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

SOURCE Reportlinker

Electronic Cigarette Retailer Announces Launch of New Website

Wed, 23 May 2012 07:11:36 +0000

My7s electronic cigarettes launches their new website in an obvious move to clarify their brand and presence in the electronic cigarette online market.

COLLEYVILLE, TX, May 23, 2012 /24-7PressRelease/ -- SS Choice, LLC, one of the leading electronic cigarette manufacturers since 2008, has renamed their company website My7s. The new website and blog have a new look and additional features designed to improve usability. Intuitive navigational tools, new fonts, and updated graphics and layouts will help users access information more quickly and easily. Feature sections on the secondary pages highlight new and frequently requested content.

The new website contains a comprehensive listing and directory of electronic cigarette related products. The website will be a tremendous value to SS Choice customers.

"This is a cutting edge Internet site far superior to anything in the marketplace," said Kyle Newton, the President of SS Choice.

SS Choice is the owner of the newly named 7s Premium Electronic Cigarettes which was previously named No.7. In 2012 the No.7 label was discontinued and replaced with the new 7s label to provide a clear, stand alone, label that will not be confused with other consumer products. "We expect tremendous sales through our convenient, user-friendly website which supports our new 7s label," said Bradford Cunningham, Senior Vice President.

The Company's mission is to manufacture and supply unsurpassed quality electronic cigarette products. Through extensive Research & Develop, SS Choice's focus on innovation provides a wide variety of reliable products that displace tobacco cigarettes. With no fire, no ash, no second-hand smoke, the 7s Premium Electronic Cigarettes are alternatives that present several advantages for the tobacco smoker that can be smoked almost anywhere.

See the company website at My7s for additional information.

Website: http://www.my7s.com

---

Press release service and press release distribution provided by http://www.24-7pressrelease.com

Researchers Find Genetic Marker that May Predict Smoking Quantity in African Americans

Tue, 22 May 2012 13:00:00 +0000

Researchers Find Genetic Marker that May Predict Smoking Quantity in African Americans

PR Newswire

MENLO PARK, Calif., May 22, 2012 /PRNewswire/ -- In a step toward understanding possible genetic differences in smoking behaviors, a team of researchers co-led by SRI International has identified a genetic marker associated with smoking quantity in people of African ancestry. The study's findings may help guide future public health decisions related to smoking, because the more people smoke, the higher their risk of lung cancer.

The genetic variant, called rs2036527, appears to function as a marker of smoking quantity in African Americans, predicting the number of cigarettes smoked per day. It is on the same nicotine receptor gene, located on Chromosome 15, as another marker previously identified in people of European descent. Earlier studies have also shown that this gene plays a role in limiting nicotine intake by affecting how pleasurable nicotine is, which in turn affects how much nicotine is consumed.

Findings from the Study of Tobacco Use in Minority Populations (STOMP) Genetics Consortium study are published in the May 22, 2012 issue of Translational Psychiatry (part of Nature Publishing Group).

To find the genetic variants for smoking behavior, researchers combined 13 genome-wide association studies. The result included data for genetics and smoking behavior for more than 32,000 African Americans.

Although African Americans are less likely to smoke than European Americans, if they do start smoking, they tend to start smoking later in life, are less likely to quit smoking, and die more often from smoking-related lung cancer. Smoking is the leading cause of premature death among African Americans. STOMP investigators did not assess lung cancer risk, but other researchers have found that the genetic marker (rs2036527) is associated with risk of lung cancer in African Americans.

"This study may have implications for personalized medicine and the need to identify targets for drug discovery," said Sean P. David, M.D., D.Phil., research physician and director of the Translational Medicine program in the Center for Health Sciences in SRI's Policy Division and also a family medicine physician and Clinical Associate Professor of Medicine at Stanford University School of Medicine. "However, we need to be careful not to draw conclusions about the degree to which a genetic variant associated with smoking quantity affects smoker's ability to quit. Future studies of smoking behavior, including smoking cessation clinical trials, should be performed in non-European ancestry groups, so that other informative biomarkers aren't missed."

