHORTAGE . 59

THE CRUNCH IN CAPACITY. 59

REASONS FOR THE NEED TO INCREASE PROTEIN DRUG PRODUCTION 60

GENOMICS AND GENE DISCOVERY DRIVE THE EXPANDING DEVELOPMENT OF PROTEIN DRUGS 61

PRODUCTION OF ANTIBODIES IN ANIMALS . 62

PRODUCTION OF ANTIBODIES … (CONTINUED) . 63

GOATS AS MONOCLONAL ANTIBODIES FACTORIES 64

PRODUCTION OF ANTIBODIES IN PLANTS 64

PLASTIDS 64

TARGETING AND COMPARTMENTALIZING 65

TRANSGENIC SEEDS FOR ANTIBODY STORAGE 65

CHAPTER FIVE: PRODUCTS 66

OVERVIEW . 66

MARKETED PRODUCTS 66

TABLE 13 GLOBAL SALES OF MONOCLONAL ANTIBODIES, BY

PRODUCT THROUGH 2016 ($ MILLIONS) . 67

TABLE 14 U.S. SALES OF MONOCLONAL ANTIBODIES, BY

PRODUCT THROUGH 2016 ($ MILLIONS) . 68

TABLE 15 REST OF WORLD SALES OF MONOCLONAL ANTIBODIES, BY PRODUCT THROUGH 2016 ($ MILLIONS) . 69

GEMTUZUMAB OZOGAMICIN (MYLOTARG) 70

DACLIZUMAB (ZENAPAX) 71

Daclizumab (Zenapax) (Continued) 72

TABLE 16 DACLIZUMAB CHOICE STUDY RESULTS . 73

CATUMAXOMAB (REMOVAB) 74

TOCILIZUMAB (ACTEMRA, ROACTEMRA, RG1569) . 75

TRASTUZUMAB (HERCEPTIN, RG597) . 76

Trastuzumab (Herceptin, RG597) (Continued) 77

BEVACLIZUMAB (AVASTIN, RG435) . 78

Bevaclizumab (Avastin, RG435) (Continued) 79

Bevaclizumab (Avastin, RG435) (Continued) 80

CETUXIMAB (ERBITUX) . 81

Cetuximab (Erbitux) (Continued) . 82

PANITUMUMAB (VECTIBIX) 83

Panitumumab (Vectibix) (Continued) . 84

IBRITUMOMAB TIUXETAN (ZEVALIN) 85

Results of Trials . 86

Sales of Zevalin 87

ALEMTUZUMAB (LEMTRADA, CAMPATH, MABCAMPATH) 88

Alemtuzumab (… (Continued) 89

Alemtuzumab (… (Continued) 90

NATALIZUMAB (TYSABRI) . 91

TABLE 17 TYSABRI SENTINEL AND AFFIRM STUDY RESULTS 92

Natalizumab (Tysabri) (Continued) 93

TOSITUMOMAB-I (BEXXAR) 94

Tositumomab-I (Bexxar) (Continued) . 95

OFATUMUMAB (ARZERRA) 96

Ofatumumab (Arzerra) (Continued) . 97

RITUXIMAB (RITUXAN, MABTHERA, RG105) . 98

INFLIXIMAB (REMICADE) 99

Infliximab (Remicade) (Continued) . 100

DENOSUMAB (PROLIA, XGEVA) . 101

IPILIMUMAB (YERVOY, MDX-010) 102

ADALIMUMAB (HUMIRA) . 103

GOLIMUMAB (SIMPONI) 104

CANAKINUMAB (ILARIS, ACZ885) 105

ECULIZUMAB (SOLIRIS) . 106

PALIVIZUMAB (SYNAGIS) 107

ABCIXIMAB (REOPRO) 108

Abciximab (ReoPro) (Continued) . 109

Abciximab (ReoPro) (Continued) . 110

RANIBIZUMAB (LUCENTIS) . 111

Ranibizumab (Lucentis) (Continued) 112

MUROMONAB (ORTHOCLONE OKT3) 113

OMALIZUMAB (XOLAIR) . 113

USTEKINUMAB (STELARA, CNTO 1275) 114

Ustekinumab (Stelara, CNTO 1275) (Continued) 115

CERTOLIZUMAB PEGOL (CIMZIA) . 116

BASILIXIMAB (SIMULECT) 116

Basiliximab (Simulect) (Continued) 117

BELIMUMAB (BENLYSTA) . 118

NIMOTUZUMAB . 119

PRODUCTS IN DEVELOPMENT . 119

TANEZUMAB (RN624) 119

VEDOLIZUMAB (MLN0002). 120

LY2127399 121

OTELIXIZUMAB . 121

MEPOLIZUMAB (BOSATRIA) 122

TEPLIZUMAB (MGA031, HOKT3-GAMMA1) . 122

BAPINEUZUMAB (AAB-001) . 123

GANITUMAB (AMG 479) 124

OBINUTUZUMAB (AFUTUZUMAB, GA101, RG7159) 125

ZANOLIMUMAB (FORMERLY HUMAX-CD4) . 126

RESLIZUMAB (CINQUIL) 127

BLINATUMOMAB (MT103) 128

FARLETUZUMAB (MORAB-003) . 128

EPRATUZUMAB 129

GIRENTUXIMAB (RENCAREX) 129

INOTUZUMAB OZOGAMICIN (CMC-544) 130

BRIAKINUMAB (ABT-874) . 131

ELOTUZUMAB 132

SILTUXIMAB (CNTO 328) 133

TRASTUZUMAB EMTANSINE (T-DM1, RG3502) 133

INOLIMOMAB (LEUKOTAC) . 134

ITOLIZUMAB (T1H, ANTI-CD6) 134

NAPTUMOMAB ESTAFENATOX (ANYARA) . 135

NECITUMUMAB (IMC-11F8) . 135

PERTUZUMAB 136

RAMUCIRUMAB (IMC-1121B, LY3009806) 137

RAXIBACUMAB 138

MK-3415, MK-6072, AND MK-3415A . 138

MK-3415, MK-6072, and MK-3415A (Continued) 139

CHAPTER SIX: APPLICATIONS 140

OVERVIEW . 140

TABLE 18 MONOCLONAL ANTIBODIES ON THE MARKET, BY

INDICATION 2011 (NUMBER/%) 140

TABLE 19 GLOBAL SALES OF THERAPEUTIC MONOCLONAL

ANTIBODIES, BY APPLICATION, THROUGH 2016 ($ MILLIONS) . 141

TABLE 20 MONOCLONAL ANTIBODIES IN CLINICAL STAGE DEVELOPMENT, BY INDICATION, 2011 (NUMBER/%) . 141

TABLE 20 (CONTINUED) . 142

AUTOIMMUNE DISEASES 142

CROHN'S DISEASE 143

PSORIASIS . 144

RHEUMATOID ARTHRITIS . 145

TABLE 21 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF INFLAMMATORY DISEASES (NOT INCLUDING MS), THROUGH 2016 ($ MILLIONS) . 145

SOLID TUMORS 146

U.S. CANCER STATISTICS 146

TABLE 22 INCIDENCE, MORTALITY, AND SURVIVAL RATES FOR COMMON CANCERS IN THE U.S., 2011 . 147

TABLE 23 CANCER PREVALENCE RATES IN THE U.S., 2008 (IN THOUSANDS) . 148

BREAST CANCER . 149

COLORECTAL CANCER 149

HEAD AND NECK CANCER 149

KIDNEY CANCER . 149

LIVER CANCER 149

LUNG CANCER . 150

MALIGNANT MELANOMA 150

OSTEOSARCOMA . 151

OVARIAN CANCER 151

PANCREATIC CANCER . 152

PROSTATE CANCER 152

STOMACH CANCER . 153

ANTIBODY PRODUCTS ON THE MARKET FOR THE TREATMENT OF CANCER . 153

TABLE 24 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF SOLID TUMORS, BY REGION, THROUGH 2016 ($ MILLIONS) . 153

LYMPHOMAS AND LEUKEMIAS 153

NON-HODGKIN LYMPHOMA . 154

LEUKEMIAS 154

Leukemias (Continued) . 155

CARDIOVASCULAR DISEASES 156

PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY 157

INFECTIOUS DISEASES 158

CYTOMEGALOVIRUS INFECTION 159

HEPATITIS 160

RESPIRATORY SYNCYTIAL VIRUS INFECTION 160

TABLE 25 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF INFECTIOUS DISEASES, BY REGION, THROUGH 2016 ($ MILLIONS) . 161

MULTIPLE SCLEROSIS . 161

TABLE 26 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF MULTIPLE SCLEROSIS, BY REGION, THROUGH 2016 ($ MILLIONS) . 162

OPHTHALMIC DISEASES 162

MACULAR DEGENERATION 162

OTHER THERAPEUTIC APPLICATIONS . 163

TABLE 27 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF OTHER DISEASES, BY REGION, THROUGH 2016 ($ MILLIONS) . 163

CHAPTER SEVEN: INDUSTRY STRUCTURE . 164

OVERVIEW . 164

ORIGINATORS . 164

COMMERCIAL DEVELOPERS . 165

VENDORS . 166

MANUFACTURERS . 166

TECHNOLOGY INNOVATORS. 167

PRICING FORECASTS 168

THE REGULATORY ENVIRONMENT 168

THE REGULATORY ENVIRONMENT (CONTINUED) . 169

GENOMICS AND MONOCLONAL ANTIBODIES: A MATCH FOR SUCCESS . 170

GENOMICS AND MONOCLONAL … (CONTINUED) . 171

GENOMICS AND MONOCLONAL … (CONTINUED) . 172

COMPANY SALES AND MARKET SHARE . 173

TABLE 28 SALES OF MARKETED ANTIBODIES BY

MANUFACTURER, THROUGH 2016 ($ MILLIONS) 174

TABLE 29 MANUFACTURERS OF ANTIBODIES BY MARKET SHARE, 2011 AND 2016 (%) 175

TABLE 30 MONOCLONAL ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY COMPANY . 176

COMPANY PROFILES 176

ABBOTT LABORATORIES . 176

ALEXION PHARMACEUTICALS 177

AMGEN 178

ASTRAZENECA . 179

AstraZeneca – U.S. Headquarters 179

BAYER AG . 180

Bayer (U.S. Location) 180

BIOGEN IDEC . 181

BRISTOL-MYERS SQUIBB 182

BTG . 183

DAIICHI SANKYO . 183

ELAN 184

EMERGENT BIOSOLUTIONS . 185

EISAI 185

ELI LILLY 186

GENMAB 186

Genmab (U.S. Location) 187

GLAXOSMITHKLINE . 187

GlaxoSmithKline (U.S. Location) 187

HUMAN GENOME SCIENCES 188

JOHNSON & JOHNSON . 188

KALOBIOS PHARMACEUTICALS 189

MERCK KGAA (MERCK SERONO) . 190

MORPHOSYS . 191

NOVARTIS . 191

PFIZER . 192

ROCHE . 193

To order this report:Biopharmaceutical Industry: Antibody Drugs: Technologies and Global Markets

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Pharmaceuticals - Global Group of Eight (G8) Industry Guide

Wed, 23 May 2012 10:41:31 +0000

Pharmaceuticals - Global Group of Eight (G8) Industry Guide

PR Newswire

NEW YORK, May 23, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Pharmaceuticals - Global Group of Eight (G8) Industry Guide

http://www.reportlinker.com/p0191857/Pharmaceuticals---Global-Group-of-Eight-G8-Industry-Guide.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pharmaceu

Pharmaceuticals - Global Group of Eight (G8) Industry Guide is an essential resource for top-level data and analysis covering the Pharmaceuticals industry in each of the G8 (United States, Canada, Germany, France, United Kingdom, Italy, Russia and Japan) countries. The report includes easily comparable data on market value, volume, segmentation and market share, plus full five year market forecasts. It examines future problems, innovations and potential growth areas within the market.

Scope of the Report

* Contains an executive summary and data on value, volume and segmentation

* Provides textual analysis of the industry's prospects, competitive landscape and profiles of the leading companies

* Incorporates in-depth five forces competitive environment analysis and scorecards

* Compares data from the US, Canada, Germany, France, UK, Italy, Russia and Japan, alongside individual chapters on each country. .

* Includes a five-year forecast of the industry

Highlights

The G8 countries contributed $510,182.1 million in 2010 to the global pharmaceuticals industry, with a compound annual growth rate (CAGR) of 3.9% between 2006 and 2010.

The G8 countries are expected to reach a value of $629,493.5 million in 2015, with a CAGR of 4.3% over the 2010–15 period.Among the G8 countries, the US holds the major share of the pharmaceuticals industry. It accounted for a share of 52.1% in 2010.

Among the G8 nations, the US is the leading country in the pharmaceuticals industry, with market revenues of $265,735.9 million in 2010.

The US is expected to lead the Pharmaceuticals industry in the G8 nations with a value of $346,744.2 million in 2015.

Why you should buy this report

* Spot future trends and developments

* Inform your business decisions

* Add weight to presentations and marketing materials

* Save time carrying out entry-level research

Market Definition

The pharmaceuticals market consists of ethical drugs for in-patient and out-patient usage, valued at ex-manufacturer prices.

Any currency conversions used within this report have been calculated using 2010 constant exchange rates.

TABLE OF CONTENTSINTRODUCTION 16What is this report about? 16Who is the target reader? 16Market definition 16GROUP OF EIGHT (G8) PHARMACEUTICALS INDUSTRY OUTLOOK 17PHARMACEUTICALS IN CANADA 24Market overview 24Market value 25Market segmentation 26Market share 27Five forces analysis 28Leading companies 39Market forecasts 50Macroeconomic indicators 51PHARMACEUTICALS IN FRANCE 53Market overview 53Market value 54Market segmentation 55Market share 56Five forces analysis 57Leading companies 68Market forecasts 80Macroeconomic indicators 81PHARMACEUTICALS IN GERMANY 83Market overview 83Market value 84Market segmentation 85Market share 86Five forces analysis 87Leading companies 98Market forecasts 110Macroeconomic indicators 111PHARMACEUTICALS IN ITALY 113Market overview 113Market value 114Market segmentation 115Market share 116Five forces analysis 117Leading companies 128Market forecasts 141Macroeconomic indicators 142PHARMACEUTICALS IN JAPAN 144Market overview 144Market value 145Market segmentation 146Market share 147Five forces analysis 148Leading companies 159Market forecasts 170Macroeconomic indicators 171PHARMACEUTICALS IN RUSSIA 173Market overview 173Market value 174Market segmentation 175Market share 176Five forces analysis 177Leading companies 189Market forecasts 200Macroeconomic indicators 201PHARMACEUTICALS IN THE UNITED KINGDOM 203Market overview 203Market value 204Market segmentation 205Market share 206Five forces analysis 207Leading companies 219Market forecasts 231Macroeconomic indicators 232PHARMACEUTICALS IN THE UNITED STATES 234Market overview 234Market value 235Market segmentation 236Market share 237Five forces analysis 238Leading companies 249Market forecasts 265Macroeconomic indicators 266APPENDIX 268Data Research Methodology 268About Datamonitor 269Disclaimer 269

LIST OF TABLES

Table 1: G8 pharmaceuticals industry, revenue($m), 2006–15 18

Table 2: G8 pharmaceuticals industry, revenue by country ($m), 2006–10 21

Table 3: G8 pharmaceuticals industry forecast, revenue by country ($m), 2010–15 23

Table 4: Canada pharmaceuticals market value: $ million, 2006–10 25

Table 5: Canada pharmaceuticals market segmentation: % share, by value, 2010 26

Table 6: Canada pharmaceuticals market share: % share, by value, 2010 27

Table 7: AstraZeneca PLC: key facts 39

Table 8: AstraZeneca PLC: key financials ($) 41

Table 9: AstraZeneca PLC: key financial ratios 41

Table 10: Johnson & Johnson: key facts 43

Table 11: Johnson & Johnson: key financials ($) 44

Table 12: Johnson & Johnson: key financial ratios 45

Table 13: Pfizer Inc.: key facts 47

Table 14: Pfizer Inc.: key financials ($) 48

Table 15: Pfizer Inc.: key financial ratios 48

Table 16: Canada pharmaceuticals market value forecast: $ million, 2010–15 50

Table 17: Canada size of population (million), 2006–10 51

Table 18: Canada gdp (constant 2000 prices, $ billion), 2006–10 51

Table 19: Canada gdp (current prices, $ billion), 2006–10 51

Table 20: Canada inflation, 2006–10 52

Table 21: Canada consumer price index (absolute), 2006–10 52

Table 22: Canada exchange rate, 2006–10 52

Table 23: France pharmaceuticals market value: $ million, 2006–10 54

Table 24: France pharmaceuticals market segmentation: % share, by value, 2010 55

Table 25: France pharmaceuticals market share: % share, by value, 2010 56

Table 26: AstraZeneca PLC: key facts 68

Table 27: AstraZeneca PLC: key financials ($) 70

Table 28: AstraZeneca PLC: key financial ratios 70

Table 29: GlaxoSmithKline Plc: key facts 72

Table 30: GlaxoSmithKline Plc: key financials ($) 74

Table 31: GlaxoSmithKline Plc: key financials (£) 75

Table 32: GlaxoSmithKline Plc: key financial ratios 75

Table 33: Pfizer Inc.: key facts 77

Table 34: Pfizer Inc.: key financials ($) 78

Table 35: Pfizer Inc.: key financial ratios 78

Table 36: France pharmaceuticals market value forecast: $ million, 2010–15 80

Table 37: France size of population (million), 2006–10 81

Table 38: France gdp (constant 2000 prices, $ billion), 2006–10 81

Table 39: France gdp (current prices, $ billion), 2006–10 81

Table 40: France inflation, 2006–10 82

Table 41: France consumer price index (absolute), 2006–10 82

Table 42: France exchange rate, 2006–10 82

Table 43: Germany pharmaceuticals market value: $ million, 2006–10 84

Table 44: Germany pharmaceuticals market segmentation: % share, by value, 2010 85

Table 45: Germany pharmaceuticals market share: % share, by value, 2010 86

Table 46: GlaxoSmithKline Plc: key facts 98

Table 47: GlaxoSmithKline Plc: key financials ($) 100

Table 48: GlaxoSmithKline Plc: key financials (£) 101

Table 49: GlaxoSmithKline Plc: key financial ratios 101

Table 50: Novartis AG: key facts 103

Table 51: Novartis AG: key financials ($) 104

Table 52: Novartis AG: key financial ratios 105

Table 53: Pfizer Inc.: key facts 107

Table 54: Pfizer Inc.: key financials ($) 108

Table 55: Pfizer Inc.: key financial ratios 108

Table 56: Germany pharmaceuticals market value forecast: $ million, 2010–15 110

Table 57: Germany size of population (million), 2006–10 111

Table 58: Germany gdp (constant 2000 prices, $ billion), 2006–10 111

Table 59: Germany gdp (current prices, $ billion), 2006–10 111

Table 60: Germany inflation, 2006–10 112

Table 61: Germany consumer price index (absolute), 2006–10 112

Table 62: Germany exchange rate, 2006–10 112

Table 63: Italy pharmaceuticals market value: $ million, 2006–10 114

Table 64: Italy pharmaceuticals market segmentation: % share, by value, 2010 115

Table 65: Italy pharmaceuticals market share: % share, by value, 2010 116

Table 66: Chiesi Farmaceutici SpA: key facts 128

Table 67: GlaxoSmithKline Plc: key facts 131

Table 68: GlaxoSmithKline Plc: key financials ($) 133

Table 69: GlaxoSmithKline Plc: key financials (£) 134

Table 70: GlaxoSmithKline Plc: key financial ratios 134

Table 71: Menarini Group, The: key facts 136

Table 72: Pfizer Inc.: key facts 138

Table 73: Pfizer Inc.: key financials ($) 139

Table 74: Pfizer Inc.: key financial ratios 139

Table 75: Italy pharmaceuticals market value forecast: $ million, 2010–15 141

Table 76: Italy size of population (million), 2006–10 142

Table 77: Italy gdp (constant 2000 prices, $ billion), 2006–10 142

Table 78: Italy gdp (current prices, $ billion), 2006–10 142

Table 79: Italy inflation, 2006–10 143

Table 80: Italy consumer price index (absolute), 2006–10 143

Table 81: Italy exchange rate, 2006–10 143

Table 82: Japan pharmaceuticals market value: $ million, 2006–10 145

Table 83: Japan pharmaceuticals market segmentation: % share, by value, 2010 146

Table 84: Japan pharmaceuticals market share: % share, by value, 2010 147

Table 85: Astellas: key facts 159

Table 86: Astellas: key financials ($) 160

Table 87: Astellas: key financials (¥) 161

Table 88: Astellas: key financial ratios 161

Table 89: Daiichi Sankyo Co., Ltd.: key facts 163

Table 90: Daiichi Sankyo Co., Ltd.: key financials ($) 164

Table 91: Daiichi Sankyo Co., Ltd.: key financials (¥) 164

Table 92: Daiichi Sankyo Co., Ltd.: key financial ratios 165

Table 93: Pfizer Inc.: key facts 167

Table 94: Pfizer Inc.: key financials ($) 168

Table 95: Pfizer Inc.: key financial ratios 168

Table 96: Japan pharmaceuticals market value forecast: $ million, 2010–15 170

Table 97: Japan size of population (million), 2006–10 171

Table 98: Japan gdp (constant 2000 prices, $ billion), 2006–10 171

Table 99: Japan gdp (current prices, $ billion), 2006–10 171

Table 100: Japan inflation, 2006–10 172

Table 101: Japan consumer price index (absolute), 2006–10 172

Table 102: Japan exchange rate, 2006–10 172

Table 103: Russia pharmaceuticals market value: $ million, 2006–10 174

Table 104: Russia pharmaceuticals market segmentation: % share, by value, 2010 175