The STOMP study, done in collaboration with 78 researchers from dozens of academic institutions and the National Institutes of Health, is the first meta-analysis of genome-wide association studies of smoking behaviors among African Americans. Meta-analysis is a powerful technique that combines a number of similar research questions and studies. Using statistical techniques, researchers were able to find genetic linkages to smoking behaviors too subtle to see in small studies.

SRI research was funded 100% by the Department of Health & Human Services (HHS) Grant No. 5-U01-DA-020830-07. The total dollar amount of the grant is $158,221, of which a nominal amount went to support the research described above. SRI received no other source of funding for this work.

About SRI International
Silicon Valley-based SRI International, a nonprofit research and development organization, performs sponsored R&D for governments, businesses, and foundations. SRI brings its innovations to the marketplace through technology licensing, new products, and spin-off ventures. SRI is known for world-changing innovations in computing, health and pharmaceuticals, chemistry and materials, sensing, energy, education, national defense, and more.

SOURCE SRI International

Winning The Battle Against Breast Cancer Metastasis

Tue, 22 May 2012 09:00:00 +0000

Winning The Battle Against Breast Cancer Metastasis

* Botanical formula slows highly invasive human breast cancer growth, reduces metastasis.

* Formula includes extracts from medicinal mushrooms and herbs and other natural compounds.

* No toxic side effects were detected.

PR Newswire

CHICAGO, May 22, 2012 /PRNewswire/ -- Scientists at Indiana University Health's Cancer Research Laboratory have found that a sophisticated botanical formula slows human breast cancer growth and inhibits breast to lung metastasis in mice. The formula contains extracts from medicinal mushrooms, medicinal herbs and purified nutritional compounds, and showed no toxic side-effects. These results were presented at the April 2012 American Association for Cancer Research Annual Meeting.

"Our results are very exciting because we clearly demonstrate the suppression of breast to lung cancer metastasis associated with the inhibition of specific pro-metastatic genes in human tumors," says Daniel Sliva, Ph.D., Associate Professor at the Indiana University School of Medicine and lead author on the study.

Researchers implanted highly invasive, triple-negative human breast cancer cells (MDA-MB-231) in mice, which were then given the formula orally for four weeks. The formula significantly decreased tumor growth and breast to lung metastasis. The cancer metastasized to the lungs in 70 percent of controls but only 20 percent of treated mice. The number of metastases per animal was also significantly reduced by the formula. Further study showed the formula down-regulates the primary tumor genes PLAU (urokinase plasminogen activator, uPA) and CXCR4 (C-X-C chemokine receptor-4), which have both been implicated in metastasis.

"Patients with breast cancer die from metastasis," said formula inventor and study co-author Isaac Eliaz, M.D. "This formula was able to change the gene expression of highly aggressive metastatic breast cancer and dramatically decrease the deadly metastatic process."

The formula uses a variety of natural compounds, each of which have demonstrated anti-cancer properties. Mycelium from medicinal mushrooms Coriolus versicolor, Ganoderma lucidum and Phellinus linteus reduced growth and invasiveness. Extracts from Scutellaria barbata, Astragalus membranaceus and Curcuma longa are known to induce programmed cell death (apoptosis) and reduced metastasis. The flavonoid quercetin reduced proliferation and helped suppress tumor growth. In addition, 3, 3'-Diindolylmethane (DIM), an active byproduct of cruciferous vegetable digestion, reduced cancer growth, migration and invasiveness.

"Here, we show that the formula is not toxic and its oral application significantly suppresses time-dependent increase in tumor sizes and
inhibits breast-to-lung cancer metastasis," says Dr. Sliva. "This formula may be considered as a biological therapeutic agent against invasive breast cancer, including the aggressive triple negative breast cancer. It can potentially increase survival of breast cancer
patients."

For more information on the breast health formula call (707) 583-8619, email info@betterhealthpublishing.com, or visit www.breasthealthsolutions.org

About Better Health Publishing:

Better Health Publishing (BHP) focuses on the publication of key works promoting health and wellness. BHP believes that education and accessible information are the core components of a healthy and sustainable society.

Media Contacts:
For Media Questions/Interviews with Dr. Isaac Eliaz, Contact:
Better Health Publishing
info@betterhealthpublishing.com
(707) 583-8619

This news release was issued on behalf of Newswise™. For more information, visit http://www.newswise.com.

SOURCE Better Health Publishing

Phase 3 MISSION trial of Nexavar (sorafenib) in Patients with Non-Small Cell Lung Cancer Did Not Meet Primary Endpoint of Improving Overall Survival

Tue, 22 May 2012 06:30:00 +0000

Phase 3 MISSION trial of Nexavar (sorafenib) in Patients with Non-Small Cell Lung Cancer Did Not Meet Primary Endpoint of Improving Overall Survival

PR Newswire

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., May 22, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Phase 3 trial evaluating Nexavar^® (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival. An improvement in the secondary endpoint of progression-free survival (PFS) was observed.

The study compared Nexavar plus best supportive care to placebo plus best supportive care. The safety and tolerability data were generally as expected. The data will be presented at an upcoming scientific meeting.

"While we are disappointed that the primary endpoint was not met, we believe the study results will advance the scientific knowledge in lung cancer," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare.

Phase 3 Trial Design

The MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) trial is an international multicenter study that randomized 703 patients with advanced relapsed or refractory non-squamous NSCLC whose disease progressed after two or three previous treatments. Patients were randomized to receive either Nexavar as single agent or placebo. In both study arms, best supportive care was provided. The primary endpoint of the trial was overall survival, and secondary endpoints included progression-free survival, disease control rate, overall response rate, time to progression and quality of life.

The study was conducted at more than 150 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cancer worldwide, with approximately 1.2 million new cases annually. There are approximately 226,000 new cases of lung cancer in the United States and approximately 417,000 in Europe each year.[i]

NSCLC accounts for 85-90 percent of lung cancer[ii] and is a disease in which malignant (cancer) cells form in the tissues of the lung. It is characterized by several types of lung cancers, each of which grow and spread in different ways, including: squamous cell carcinoma, adenocarcinoma, and large cell carcinoma.

About Nexavar (sorafenib)
Nexavar is approved in the U.S. for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer. Nexavar inhibits both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is currently approved in more than 100 countries.

Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.

Important Safety Considerations For Nexavar (sorafenib)

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.

Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential are advised to avoid becoming pregnant and female patients should also be advised against breastfeeding while receiving Nexavar.

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Uncommon but serious adverse reactions, including keratoacanthomas/squamous cell cancer of the skin and Stevens-Johnson Syndrome, have been reported in clinical trials.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar.

Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.

Nexavar can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias. Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar. Monitor patients taking concomitant warfarin regularly for changes in prothrombin time, INR, or clinical bleeding episodes. Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of sorafenib. Nexavar exposure decreases when co-administered with oral neomycin. Effects of other antibiotics on Nexavar pharmacokinetics have not been studied.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%.

During post approval use of Nexavar, the following adverse drug reactions have been identified: angioedema and drug-induced hepatitis, including reports of hepatic failure and death.

For information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.

Forward Looking Statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer Web site at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.

[i] http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer-facts-figures-2012

[ii] http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer

SOURCE Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.

Results of Phase II Study of Boehringer Ingelheim's Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference

Mon, 21 May 2012 17:45:07 +0000

Results of Phase II Study of Boehringer Ingelheim's Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference

Data presented at the 2012 Annual International Conference of the American Thoracic Society (ATS 2012)

PR Newswire

SAN FRANCISCO, May 21, 2012 /PRNewswire/ -- Data from a Phase II trial of olodaterol presented today at the 2012 Annual International Conference of the American Thoracic Society (ATS 2012) compared the efficacy of once-daily (QD) versus twice-daily (BID) olodaterol, a long-acting beta2-agonist (LABA) that Boehringer Ingelheim is evaluating as a possible maintenance treatment for chronic obstructive pulmonary disease (COPD), delivered via the Respimat® Inhaler. In this Phase II randomized, double-blind, cross-over study, olodaterol administered QD as 5 micrograms or 10 micrograms provided a significant and identical increase in the lung function parameter FEV1 over a 24-hour period.This data completes the olodaterol monotherapy Phase II clinical trial program in patients with COPD.