Table 105: Russia pharmaceuticals market share: % share, by value, 2010 176

Table 106: Novartis AG: key facts 189

Table 107: Novartis AG: key financials ($) 190

Table 108: Novartis AG: key financial ratios 191

Table 109: Pharmstandard OJSC: key facts 193

Table 110: Pharmstandard OJSC: key financials ($) 194

Table 111: Pharmstandard OJSC: key financials (RUB) 194

Table 112: Pharmstandard OJSC: key financial ratios 194

Table 113: Sanofi-Aventis SA: key facts 196

Table 114: Sanofi-Aventis SA: key financials ($) 197

Table 115: Sanofi-Aventis SA: key financials (€) 197

Table 116: Sanofi-Aventis SA: key financial ratios 198

Table 117: Russia pharmaceuticals market value forecast: $ million, 2010–15 200

Table 118: Russia size of population (million), 2006–10 201

Table 119: Russia gdp (constant 2000 prices, $ billion), 2006–10 201

Table 120: Russia gdp (current prices, $ billion), 2006–10 201

Table 121: Russia inflation, 2006–10 202

Table 122: Russia consumer price index (absolute), 2006–10 202

Table 123: Russia exchange rate, 2006–10 202

Table 124: United Kingdom pharmaceuticals market value: $ million, 2006–10 204

Table 125: United Kingdom pharmaceuticals market segmentation: % share, by value, 2010 205

Table 126: United Kingdom pharmaceuticals market share: % share, by value, 2010 206

Table 127: AstraZeneca PLC: key facts 219

Table 128: AstraZeneca PLC: key financials ($) 221

Table 129: AstraZeneca PLC: key financial ratios 221

Table 130: GlaxoSmithKline Plc: key facts 223

Table 131: GlaxoSmithKline Plc: key financials ($) 225

Table 132: GlaxoSmithKline Plc: key financials (£) 226

Table 133: GlaxoSmithKline Plc: key financial ratios 226

Table 134: Pfizer Inc.: key facts 228

Table 135: Pfizer Inc.: key financials ($) 229

Table 136: Pfizer Inc.: key financial ratios 229

Table 137: United Kingdom pharmaceuticals market value forecast: $ million, 2010–15 231

Table 138: United Kingdom size of population (million), 2006–10 232

Table 139: United Kingdom gdp (constant 2000 prices, $ billion), 2006–10 232

Table 140: United Kingdom gdp (current prices, $ billion), 2006–10 232

Table 141: United Kingdom inflation, 2006–10 233

Table 142: United Kingdom consumer price index (absolute), 2006–10 233

Table 143: United Kingdom exchange rate, 2006–10 233

Table 144: United States pharmaceuticals market value: $ million, 2006–10 235

Table 145: United States pharmaceuticals market segmentation: % share, by value, 2010 236

Table 146: United States pharmaceuticals market share: % share, by value, 2010 237

Table 147: GlaxoSmithKline Plc: key facts 249

Table 148: GlaxoSmithKline Plc: key financials ($) 251

Table 149: GlaxoSmithKline Plc: key financials (£) 252

Table 150: GlaxoSmithKline Plc: key financial ratios 252

Table 151: Johnson & Johnson: key facts 254

Table 152: Johnson & Johnson: key financials ($) 255

Table 153: Johnson & Johnson: key financial ratios 256

Table 154: Merck & Co., Inc.: key facts 258

Table 155: Merck & Co., Inc.: key financials ($) 259

Table 156: Merck & Co., Inc.: key financial ratios 260

Table 157: Pfizer Inc.: key facts 262

Table 158: Pfizer Inc.: key financials ($) 263

Table 159: Pfizer Inc.: key financial ratios 263

Table 160: United States pharmaceuticals market value forecast: $ million, 2010–15 265

Table 161: United States size of population (million), 2006–10 266

Table 162: United States gdp (constant 2000 prices, $ billion), 2006–10 266

Table 163: United States gdp (current prices, $ billion), 2006–10 266

Table 164: United States inflation, 2006–10 267

Table 165: United States consumer price index (absolute), 2006–10 267

Table 166: United States exchange rate, 2006–10 267

LIST OF FIGURESFigure 1: G8 pharmaceuticals industry, revenue($m), 2006–15 17Figure 2: G8 Pharmaceuticals industry, revenue by country (%), 2010 19Figure 3: G8 pharmaceuticals industry, revenue by country ($m), 2006–10 20Figure 4: G8 pharmaceuticals industry forecast, revenue by country ($m), 2010–15 22Figure 5: Canada pharmaceuticals market value: $ million, 2006–10 25Figure 6: Canada pharmaceuticals market segmentation: % share, by value, 2010 26Figure 7: Canada pharmaceuticals market share: % share, by value, 2010 27Figure 8: Forces driving competition in the pharmaceuticals market in Canada, 2010 28Figure 9: Drivers of buyer power in the pharmaceuticals market in Canada, 2010 29Figure 10: Drivers of supplier power in the pharmaceuticals market in Canada, 2010 31Figure 11: Factors influencing the likelihood of new entrants in the pharmaceuticals market in Canada, 2010 33Figure 12: Factors influencing the threat of substitutes in the pharmaceuticals market in Canada, 2010 35Figure 13: Drivers of degree of rivalry in the pharmaceuticals market in Canada, 2010 37Figure 14: AstraZeneca PLC: revenues & profitability 42Figure 15: AstraZeneca PLC: assets & liabilities 42Figure 16: Johnson & Johnson: revenues & profitability 45Figure 17: Johnson & Johnson: assets & liabilities 46Figure 18: Pfizer Inc.: revenues & profitability 49Figure 19: Pfizer Inc.: assets & liabilities 49Figure 20: Canada pharmaceuticals market value forecast: $ million, 2010–15 50Figure 21: France pharmaceuticals market value: $ million, 2006–10 54Figure 22: France pharmaceuticals market segmentation: % share, by value, 2010 55Figure 23: France pharmaceuticals market share: % share, by value, 2010 56Figure 24: Forces driving competition in the pharmaceuticals market in France, 2010 57Figure 25: Drivers of buyer power in the pharmaceuticals market in France, 2010 58Figure 26: Drivers of supplier power in the pharmaceuticals market in France, 2010 60Figure 27: Factors influencing the likelihood of new entrants in the pharmaceuticals market in France, 2010 62Figure 28: Factors influencing the threat of substitutes in the pharmaceuticals market in France, 2010 64Figure 29: Drivers of degree of rivalry in the pharmaceuticals market in France, 2010 66Figure 30: AstraZeneca PLC: revenues & profitability 71Figure 31: AstraZeneca PLC: assets & liabilities 71Figure 32: GlaxoSmithKline Plc: revenues & profitability 76Figure 33: GlaxoSmithKline Plc: assets & liabilities 76Figure 34: Pfizer Inc.: revenues & profitability 79Figure 35: Pfizer Inc.: assets & liabilities 79Figure 36: France pharmaceuticals market value forecast: $ million, 2010–15 80Figure 37: Germany pharmaceuticals market value: $ million, 2006–10 84Figure 38: Germany pharmaceuticals market segmentation: % share, by value, 2010 85Figure 39: Germany pharmaceuticals market share: % share, by value, 2010 86Figure 40: Forces driving competition in the pharmaceuticals market in Germany, 2010 87Figure 41: Drivers of buyer power in the pharmaceuticals market in Germany, 2010 88Figure 42: Drivers of supplier power in the pharmaceuticals market in Germany, 2010 90Figure 43: Factors influencing the likelihood of new entrants in the pharmaceuticals market in Germany, 2010 92Figure 44: Factors influencing the threat of substitutes in the pharmaceuticals market in Germany, 2010 94Figure 45: Drivers of degree of rivalry in the pharmaceuticals market in Germany, 2010 96Figure 46: GlaxoSmithKline Plc: revenues & profitability 102Figure 47: GlaxoSmithKline Plc: assets & liabilities 102Figure 48: Novartis AG: revenues & profitability 105Figure 49: Novartis AG: assets & liabilities 106Figure 50: Pfizer Inc.: revenues & profitability 109Figure 51: Pfizer Inc.: assets & liabilities 109Figure 52: Germany pharmaceuticals market value forecast: $ million, 2010–15 110Figure 53: Italy pharmaceuticals market value: $ million, 2006–10 114Figure 54: Italy pharmaceuticals market segmentation: % share, by value, 2010 115Figure 55: Italy pharmaceuticals market share: % share, by value, 2010 116Figure 56: Forces driving competition in the pharmaceuticals market in Italy, 2010 117Figure 57: Drivers of buyer power in the pharmaceuticals market in Italy, 2010 118Figure 58: Drivers of supplier power in the pharmaceuticals market in Italy, 2010 120Figure 59: Factors influencing the likelihood of new entrants in the pharmaceuticals market in Italy, 2010 122Figure 60: Factors influencing the threat of substitutes in the pharmaceuticals market in Italy, 2010 124Figure 61: Drivers of degree of rivalry in the pharmaceuticals market in Italy, 2010 126Figure 62: GlaxoSmithKline Plc: revenues & profitability 135Figure 63: GlaxoSmithKline Plc: assets & liabilities 135Figure 64: Pfizer Inc.: revenues & profitability 140Figure 65: Pfizer Inc.: assets & liabilities 140Figure 66: Italy pharmaceuticals market value forecast: $ million, 2010–15 141Figure 67: Japan pharmaceuticals market value: $ million, 2006–10 145Figure 68: Japan pharmaceuticals market segmentation: % share, by value, 2010 146Figure 69: Japan pharmaceuticals market share: % share, by value, 2010 147Figure 70: Forces driving competition in the pharmaceuticals market in Japan, 2010 148Figure 71: Drivers of buyer power in the pharmaceuticals market in Japan, 2010 149Figure 72: Drivers of supplier power in the pharmaceuticals market in Japan, 2010 151Figure 73: Factors influencing the likelihood of new entrants in the pharmaceuticals market in Japan, 2010 153Figure 74: Factors influencing the threat of substitutes in the pharmaceuticals market in Japan, 2010 155Figure 75: Drivers of degree of rivalry in the pharmaceuticals market in Japan, 2010 157Figure 76: Astellas: revenues & profitability 162Figure 77: Astellas: assets & liabilities 162Figure 78: Daiichi Sankyo Co., Ltd.: revenues & profitability 165Figure 79: Daiichi Sankyo Co., Ltd.: assets & liabilities 166Figure 80: Pfizer Inc.: revenues & profitability 169Figure 81: Pfizer Inc.: assets & liabilities 169Figure 82: Japan pharmaceuticals market value forecast: $ million, 2010–15 170Figure 83: Russia pharmaceuticals market value: $ million, 2006–10 174Figure 84: Russia pharmaceuticals market segmentation: % share, by value, 2010 175Figure 85: Russia pharmaceuticals market share: % share, by value, 2010 176Figure 86: Forces driving competition in the pharmaceuticals market in Russia, 2010 177Figure 87: Drivers of buyer power in the pharmaceuticals market in Russia, 2010 179Figure 88: Drivers of supplier power in the pharmaceuticals market in Russia, 2010 181Figure 89: Factors influencing the likelihood of new entrants in the pharmaceuticals market in Russia, 2010 183Figure 90: Factors influencing the threat of substitutes in the pharmaceuticals market in Russia, 2010 185Figure 91: Drivers of degree of rivalry in the pharmaceuticals market in Russia, 2010 187Figure 92: Novartis AG: revenues & profitability 191Figure 93: Novartis AG: assets & liabilities 192Figure 94: Pharmstandard OJSC: revenues & profitability 195Figure 95: Sanofi-Aventis SA: revenues & profitability 198Figure 96: Sanofi-Aventis SA: assets & liabilities 199Figure 97: Russia pharmaceuticals market value forecast: $ million, 2010–15 200Figure 98: United Kingdom pharmaceuticals market value: $ million, 2006–10 204Figure 99: United Kingdom pharmaceuticals market segmentation: % share, by value, 2010 205Figure 100: United Kingdom pharmaceuticals market share: % share, by value, 2010 206Figure 101: Forces driving competition in the pharmaceuticals market in the United Kingdom, 2010 207Figure 102: Drivers of buyer power in the pharmaceuticals market in the United Kingdom, 2010 209Figure 103: Drivers of supplier power in the pharmaceuticals market in the United Kingdom, 2010 211Figure 104: Factors influencing the likelihood of new entrants in the pharmaceuticals market in the United Kingdom, 2010 213Figure 105: Factors influencing the threat of substitutes in the pharmaceuticals market in the United Kingdom, 2010 215Figure 106: Drivers of degree of rivalry in the pharmaceuticals market in the United Kingdom, 2010 217Figure 107: AstraZeneca PLC: revenues & profitability 222Figure 108: AstraZeneca PLC: assets & liabilities 222Figure 109: GlaxoSmithKline Plc: revenues & profitability 227Figure 110: GlaxoSmithKline Plc: assets & liabilities 227Figure 111: Pfizer Inc.: revenues & profitability 230Figure 112: Pfizer Inc.: assets & liabilities 230Figure 113: United Kingdom pharmaceuticals market value forecast: $ million, 2010–15 231Figure 114: United States pharmaceuticals market value: $ million, 2006–10 235Figure 115: United States pharmaceuticals market segmentation: % share, by value, 2010 236Figure 116: United States pharmaceuticals market share: % share, by value, 2010 237Figure 117: Forces driving competition in the pharmaceuticals market in the United States, 2010 238Figure 118: Drivers of buyer power in the pharmaceuticals market in the United States, 2010 239Figure 119: Drivers of supplier power in the pharmaceuticals market in the United States, 2010 241Figure 120: Factors influencing the likelihood of new entrants in the pharmaceuticals market in the United States, 2010 243Figure 121: Factors influencing the threat of substitutes in the pharmaceuticals market in the United States, 2010 245Figure 122: Drivers of degree of rivalry in the pharmaceuticals market in the United States, 2010 247Figure 123: GlaxoSmithKline Plc: revenues & profitability 253Figure 124: GlaxoSmithKline Plc: assets & liabilities 253Figure 125: Johnson & Johnson: revenues & profitability 256Figure 126: Johnson & Johnson: assets & liabilities 257Figure 127: Merck & Co., Inc.: revenues & profitability 260Figure 128: Merck & Co., Inc.: assets & liabilities 261Figure 129: Pfizer Inc.: revenues & profitability 264Figure 130: Pfizer Inc.: assets & liabilities 264Figure 131: United States pharmaceuticals market value forecast: $ million, 2010–15 265

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Antibacterials Market to 2017 - Innovative Anti-Infectives that Target MDR Gram-Negative Pathogens Offer Significant Revenue Potential

Wed, 23 May 2012 09:38:13 +0000

Antibacterials Market to 2017 - Innovative Anti-Infectives that Target MDR Gram-Negative Pathogens Offer Significant Revenue Potential

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NEW YORK, May 23, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Antibacterials Market to 2017 - Innovative Anti-Infectives that Target MDR Gram-Negative Pathogens Offer Significant Revenue Potential

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Antibacterials Market to 2017 - Innovative Anti-Infectives that Target MDR Gram-Negative Pathogens Offer Significant Revenue Potential

Summary

GBI Research, the leading business intelligence provider, has released its latest report, "Antibacterials Market to 2017 - Innovative Anti-Infectives that Target MDR Gram-Negative Pathogens Offer Significant Revenue Potential", which provides key data, information and analysis for the global antibacterials market (covering tuberculosis, pneumonia, urinary tract infections, atypical bronchitis, tonsillitis, sinusitis and otitis media in the US, the top five countries in Europe and Japan).

This report offers a comprehensive insight into antibacterial market based on the seven indications covered. It provides a disease overview for each indication, market forecasting, drivers and barriers, key marketed products, pipeline information and deals information for each disease in the top seven markets, as well as profiles for the main companies operating in the market.

The report is based on proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts to provide a comprehensive view of the antibacterials market.

The market is large and established, but still seeing good growth despite this due to the increasing problem of nosocomial infection and the increasing incidence of some bacterial diseases in the developed world. Despite several patent expiries, including of Levaquin, one of the highest selling antibacterials, growth will continue over the forecast period. Antibacterial stewardship programs for general practitioners and hospitals, aimed at countering the development of resistance in bacteria, will not significantly slow revenues in the forecast period. While the development of new antibacterials is not currently a hugely dynamic area, targeting multi-drug resistant TB and other indications will require innovative solutions in the future.

The antibacterials market is expected to reach $12.7 billion in 2017, growing from $11.3 billion in 2010 at a CAGR of 1.7%. The market is well served currently and patent expiries are slowing the overall growth. However, despite this saturation, hospital-acquired infections are providing an impetus to development.

Scope

- Overview of the global market for antibacterials.

- Breakdown of the market by region.

- Market analysis for each indication – including disease overviews, market forecasting, annual cost of therapy, treatment usage patterns, key marketed products and drivers and barriers.

- Comprehensive pipeline analysis by indications across all phases of development.

- Company profiles including SWOT analysis for major companies operating in the market.

- Key deals in the antibacterials space.

Reasons to buy

- Make more informed business decisions from the insightful and in-depth analysis of the antibacterials market.

- Identify the opportunities and challenges that exist within the antibacterials market.

- Build effective strategies to launch pipeline products.

- Identify the opportunities for collaboration with the participants in the antibacterials market.