"In this Phase II study, olodaterol administered once daily provided significant bronchodilation over a complete 24-hour period," said Professor Guy Joos, Head of the Department of Respiratory Diseases at Ghent University Hospital, Belgium, and the coordinating investigator for the trial. "These data are encouraging, and set the stage for olodaterol to be further investigated in Phase III studies in patients with COPD."

Results of the study found olodaterol 5 microgram QD provided significant improvement in lung function as measured by FEV1 AUC(0-12) versus twice-daily olodaterol 2 microgram, while twice-daily dosing of olodaterol 5 microgram had a better FEV1 AUC(0-12)profile versus once-daily olodaterol 10 microgram.There were no safety or tolerability concerns seen in the study, with no relationship between total daily dose to the overall incidence of adverse events. These results were comparable to previous Phase II studies.

"These trial results and the completion of the olodaterol monotherapy Phase II clinical trial program underscore the Company's focus on advancing respiratory research and treatment," said Tunde Otulana, MD, Vice President, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to finding solutions for people living with COPD and are working to develop treatment options that will provide the most benefit for patients."

Boehringer Ingelheim is currently studying the efficacy and safety of a once-daily fixed-dose combination of tiotropium and olodaterol in the TOviTO Phase III trial program.

About COPD

Chronic obstructive pulmonary disease (COPD) is also known as chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 24 million Americans may have COPD – even those who haven't smoked in years – and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every four minutes.

Common symptoms of COPD include coughing with excess mucus or shortness of breath.

Boehringer Ingelheim: Leading respiratory forward

Treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for over 90 years and significant resources are dedicated to research in this field. In addition to new possible treatments for asthma, Boehringer Ingelheim has also branched out into developing potential treatment options for other airway diseases, including COPD, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. Subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act in a socially responsible manner. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

More information
www.boehringer-ingelheim.com

More information on Boehringer Ingelheim's COPD portfolio
http://www.boehringer-ingelheim.com/products/prescription_medicines/chronic_obstructivepulmonarydisease.html

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

LUNGevity Breathe Deep PSAs to Air During Indianapolis 500 Festivities, Race

Mon, 21 May 2012 14:41:42 +0000

LUNGevity Breathe Deep PSAs to Air During Indianapolis 500 Festivities, Race

PR Newswire

Nation's largest lung cancer-focused nonprofit asks viewers to help stop lung cancer now

WASHINGTON, May 21, 2012 /PRNewswire-USNewswire/ -- LUNGevity Foundation, the nation's largest lung cancer-focused nonprofit, is pleased to announce its Public Service Announcements will play on the JumboTron during the May 25-27, 2012 Indy 500 festivities and race, in conjunction with May's designation as Lung Cancer Hope Month. The PSAs will promote awareness of the need for lung cancer research, inviting all Indianapolis Motor Speedway attendees to join in LUNGevity Breathe Deep events to raise awareness and funds for earlier detection and more effective treatments of lung cancer. LUNGevity's 60-second version (http://youtu.be/bEMl9JWw4mA) and a 30-second version PSAs (http://youtu.be/Si5b5jM7Cww) will both be featured.

The Breathe Deep walks and runs are LUNGevity's signature events that occur in dozens of communities nationwide. Breathe Deep events were launched by the Foundation to raise public awareness and critical funds needed for lung cancer research. One in 14 Americans is diagnosed with lung cancer in their lifetime. The disease kills almost twice as many women as breast cancer and more than three times as many men as prostate cancer. About 55% of all new lung cancer diagnoses are among people who have never smoked or are former smokers. Compared to other cancers, the disease receives relatively little government research funding.

"We are grateful for the opportunity to reach over 1.5 million viewers with our PSAs," said LUNGevity Foundation President Andrea Stern Ferris. "The PSAs capture the energy and spirit of those participating in Breathe Deep events, and we hope they inspire Indy 500 fans to take action, join us, and start their own events. LUNGevity is committed to finding early diagnoses and more effective treatments for lung cancer."

LUNGevity is the nation's largest lung cancer-focused nonprofit. It has the largest grants award program for lung cancer research among lung cancer nonprofit organizations in the United States. In 2011 alone, LUNGevity awarded $2 million to fund nine of the most promising lung cancer research proposals in the areas of early detection and targeted therapeutics. In addition to funding research, the Foundation has a robust national grassroots network, with events happening across the country. The organization also has the largest online support community for lung cancer patients and their loved ones.

The Foundation created Lung Cancer Hope Month, in May, to recognize the hope for better treatments and earlier diagnoses for lung cancer, improving lung cancer survival rates and quality of life for lung cancer patients and their loved ones. During the month, LUNGevity has hosted a number of events to build awareness of the lung cancer community and raise funds for critical lifesaving research. LUNGevity's presence at the Indy 500 will conclude an important month of community engagement for the organization.

To schedule an interview with LUNGevity Foundation President Andrea Stern Ferris, contact Victoria Shapiro at (202) 414-0774 or vshapiro@susandavis.com

About LUNGevity Foundation

The mission of LUNGevity Foundation is to have a meaningful impact on improving lung cancer survival rates, ensure a higher quality of life for lung cancer patients, and provide a community for those impacted by lung cancer.

Through the support of critical research into the early detection and successful treatment of lung cancer, as well as providing information, resources and a community to patients and caregivers, LUNGevity is creating and sharing hope for cures, treatments and enhanced quality of life for lung cancer patients.

LUNGevity seeks to inspire the nation to commit to ending lung cancer.

For more information, please visit www.lungevity.org.

About Lung Cancer

1 in 14 Americans is diagnosed with lung cancer in their lifetime
Lung cancer is the leading cause of cancer death, regardless of gender or ethnicity
Lung cancer kills almost twice as many women as breast cancer and more than three times as many men as prostate cancer
About 55 percent of all new lung cancer diagnoses are among people who have never smoked or are former smokers
Only 16 percent of all people diagnosed with lung cancer will survive 5 years or more, but if it's caught before it spreads, the chance for 5-year survival improves to 52 percent

SOURCE LUNGevity Foundation

Momentum Continues To Build For Federal Plan Of Action For Lung Cancer -- Advocate Voices Play Leading Role

Fri, 18 May 2012 20:01:04 +0000

Momentum Continues To Build For Federal Plan Of Action For Lung Cancer -- Advocate Voices Play Leading Role

PR Newswire

Over a Dozen New Members of Congress Added to the Lung Cancer Mortality Reduction Act

WASHINGTON, May 18, 2012 /PRNewswire-USNewswire/ -- As Congress prepares for its Memorial Day District Work Period, Lung Cancer Alliance (LCA) announced that more than a dozen Congressional leaders have signed on as new co-sponsors of the Lung Cancer Mortality Reduction Act.

This comes on the heels of Lung Cancer Alliance's fifth annual advocacy conference, recently held in Washington, DC. Over 140 advocates participated, from as far west as Hawaii to as far east as New Hampshire.

The Lung Cancer Mortality Reduction Act, S.752 and H.R.1394 respectively, is the first-ever legislation calling for a coordinated and comprehensive federal plan to address all aspects of lung cancer.

NEW CONGRESSIONAL SUPPORTERS
Senator Jeanne Shaheen (NH)
Representative Lois Capps (CA-23)
Representative Jim McDermott (WA-7)
Representative Diane DeGette (CO-1)
Representative Mazie Hirono (HI-2)
Representative Ben Lujan (NM-3)
Representative Tom Marino (PA-10)
Representative Mike Thompson (CA-1)
Representative Tammy Baldwin (WI-2)
Representative Chris Van Hollen (MD-8)
Representative Mike Doyle (PA-14)
Representative Jim McGovern (MA-3)
Representative Jerrold Nadler (NY-8)
Representative Niki Tsongas (MA-5)

This brings the total number of Senators to 28 and the total number of Members of Congress to 59.