Table of Contents

1 Table of Contents1 Table of Contents 51.1 List of Tables 101.2 List of Figures 122 Antibacterials - Introduction 143 Antibacterials - Overview 153.1 Bacterial Classification 153.1.1 Antimicrobial Spectrum 153.1.2 Bacterial Resistance 163.2 Antibacterial Classification 163.2.1 Cephalosporin Antibacterials 163.2.2 Penicillin Antibacterials 193.2.3 Quinolone Antibacterials 203.2.4 Macrolide Antibacterials 213.3 Global Revenues for Antibacterials 213.3.1 Global Revenue and Forecast 213.3.2 Revenue Share by Indication 233.4 The US 243.4.1 Total Revenues 243.5 Europe (The UK, France, Germany, Spain, Italy) 253.5.1 Total Revenues 253.6 Japan 273.6.1 Total Revenues 273.7 Drivers and Barriers for the Antibacterials Market 283.7.1 Drivers for the Antibacterials Market 283.7.2 Barriers for the Antibacterials Market 283.8 Opportunities 313.8.1 Alliances with Academic and Research Institutions are the Way Forward for Big Pharma 314 Tuberculosis 324.1 Overview 324.1.1 Microbiology 334.1.2 Diagnosis 334.1.3 Treatment 334.1.4 Prevention 344.2 Tuberculosis Therapeutics Market Size 354.2.1 Total Revenue 354.2.2 Average Annual Cost of Treatment (ACT) 384.2.3 Treatment Usage Patterns 394.3 Drivers and Barriers for the Tuberculosis Therapeutics Market 424.3.1 Drivers for the Tuberculosis Therapeutics Market 424.3.2 Barriers to the Tuberculosis Therapeutics Market 434.4 Product Profile of the Major Marketed Products in the Tuberculosis Market 434.4.1 Isoniazid (Isonicotinylhydrazine, INH) 434.4.2 Rifampin (RIF) 444.4.3 Pyrazinamide (PZA) 444.4.4 Ethambutol (EMB) 455 Pneumonia 465.1 Overview 465.1.1 Microbiology 465.1.2 Diagnosis 465.1.3 Treatment 475.1.4 Prevention 485.2 Pneumonia Therapeutics Market Size 495.2.1 Total Revenue 495.2.2 Annual Cost of Treatment (ACT) 525.2.3 Treatment Usage Patterns 535.3 Drivers and Barriers to the Pneumonia Therapeutics Market 555.3.1 Drivers for the Pneumonia Therapeutics Market 555.3.2 Barriers to the Pneumonia Antibacterials Market 555.4 Product Profile of the Major Marketed Products in the Pneumonia Antibacterials Market 575.4.1 Zyvox (linezolid) 575.4.2 Zosyn (piperacillin and tazobactum) 585.4.3 Levaquin (levofloxacin) 585.4.4 Avelox (moxifloxacin) 595.4.5 Omnicef (cefnidir) 595.4.6 Tygacil (tigecycline) 605.4.7 Doribax (doripenem) 616 Urinary Tract Infections 626.1 Overview 626.1.1 Cystitis 626.1.2 Urethritis 626.1.3 Pyelonephritis 626.1.4 Microbiology 626.1.5 Diagnosis 626.1.6 Urinalysis 626.1.7 Urine Culture 626.1.8 Treatment 636.1.9 Prevention 646.2 Urinary Tract Infection Therapeutics Market Size 646.2.1 Total Revenue 646.2.2 Annual Cost of Treatment (ACT) 676.2.3 Treatment Usage Patterns 686.3 Drivers and Barriers for the Urinary Tract Infection Therapeutics Market 706.3.1 Drivers for the UTI Therapeutics Market 706.3.2 Barriers for the UTI Therapeutics Market 706.4 Product Profile of the Major Marketed Products in the Urinary Tract Infection Market 716.4.1 Doribax (doripenem) 716.4.2 Ciprofloxacin 726.4.3 Levaquin (levafloxacin) 736.4.4 Monurol (fosfomycin tromethamine) 746.4.5 Macrobid (nitrofurantoin) 747 Atypical Bronchitis 767.1 Overview 767.1.1 Microbiology 767.1.2 Diagnosis 767.1.3 Treatment 767.1.4 Prevention 767.2 Atypical Bronchitis Therapeutics Market Size 777.2.1 Total Revenue 777.2.2 Annual Cost of Treatment (ACT) 797.2.3 Treatment Usage Patterns 807.3 Drivers and Barriers for the Atypical Bronchitis Therapeutics Market 827.3.1 Drivers for the Atypical Bronchitis Therapeutics Market 827.3.2 Barriers for the Atypical Bronchitis Therapeutics Market 827.4 Marketed Products 838 Tonsillitis 848.1 Overview 848.1.1 Microbiology 848.1.2 Diagnosis 848.1.3 Treatment 848.1.4 Prevention 858.2 Tonsillitis Therapeutics Market Size 858.2.1 Total Revenue 858.2.2 Annual Cost of Treatment (ACT) 878.2.3 Treatment Usage Patterns 888.3 Drivers and Barriers for the Tonsillitis Therapeutics Market 908.3.1 Drivers for the Tonsillitis Therapeutics Market 908.3.2 Barriers for the Tonsillitis Therapeutics Market 908.4 Marketed Products 918.4.1 Spectracef 919 Sinusitis 929.1 Overview 929.1.1 Frontal Sinusitis (located behind the forehead) 929.1.2 Ethmoid Sinusitis (behind the bridge of the nose) 929.1.3 Sphenoid Sinusitis (behind the eyes) 929.1.4 Maxillary Sinusitis (behind the cheeks) 929.1.5 Acute Sinusitis 929.1.6 Chronic Sinusitis 929.1.7 Microbiology 939.1.8 Diagnosis 939.1.9 Treatment 939.1.10 Prevention 939.2 Sinusitis Therapeutics Market Size 949.2.1 Total Revenue 949.2.2 Annual Cost of Therapy 969.2.3 Therapeutic Patterns 979.3 Drivers and Barriers for the Sinusitis Therapeutics Market 989.3.1 Drivers for the Sinusitis Therapeutics Market 989.3.2 Barriers for the Sinusitis Therapeutics Market 999.4 Marketed Products 999.4.1 Augmentin 999.4.2 Levaquin 1009.4.3 Doryx 10110 Otitis Media 10210.1 Overview 10210.1.1 Acute 10210.1.2 Serous 10210.1.3 Chronic Suppurative 10210.2 Otitis Media Therapeutics Market Size 10310.2.1 Total Revenue 10310.2.2 Annual Cost of Therapy 10510.2.3 Therapeutic Patterns 10610.3 Drivers and Barriers for the Otitis Media Therapeutics Market 10710.3.1 Drivers for the Otitis Media Therapeutics Market 10710.3.2 Barriers for the Otitis Media Therapeutics Market 10710.4 Marketed Products 10810.4.1 Amoxicillin 10811 Antibacterials - Pipeline Analysis 10911.1 Introduction 10911.2 Global Tuberculosis Market: Pipeline Analysis 11011.2.1 Overview 11011.2.2 Research and Development Pipeline - Phase III 11011.2.3 Research and Development Pipeline - Phase II 11111.2.4 Research and Development Pipeline - Phase I 11211.2.5 Research and Development Pipeline - Preclinical 11211.3 Global Pneumonia Therapeutics Market: Pipeline Assessment 11311.3.1 Overview 11311.3.2 NDA Filed 11311.3.3 Phase III 11311.3.4 Phase II 11411.3.5 Phase I 11511.3.6 Preclinical 11511.4 Global Urinary Tract Infection Therapeutics Market: Pipeline Assessment 11611.4.1 Overview 11611.4.2 Phase III 11611.4.3 Phase II 11711.4.4 Phase I 11711.4.5 Discovery 11711.5 Global Atypical Bronchitis Therapeutics Market: Pipeline Assessment 11811.5.1 Phase I 11811.6 Global Tonsillitis Therapeutics Market: Pipeline Assessment 11811.6.1 Overview 11811.7 Global Sinusitis Therapeutics Market: Pipeline Assessment 11811.7.1 Phase I 11811.8 Global Otitis Media Therapeutics Market: Pipeline Assessment 11911.8.1 Overview 11911.8.2 Phase II 11911.8.3 Preclinical 11912 Antibacterials: Competitive Landscape 12012.1 Major Players 12012.2 Major Company Profiles 12012.2.1 Pfizer 12012.2.2 Sanofi 12112.2.3 Bayer 12212.2.4 GlaxoSmithKline 12312.2.5 AstraZeneca 12412.2.6 Cubist 12512.2.7 Daiichi Sankyo 12612.2.8 Tetraphase 12712.2.9 Johnson and Johnson 12813 Antibacterials - Strategic Consolidations 12913.1 Overview - Antibacterials Market 12913.1.1 Deals by Indication 12913.1.2 Deals by Year 13013.2 Tuberculosis 13013.2.1 Mergers and Acquisitions 13013.2.2 Licensing and Co-Developments 13013.3 Pneumonia 13313.3.1 Furiex Pharmaceuticals Enters into Licensing Agreement with Janssen Pharmaceutica for JNJ-Q2 (April 19, 2011) 13313.3.2 TaiGen Biotechnology Amends its Licensing Agreement with Warner Chilcott for Nemonoxacin (October 14, 2010) 13313.3.3 Anacor Pharmaceuticals Enters into Licensing Agreement with GlaxoSmithKline (June 29, 2010) 13413.3.4 Paratek Pharmaceuticals Enters into Licensing Agreement with Novartis (October 8, 2009) 13413.3.5 AstraZeneca Enters into Co-Development Agreement with Forest Laboratories (August 12, 2009) 13413.3.6 Protea Vaccine Enters into Co-Development Agreement with GlaxoSmithKline Biologicals (June 16, 2009) 13413.3.7 Sanofi-aventis Enters into Licensing and Collaboration Agreement with Novozymes (December 22, 2008) 13513.3.8 Laboratorios Farmaceuticos ROVI Enters into Co-Development Agreement with Sanofi Pasteur (May 5, 2008) 13513.3.9 Aridis Pharmaceuticals Enters into Licensing Agreement with University of Iowa Research (February 19, 2008) 13513.3.10 Nektar Therapeutics Enters into Co-Development Agreement with Bayer HealthCare (August 6, 2007) 13513.3.11 Oscient Pharmaceuticals Enters into License Agreement with Menarini Group for FACTIVE (January 4, 2007) 13613.4 UTI 13613.4.1 Teva Pharmaceutical Acquires CoGenesys from New Enterprise, Orbimed and Red Abbey (February 21, 2008) 13613.4.2 NanoBio Enters into Licensing Agreement with University of Michigan (April 20, 2011) 13613.4.3 Anacor Pharmaceuticals Enters into Licensing Agreement with GlaxoSmithKline (June 29, 2010) 13613.4.4 Depomed Amends Licensing Agreement with Madaus (April 30, 2009) 13713.5 Atypical Bronchitis 13713.5.1 Teva Pharmaceutical Industries Completes Acquisition of Ratiopharm (August 10, 2010) 13713.6 Tonsillitis 13713.6.1 Meiji Seika Enters into Licensing Agreement with Cornerstone Biopharma (November 9, 2006) 13713.7 Sinusitis 13813.7.1 Oscient Pharmaceuticals Enters into License Agreement with Menarini Group for FACTIVE (January 4, 2007) 13813.8 Otitis Media 13813.8.1 MerLion Pharmaceuticals Enters into Licensing Agreement with Alcon Pharmaceuticals for Finafloxacin (January 11, 2011) 13813.8.2 OctoPlus Enters into Licensing Agreement with Green Cross (November 22, 2006) 13814 Antibacterials - Appendix 13914.1 Market Definition 13914.2 Abbreviations 13914.3 Sources 14114.4 Research Methodology 14114.4.1 Coverage 14214.4.2 Secondary Research 14214.4.3 Primary Research 14214.5 Forecasting 14314.5.1 Epidemiology-based Forecasting 14314.5.2 Expert Panels Validation 14414.6 Geographical Landscape 14414.7 Pipeline Analysis 14414.8 Competitive Landscape 14414.9 Contact Us 14414.10 Disclaimer 145

List of Tables

1.1 List of TablesTable 1: Antibacterials Market, Classification, Cephalosporin Antibacterials by Generations 18Table 2: Antibacterials, Classification, Penicillin Antibacterials 20Table 3: Antibacterials Market, Global, Revenue, $bn, 2002-2010 21Table 4: Antibacterials Market, Global, Revenue Forecasts, $bn, 2010-2017 22Table 5: Antibacterials Market, The US, Revenue, $bn, 2002-2010 24Table 6: Antibacterials Market, The US, Revenue Forecasts, $bn, 2010-2017 24Table 7: Antibacterials Market, EU-5, Revenue, $bn, 2002-2010 25Table 8: Antibacterials Market, EU-5, Revenue Forecasts, $bn, 2010-2017 25Table 9: Antibacterials Market, Japan, Revenue, $m, 2002-2010 27Table 10: Antibacterials Market, Japan, Revenue Forecasts, $m, 2010–2017 27Table 11: Tuberculosis Therapeutics Market, Global, Revenue, $m, 2002-2010 35Table 12: Tuberculosis Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 35Table 13: Tuberculosis Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2002-2010 36Table 14: Tuberculosis Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2010-2017 36Table 15: Tuberculosis Antibacterials Market, Global, ACT, $, 2002-2010 38Table 16: Tuberculosis Antibacterials Market, Global, ACT, $, 2010-2017 38Table 17: Tuberculosis Therapeutics Market, Global, Prevalence Population, '000, 2002-2010 39Table 18: Tuberculosis Therapeutics Market, Global, Prevalence Population, '000, 2010-2017 39Table 19: Tuberculosis Therapeutics Market, Global, MDR and DOTs Treated Patients, 2002-2010 40Table 20: Tuberculosis Therapeutics Market, Global, MDR and DOTs Treated Patients, 2010-2017 40Table 21: Tuberculosis Therapeutics Market, Global, Prevalence Population by Country, '000, 2002-2010 41Table 22: Tuberculosis Therapeutics Market, Global, Prevalence Population by Country, '000, 2010-2017 41Table 23: Pneumonia Therapeutics Market, Global, Revenue, $m, 2002-2010 49Table 24: Pneumonia Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 49Table 25: Pneumonia Therapeutics Market, Global, Revenue Forecasts, $m, 2002-2010 50Table 26: Pneumonia Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 51Table 27: Pneumonia Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2010 52Table 28: Pneumonia Therapeutics Market, Global, Annual Cost of Therapy, $, 2010-2017 52Table 29: Pneumonia Therapeutics Market, Global, Treatment Usage Patterns, Million, 2002-2010 53Table 30: Pneumonia Therapeutics Market, Global, Treatment Usage Patterns, Million, 2010-2017 53Table 31: Urinary Tract Infection Therapeutics Market, Global, Revenue, $m, 2002-2010 64Table 32: Urinary Tract Infection Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 64Table 33: Urinary Tract Infection Therapeutics Market, Global, Revenue, $m, 2002-2010 65Table 34: Urinary Tract Infection Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 66Table 35: Urinary Tract Infection Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2010 67Table 36: Urinary Tract Infection Therapeutics Market, Global, Annual Cost of Therapy, $, 2010-2017 67Table 37: Urinary Tract Infection Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2010 68Table 38: Urinary Tract Infection Therapeutics Market, Global, Treatment Usage Pattern, Million, 2010-2017 68Table 39: Atypical Bronchitis Therapeutics Market, Global, Revenue, $m, 2002-2010 77Table 40: Atypical Bronchitis Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 77Table 41: Atypical Bronchitis Therapeutics Market, Global, Revenue, $m, 2002-2010 78Table 42: Atypical Bronchitis Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 78Table 43: Atypical Bronchitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2010 79Table 44: Atypical Bronchitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2010-2017 79Table 45: Atypical Bronchitis Therapeutics Market, Global, Treatment Usage Patterns, Million, 2002-2010 80Table 46: Atypical Bronchitis Therapeutics Market, Global, Treatment Usage Patterns, Million, 2010-2017 80Table 47: Tonsillitis Therapeutics Market, Global, Revenue, $m, 2002-2010 85Table 48: Tonsillitis Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 85Table 49: Tonsillitis Therapeutics Market, Global, Revenue, $m, 2002-2010 86Table 50: Tonsillitis Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 86Table 51: Tonsillitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2010 87Table 52: Tonsillitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2010-2017 87Table 53: Tonsillitis Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2010 88Table 54: Tonsillitis Therapeutics Market, Global, Treatment Usage Pattern, Million, 2010-2017 88Table 55: Sinusitis Therapeutics Market, Global, Revenue, $bn, 2002-2010 94Table 56: Sinusitis Therapeutics Market, Global, Revenue Forecasts, $bn, 2010-2017 94Table 57: Sinusitis Therapeutics Market, Global, Revenue by Country, $bn 2002-2010 95Table 58: Sinusitis Therapeutics Market, Global, Revenue Forecasts by Country, $bn, 2010-2017 95Table 59: Sinusitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2010 96Table 60: Sinusitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2010-2017 96Table 61: Sinusitis Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2010 97Table 62: Sinusitis Therapeutics Market, Global, Treatment Usage Pattern, Million, 2010-2017 97Table 63: Otitis Media Therapeutics Market, Global, Revenue, $m, 2002-2010 103Table 64: Otitis Media Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 103Table 65: Otitis Media Therapeutics Market, Global, Revenue Forecasts, $m, 2002-2010 104Table 66: Otitis Media Therapeutics Market, Global, Revenue Forecasts, $m, 2010-2017 104Table 67: Otitis Media Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2010 105Table 68: Otitis Media Therapeutics Market, Global, Annual Cost of Therapy, $, 2010-2017 105Table 69: Otitis Media Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2010 106Table 70: Otitis Media Therapeutics Market, Global, Treatment Usage Pattern, Million, 2010-2017 106Table 71: Tuberculosis Therapeutics Market, Pipeline, Phase III Molecules, 2010 110Table 72: Tuberculosis Therapeutics Market, Pipeline, Phase II Molecules, 2010 111Table 73: Tuberculosis Therapeutics Market, Pipeline, Phase I Molecules, 2010 112Table 74: Tuberculosis Therapeutics Market, Pipeline, Preclinical Molecules, 2010 112Table 75: Pneumonia Therapeutics Market, Pipeline, NDA Filed Molecules, 2010 113Table 76: Pneumonia Therapeutics Market, Pipeline, Phase III Molecules, 2010 113Table 77: Pneumonia Therapeutics Market, Pipeline, Phase II Molecules, 2010 114Table 78: Pneumonia Therapeutics Market, Pipeline, Phase I Molecules, 2010 115Table 79: Pneumonia Therapeutics Market, Pipeline, Preclinical Molecules, 2010 115Table 80: Urinary Tract Infection Therapeutics Market, Pipeline, Phase III Molecules, 2010 116Table 81: Urinary Tract Infection Therapeutics Market, Pipeline, Phase II Molecules, 2010 117Table 82: Urinary Tract Infection Therapeutics Market, Pipeline, Phase I Molecules, 2010 117Table 83: Urinary Tract Infection Therapeutics Market, Pipeline, Discovery Molecules, 2010 117Table 84: Atypical Bronchitis Therapeutics Market, Pipeline, Phase I Molecules, 2010 118Table 85: Sinusitis Therapeutics Market, Pipeline, Phase I Molecules, 2010 118Table 86: Otitis Media Therapeutics Market, Pipeline, Phase II Molecules, 2010 119Table 87: Otitis Media Therapeutics Market, Pipeline, Preclinical Molecules, 2010 119