"Bravo to all the advocates who, by coming to Washington and sharing their personal stories, helped make this happen," said Laurie Fenton-Ambrose, President and CEO of Lung Cancer Alliance. "These advocates not only represent their own personal journeys but the journeys of so many others. These stories underscore the need for a more compassionate and comprehensive plan for all aspects of lung cancer."

The full list of supporters can be found at http://www.lungcanceralliance.org.

Lung Cancer Alliance (LCA), www.lungcanceralliance.org, is committed to ending injustice and saving lives through an alliance of advocacy, education and support. LCA provides live, real time support, referral and information services for patients, their loved ones and those at risk for lung cancer; conducts national awareness campaigns; and advocates for multiple millions in public health dollars for lung cancer research.

Follow Lung Cancer Alliance on Facebook: www.facebook.com/lungcanceralliance. Follow us on Twitter: @LCAorg.

Media Contact:
Kay Cofrancesco
kay@lungcanceralliance.org
202-463-2080

SOURCE Lung Cancer Alliance

Arqule and Daiichi Sankyo Announce Completion of Patient Recruitment in Phase 3 Clinical Trial of Tivantinib in Non-small Cell Lung Cancer

Fri, 18 May 2012 11:30:00 +0000

Arqule and Daiichi Sankyo Announce Completion of Patient Recruitment in Phase 3 Clinical Trial of Tivantinib in Non-small Cell Lung Cancer

PR Newswire

WOBURN, Massachusetts and TOKYO, May 18, 2012 /PRNewswire/ --

ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. (TSE 4568) today announced that recruitment of patients has been completed in the randomized, double-blind, controlled Phase 3 MARQUEE pivotal trial of their investigational selective c-MET inhibitor, tivantinib, in combination with erlotinib in previously treated patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).

The MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial began enrollment in January 2011 and is being conducted under a Special Protocol Assessment (SPA), which was established following agreement with the U.S. Food and Drug Administration (FDA). Tivantinib is currently in Phase 3 development and has not yet been approved for any indication.

"At the time of diagnosis with lung cancer, more than half of all patients have progressed to advanced stages of the disease, with a poor prognosis for long-term survival. There is a high unmet need for additional effective treatment options for patients and their families," said Glenn Gormley, MD, PhD, Global Head, Research & Development and Senior Executive Officer, Daiichi Sankyo and President, Daiichi Sankyo Pharma Development.

Lung cancer is one of the most commonly diagnosed cancers around the globe,^[1] with an estimated 1.6 million new cases diagnosed worldwide each year.^[2] NSCLC is the most common form of lung cancer, accounting for approximately 85 percent of all cases.^[3] The majority of all lung cancers are non-squamous.^[4]

"We would like to thank the patients, investigators and clinical sites who are participating in the MARQUEE trial," said Brian Schwartz, chief medical officer of ArQule. "Their commitment, diligence and care have been essential in the timely achievement of this important milestone in the development of tivantinib."

Approximately 1,000 patients have been recruited in MARQUEE from more than 200 clinical sites worldwide. The primary endpoint in the trial is overall survival in the overall intent-to-treat population. Giorgio Scagliotti, MD, PhD, Head of the Department of Clinical and Biological Sciences at S. Luigi Hospital, Orbassano (Torino), Italy is the principal European investigator for MARQUEE, and the principal U.S. investigator is Alan Sandler, MD, Professor of Medicine in the Division of Hematology and Medical Oncology, Department of Medicine, at Oregon Health and Science University in Portland.

In December 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialization agreement to co-develop tivantinib (ARQ 197) in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.

About ArQule

ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company's targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule's lead product candidate, in Phase 2 and Phase 3 clinical development together with development and commercialization partner, Daiichi Sankyo, Co. Ltd., is tivantinib, an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company's pipeline consists of ARQ 621, designed to inhibit the Eg5 kinesin motor protein, and ARQ 736, designed to inhibit the RAF kinases. ArQule's current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP™), are focused on the identification of novel kinase inhibitors that are potent, selective and do not compete with ATP (adenosine triphosphate) for binding to the kinase.