List of Figures

1.2 List of FiguresFigure 1: Antibacterials Market, Global, Revenue Forecasts, $bn, 2002-2017 21Figure 2: Antibacterials Market, Global, Revenue Share by Indication, %, 2010 23Figure 3: Antibacterials Market, The US, Revenue Forecasts, $bn, 2002-2017 24Figure 4: Antibacterials Market, EU-5, Revenue Forecasts, $bn, 2002-2017 25Figure 5: Antibacterials Market, Japan, Revenue Forecasts, $m, 2002-2017 27Figure 6: Tuberculosis, Recommended Initial Therapy, 2011 33Figure 7: Tuberculosis, Treatment Flow Pattern, 2011 34Figure 8: Tuberculosis Therapeutics Market, Global, Revenue Forecasts, $m, 2002-2017 35Figure 9: Tuberculosis Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2002-2017 36Figure 10: Tuberculosis Therapeutics Market, Global, ACT, $, 2002-2017 38Figure 11: Tuberculosis Therapeutics Market, Global, Prevalence Population, '000, 2002-2017 39Figure 12: Tuberculosis Therapeutics Market, Global, MDR and DOTs Treated Patients, 2002-2017 40Figure 13: Tuberculosis Therapeutics Market, Global, Prevalence Population by Country, '000, 2002-2017 41Figure 14: Pneumonia Therapeutics Market, Drugs used in the Treatment of Pneumonia, 2011 48Figure 15: Pneumonia Therapeutics Market, Global, Revenue Forecasts, $m, 2002-2017 49Figure 16: Pneumonia Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2002-2017 50Figure 17: Pneumonia Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2017 52Figure 18: Pneumonia Therapeutics Market, Global, Treatment Usage Patterns, Million, 2002-2017 53Figure 19: Urinary Tract Infection Therapeutics Market, Treatment of Uncomplicated UTI, 2011 63Figure 20: Urinary Tract Infection Therapeutics Market, Treatment of Complicated UTI, 2011 63Figure 21: Urinary Tract Infection Therapeutics Market, Global, Revenue Forecast, $m, 2002-2017 64Figure 22: Urinary Tract Infection Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2002-2017 65Figure 23: Urinary Tract Infection Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2017 67Figure 24: Urinary Tract Infection Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2017 68Figure 25: Atypical Bronchitis Therapeutics Market, Global, Revenue Forecast, $m, 2002-2017 77Figure 26: Atypical Bronchitis Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2002-2017 78Figure 27: Atypical Bronchitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2017 79Figure 28: Atypical Bronchitis Therapeutics Market, Global, Treatment Usage Patterns, Million, 2002-2017 80Figure 29: Tonsillitis Therapeutics Market, Global, Revenue Forecast, $m, 2002-2017 85Figure 30: Tonsillitis Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2002-2017 86Figure 31: Tonsillitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2017 87Figure 32: Tonsillitis Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2017 88Figure 33: Sinusitis Therapeutics Market, Global, Revenue Forecast, $bn, 2002-2017 94Figure 34: Sinusitis Therapeutics Market, Global, Revenue Forecasts by Country, $bn, 2010-2017 95Figure 35: Sinusitis Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2017 96Figure 36: Sinusitis Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2017 97Figure 37: Otitis Media Therapeutics Market, Global, Revenue Forecasts, $m, 2002-2017 103Figure 38: Otitis Media Therapeutics Market, Global, Revenue Forecasts by Country, $m, 2010-2017 104Figure 39: Otitis Media Therapeutics Market, Global, Annual Cost of Therapy, $, 2002-2017 105Figure 40: Otitis Media Therapeutics Market, Global, Treatment Usage Pattern, Million, 2002-2017 106Figure 41: Tuberculosis Therapeutics Market, Global, R&D Pipeline by Phase, %, 2010 110Figure 42: Pneumonia Therapeutics Market, Global, R&D Pipeline by Phase, %, 2010 113Figure 43: Urinary Tract Infection Therapeutics Market, Global, R&D Pipeline by Phase, %, 2010 116Figure 44: Otitis Media Therapeutics Market, Global, R&D Pipeline by Phase, %, 2010 119Figure 45: Antibacterial Therapeutics Market, SWOT Analysis of Pfizer, 2010 120Figure 46: Antibacterial Therapeutics Market, Sanofi SWOT Profile, 2010 121Figure 47: Antibacterials Market, Bayer SWOT Profile, 2010 122Figure 48: Antibacterials Market, GSK SWOT Profile, 2010 123Figure 49: Antibacterials Market, AstraZeneca SWOT Profile, 2010 124Figure 50: Antibacterial, Cubist SWOT Profile, 2010 125Figure 51: Antibacterial, Daiichi-Sankyo SWOT Profile, 2010 126Figure 52: Antibacterial, Tetraphase SWOT Profile, 2010 127Figure 53: Antibacterial, Johnson & Johnson SWOT Profile, 2010 128Figure 54: Antibacterials Market, Global, Deals by Indication (%), 2011 129Figure 55: Antibacterials Market, Global, Deals by Year (%), 2004-2011 130

Companies Mentioned

PfizerSanofiBayerGlaxoSmithKlineAstraZenecaCubistDaiichi SankyoTetraphaseJohnson and Johnson

To order this report:Therapy Industry: Antibacterials Market to 2017 - Innovative Anti-Infectives that Target MDR Gram-Negative Pathogens Offer Significant Revenue Potential

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Orphan Disease Therapeutics in Genetic Disorders to 2018 - Emerging Agents in Cystic Fibrosis Offer Strong Opportunities for Investment and Licensing Activity

Wed, 23 May 2012 09:36:00 +0000

Orphan Disease Therapeutics in Genetic Disorders to 2018 - Emerging Agents in Cystic Fibrosis Offer Strong Opportunities for Investment and Licensing Activity

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Orphan Disease Therapeutics in Genetic Disorders to 2018 - Emerging Agents in Cystic Fibrosis Offer Strong Opportunities for Investment and Licensing Activity

http://www.reportlinker.com/p0866958/Orphan-Disease-Therapeutics-in-Genetic-Disorders-to-2018---Emerging-Agents-in-Cystic-Fibrosis-Offer-Strong-Opportunities-for-Investment-and-Licensing-Activity.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Therapy

Orphan Disease Therapeutics in Genetic Disorders to 2018 - Emerging Agents in Cystic Fibrosis Offer Strong Opportunities for Investment and Licensing Activity

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Orphan Disease Therapeutics in Genetic Disorders to 2018 - Emerging Agents in Cystic Fibrosis Offer Strong Opportunities for Investment and Licensing Activity", which provides insights into the global orphan diseases in genetic disorders therapeutics market, including market forecasts until 2018. The report provides an in-depth analysis of major orphan genetic disease indications, covering Cystic Fibrosis (CF), Duchenne Muscular Dystrophy (DMD), Fabry disease and Pompe disease. The report also includes insights into the orphan genetic disease therapeutics R&D pipeline. It analyzes the competitive landscape, including M&As, and licensing and co-development deals. The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

GBI Research found that the global orphan disease therapeutics in genetic disorders market was worth $1.5 billion in 2010, having grown from $559m in 2004 at a Compound Annual Growth Rate (CAGR) of 17.3%. It is expected to increase to $4.1 billion by 2018, growing at a CAGR of 13.8% over the period from 2010. This high rate of growth in the historic period can be attributed to the entry of novel, highly priced therapies into markets with high unmet need. These include Myozyme for Pompe disease and enzyme replacement therapies for Fabry disease, which have high costs of over $200,000 per patient per year. More highly-priced therapies are expected in the forecast period, to further drive growth. The recent approval of Kalydeco in CF and the expected approval of exon-skipping therapies for DMD are examples of this. Competitive activity is also increasing as larger companies realize the rewards of investing in orphan therapeutics, and the high unmet need and low competition in many markets is expected to attract more into the space in the future.

Scope

- Data and analysis on the global orphan disease therapeutics in genetic disorders in the leading geographies of the world– the US, the UK, Germany, France, Italy, Spain, and Japan.- Annualized market data for the orphan disease therapeutics in genetic disorders market from 2002–2010 with forecasts to 2018.- Market data on the therapeutic landscape, covering CF, DMD, Fabry disease and Pompe disease. This includes market size, market share, annual cost of therapy, treatment flow algorithm and branded and generic share.- Key drivers and restraints that have had a significant impact on the market and on each indication.- The competitive landscape of the global orphan disease therapeutics in genetic disorders, including companies such as Genzyme, GlaxoSmithKline, Novartis, Santhera, and Shire.- Key M&A activities and licensing and co-development agreements that took place from 2006–2011 in the global orphan disease therapeutics in genetic disorders market.

Reasons to buy

- Align your product portfolio to the markets with high growth potential.- Develop market-entry and market expansion strategies by identifying the potential region and global orphan disease therapeutics in genetic disorders market segments poised for strong growth.- Create a more tailored country strategy through the understanding of key drivers and barriers of the global oncology therapeutics market.- Develop key strategic initiatives by understanding the key focus areas and top selling therapeutics of leading companies.- Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships.

Table of Contents

1 Table of Contents1 Table of Contents 51.1 List of Tables 81.2 List of Figures 112 Orphan Disease Therapeutics in Genetic Disorders to 2018 – Introduction 133 Orphan Disease Therapeutics in Genetic Disorders to 2018 – Market Overview 143.1 Introduction 143.1.1 Orphan Disease Regulation and Incentives 143.2 Revenue Forecasts for Orphan Disease Therapeutics in Genetic Disorders 163.2.1 Revenue 163.2.2 Annual Cost of Treatment 183.3 Global Treatment Usage Patterns 193.3.1 Diseased Population 193.3.2 Treatment Seeking Population 203.3.3 Diagnosed Population 213.3.4 Prescription Population 223.4 Drivers and Restraints for Orphan Genetic Disease Therapeutics Market 233.4.1 Drivers for Orphan Genetic Disease Therapeutics Market 233.4.2 Restraints for Orphan Genetic Disease Therapeutics Market 253.4.3 Unmet Needs 253.4.4 Opportunities 254 Orphan Disease Therapeutics in Genetic Disorders to 2018 – Geographical Landscape 264.1 The US 264.1.1 Revenue 264.1.2 Annual Cost of Treatment 274.1.3 Treatment Usage Patterns 284.2 Top Five Countries of Europe 324.2.1 Revenue 324.2.2 Annual Cost of Treatment 334.2.3 Treatment Usage Patterns 344.3 Japan 384.3.1 Revenue 384.3.2 Annual Cost of Treatment 394.3.3 Treatment Usage Patterns 405 Orphan Disease Therapeutics in Genetic Disorders to 2018 – Therapeutic Landscape 445.1 Cystic Fibrosis 445.1.1 Introduction 445.1.2 Symptoms 455.1.3 Diagnosis 455.1.4 Treatment Flow 465.1.5 Revenue 475.1.6 Annual Cost of Treatment 495.1.7 Treatment Usage Patterns 505.1.8 Marketed Products 545.1.9 Drivers and Restraints for the Cystic Fibrosis Therapeutics Market 585.2 Duchenne Muscular Dystrophy 615.2.1 Introduction 615.2.2 Symptoms 615.2.3 Treatment Algorithm 625.2.4 Revenue 635.2.5 Annual Cost of Treatment 665.2.6 Treatment Usage Patterns 675.2.7 Marketed Therapies 715.2.8 Drivers and Restraints for Duchenne Muscular Dystrophy Therapeutics Market 715.3 Fabry Disease 735.3.1 Introduction 735.3.2 Symptoms 735.3.3 Treatment Flow 745.3.4 Revenue 745.3.5 Annual Cost of Treatment 765.3.6 Treatment Usage Patterns 785.3.7 Drivers and Restarints for Fabry Disease Therapeutics Market 825.3.8 Restraints for Fabry Disease Therapeutics Market 835.3.9 Marketed Products 835.4 Pompe Disease 855.4.1 Introduction 855.4.2 Symptoms 865.4.3 Treatment Flow Algorithm 865.4.4 Revenue 875.4.5 Annual Cost of Treatment 885.4.6 Treatment Usage Patterns 895.4.7 Marketed Products 946 Orphan Disease Therapeutics in Genetic Disorders to 2018 –Pipeline Analysis 966.1 Introduction 966.2 R&D Pipeline – Cystic Fibrosis 976.2.1 Pre-Clinical Stage 976.2.2 Phase I 986.2.3 Phase II 996.2.4 Phase III 1026.2.5 Promising Drugs in the Pipeline 1026.3 R&D Pipeline – Duchenne Muscular Dystrophy 1046.3.1 Pre-Clinical 1046.3.2 Phase I 1056.3.3 Phase II 1066.3.4 Phase III 1066.3.5 Promising Molecules in the Pipeline 1076.4 R&D Pipeline – Fabry Disease 1086.4.1 Pre-Clinical 1086.4.2 Phase II 1096.4.3 Phase III 1096.5 R&D Pipeline – Pompe Disease 1106.5.1 Pre-Clinical 1106.5.2 Phase II 1107 Orphan Disease Therapeutics in Genetic Disorders to 2018 – Competitive Landscape 1117.1 Competitive Profiling 1117.1.1 GlaxoSmithKline 1117.1.2 Prosensa 1127.1.3 Santhera 1127.1.4 AVI BioPharma 1137.1.5 Genzyme (Sanofi Subsidiary) 1147.1.6 Shire 1147.1.7 PTC Therapeutics 1157.1.8 Novartis 1167.1.9 Genentech (Roche) 1177.1.10 Gilead 1178 Orphan Disease Therapeutics in Genetic Disorders to 2018 – Strategic Consolidations 1198.1 M&A Landscape 1198.1.1 Key Deals 1198.1.2 M&A Deals by Year 1218.1.3 M&A Deals by Geography 1218.1.4 M&A Deals by Value 1228.2 R&D Licensing Agreements 1228.2.1 Key Deals 1228.2.2 Deals by Year 1268.2.3 Deals by Geography 1278.3 Co-Development Agreements 1278.3.2 Deals by Year 1328.3.3 Deals by Geography 1329 Appendix 1339.1 Market Definitions 1339.2 Abbreviations 1339.3 Sources 1349.4 Research Methodology 1359.4.1 Coverage 1359.4.2 Secondary Research 1359.4.3 Primary Research 1369.4.4 Forecasting 1369.4.5 Geographical Landscape 1379.4.6 Pipeline Analysis 1379.4.7 Competitive Landscape 1379.4.8 Expert Panel Validation 1389.5 Contact Us 1389.6 Disclaimer 138

List of Tables

1.1 List of TablesTable 1: Orphan Disease Therapeutics in Genetic Disorders, Global, Revenue ($m), 2004–2010 16Table 2: Orphan Disease Therapeutics in Genetic Disorders, Global, Revenue Forecasts ($m), 2010–2018 16Table 3: Orphan Disease Therapeutics in Genetic Disorders, Global, Average ACT ($), 2004–2010 18Table 4: Orphan Disease Therapeutics in Genetic Disorders, Global, Average ACT ($), 2010–2018 18Table 5: Orphan Disease Therapeutics in Genetic Disorders, Global, Diseased Population, 2004–2010 19Table 6: Orphan Disease Therapeutics in Genetic Disorders, Global, Diseased Population, 2010–2018 19Table 7: Orphan Disease Therapeutics in Genetic Disorders, Global, Treatment Seeking Population, 2004–2010 20Table 8: Orphan Disease Therapeutics in Genetic Disorders, Global, Treatment Seeking Population, 2010–2018 20Table 9: Orphan Disease Therapeutics in Genetic Disorders, Global, Diagnosed Population, 2004–2010 21Table 10: Orphan Disease Therapeutics in Genetic Disorders, Global, Diagnosed Population, 2010–2018 21Table 11: Orphan Disease Therapeutics in Genetic Disorders, Global, Prescription Population, 2004–2010 22Table 12: Orphan Disease Therapeutics in Genetic Disorders, Global, Prescription Population, 2010–2018 22Table 13: Orphan Disease Therapeutics in Genetic Disorders, The US, Revenue ($m), 2004–2010 26Table 14: Orphan Disease Therapeutics in Genetic Disorders, The US, Revenue Forecasts ($m), 2010–2018 26Table 15: Orphan Disease Therapeutics in Genetic Disorders, The US, Average ACT ($), 2004–2010 27Table 16: Orphan Disease Therapeutics in Genetic Disorders, The US, Average ACT ($), 2010–2018 27Table 17: Orphan Disease Therapeutics in Genetic Disorders, The US, Diseased Population, 2004–2010 28Table 18: Orphan Disease Therapeutics in Genetic Disorders, The US, Diseased Population, 2010–2018 28Table 19: Orphan Disease Therapeutics in Genetic Disorders, The US, Treatment Seeking Population, 2004–2010 29Table 20: Orphan Disease Therapeutics in Genetic Disorders, The US, Treatment Seeking Population, 2010–2018 29Table 21: Orphan Disease Therapeutics in Genetic Disorders, The US, Diagnosed Population, 2004–2010 30Table 22: Orphan Disease Therapeutics in Genetic Disorders, The US, Diagnosed Population, 2010–2018 30Table 23: Orphan Disease Therapeutics in Genetic Disorders, The US, Prescription Population, 2004–2010 31Table 24: Orphan Disease Therapeutics in Genetic Disorders, The US, Prescription Population, 2010–2018 31Table 25: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Revenue ($m), 2004–2010 32Table 26: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Revenue Forecasts ($m), 2010–2018 32Table 27: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Average ACT ($), 2004–2010 33Table 28: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Average ACT ($), 2010–2018 33Table 29: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe Diseased Population, 2004–2010 34Table 30: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Diseased Population, 2010–2018 34Table 31: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Treatment Seeking Population, 2004–2010 35Table 32: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Treatment Seeking Population, 2010–2018 35Table 33: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Diagnosed Population, 2004–2010 36Table 34: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Diagnosed Population, 2010–2018 36Table 35: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Prescription Population, 2004–2010 37Table 36: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Prescription Population, 2010–2018 37Table 37: Orphan Disease Therapeutics in Genetic Disorders, Japan, Revenue ($m), 2004–2010 38Table 38: Orphan Disease Therapeutics in Genetic Disorders, Japan, Revenue Forecasts ($m), 2010–2018 38Table 39: Orphan Disease Therapeutics in Genetic Disorders, Japan, ACT ($), 2004–2010 39Table 40: Orphan Disease Therapeutics in Genetic Disorders, Japan, ACT ($), 2010–2018 39Table 41: Orphan Disease Therapeutics in Genetic Disorders, Japan, Diseased Population, 2004–2010 40Table 42: Orphan Disease Therapeutics in Genetic Disorders, Japan, Diseased Population, 2010–2018 40Table 43: Orphan Disease Therapeutics in Genetic Disorders, Japan, Treatment Seeking Population, 2004–2010 41Table 44: Orphan Disease Therapeutics in Genetic Disorders, Japan, Treatment Seeking Population, 2010–2018 41Table 45: Orphan Disease Therapeutics in Genetic Disorders, Japan, Diagnosed Population, 2004–2010 42Table 46: Orphan Disease Therapeutics in Genetic Disorders, Japan, Diagnosed Population, 2010–2018 42Table 47: Orphan Disease Therapeutics in Genetic Disorders, Japan, Prescription Population, 2004–2010 43Table 48: Orphan Disease Therapeutics in Genetic Disorders, Japan, Prescription Population, 2010–2018 43Table 49: Cystic Fibrosis Therapeutics Market, Global, Revenue ($m), 2004–2010 47Table 50: Cystic Fibrosis Therapeutics Market, Global, Revenue Forecasts ($m), 2010–2018 47Table 51: Cystic Fibrosis Therapeutics Market, Global, Average ACT ($), 2004–2010 49Table 52: Cystic Fibrosis Therapeutics Market, Global, Average ACT ($), 2010–2018 49Table 53: Cystic Fibrosis Therapeutics Market, Global, Diseased Population, 2004–2010 50Table 54: Cystic Fibrosis Therapeutics Market, Global, Diseased Population, 2010–2018 50Table 55: Cystic Fibrosis Therapeutics Market, Global, Treatment Seeking Population , 2004–2010 51Table 56: Cystic Fibrosis Therapeutics Market, Global, Treatment Seeking Population, 2010–2018 51Table 57: Cystic Fibrosis Therapeutics Market, Global, Diagnosed Population, 2004–2010 52Table 58: Cystic Fibrosis Therapeutics Market, Global, Diagnosed Population, 2010–2018 52Table 59: Cystic Fibrosis Therapeutics Market, Global, Prescription Population, 2004–2010 53Table 60: Cystic Fibrosis Therapeutics Market, Global, Prescription Population, 2010–2018 53Table 61: Duchenne Muscular Dystrophy Therapeutics Market, Global, Revenue ($m), 2004–2010 63Table 62: Duchenne Muscular Dystrophy Therapeutics Market, Global, Revenues Forecasts ($m), 2010–2018 63Table 63: Duchenne Muscular Dystrophy Therapeutics Market, Global, ACT ($), 2004–2010 66Table 64: Duchenne Muscular Dystrophy Therapeutics Market, Global, ACT ($), 2010–2018 66Table 65: Duchenne Muscular Dystrophy Therapeutics Market, Global, Diseased Population, 2004–2010 67Table 66: Duchenne Muscular Dystrophy Therapeutics Market, Global, Diseased Population, 2010–2018 67Table 67: Duchenne Muscular Dystrophy Therapeutics Market, Global, Treatment Seeking Population, 2004–2010 68Table 68: Duchenne Muscular Dystrophy Therapeutics Market, Global, Treatment Seeking Population, 2010–2018 68Table 69: Duchenne Muscular Dystrophy Therapeutics Market, Global, Diagnosed Population, 2004–2010 69Table 70: Duchenne Muscular Dystrophy Therapeutics Market, Japan, Diagnosed Population, 2010–2018 69Table 71: Duchenne Muscular Dystrophy Therapeutics Market, Global, Prescription Population, 2004–2010 70Table 72: Duchenne Muscular Dystrophy Therapeutics Market, Global, Prescription Population, 2010–2018 70Table 73: Fabry Disease Therapeutics Market, Global, Revenue ($m), 2004–2010 74Table 74: Fabry Disease Therapeutics Market, Global, Revenue Forecasts ($m), 2010–2018 74Table 75: Fabry Disease Therapeutics Market, Global, Average ACT ($), 2004–2010 76Table 76: Fabry Disease Therapeutics Market, Global, Average ACT ($), 2010–2018 76Table 77: Fabry Disease Therapeutics Market, Global, Diseased Population, 2004–2010 78Table 78: Fabry Disease Therapeutics Market, Global, Diseased Population, 2010–2018 78Table 79: Fabry Disease Therapeutics Market, Global, Treatment Seeking Population, 2004–2010 79Table 80: Fabry Disease Therapeutics Market, Global,Treatment Seeking Population, 2010–2018 79Table 81: Fabry Disease Therapeutics Market, Global, Diagnosed Population, 2004–2010 80Table 82: Fabry Disease Therapeutics Market, Global, Diagnosed Population, 2010–2018 80Table 83: Fabry Disease Therapeutics Market, Global, Prescription Population, 2004–2010 81Table 84: Fabry Disease Therapeutics Market, Global, Prescription Population, 2010–2018 81Table 85: Pompe Disease Therapeutics Market, Global, Revenue ($m), 2004–2010 87Table 86: Pompe Disease Therapeutics Market, Global, Revenues Forecasts ($m), 2010–2018 87Table 87: Pompe Disease Therapeutics Market, Global, Average ACT ($), 2004–2010 88Table 88: Pompe Disease Therapeutics Market, Global, Average ACT ($), 2010–2018 88Table 89: Pompe Disease Therapeutics Market, Global, Diseased Population, 2004–2010 89Table 90: Pompe Disease Therapeutics Market, Global, Diseased Population, 2010–2018 89Table 91: Pompe Disease Therapeutics Market, Global, Treatment Seeking Population, 2004–2010 90Table 92: Pompe Disease Therapeutics Market, Global, Treatment Seeking Population, 2010–2018 90Table 93: Pompe Disease Therapeutics Market, Global, Diagnosed Population, 2004–2010 91Table 94: Pompe Disease Therapeutics Market, Global, Diagnosed Population, 2010–2018 91Table 95: Pompe Disease Therapeutics Market, Global, Prescription Population, 2004–2010 92Table 96: Pompe Disease Therapeutics Market, Global, Prescription Population, 2010–2018 92Table 97: Cystic Fibrosis Therapeutics Market, Global, Pre-Clinical Pipeline, 2011 97Table 98: Cystic Fibrosis Therapeutics Market, Global, Phase I Pipeline, 2011 98Table 99: Cystic Fibrosis Therapeutics Market, Global, Phase II Pipeline, 2011 99Table 100: Cystic Fibrosis Therapeutics Market, Global, Phase III Pipeline, 2011 102Table 101: Duchenne Muscular Dystrophy Therapeutics Market, Global, Pre-Clinical Pipeline, 2011 104Table 102: Duchenne Muscular Dystrophy Therapeutics Market, Global, Phase I Pipeline, 2011 105Table 103: Duchenne Muscular Dystrophy Therapeutics Market, Global, Phase II Pipeline, 2011 106Table 104: Duchenne Muscular Dystrophy Therapeutics Market, Global, Phase II Pipeline, 2011 106Table 105: Fabry Disease Therapeutics Market, Global, Pre-Clinical Pipeline, 2011 108Table 106: Fabry Disease Therapeutics Market, Global, Phase II Pipeline, 2011 109Table 107: Fabry Disease Therapeutics Market, Global, Phase III Pipeline, 2011 109Table 108: Pompe Disease Therapeutics Market, Global, Pre-Clinical Pipeline, 2011 110Table 109: Pompe Disease Therapeutics Market, Global, Phase II Pipeline, 2011 110

List of Figures

1.2 List of FiguresFigure 1: Orphan Disease Therapeutics in Genetic Disorders, Global, Revenue Forecasts ($m), 2004–2018 16Figure 2: Orphan Disease Therapeutics in Genetic Disorders, Global, Revenue Forecasts by Region ($m), 2004–2018 17Figure 3: Orphan Disease Therapeutics in Genetic Disorders, Global, ACT ($), 2004–2018 18Figure 4: Orphan Disease Therapeutics in Genetic Disorders, Global, Diseased Population, 2004–2018 19Figure 5: Orphan Disease Therapeutics i`n Genetic Disorders Market, Global, Treatment Seeking Population, 2004–2018 20Figure 6: Orphan Disease Therapeutics in Genetic Disorders, Global, Diagnosed Population, 2004–2018 21Figure 7: Orphan Disease Therapeutics in Genetic Disorders, Global, Prescription Population, 2004–2018 22Figure 8: Orphan Disease Therapeutics in Genetic Disorders, Global, Drivers and Restraints 23Figure 9: Orphan Disease Therapeutics in Genetic Disorders, The US, Revenue ($m), 2004–2018 26Figure 10: Orphan Disease Therapeutics in Genetic Disorders, The US, ACT ($), 2004–2018 27Figure 11: Orphan Disease Therapeutics in Genetic Disorders, The US, Diseased Population, 2004–2018 28Figure 12: Orphan Disease Therapeutics in Genetic Disorders, The US, Treatment Seeking Population, 2004–2018 29Figure 13: Orphan Disease Therapeutics in Genetic Disorders, The US, Diagnosed Population, 2004–2018 30Figure 14: Orphan Disease Therapeutics in Genetic Disorders, The US, Prescription Population, 2004–2018 31Figure 15: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Revenue ($m), 2004–2018 32Figure 16: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, ACT ($), 2004–2018 33Figure 17: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Diseased Population, 2004–2018 34Figure 18: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Treatment Seeking Population, 2004–2018 35Figure 19: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Diagnosed Population, 2004–2018 36Figure 20: Orphan Disease Therapeutics in Genetic Disorders, Top Five Countries of Europe, Prescription Population, 2004–2018 37Figure 21: Orphan Disease Therapeutics in Genetic Disorders, Japan, Revenue ($m), 2004–2018 38Figure 22: Orphan Disease Therapeutics in Genetic Disorders, Japan, ACT ($), 2004–2018 39Figure 23: Orphan Disease Therapeutics in Genetic Disorders, Japan, Diseased Population, 2004–2018 40Figure 24: Orphan Disease Therapeutics in Genetic Disorders, Japan, Treatment Seeking Population, 2004–2018 41Figure 25: Orphan Disease Therapeutics in Genetic Disorders, Japan, Diagnosed Population, 2004–2018 42Figure 26: Orphan Disease Therapeutics in Genetic Disorders, Japan, Prescription Population, 2004–2018 43Figure 27: Cystic Fibrosis Therapeutics Market, Global, Treatment Flow Algorithm, 2011 46Figure 28: Cystic Fibrosis Therapeutics Market, Global, Revenue ($m), 2004–2018 47Figure 29: Cystic Fibrosis Therapeutics Market, Global, Branded and Generic Market Share (%), 2010 and 2018 48Figure 30: Cystic Fibrosis Therapeutics Market, Global, ACT ($), 2004–2018 49Figure 31: Cystic Fibrosis Therapeutics Market, Global, Diseased Population, 2004–2018 50Figure 32: Cystic Fibrosis Therapeutics Market, Global, Treatment Seeking Population, 2004–2018 51Figure 33: Cystic Fibrosis Therapeutics Market, Global, Diagnosed Population, 2004–2018 52Figure 34: Cystic Fibrosis Therapeutics Market, Global, Prescription Population, 2004–2018 53Figure 35: Cystic Fibrosis Therapeutics Market, Global, Drivers and Restraints 58Figure 36: Duchenne Muscular Dystrophy Therapeutics Market, Global, Treatment Flow Algorithm 62Figure 37: Duchenne Muscular Dystrophy Therapeutics Market, Global, Revenues ($m), 2004–2018 63Figure 38: Duchenne Muscular Dystrophy Therapeutics Market, Global, Branded and Generic Market Share (%), 2010 and 2018 64Figure 39: Duchenne Muscular Dystrophy Therapeutics Market, Global, ACT ($), 2004–2018 66Figure 40: Duchenne Muscular Dystrophy Therapeutics Market, Global, Diseased Population, 2004–2018 67Figure 41: Duchenne Muscular Dystrophy Therapeutics Market, Global, Treatment Seeking Population, 2004–2018 68Figure 42: Duchenne Muscular Dystrophy Therapeutics Market, Global, Diagnosed Population, 2004–2018 69Figure 43: Duchenne Muscular Dystrophy Therapeutics Market, Global, Prescription Population, 2004–2018 70Figure 44: Duchenne Muscular Dystrophy Therapeutics Market, Global, Drivers and Restraints 71Figure 45: Fabry Disease Therapeutics Market, Global, Treatment Flow Algorithm, 2011 74Figure 46: Fabry Disease Therapeutics Market, Global, Revenue ($m), 2004–2018 74Figure 47: Fabry Disease Therapeutics Market, Global, ACT ($), 2004–2018 76Figure 48: Fabry Disease Therapeutics Market, Global, Diseased Population, 2004–2018 78Figure 49: Fabry Disease Therapeutics Market, Global, Treatment Seeking Population, 2004–2018 79Figure 50: Fabry Disease Therapeutics Market, Global, Diagnosed Population, 2004–2018 80Figure 51: Fabry Disease Therapeutics Market, Global, Prescription Population, 2004–2018 81Figure 52: Fabry Disease Therapeutics Market, Global, Drivers and Restraints 82Figure 53: Pompe Disease Therapeutics Market, Global, Treatment Flow Algorithm 86Figure 54: Pompe Disease Therapeutics Market, Global, Revenue ($m), 2004–2018 87Figure 55: Pompe Disease Therapeutics Market, Global, ACT ($), 2004–2018 88Figure 56: Pompe Disease Therapeutics Market, Global, Diseased Population, 2004–2018 89Figure 57: Pompe Disease Therapeutics Market, Global, Treatment Seeking Population, 2004–2018 90Figure 58: Pompe Disease Therapeutics Market, Global, Diagnosed Population, 2004–2018 91Figure 59: Pompe Disease Therapeutics Market, Global, Prescription Population, 2004–2018 92Figure 60: Pompe Disease Therapeutics Market, Global, Drivers and Restraints 93Figure 61: Orphan Disease Therapeutics in Genetic Disorders, GSK, SWOT, 2011 111Figure 62: Orphan Disease Therapeutics in Genetic Disorders, Prosensa, SWOT, 2011 112Figure 63: Orphan Disease Therapeutics in Genetic Disorders, Santhera, SWOT, 2011 113Figure 64: Orphan Disease Therapeutics in Genetic Disorders, Avi BioPharma, SWOT, 2011 113Figure 65: Orphan Disease Therapeutics in Genetic Disorders, Genzyme (Sanofi Subsidiary), SWOT, 2011 114Figure 66: Orphan Disease Therapeutics in Genetic Disorders, Shire, SWOT, 2011 115Figure 67: Orphan Disease Therapeutics in Genetic Disorders, PTC Therapeutics, SWOT, 2011 115Figure 68: Orphan Disease Therapeutics in Genetic Disorders, Novartis, SWOT, 2011 116Figure 69: Orphan Disease Therapeutics in Genetic Disorders, Genentech (Roche), SWOT, 2011 117Figure 70: Orphan Disease Therapeutics in Genetic Disorders, Gilead, SWOT, 2011 118Figure 71: Orphan Disease Therapeutics in Genetic Disorders, Global, Number of M&A Deals by Year, 2006–2011 121Figure 72: Orphan Disease Therapeutics in Genetic Disorders, Global, Number of M&A Deals by Geography (%), 2006–2011 121Figure 73: Orphan Disease Therapeutics in Genetic Disorders, Global, Number of M&A Deals by Value (%), 2006–2011 122Figure 74: Orphan Disease Therapeutics in Genetic Disorders, Global, Number of Licensing Deals by Year, 2007–2011 126Figure 75: Orphan Disease Therapeutics in Genetic Disorders, Global, Number of Licensing Deals by Geography (%), 2006–2011 127Figure 76: Orphan Disease Therapeutics in Genetic Disorders, Global, Number of Co-Development Deals by Year, 2006–2011 132Figure 77: Orphan Disease Therapeutics in Genetic Disorders, Global, Number of Co-Development Deals by Geography (%), 2006–2011 132

Companies Mentioned

GlaxoSmithKlineProsensa Santhera AVI BioPharmaGenzyme (Sanofi Subsidiary)Shire PTC TherapeuticsNovartis Genentech (Roche)Gilead

To order this report:Therapy Industry: Orphan Disease Therapeutics in Genetic Disorders to 2018 - Emerging Agents in Cystic Fibrosis Offer Strong Opportunities for Investment and Licensing Activity

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Check our Industry Analysis and Insights

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Non-Insulin Diabetes Management: Products, Players, Markets and Forecasts

Wed, 23 May 2012 09:25:38 +0000

Non-Insulin Diabetes Management: Products, Players, Markets and Forecasts

PR Newswire

NEW YORK, May 23, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Non-Insulin Diabetes Management: Products, Players, Markets and Forecasts

http://www.reportlinker.com/p0865302/Non-Insulin-Diabetes-Management-Products-Players-Markets-and-Forecasts.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

The diabetes market is changing. The convergence of environmental factors, lifestyle factors and increased patient longevity are driving double-digit growth projections for the incidence of non-insulin dependent (Type 2) diabetes globally. Type 2 diabetes accounts for about 90% of all diagnosed cases of diabetes and is increasingly being diagnosed in children and adolescents. There are eight drug classes, analyzed in this report, with proven efficacy for aiding in glycemic control in this patient population. Because of the size and business potential of this market, pipeline activity is high. In addition to derivative products and products that combine approved APIs in a single dosage form, drugs based on newer chemistries and mechanisms that include amylin analogs and GLP-1 drugs have been introduced. Globally, revenues of drugs for managing Type 2 diabetes will grow by 14% between 2011 and 2016. Safety issues associated with post-launch-reported events will continue to be a major concern for market participants.

Highlights

· Analyzes and evaluates non-insulin or insulin analog drug products and development-stage candidates for glycemic control

· Provides assessments of diabetes managemnet markets for non-insulin drugsl and examines key market and commercialization factors

· Evaluates the impact of economic, technology, and regulatory factors on diabetes management markets

· Provides market data and forecasts to 2016

· Profiles market sector participants, their product development activities and business strategies

Summary of Contents

Executive Summary

Diabetes Management Market Dynamics

The Economics of Diabetes

Therapeutic Options and Patient Outcomes

Evolving Healthcare Initiatives

Demand Drivers

Competitive Landscape

Risk Factors

Non-Insulin Diabetes Management – Product Development Factors

Formulation and Administration

Oral Form Factors

Injectable Formulations

Dosing Frequency

Injectable Device Strategies

Clinical Trial Factors

Combination Therapeutics

Non-Insulin Drug Therapeutics – Classes, Mechanisms and Prescribing Factors

Alpha-glucosidase Inhibitors

Amylin Analogs

Di-peptidyl peptidase IV

Glitazones (Thiazolidinediones)

Glucagon-Like Peptide-1 (GLP-1)

Metformin

Meglitinides

Sulfonylureas

Non-Insulin Drug Therapeutics – Commercial Product Assessments

Branded Drugs

Alpha-glucosidase Inhibitors

Glyset (Miglitol)

Precose (Acarbose)

Amylin Analogs

Symlin (pramlintide acetate)

Dipeptidyl peptidase IV

Januvia (Sitagliptin)

Onglyza (BMS)

Tradjenta (Linagliptin)

Glitazones (Thiazolidinediones)

Pioglitazones

Rosiglitazones

Glucagon-Like Peptide-1 (GLP-1)

Byetta (Amylin)

Bydureon (Amylin)

Victoza (NovoNordisk)

Meglitinides

Starlix (Nateglinide)

Prandin (Repaglinide)

Sulfonylureas

Glipizide

Glimepirides

Other Therapeutic Classes

Dopamine Receptor Agonists

Combination Drug Products

Actoplus Met (Takeda)

Avandamet (GloxoSmithKline)

Avandaryl (GlaxoSmithKline)

Duetact (Takeda)

Glucovance (BMS)

Janumet (Merck)

Jentadueto (Boehringer Ingelheim)

Kombiglyze XR (BMS)

Metaglip (BMS)

Prandimet (NovoNordisk)

Commercialized Drugs Not Approved by the FDA

Alpha-glucosidase Inhibitors

Basen (Voglibose)

Alogliptin

Galvus (Vildagliptin)

Nesina

Generic Non-Insulin Diabetes Management Drugs

Pipeline Candidates - Analysis and Prospects

Dipeptidyl peptidase IV

Dutogliptin (Phenomix)

Gemigliptin (LG Life Sciences)

Glucagon-Like Peptide-1 (GLP-1)

Lyxumia (Lixisenatide)

Syncria (GlaxoSmithKline)

Peroxisome Proliferator-activated Receptor agonist (PPAR)

Aleglitazar

SGLT2 Inhibitors

Dapagliflozin

Canagliflozin

Non-Insulin Diabetes Management - Market Segment Analysis & Forecasts

Analysis and Forecasts by Drug Class

Analysis and Forecasts by Region

Market Factors

Regulatory Factors

North America

European Union

Japan

Demographic Factors

Safety and Reporting

Patient Compliance Factors

Sector Participant Company Profiles

To order this report:Drug and Medication Industry: Non-Insulin Diabetes Management: Products, Players, Markets and Forecasts

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Nicolas Bombourg
Reportlinker
Email: nicolasbombourg@reportlinker.com
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Intl: +1 805-652-2626

SOURCE Reportlinker

Commercializing Pancreatic Cancer Drugs in Cancer: The Faster Route to Consider Your Options and Position of Others

Tue, 22 May 2012 14:21:13 +0000

Commercializing Pancreatic Cancer Drugs in Cancer: The Faster Route to Consider Your Options and Position of Others

PR Newswire

NEW YORK, May 22, 2012 /PRNewswire/ --Reportlinker.com announces that a new market research report is available in its catalogue:

Commercializing Pancreatic Cancer Drugs in Cancer: The Faster Route to Consider Your Options and Position of Others

http://www.reportlinker.com/p0794929/Commercializing-Pancreatic-Cancer-Drugs-in-Cancer-The-Faster-Route-to-Consider-Your-Options-and-Position-of-Others.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

This report will excel your competitive awareness and decrease your decision making time in managing pancreatic cancer drug development. Find out whether you are number one, two or further down the ladder in this highly competitive market. Locate the right drugs to benchmark against and see were others may have succeeded or failed before you.

This report comprises defined and up to date development strategies for 247 pancreatic cancer drugs within the portfolio of 158 companies world-wide, from Ceased to Marketed. The report extensively analyses their 197 identified drug targets, organized into 163 drug target strategies, and assesses them in pancreatic cancer. BioSeeker has applied its unique drug assessment methodology to stratify the pancreatic cancer drug pipeline and discern the level of competition in fine detail.

Major Findings from this report:

* The identified competitive landscape of pancreatic cancer drugs is split between the half which have unique drug target strategies and the other half which have head-to-head target competing drugs in 37 different clusters. The latter has a competing ratio which is more than two times higher than the comparable average of the pancreatic cancer drugs in general.

* Nine out of every ten drug target strategies in Phase III and Phase II development are new to pancreatic cancer drugs.

* The greatest number of new target strategies are found in Phase II (37%) and Phase I (18%) development.

* Small molecules, Antibodies and Reformulated drugs are the dominating compound strategies of pancreatic cancer drugs, which represent almost 80% of the entire pipeline.

* Besides Reformulated drugs, it is Protein and Peptide based pancreatic cancer drugs that have the highest cross-over of drug target strategies with other compound strategies, especially with that of Antibodies.

* The highest number of described drug target strategies of pancreatic cancer drugs belongs to Pfizer, Hoffmann-La Roche, Novartis and AstraZeneca.

The report is written for you to understand and assess the impact of competitor entry and corresponding changes to development strategies for your own portfolio products. It helps teams to maximize molecule value by selecting optimal development plans and manage risk and uncertainty. The report serves as an external commercial advocate for pharmaceutical companies' pipeline and portfolio planning (PPP) in cancer by:

* Providing you with competitive input to the R&D organization to guide development of early product ideas and ensure efforts are aligned with business objectives

* Assisting you to make informed decisions in selecting cancer indications that are known to be appropriate for your drug's properties

* Analyzing, correlating and integrating valuable data sources in order to provide accurate data for valuation of pipeline, in-licensing and new business opportunities

* Providing you with commercial analytic support for due diligence on in-licensing and acquisition opportunities

* Supporting development of integrative molecule, pathway and disease area strategies

* Integrating knowledge for you to consider the therapeutic target for the highest therapeutic outcome and return on investment

This report provides systems, analytical and strategic support both internally to PPP and to stakeholders across your own organization. The report will also be an important part of creating and implementing a market development plan for any pancreatic cancer drug in cancer to ensure that the optimal market conditions exist by the time the product is commercialized.

1 Executive Summary 3

2 About Cancer Highlights™ 5

2.1 Cancer Focus Areas 5

2.2 Subscribe Today and Start Saving 6

2.2.1 Type of License 6

2.3 Additional Information 6

2.4 BioSeeker Group's Oncology Team 6

3 Methodology 7

3.1 Cancer Highlights'™ Five Pillar Drug Assessment 7

4 Table of Contents 9

4.1 List of Figures 19

4.2 List of Tables19

5 Introduction 27

5.1 The Scope of this Report 27

5.2 Definitions 30

5.3 Abbreviations 30

6 Consider the Therapeutic Target Among Pancreatic Cancer Drugs for the Highest Therapeutic Outcome and Return on Investment 31

6.1 Drug Repositioning in Oncology 31

6.2 Introduction to Targets of Pancreatic Cancer Drugs 32

6.2.1 Carboxy-lyase Activity Targets 39

6.2.2 Catalytic Activity Targets 40

6.2.3 Cell Adhesion Molecule Activity Targets 51

6.2.4 Chaperone Activity Targets 59

6.2.5 Cofactor Binding Targets 60

6.2.6 Cysteine-type Peptidase Activity Targets 62

6.2.7 Cytokine Activity Targets 69

6.2.8 DNA Binding Targets 75

6.2.9 DNA Repair Protein Targets 77

6.2.10 DNA Topoisomerase Activity Targets 80

6.2.11 DNA-directed DNA Polymerase Activity Targets 85

6.2.12 Extracellular Ligand-gated Ion Channel Activity Targets 92

6.2.13 Extracellular Matrix Structural Constituent Targets 94

6.2.14 G-protein Coupled Receptor Activity Targets 98

6.2.15 Growth Factor Activity Targets 108

6.2.16 GTPase Activity Targets 114

6.2.17 Hormone Activity Targets 123

6.2.18 Hydrolase Activity Targets 124

6.2.19 Ion Channel Activity Targets 125

6.2.20 Kinase Activity Targets 126

6.2.21 Kinase Binding Targets 138

6.2.22 Kinase Regulator Activity Targets 139

6.2.23 Ligand-dependent Nuclear Receptor Activity Targets 143

6.2.24 Ligase Activity Targets 144

6.2.25 Lipase activity 150

6.2.26 Lipid kinase activity 151

6.2.27 Lipid Phosphatase Activity Targets 154

6.2.28 Molecular Function Unknown Targets 155

6.2.29 Motor Activity Targets 165

6.2.30 Oxidoreductase Activity Targets 167

6.2.31 Peptidase Activity Targets 173

6.2.32 Peptide Hormone Targets 183

6.2.33 Peroxidase Activity Targets 185

6.2.34 Protein Binding Targets 186

6.2.35 Protein Serine/Threonine Kinase Activity Targets 188

6.2.36 Protein Threonine/Tyrosine Kinase Activity Targets 213

6.2.37 Protein Tyrosine Phosphatase Activity Targets 218

6.2.38 Protein-tyrosine Kinase Activity Targets 226

6.2.39 Receptor Activity Targets 237

6.2.40 Receptor Binding Targets 255

6.2.41 Receptor Signaling Complex Scaffold Activity Targets 260

6.2.42 RNA Binding Targets 264

6.2.43 RNA-directed DNA Polymerase Activity Targets 265

6.2.44 Serine-type Peptidase Activity Targets 266

6.2.45 Structural Constituent of Cytoskeleton Targets 271

6.2.46 Structural Molecule Activity Targets 273

6.2.47 Transcription Factor Activity Targets 274

6.2.48 Transcription Regulator Activity Targets 292

6.2.49 Transferase Activity Targets 298

6.2.50 Translation Regulator Activity Targets 299

6.2.51 Transmembrane Receptor Activity Targets 301

6.2.52 Transmembrane Receptor Protein Tyrosine Kinase Activity Targets 304

6.2.53 Transporter Activity Targets 340

6.2.54 Unclassified Targets 345

6.2.55 Voltage-gated Ion Channel Activity Targets 346

6.2.56 Other Targets 347

6.3 The Cancer Genome Project and Targets of Pancreatic Cancer Drugs 348

6.3.1 Targets of Pancreatic Cancer Drugs Present in the Cancer Gene Census and in the Catalogue of Somatic Mutations in Cancer 348

6.4 Pancreatic Cancer Therapeutics is Stimulated by Available Structure Data on Targets 354

6.5 Target-Target Interactions among Identified Targets of Pancreatic Cancer Drugs 358

6.6 The Drug-Target Competitive Landscape 362

6.7 Protein Expression Levels of Identified Targets of Pancreatic Cancer Drugs 366

6.8 Pathway Assessment of Pancreatic Cancer Drugs 369

6.8.1 Tools for Analysis of Cancer Pathways 370

6.8.2 Pathway Assessment 371

7 Emerging New Products to Established Ones: Drug Target Strategies of Pancreatic Cancer Drugs by their Highest Stage of Development 423

7.1 Registered to Marketed: New and Unique Drug Target Strategies of Pancreatic Cancer Drugs 425

7.2 Phase III Clinical Development: New and Unique Drug Target Strategies of Pancreatic Cancer Drugs 426

7.3 Phase II Clinical Development: New and Unique Drug Target Strategies of Pancreatic Cancer Drugs 428

7.4 Phase I Clinical Development: New and Unique Drug Target Strategies of Pancreatic Cancer Drugs 433

7.5 Preclinical Development: New and Unique Drug Target Strategies of Pancreatic Cancer Drugs 436

7.6 Drug Target Strategies of Suspended or Terminated Pancreatic Cancer Drugs 438

7.7 Target Strategy Development Profiles of Pancreatic Cancer Drugs 440

7.7.1 Marketed 444

7.7.2 Phase III 447

7.7.3 Phase II 462

7.7.4 Phase I 522

7.7.5 Preclinical 552

7.7.6 Suspended 575

7.7.7 Ceased 577

7.8 The Competition Through Close Mechanistic Approximation of Pancreatic Cancer Drugs 609

8 Compound Strategies at Work: Competitive Benchmarking of Pancreatic Cancer Drugs by Compound Strategy 613

8.1 Small Molecules 615

8.1.1 Background 615

8.1.2 Target Strategies of Small Molecule Drugs 616

8.2 Peptide & Protein Drugs 624

8.2.1 Background 624

8.2.2 Target Strategies of Peptide and Protein Drugs 625

8.3 Antibodies 630

8.3.1 Background 630

8.3.2 Target Strategies of Antibody Drugs 630

8.4 Nucleic Acid Therapies 634

8.4.1 Background 634

8.4.2 Target Strategies of Nucleic Acid Drugs 635

8.5 Cell & Gene Therapy 637

8.5.1 Background 637

8.5.2 Target Strategies of Cell and Gene Therapy Drugs 638

8.6 Drug Delivery and Nanotechnology 642

8.6.1 Background 642

8.6.2 Target Strategies of Reformulated Drugs 642

8.7 Compound Strategies based on Sub-Cellular Localization of Drug Targets 645

9 Pipeline and Portfolio Planning: Competitive Benchmarking of the Pancreatic Cancer Drug Pipeline by Investigator 652

9.1 Changes in the Competitive Landscape: M&A, Bankruptcy and Name Change 656

9.2 Company Facts and Ranking 658

9.3 Competitive Fall-Out Assessment 666

9.4 AB Science 668

9.5 Abbott 670

9.6 Active Biotech 673

9.7 Advantagene 675

9.8 Advaxis 678

9.9 Aegera 681

9.10 Aida Pharmaceuticals 683

9.11 Amgen 685

9.12 Antisense Pharma 690

9.13 Anza Therapeutics 692

9.14 Apogee Biotechnology 694

9.15 Apotex 696

9.16 Ardea Biosciences 698

9.17 Ariad 701

9.18 ArQule 703

9.19 Array BioPharma 705

9.20 Astellas 709

9.21 AstraZeneca 714

9.22 AVEO 719

9.23 AVI BioPharma 721

9.24 Bayer 724

9.25 Betapharma 727

9.26 Biogen Idec 730

9.27 Bionovo 733

9.28 BioNumerik 735

9.29 BioSante 738

9.30 Boehringer Ingelheim 740

9.31 Bristol-Myers Squibb 742

9.32 BTG 747

9.33 Calando Pharmaceuticals 751

9.34 Cancer Advances 753

9.35 Cancer Research Technology 755

9.36 Celera 757

9.37 Celgene 759

9.38 Cell Therapeutics 763

9.39 Celldex Therapeutics 766

9.40 Celsion 769

9.41 Celtic Pharma 772

9.42 Center of Molecular Immunology 774

9.43 CG Therapeutics 777

9.44 CompleGen 780

9.45 Cornerstone Pharmaceuticals 782

9.46 CritiTech 784

9.47 Curaxis 787

9.48 Curis 789

9.49 Cyclacel 791

9.50 Cylene Pharmaceuticals 793

9.51 Cynvec 795

9.52 CytImmune Sciences 797

9.53 Cytokinetics 799

9.54 CytRx 801

9.55 Daiichi Sankyo 804

9.56 Dara Biosciences 809

9.57 EGEN Inc 811

9.58 Eisai 813

9.59 Eli Lilly 818

9.60 EntreMed 823

9.61 Epeius Biotechnologies 825

9.62 EpiCept 827

9.63 Esperance Pharmaceuticals 830

9.64 Exelixis 832

9.65 FibroGen 834

9.66 Galectin Therapeutics 836

9.67 Genta 839

9.68 GenVec 841

9.69 Geron 843

9.70 GlaxoSmithKline 845

9.71 GlycoGenesys 850

9.72 Hoffmann-La Roche 852

9.73 Human Genome Sciences 858

9.74 ImmunoCellular Therapeutics 860

9.75 ImmunoGen 862

9.76 Immunomedics 865

9.77 ImmuPharma 869

9.78 Immutep 871

9.79 Innate Pharma 873

9.80 Innovive 875

9.81 Insmed 878

9.82 Insys Therapeutics 881

9.83 Introgen Therapeutics 887

9.84 Ipsen 889

9.85 Johnson & Johnson 892

9.86 Kadmon 894

9.87 Kyowa Hakko Kirin 896

9.88 Leo 898

9.89 Mbiotec 900

9.90 Meda 902

9.91 MediGene 904

9.92 Medisyn Technologies 908

9.93 Merck & Co 910

9.94 Merck KGaA 914

9.95 Merrimack 918

9.96 Mersana Therapeutics 921

9.97 MethylGene 924

9.98 Micromet 926

9.99 Nektar Therapeutics 928

9.100 Nereus Pharmaceuticals 931

9.101 Nippon Kayaku 933

9.102 Nippon Shinyaku 936

9.103 Non-industrial Source 938

9.104 Novacea 941

9.105 NovaLead 944

9.106 Novartis 947

9.107 Novogen 953

9.108 OncoMed 955

9.109 OncoTherapy Science 957

9.110 Oncothyreon 959

9.111 Oncozyme Pharma 961

9.112 Oxford BioMedica 963

9.113 OXiGENE 965

9.114 Paladin Labs 967

9.115 PanaGin 970

9.116 Patrys 972

9.117 Pepscan Therapeutics 974

9.118 Pfizer 976

9.119 Pharmacyclics 983

9.120 PharmaMar 985

9.121 Pharmexa 987

9.122 Pierre Fabre 990

9.123 Piramal 993

9.124 ProMetic Life Sciences 995

9.125 Protgen 997

9.126 Ras Therapeutics 999

9.127 Reata Pharmaceuticals 1001

9.128 Regeneron 1003

9.129 Regulon 1005

9.130 RESprotect 1007

9.131 Rexahn 1009

9.132 Rigel 1012

9.133 Rottapharm Madaus 1014

9.134 Samyang 1017

9.135 Sanofi 1021

9.136 Santaris Pharma 1026

9.137 Shire 1028

9.138 SuperGen 1030

9.139 Taiho 1034

9.140 Takeda 1038

9.141 Talon Therapeutics 1040

9.142 Tapestry Pharmaceuticals 1043

9.143 Tau Therapeutics 1046

9.144 Teva 1048

9.145 Thallion Pharmaceuticals 1050

9.146 Therion Biologics 1052

9.147 Titan Pharmaceuticals 1054

9.148 TopoTarget 1057

9.149 Tragara Pharmaceuticals 1060

9.150 Trion Pharma 1062

9.151 UMN Pharma 1064

9.152 VaxOnco 1066

9.153 Vertex Pharmaceuticals 1068

9.154 Vion Pharmaceuticals 1070

9.155 VioQuest 1072

9.156 ViroMed 1075

9.157 Wilex 1078

9.158 Xerion 1080

9.159 Yakult Honsha 1082

9.160 YM BioSciences 1085

9.161 Zeria 1088

Disclaimer 1090

10 Drug Index 1091

11 Company Index 1098

4.1 List of Figures

Figure 1: Visualization of Target-Target Interactions among Targets of Pancreatic Cancer Drugs 361

Figure 2: The Drug-Target Competitive Landscape of Pancreatic Cancer Drugs - Large Clusters 363

Figure 3: The Drug-Target Competitive Landscape Pancreatic Cancer Drugs - Smaller Clusters 364

Figure 4: Head-to-Head Targeting Competitive Landscape of Pancreatic Cancer Drugs 365

Figure 5: Distribution of Compound Strategies among Pancreatic Cancer Drugs 645

Figure 6: Primary Sub-cellular Localization of Drug Targets 646

Figure 7: Number of Companies per Ranking Level 661

4.2 List of Tables

Table 1: Cancer Highlights'™ Five Pillar Drug Assessment 7

Table 2: Breakdown of the Included Pancreatic Cancer Drug Pipeline by Stage of Development 27

Table 3: Head to Head Target Competition among Pancreatic Cancer Drugs 27

Table 4: Overview of Drug Target Strategy Themes 32

Table 5: Terminally Ceased Targets of Pancreatic Cancer Drugs 33

Table 6: Official Gene Symbol to Target Profle 34

Table 7: Targets of Pancreatic Cancer Drugs Present in the Catalogue of Somatic Mutations in Cancer and in the Cancer Gene Census 349

Table 8: Identity of Drug Targets with Available Biological Structures 354

Table 9: Number of Target-Target Interactions among Targets of Pancreatic Cancer Drugs 359

Table 10: Available Protein Expression Profiles of Pancreatic Cancer Drug Targets 366

Table 11: Pathway Summary 371

Table 12: Drug Targets without any Identified Assigned Pathways 371

Table 13: Pathway Profiles According to BioCarta of Pancreatic Cancer Drug Targets 373

Table 14: Pathway Profiles According to KEGG of Pancreatic Cancer Drug Targets 392

Table 15: Pathway Profiles According to NetPath of Pancreatic Cancer Drug Targets 415

Table 16: Number of Drug Target Strategies by their Highest Developmental Stage and Uniqueness 423

Table 17: Top Competitive Target Strategies of Pancreatic Cancer Drugs 424

Table 18: New and Unique Target Strategies of Registered and Marketed Pancreatic Cancer Drugs 425

Table 19: The Competition Through Close Mechanistic Approximation Between Pancreatic Cancer Drugs in Registered to Marketed 425

Table 20: New and Unique Target Strategies in Phase III Clinical Development of Pancreatic Cancer Drugs 426

Table 21: The Competition Through Close Mechanistic Approximation Between Phase III Pancreatic Cancer Drugs 427

Table 22: New and Unique Target Strategies in Phase II Clinical Development of Pancreatic Cancer Drugs 428

Table 23: The Competition Through Close Mechanistic Approximation Between Phase II Pancreatic Cancer Drugs 431

Table 24: New and Unique Target Strategies in Phase I Clinical Development of Pancreatic Cancer Drugs 433

Table 25: The Competition Through Close Mechanistic Approximation Between Phase I Pancreatic Cancer Drugs 435

Table 26: New and Unique Target Strategies in Preclinical Development of Pancreatic Cancer Drugs 436

Table 27: The Competition Through Close Mechanistic Approximation Between Preclinical Pancreatic Cancer Drugs 437

Table 28: Target Strategies of Suspended or Terminated Pancreatic Cancer Drugs 438

Table 29: Connecting Target Strategy with Its Profile Identification Number 440

Table 30: The Competition Through Close Mechanistic Approximation Among Pancreatic Cancer Drugs 609

Table 31: Overview of Compound Strategy Competition Among Pancreatic Cancer Drugs 614

Table 32: Overview of the Competitive Landscape of Small Molecule Based Pancreatic Cancer Drugs 616

Table 33: Competitive Comparison of Target Strategies of Small Molecule Pancreatic Cancer Drugs 617

Table 34: Pursued Target Strategies of Small Molecule Drugs Based Pancreatic Cancer Drugs 619

Table 35: Overview of the Competitive Landscape of Peptide Based Pancreatic Cancer Drugs 625

Table 36: Competitive Comparison of Target Strategies of Peptide Based Pancreatic Cancer Drugs 626

Table 37: Pursued Target Strategies of Peptide Based Pancreatic Cancer Drugs 626

Table 38: Overview of the Competitive Landscape of Protein Based Pancreatic Cancer Drugs 628

Table 39: Pursued Target Strategies of Protein Based Pancreatic Cancer Drugs 629

Table 40: Overview of the Competitive Landscape of Antibody Based Pancreatic Cancer Drugs 630

Table 41: Competitive Comparison of Target Strategies of Antibody Based Pancreatic Cancer Drugs 631

Table 42: Pursued Target Strategies of Antibody Based Pancreatic Cancer Drugs 632

Table 43: Overview of the Competitive Landscape of Nucleic Acid Based Pancreatic Cancer Drugs 635

Table 44: Competitive Comparison of Target Strategies of Nucleic Acid Based Pancreatic Cancer Drugs 636

Table 45: Pursued Target Strategies of Nucleic Acid Based Pancreatic Cancer Drugs 636

Table 46: Potential Forms of Cell Therapy 637

Table 47: Vectors in Gene Therapy 638

Table 48: Overview of the Competitive Landscape of Cell Therapy Based Pancreatic Cancer Drugs 638

Table 49: Pursued Target Strategies of Cell Therapy Based Pancreatic Cancer Drugs 639

Table 50: Overview of the Competitive Landscape of Gene Therapy Based Pancreatic Cancer Drugs 640

Table 51: Competitive Comparison of Target Strategies of Gene Therapy Based Pancreatic Cancer Drugs 641

Table 52: Pursued Target Strategies of Gene Therapy Based Pancreatic Cancer Drugs 641

Table 53:Overview of the Competitive Landscape of Reformulated Pancreatic Cancer Drugs 642

Table 54: Competitive Comparison of Target Strategies of Reformulated Pancreatic Cancer Drugs 643

Table 55: Pursued Target Strategies of Reformulated Pancreatic Cancer Drugs 644

Table 56: Compound Strategies based on Sub-Cellular Localization of Pancreatic Cancer Drug Targets 646

Table 57: Competitive Summary by Investigator of Pancreatic Cancer Drug Development 652

Table 58: Summary Table of Corporate Changes in the Competitive Landscape of Pancreatic Cancer Drug Development 656

Table 59: The Worst Ranking and the Highest Populated Level for Each of the 15 Ranking Parameters 660

Table 60: Example of a Competitive Fall-Out Table (Targeting TYMS/Modified) 666

Table 61: AB Science's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 669

Table 62: Abbott's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 672

Table 63: Active Biotech's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 674

Table 64: Advantagene's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 677

Table 65: Advaxis' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 680

Table 66: Aegera's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 682

Table 67: Aida Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 684

Table 68: Amgen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 687

Table 69: Antisense Pharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 691

Table 70: Anza Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 693

Table 71: Apogee Biotechnology's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 695

Table 72: Apotex's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 697

Table 73: Ardea Biosciences' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 700

Table 74: Ariad's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 702

Table 75: ArQule's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 704

Table 76: Array BioPharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 707

Table 77: Astellas' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 711

Table 78: AstraZeneca's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 716

Table 79: AVEO's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 720

Table 80: AVI BioPharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 723

Table 81: Bayer's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 725

Table 82: Betapharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 729

Table 83: Biogen Idec's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 732

Table 84: Bionovo's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 734

Table 85: BioNumerik's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 737

Table 86: BioSante's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 739

Table 87: Boehringer Ingelheim's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 741

Table 88: Bristol-Myers Squibb's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 744

Table 89: BTG's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 749

Table 90: Calando Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 752

Table 91: Cancer Advances' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 754

Table 92: Cancer Research Technology's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 756

Table 93: Celera's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 758

Table 94: Celgene's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 761

Table 95: Cell Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 765

Table 96: Celldex Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 768

Table 97: Celsion's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 771

Table 98: Celtic Pharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 773

Table 99: Center of Molecular Immunology's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 776

Table 100: CG Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 779

Table 101: CompleGen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 781

Table 102: Cornerstone Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 783

Table 103: CritiTech's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 786

Table 104: Curaxis' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 788

Table 105: Curis' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 790

Table 106: Cyclacel's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 792

Table 107: Cylene Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 794

Table 108: Cynvec's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 796

Table 109: CytImmune Sciences' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 798

Table 110: Cytokinetics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 800

Table 111: CytRx's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 803

Table 112: Daiichi Sankyo's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 807

Table 113: Dara Biosciences' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 810

Table 114: EGEN Inc's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 812

Table 115: Eisai's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 815

Table 116: Eli Lilly's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 820

Table 117: EntreMed's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 824

Table 118: Epeius Biotechnologies' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 826

Table 119: EpiCept's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 829

Table 120: Esperance Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 831

Table 121: Exelixis' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 833

Table 122: FibroGen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 835

Table 123: Galectin Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 838

Table 124: Genta's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 840

Table 125: GenVec's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 842

Table 126: Geron's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 844

Table 127: GlaxoSmithKline's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 847

Table 128: GlycoGenesys' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 851

Table 129: Hoffmann-La Roche's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 854

Table 130: Human Genome Sciences' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 859

Table 131: ImmunoCellular Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 861

Table 132: ImmunoGen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 864

Table 133: Immunomedics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 867

Table 134: ImmuPharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 870

Table 135: Immutep's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 872

Table 136: Innate Pharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 874

Table 137: Innovive's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 877

Table 138: Insmed's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 880

Table 139: Insys Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 884

Table 140: Introgen Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 888

Table 141: Ipsen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 891

Table 142: Johnson & Johnson's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 893

Table 143: Kadmon's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 895

Table 144: Kyowa Hakko Kirin's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 897

Table 145: Leo's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 899

Table 146: Mbiotec's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 901

Table 147: Meda's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 903

Table 148: MediGene's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 906

Table 149: Medisyn Technologies' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 909

Table 150: Merck & Co's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 912

Table 151: Merck KGaA's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 916

Table 152: Merrimack's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 920

Table 153: Mersana Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 923

Table 154: MethylGene's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 925

Table 155: Micromet's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 927

Table 156: Nektar Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 930

Table 157: Nereus Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 932

Table 158: Nippon Kayaku's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 935

Table 159: Nippon Shinyaku's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 937

Table 160: Non-industrial source's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 940

Table 161: Novacea's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 943

Table 162: NovaLead's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 946

Table 163: Novartis' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 949

Table 164: Novogen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 954

Table 165: OncoMed's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 956

Table 166: OncoTherapy Science's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 958

Table 167: Oncothyreon's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 960

Table 168: Oncozyme Pharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 962

Table 169: Oxford BioMedica's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 964

Table 170: OXiGENE's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 966

Table 171: Paladin Labs' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 969

Table 172: PanaGin's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 971

Table 173: Patrys' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 973

Table 174: Pepscan Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 975

Table 175: Pfizer's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 978

Table 176: Pharmacyclics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 984

Table 177: PharmaMar's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 986

Table 178: Pharmexa's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 989

Table 179: Pierre Fabre's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 992

Table 180: Piramal's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 994

Table 181: ProMetic Life Sciences' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 996

Table 182: Protgen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 998

Table 183: Ras Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1000

Table 184: Reata Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1002

Table 185: Regeneron's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1004

Table 186: Regulon's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1006

Table 187: RESprotect's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1008

Table 188: Rexahn's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1011

Table 189: Rigel's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1013

Table 190: Rottapharm Madaus' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1016

Table 191: Samyang's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1019

Table 192: Sanofi's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1023

Table 193: Santaris Pharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1027

Table 194: Shire's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1029

Table 195: SuperGen's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1032

Table 196: Taiho's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1036

Table 197: Takeda's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1039

Table 198: Talon Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1042

Table 199: Tapestry Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1045

Table 200: Tau Therapeutics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1047

Table 201: Teva's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1049

Table 202: Thallion Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1051

Table 203: Therion Biologics' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1053

Table 204: Titan Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1056

Table 205: TopoTarget's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1059

Table 206: Tragara Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1061

Table 207: Trion Pharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1063

Table 208: UMN Pharma's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1065

Table 209: VaxOnco's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1067

Table 210: Vertex Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1069

Table 211: Vion Pharmaceuticals' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1071

Table 212: VioQuest's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1074

Table 213: ViroMed's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1077

Table 214: Wilex's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1079

Table 215: Xerion's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1081

Table 216: Yakult Honsha's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1084

Table 217: YM BioSciences' Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1087

Table 218: Zeria's Included Pancreatic Cancer Drug Pipeline and Competitive Fall-Out 1089

To order this report:

Drug and Medication Industry: Commercializing Pancreatic Cancer Drugs in Cancer: The Faster Route to Consider Your Options and Position of Others

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Global Testosterone Replacement Therapy (TRT) Industry

Mon, 21 May 2012 12:53:50 +0000

Global Testosterone Replacement Therapy (TRT) Industry

PR Newswire

NEW YORK, May 21, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Testosterone Replacement Therapy (TRT) Industry

http://www.reportlinker.com/p0552808/Global-Testosterone-Replacement-Therapy-TRT-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Therapy

This report analyzes the worldwide markets for Testosterone Replacement Therapy (TRT) in US$ Million. The global and the US markets are further analyzed by the following Product Segments: Gels, Patches, and Others. The report provides separate comprehensive analytics for the US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 19 companies including many key and niche players such as Abbott Laboratories, Acrux Limited, Auxilium Pharmaceuticals, Inc., Bayer Schering Pharma AG, Columbia Laboratories, Inc., Eli Lilly and Company, Endo Pharmaceuticals, Inc., GlaxoSmithKline plc, Kyowa Hakko Kirin Co., Ltd., ProStrakan Group PLC, Slate Pharmaceuticals, Inc., Trimel BioPharma SRL, and Watson Pharmaceuticals, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1

Disclaimers I-2

Data Interpretation & Reporting Level I-3

Quantitative Techniques & Analytics I-3

Product Definitions and Scope of Study I-3

Testosterone Replacement Therapy (TRT) I-3

Gels I-4

Patches I-4

Others I-4

II. EXECUTIVE SUMMARY

1. OUTLOOK II-1

2. INDUSTRY OVERVIEW II-2

High Incidence, Low Treatment II-2

Gels Displacing Alternative Therapies II-2

Testosterone Treatment in Females: An Unmet Clinical Need II-2

Growth Drivers II-3

Favorable Demographics II-3

Table 1: Percentage of Total Population Above 65 Years of

Age in Select Countries for 2000 and 2025(F) (includes

corresponding Graph/Chart) II-3

Table 2: Global Male Population Distribution (15-64 Yrs) by

Geographic Region/Country: 2010 (includes corresponding

Graph/Chart) II-4

Table 3: Global Male Population Distribution (65+Yrs) by

Geographic Region/Country: 2010 (includes corresponding

Graph/Chart) II-4

Table 4: Top 20 Countries with Male Population Aged 15 - 64:

2010 (in millions) (includes corresponding Graph/Chart) II-5

Table 5: Top 20 Countries with Male Population Aged 65 &

Above: 2010 (in millions) (includes corresponding

Graph/Chart) II-6

Rising Awareness II-6

Innovation and Improvement: Keys to Success II-6

Untapped Markets II-7

Undiagnosed Patients II-7

3. PRODUCT OVERVIEW II-8

Testosterone - An Introduction II-8

Testosterone Deficiency II-8

Primary Hypogonadism II-8

Secondary Hypogonadism II-8

Symptoms II-8

General Symptoms II-8

Clinical Symptoms II-9

Table 6: Major Symptoms in Hypogonadal Patients: Percentage

of Hypogonadal Patients Affected with Moderate to Severe

Symptoms of Low Energy Levels, Irritability, Sparse Beard,

Diminished Libido, and Sleepiness After Lunch (includes

corresponding Graph/Chart) II-9

Causes II-10

Co-Morbid Conditions II-10

Table 7: Hypogonadism Prevalence in Some Common Medical

Conditions (includes corresponding Graph/Chart) II-10

Diabetes and Hypogonadism II-11

Diagnosis II-11

Testosterone Replacement II-11

Testosterone Replacement Therapy - Evolution II-11

Treatment Alternatives II-11

Gels II-12

Patches II-12

Others II-12

Injections II-12

Orals II-12

Pellets II-13

Guidelines for Treatment of Hypogonadism II-13

Side Effects of TRT II-13

Precautions II-13

4. COMPETITIVE ANALYSIS II-14

Table 8: Global TRT Market (2010): Percentage Breakdown of

Value Revenue for Androgel, Testim, Androderm and Others

(includes corresponding Graph/Chart) II-14

Entry of Large Multinational Players II-15

Companies and Leading Brands II-15

Review of Select Brands II-15

The Generic Incursion II-17

Patent Expiration of Leading TRT Brands II-17

Threat from New Products II-17

Testosterone Therapies in Pipeline II-18

New Delivery Methods II-18

Androxal II-18

SARMs II-18

5. CLINICAL STUDIES/TRIALS II-19

Repros Therapeutics receives IRB for Phase 2b study of Androxal II-19

Acrux Announces Phase III Clinical Trial Results for Axiron II-19

Repros Announces Phase 2b Proof-of-Concept Clinical Trial

Results for Androxal II-19

ProStrakan Announces Positive Results from Study on

Testosterone Replacement in Diabetic Males II-19

ProStrakan Announces Positive Results from US Clinical Study

on Fortigel™ II-20

6. PRODUCT LAUNCHES/INNOVATIONS/ REGULATORY APPROVALS II-21

BioSante's Bio-T-Gel™ Receives FDA Clearance II-21

Abbott Obtains FDA Clearance for AndroGel® 1.62% II-21

Teva Pharmaceuticals Receives NDA Acceptance from FDA for Bio

-T-Gel II-21

Endo Pharmaceuticals' Fortesta Gel Secures FDA Acceptance II-21

Acrux Receives US FDA Approval for Axiron® Topical Solution II-22

Acrux Applies to FDA for NDA for AXIRON™ II-22

Endo Pharmaceuticals Files Class 2 Resubmission for Fortesta II-22

Endo Pharmaceuticals Receives Complete Response Letter from

FDA for Aveed™ II-22

ProStrakan Submits Response to FDA's Action Letter Regarding

NDA for Fortigel™ II-23

7. RECENT INDUSTRY ACTIVITY II-24

Kyowa Hakko Kirin Acquires ProStrakan Group II-24

Trimel Pharmaceuticals Amalgamates Operations with Trimel

BioPharma Holdings II-24

Actient Pharmaceuticals Bags the US Rights to Columbia

Laboratories' Striant® II-24

Abbott Takes Over Solvay Pharmaceuticals II-24

Eli Lilly Signs Global License Agreement with Acrux II-25

ProStrakan and Paladin Labs to Enter Strategic Partnership II-25

Boston Medical Group Expands Extensive ED Treatment by Adding

Testopel® TRT II-25

Cell Genesys Merges with BioSante Pharmaceuticals II-26

Endo Purchases US Rights for Fortesta II-26

Endo Pharmaceutical Inks Merger Agreement with Indevus

Pharmaceuticals II-26

Solvay Pharmaceutical to Market Lipocine's Oral Testosterone Pill II-27

US FTC Files Lawsuit Against Solvay, Watson and Par for 2006

Patent Settlement for Androgel II-27

Auxilium and Ferring Ink Licensing Deal for Testim® II-27

Noven Inks Supply and License Pact with P&GP for Testosterone

Patches to Treat HSDD in Women II-27

Auxilium Terminates Distribution Deal for Testim with Ipsen II-28

ProStrakan Grants Exclusive License to Bayer Schering Pharma

for the Development of Tostran® in 65 Countries II-28

8. FOCUS ON SELECT GLOBAL PLAYERS II-29

Abbott Laboratories (US) II-29

Acrux Limited (Australia) II-29

Auxilium Pharmaceuticals, Inc. (US) II-29

Bayer Schering Pharma AG (Germany) II-30

Columbia Laboratories, Inc. (US) II-30

Eli Lilly and Company (US) II-30

Endo Pharmaceuticals, Inc. (US) II-31

GlaxoSmithKline plc. (UK) II-31

Kyowa Hakko Kirin Co., Ltd. (Japan) II-31

ProStrakan Group PLC. (UK) II-32

Slate Pharmaceuticals, Inc. (US) II-32

Trimel BioPharma SRL (Canada) II-32

Watson Pharmaceuticals, Inc. (US) II-32

9. GLOBAL MARKET PERSPECTIVE II-33

Table 9: World Recent Past, Current & Future Analysis for

Testosterone Replacement Therapy by Geographic Region - US,

Canada, Europe, Asia-Pacific, Latin America and Rest of World

Markets Independently Analyzed with Annual Revenue Figures in

US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) II-33

Table 10: World Historic Review for Testosterone Replacement

Therapy by Geographic Region - US, Canada, Europe,

Asia-Pacific, Latin America and Rest of World Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2003 through 2008 (includes corresponding

Graph/Chart) II-34

Table 11: World 15-Year Perspective for Testosterone

Replacement Therapy by Geographic Region - Percentage

Breakdown of Dollar Revenues for US, Canada, Europe,

Asia-Pacific, Latin America, and Rest of World Markets for

Years 2003, 2010 & 2017 (includes corresponding Graph/Chart) II-35

Table 12: World Recent Past, Current & Future Analysis for

Testosterone Replacement Therapy by Product Segments - Gels,

Patches, and Others Markets Independently Analyzed with Annual

Revenue Figures in US$ Million for Years 2009 through 2017

(includes corresponding Graph/Chart) II-36

Table 13: World Historic Review for Testosterone Replacement

Therapy by Product Segments - Gels, Patches, and Others

Markets Independently Analyzed with Annual Sales Figures in

US$ Million for Years 2003 through 2008 (includes

corresponding Graph/Chart) II-37

Table 14: World 15-Year Perspective for Testosterone

Replacement Therapy by Product Segments - Percentage Breakdown

of Dollar Revenues for Gels, Patches, and Others Markets for

Years 2003, 2011& 2017 (includes corresponding Graph/Chart) II-38

III. MARKET

1. THE UNITED STATES III-1

A.Market Analysis III-1

Hypogonadism Prevalence III-1

Table 15: Low Testosterone Prevalence in US Men Above 45

Years of Age (2010): Percentage of Men Population Suffering

from Low Testosterone for Different Age Groups (includes

corresponding Graph/Chart) III-1

Competitive Scenario III-1

Table 16: US Gel TRT Market (2009): Percentage Breakdown of

Prescriptions for Androgel and Testim (includes

corresponding Graph/Chart) III-2

Table 17: US Gel TRT Market (2009): Percentage Breakdown of

Value Revenue for Androgel and Testim (includes

corresponding Graph/Chart) III-2

Generic Threat to Gel Brands III-2

Secondary Exposure III-3

B.Market Analytics III-4

Table 18: US Recent Past, Current & Future Analysis for

Testosterone Replacement Therapy by Product Segment - Gels,

Patches and Others Markets Independently Analyzed with

Annual Revenue Figures in US$ Million for Years 2009 through

2017 (includes corresponding Graph/Chart) III-4

Table 19: US Historic Review for Testosterone Replacement

Therapy by Product Segment - Gels, Patches and Others

Markets Independently Analyzed with Annual Sales Figures in

US$ Million for Years 2003 Through 2008 (includes

corresponding Graph/Chart) III-5

Table 20: US 15-Year Perspective for Testosterone

Replacement Therapy by Product Segment - Percentage

Breakdown of Dollar Revenue for Gels, Patches and Others

Markets for Years 2003, 2011& 2017 (includes corresponding

Graph/Chart) III-6

2. CANADA III-7

Market Analytics III-7

Table 21: Canadian Recent Past, Current & Future Analysis

for Testosterone Replacement Therapy Markets Analyzed with

Annual Revenue Figures in US$ Million for Years 2009 through

2017 (includes corresponding Graph/Chart) III-7

Table 22: Canadian Historic Review for Testosterone

Replacement Therapy Markets Independently Analyzed with

Annual Sales Figures in US$ Million for Years 2003 through

2008 (includes corresponding Graph/Chart) III-8

3. EUROPE III-9

A.Market Analysis III-9

Lower Normal Serum Testosterone Concentration in Select

European Nations III-9

B.Market Analytics III-10

Table 23: European Recent Past, Current & Future Analysis

for Testosterone Replacement Therapy by Geographic Region -

France, Germany, Italy, UK, and Rest of Europe Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2009 Through 2017 (includes corresponding

Graph/Chart) III-10

Table 24: European Historic Review for Testosterone

Replacement Therapy by Geographic Region - France, Germany,

Italy, UK, and Rest of Europe Markets Independently Analyzed

with Annual Sales Figures in US$ Million for Years 2003

through 2008 (includes corresponding Graph/Chart) III-11

Table 25: European 15-Year Perspective for Testosterone

Replacement Therapy by Geographic Region - Percentage

Breakdown of Dollar Sales for France, Germany, Italy, UK,

and Rest of Europe Markets for Years 2003, 2011 &

2017(includes corresponding Graph/Chart) III-12

4. ASIA-PACIFIC III-13

Market Analytics III-13

Table 26: Asia-Pacific Recent Past, Current & Future

Analysis for Testosterone Replacement Therapy Markets

Analyzed with Annual Revenue Figures in US$ Million for

Years 2009 through 2017 (includes corresponding Graph/Chart) III-13

Table 27: Asia-Pacific Historic Review for Testosterone

Replacement Therapy Markets Analyzed with Annual Sales

Figures in US$ Million for Years 2003 through 2008 (includes

corresponding Graph/Chart) III-14

5. LATIN AMERICA III-15

Market Analytics III-15

Table 28: Latin American Recent Past, Current & Future

Analysis for Testosterone Replacement Therapy Markets

Analyzed with Annual Revenue Figures in US$ Million for

Years 2009 through 2017 (includes corresponding Graph/Chart) III-15

Table 29: Latin American Historic Review for Testosterone

Replacement Therapy Markets Analyzed with Annual Sales

Figures in US$ Million for Years 2003 through 2008 (includes

corresponding Graph/Chart) III-16

6. REST OF WORLD III-17

Market Analytics III-17

Table 30: Rest of World Recent Past, Current & Future

Analysis for Testosterone Replacement Therapy Markets

Analyzed with Annual Revenue Figures in US$ Million for

Years 2009 through 2017 (includes corresponding Graph/Chart) III-17

Table 31: Rest of World Historic Review for Testosterone

Replacement Therapy Markets Analyzed with Annual Sales

Figures in US$ Million for Years 2003 through 2008 (includes

corresponding Graph/Chart) III-18

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 19

------------------------------------------

Region/Country Players

------------------------------------------

The United States 12

Canada 1

Europe 5

France 1

Germany 1

The United Kingdom 2

Rest of Europe 1

Asia-Pacific (Excluding Japan) 1

------------------------------------------

To order this report:

Therapy Industry: Global Testosterone Replacement Therapy (TRT) Industry

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__________________________

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US: (805)-652-2626

Intl: +1 805-652-2626

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Auxilium Pharmaceuticals, Inc. and GlaxoSmithKline LLC Enter Into a Co-Promotion Agreement for Testim® in the U.S.

Mon, 21 May 2012 11:00:00 +0000

Auxilium Pharmaceuticals, Inc. and GlaxoSmithKline LLC Enter Into a Co-Promotion Agreement for Testim® in the U.S.

PR Newswire

MALVERN, Pa. and PHILADELPHIA, May 21, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and GlaxoSmithKline LLC, the U.S. subsidiary of GlaxoSmithKline plc (LSE: GSK), announced today that they have entered into an agreement for the co-promotion of Testim® 1% (testosterone gel), which is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone.

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO )

"Today, GlaxoSmithKline and Auxilium have forged a collaboration to expand our reach to U.S. physicians who treat men with low testosterone and its resulting symptoms, known as hypogonadism, which we believe is a prevalent, but poorly recognized condition," said Adrian Adams, Chief Executive Officer and President of Auxilium. "While the Auxilium sales force has consistently performed well in an increasingly competitive environment, adding the strength and breadth of GSK's U.S. commercialization organization will further enhance our sales efforts with U.S. physicians who treat this condition."

"Urology remains one of GSK's key therapeutic areas, and our sales professionals are well positioned to provide physicians with information on the treatment of hypogonadism," said Cheryl MacDiarmid, Vice President of GSK's Cardiovascular/Metabolic/Urology business unit. "We look forward to our collaboration with Auxilium and adding Testim to our portfolio so we can help meet the needs of men with this condition."

Under the terms of the agreement, Auxilium granted GSK the exclusive right to co-promote the sale of Testim with Auxilium in the U.S. through September 30, 2015. GSK will promote Testim using a sizeable established field sales force which has relationships with current Testosterone Replacement Therapy (TRT) prescribers, particularly primary care physicians, in the U.S. These GSK sales representatives currently promote a range of cardiovascular, metabolic and urology products, and Testim will complement GSK's existing portfolio of products.

Auxilium and GSK have agreed on a baseline revenue forecast for Testim through September 30, 2015, and GSK will be compensated to the extent that Testim net sales exceed this baseline. In addition, in certain circumstances, Auxilium will pay GSK specified tail payments following the term of the agreement. The GSK sales force is expected to begin promoting Testim to physicians early in the third quarter 2012. Auxilium will remain responsible for all Testim commercial drug manufacturing, supply, and regulatory activities.

About Low Testosterone
Testosterone and dihydrotestosterone (DHT), endogenous androgens, are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations (total testosterone levels below 300 ng / dL). Symptoms associated with male hypogonadism include decreased sexual desire with or without impotence, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis. Hypogonadism is a risk factor for osteoporosis in men.(1)

About Testim
Testim is a proprietary, clear, topical gel containing 1% testosterone, the same type of hormone that is produced by the human body. When applied once-daily to the upper arms and shoulders, clinical studies have shown that Testim helps restore and maintain testosterone levels. Once Testim is absorbed through the skin, it enters the bloodstream and helps return testosterone to normal levels.

According to IMS data for 2011, U.S. sales of testosterone therapies have grown to more than $1.6 billion per year, with sales of testosterone gels in the U.S. comprising $1.4 billion.

Important Safety Information
Testim has not been clinically evaluated in males under 18 years of age. Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testim is not indicated for use in women, has not been evaluated for use in women, and must not be used in women.

For more important safety information regarding the use ofIescribing iase see the full pof Testim, please see the full Prescribing Information, including Boxed Warning, and Medication Guide at http://www.testim.com

About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 46 countries in Eurasia; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie's disease, in phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and is in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information go to us.gsk.com, follow us on twitter.com/GSKUS or visit our blog (www.morethanmedicine.us.gsk.com/blog/).

Reference

1. Testim Prescribing Information http://www.testim.com/pdf/Testim_PI_Medication_Guide.pdf

AUXILIUM SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which discuss matters that are not facts, and may include words to indicate their uncertain nature such as "believe," "expect," anticipate," "intend," "plan," "should," "could," "estimate," "project," "will," and "target." Our forward-looking statements convey management's expectations, beliefs, plans and objectives regarding future performance of Auxilium and are based upon preliminary information and management assumptions. No specific assurances can be given with respect to whether: Auxilium or GlaxoSmithKline will be successful in co-promoting Testim in the U.S., the co-promotion will expand Auxilium's reach to U.S. physicians who treat patients with male hypogonadism, the relationship with GSK will further enhance Auxilium's sales efforts with U.S. physicians who treat hypogonadism, Testim will complement GSK's existing portfolio, the co-promotion will expand Testim market share; net sales of Testim will exceed prior years' net sales, Auxilium will be able to manufacture and supply sufficient quantities of Testim, if at all, the co-promotion agreement will not be terminated early by either party. While the Company may elect to update the forward-looking statements made in this news release in the future, the Company specifically disclaims any obligation to do so. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration, and those risks discussed in our reports on file with the Securities and Exchange Commission (the "SEC"). Our SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "For Investors - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.

GSK Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2011.

Auxilium contact:
James E. Fickenscher / CFO	William Q. Sargent, Jr. / V.P., IR
Auxilium Pharmaceuticals, Inc.	Auxilium Pharmaceuticals, Inc.
(484) 321-5900	(484) 321-5900
jfickenscher@auxilium.com	wsargent@auxilium.com


GSK Inquiries:
US Media:	Bernadette King	(215) 751 3632	(Philadelphia)
	Karen Collins	(919) 483 2527	(Raleigh)

Analyst/Investor	Sally Ferguson	+44 (0) 20 8047 5543	(London)
	Tom Curry	+ 1 215 751 5419	(Philadelphia)
	Gary Davies	+ 44 (0) 20 8047 5503	(London)
	Jeff McLaughlin	+ 1 215 751 7002	(Philadelphia)
	Ziba Shamsi	+ 44 (0) 20 8047 3289	(London)

SOURCE Auxilium Pharmaceuticals, Inc.; GSK

Auxilium Pharmaceuticals, Inc. Raises Revenue Guidance And Reduces Net Loss Guidance For 2012

Mon, 21 May 2012 11:00:00 +0000

Auxilium Pharmaceuticals, Inc. Raises Revenue Guidance And Reduces Net Loss Guidance For 2012

Conference Call Scheduled for 10:00 am ET to Discuss Testim Co-Promotion Agreement with GlaxoSmithKline

PR Newswire

MALVERN, Pa., May 21, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) is raising its full year 2012 revenue guidance to a range of $293 to $315 million and is reducing its guidance for net loss to a range of $5 to $10 million. The Company will be holding a conference call today, May 21, 2012, at 10:00 am ET to discuss the agreement for the Testim^®U.S. co-promotion with GlaxoSmithKline LLC, the U.S. subsidiary of GlaxoSmithKline plc (LSE: GSK).

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO)

The Company's previous and revised full year 2012 financial guidance is ($ millions):

	Previous	Revised

Total Revenue	$283 - $305	$293 - $315

Global Testim Revenues	$215 - $225	$225 - $235

Xiaflex:
U.S. Revenues	$55 - $65	$55 - $65
Ex-U.S. / Def. Rev	$13 - $15	$13 - $15
Total XIALEX	$68 - $80	$68 - $80

R&D Expense	$55 - $65	$55 - $65

S G & A Expense	$180 - $190	$180 - $190

Net Income (Loss)	$(5) - $(15)	$(5) - $(10)

"As a result of this morning's announcement concerning the Testim U.S. co-promotion agreement, we are increasing Testim revenue guidance and trimming net loss guidance for 2012," said Jim Fickenscher, Chief Financial Officer of Auxilium. "While we have not changed our previously stated guidance for Selling, General & Administrative expense, it is likely that we will be near the top end of the range."

Conference Call
The presentation slides to be used during the call will be available on the "For Investors" section of the Company's web site under the "Presentations" tab at 10:00 a.m. ET. A question and answer session will follow the presentation. The conference call and the presentation slides will be simultaneously web cast on the "For Investors" section of the Company's web site under the "Events" tab. The conference call will be archived for future review until August 21, 2012.

Conference call details:
Date:	Monday, May 21, 2012
Time:	10:00 a.m. ET
Dial-in (U.S.):	866-700-7173
Dial-in (International):	617-213-8838
Web cast:	http://www.auxilium.com
Passcode:	AUXILIUM
To access an audio replay of the call:
Access number (U.S.):	888-286-8010
Access number (International):	617-801-6888
Replay Passcode #:	38358052

About Low Testosterone
Testosterone and dihydrotestosterone (DHT), endogenous androgens, are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Symptoms associated with male hypogonadism include decreased sexual desire with or without impotence, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis. Hypogonadism is a risk factor for osteoporosis in men.⁽¹⁾

About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord. GlaxoSmithKline LLC is expected to co-promote Testim with Auxilium in the U.S. beginning in the third quarter of 2012. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 46 countries in Eurasia; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie's disease, phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.

Reference

(1) Testim Prescribing Information http://www.testim.com/pdf/Testim_PI_Medication_Guide.pdf

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which discuss matters that are not facts, and may include words to indicate their uncertain nature such as "believe," "expect," anticipate," "intend," "plan," "should," "could," "estimate," "project," "will," and "target." Our forward-looking statements convey management's expectations, beliefs, plans and objectives regarding future performance of Auxilium and are based upon preliminary information and management assumptions. No specific assurances can be given with respect to whether: we will achieve 2012 financial results consistent with the guidance we have provided or Auxilium or GlaxoSmithKline will commence co-promotional activities when expected or will be successful in co-promoting Testim in the U.S. While the Company may elect to update the forward-looking statements made in this news release in the future, the Company specifically disclaims any obligation to do so. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration, and those risks discussed in our reports on file with the Securities and Exchange Commission (the "SEC"). Our SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "For Investors - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.

Auxilium contact:
James E. Fickenscher / CFO	William Q. Sargent, Jr. / V.P., IR
Auxilium Pharmaceuticals, Inc.	Auxilium Pharmaceuticals, Inc.
(484) 321-5900	(484) 321-5900
jfickenscher@auxilium.com	wsargent@auxilium.com

SOURCE Auxilium Pharmaceuticals, Inc.

JacksonWhite Files Overtime Lawsuit Against Quintiles Commercial U.S., Inc.

Fri, 18 May 2012 22:24:11 +0000

JacksonWhite Files Overtime Lawsuit Against Quintiles Commercial U.S., Inc.

PR Newswire

MESA, Ariz., May 18, 2012 /PRNewswire/ -- On May 15, attorneys at the Arizona law firm of JacksonWhite filed a collective action lawsuit against Quintiles Commercial U.S., Inc., for failure to pay its employees the overtime wages to which they are entitled under the Fair Labor Standards Act (FLSA). The Complaint was filed in the United States District Court for the District of Arizona on behalf of all Quintiles pharmaceutical reps employed in the U.S. from May 2009 until the present.

Quintiles is a contract sales organization that caters specifically to the pharmaceutical industry. Quintiles requires its employees to work well over forty hours per week, and it has never paid its employees overtime wages, despite the overtime requirement that is clearly defined and outlined by federal law. Quintiles' willful violation of this law could entitle reps to damages of up to two times the amount of overtime wages that Quintiles should have paid them over the past three years.

Quintiles' policy of withholding overtime wages is by no means unique Industry-wide, major pharmaceutical companies have knowingly misclassified their pharmaceutical reps as exempt from the FLSA's overtime requirement. The tide seems to be turning, however, as reps have banded together en masse to assert their legal rights. In January 2012, for instance, a federal court in New York preliminarily approved a $99 million settlement for Novartis reps that were unlawfully deprived of overtime wages.

In addition to the Quintiles lawsuit, JacksonWhite has collective action lawsuits against several pharmaceutical companies. For instance, JacksonWhite has been litigating against GlaxoSmithKline since 2008, and the case is presently awaiting a decision by the Supreme Court of the United States. The attorneys working on the case are cautiously optimistic about its outcome. "If the Supreme Court sides with reps in the Glaxo case, it is that much more likely that Quintiles reps will also prevail on their claim," said Michael Pruitt, lead counsel for the individual and collective plaintiffs.

Importantly, Quintiles reps can only participate in this collective action lawsuit if they provide a written consent to join. And, given that there is a statute of limitations in these types of cases, reps who delay are subject to losing damages to which they might otherwise be entitled. The attorneys at JacksonWhite are interested in speaking with Quintiles reps about opting in to this collective action. Reps who work for other companies might also be able to join a legal action, or file a new action against the company for which they work. For more information, contact JacksonWhite at 888-866-2293 or visit www.pharmaovertime.com.

MEDIA CONTACT: Liz Coyle
(480)-464-1111 x151; LCoyle@jacksonwhitelaw.com

SOURCE JacksonWhite P.C.

Actavis Launches First Generic Equivalent of Requip® XL (Ropinirole Extended-Release Tablets)

Fri, 18 May 2012 13:00:00 +0000

Actavis Launches First Generic Equivalent of Requip® XL (Ropinirole Extended-Release Tablets)

PR Newswire

MORRISTOWN, N.J., May 18, 2012 /PRNewswire/ -- Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Ropinirole Extended-Release Tablets, 2mg, 4mg, 6mg, 8mg and 12mg, a generic equivalent to GlaxoSmithKline's Requip® XL. Actavis believes this is the first generic Requip® XL available in the US. Distribution of the product has commenced.

Requip® XL, 2mg, 4mg, 6mg, 8mg and 12mg, had US sales of approximately $59.4 million for the 12 months ending December 31, 2011, according to IMS Health.

Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:

"The launch of Ropinirole Extended-Release Tablets showcases Actavis' commitment in bringing new products to market to benefit both patients and payors. We are proud to play a part in lowering healthcare costs through the introduction of quality generic products."

Inquiries
David Myers, Jr.
Senior Manager, Products & Communications
Tel: (973)993-4503
E-mail: dmyers@actavis.com

About Actavis:
Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one third of Actavis' sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing and packaging facilities in Elizabeth, NJ; a manufacturing facility in Lincolnton, NC; and research and development facilities in Owings Mills, MD and Sunrise, FL. Please visit www.actavis.us for more information.

Requip® XL is a registered trademark of a party other than Actavis.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.

SOURCE Actavis Inc.

Two overall winners announced at prestigious national award ceremony in London’s Science Museum

Fri, 18 May 2012 12:10:00 +0000

Issued: Friday 18 May 2012, London UK

For the first time in its 15 year history the judges of the GlaxoSmithKline (GSK) IMPACT Awards could not choose one overall winner for the awards so instead awarded two prizes. The accolade was received by both the Cornish Women’s Rape and Sexual Abuse Centre (WRSAC) and Target Ovarian Cancer at a ceremony at London’s Science Museum last night, where they beat a shortlist of eight charities. Each winner received £35,000 in funding.

GSK’s prestigious awards, run in partnership with The King’s Fund, were decided by a judging panel of health care leaders including Professor Steve Field, former Chair of the Royal College of General Practioners; Peter Wanless, Chief Executive of Big Lottery; Gilly Green, Head of UK Grants at Comic Relief; Sir Christopher Gent, Chairman of GSK; and Sir Chris Kelly, Chair of The King’s Fund.

The IMPACT Awards, GSK’s flagship UK corporate responsibility programme, highlights the crucial role charities play in dealing with some of the most difficult health issues, while promoting innovation and good practice across the sector.

WRSAC outshone the other competition by working creatively in one of the most challenging areas of health, providing care and support for women and girls who have experienced sexual or domestic abuse. Its services include a rape andsexual abuse helpline, specialist sexual violence counselling and an independent domestic violence advocacy service. It also provides a potentially life-changing programme, Pattern Changing , a 14-week course to help women understand and change their own patterns of behaviour.

Target Ovarian Cancer was established only three years ago by a businesswoman who lost both her mother and sister to ovarian cancer within a few weeks of each other. It aims to save lives among the 6,500 women who develop ovarian cancer annually. To improve the UK’s poor survival rates, Target Ovarian Cancer raises awareness of symptoms, offers a national support programme and treatment guides, campaigns for better management and survival rates for the disease, and funds clinical research into its prevention and treatment.

Sir Christopher Gent, Chairman of GlaxoSmithKline and one of the judges said:

‘For fifteen years, the IMPACT Awards have been rewarding innovative charities that transform people’s lives, and over £4 million has been awarded. This is the first time that it has been impossible to decide between two very different but equally innovative charities. They both show how charities can have an incredible impact both on a national and local level. We hope the funding we provide, along with the prestige of the awards, helps the charities go from strength to strength.’

Maggie Parks, Chief Executive of WRSAC, said:

’Being an overall winner recognises the incredible work undertaken the organisation and reflects our exceptionally high quality of service provision. Endemic levels of violence against women and girls is a major health issue and we applaud GSK and The King’s Fund for recognising this. We believe that this award will help us continue to make a significant difference in women’s lives in Cornwall and we would like to thank our staff, volunteers and trustees for all their hard work and creativity.’

Annwen Jones, chief executive of Target Ovarian Cancer, said:

‘We were already thrilled to be one of the eight winners, so we are over the moon to be announced as the overall winner by such a recognised panel of professionals. The award is testament to how hard everyone involved in Target Ovarian Cancer has worked over the past few years.

“The award recognises the work we do in improving survival and quality of life for women with ovarian cancer across the UK. We work with a number of hugely passionate and inspirational women, and it is thanks to them that we have been able to achieve such change.’

Please note that case studies and spokespeople are available for interview, along with photographs. For further information or interviews, please contact Saskia Kendall at The King’s Fund press office on 020 7307 2603 or by email on s.kendall@kingsfund.org.uk.

Supporting information

The NHS spends around £3.4 billion a year on services provided by charities.

The voluntary sector provides a significant proportion of NHS services – a quarter of third sector organisations are involved in the provision of adult health and social care services. Small, local charities are often best placed to understand the needs of the UK’s increasingly diverse population. They can often respond more flexibly and innovatively than large public sector providers. The government has recognised this. Charities can be beneficiaries of a more open approach to the delivery of public services and in forging strong links with new health and wellbeing boards. However, small charities face particular challenges at this time.

Income streams are more uncertain and small charities do not have the diversity of funding that larger charities do. These Awards will therefore help financially. The five-day development programme with The King’s Fund will help equip these excellent charities with the skills to maintain and continue their success in the future.