About Daiichi Sankyo

The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit http://www.daiichisankyo.com.

This press release contains statements regarding the clinical trials with tivantinib (ARQ 197) by ArQule and its business partner, Daiichi Sankyo. These statements are based on the current beliefs and expectations of both companies, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, tivantinib may not demonstrate a promising therapeutic effect; in addition, it may not demonstrate an appropriate safety profile in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead ArQule or its partners to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with ArQule's view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials for tivantinib are subject to the ability of ArQule, Daiichi Sankyo, and Kyowa Hakko Kirin, a licensee of tivantinib, to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome technical hurdles and other issues related to the conduct of the trials for which each of them is responsible. There is a risk that these issues may not be successfully resolved. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Positive pre-clinical data may not be supported in later stages of development. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. Moreover, with respect to partnered programs, even if certain compounds show initial promise, Daiichi Sankyo or Kyowa Hakko Kirin may decide not to license or continue to develop them, as the case may be. In addition, Daiichi Sankyo and Kyowa Hakko Kirin have certain rights to unilaterally terminate their agreements with ArQule. If either company were to do so, ArQule might not be able to complete development and commercialization of the applicable licensed products on its own. For more detailed information on the risks and uncertainties associated with ArQule's drug development and other activities, see ArQule's periodic reports filed with the Securities and Exchange Commission. Neither ArQule nor Daiichi Sankyo undertake any obligation to publicly update any forward-looking statements.

1. American Cancer Society. Global Cancer Facts & Figures 2nd Edition. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pdf. Accessed April 11, 2012.

2. American Cancer Society. Global Cancer Facts & Figures 2nd Edition. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pdf. Accessed April 11, 2012.

3. American Cancer Society. Non-Small Cell Lung Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Accessed April 11, 2012.

4. American Cancer Society. Non-Small Cell Lung Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Accessed April 11, 2012.

Eisai Oncology to Present New Research on Product Portfolio and Pipeline at ASCO Annual Meeting

Thu, 17 May 2012 23:01:00 +0000

Eisai Oncology to Present New Research on Product Portfolio and Pipeline at ASCO Annual Meeting

PR Newswire

HATFIELD, England, May 18, 2012 /PRNewswire/ --

Eisai announced today that 12 abstracts highlighting new study results will be presented during the 48^th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, USA, from 1-5 June 2012.

These studies highlight Eisai's current product portfolio and oncology pipeline, reinforcing the company's commitment to patients and their families affected by cancer.

"Our human health care mission is to help address unmet medical needs and increase benefits to patients and their families," said Takashi Owa, Ph.D., Chief Scientific Officer, Eisai Product Creation Systems. "Our portfolio of oncology compounds and therapies underscores our commitment to this important mission."

The following Eisai abstracts are accepted for presentation at this year's ASCO meeting:

    Product           Abstract Name
                      A Phase II Single Arm, Feasibility Study of Dose Dense
                      Doxorubicin and Cyclophosphamide (AC) Followed by
    Eribulin          Eribulin Mesylate for the Adjuvant Treatment of Early
                      Stage Breast Cancer (EBC)
    Abstract No:
    TPS1145           Poster Session
                      A Phase 1b Dose Escalation Study of Eribulin Mesylate in
                      Combination with Capecitabine in Patients with
    Eribulin          Advanced/Metastatic Cancer
 
    Abstract No: 2552 Poster Session
    Lenvatinib
 
    (E7080)           Treatment of Refractory Metastatic Renal Cell Carcinoma
                      (RCC) with Lenvatinib (E7080) and Everolimus
    Abstract No:
    TPS4682           Poster Session
    Lenvatinib
                      A Phase IB Study of Lenvatinib (E7080) in Combination
    (E7080)           with Temozolomide for Treatment of Advanced Melanoma
 
    Abstract No: 8594 Poster Session
                      Lenvatinib Treatment of Advanced RAI-refractory
                      Differentiated Thyroid Cancer (DTC); Cytokine and
    Lenvatinib        Angiongenic Factor (CAF) Profiling in Combination with
                      Tumour Genetic Analysis to Identify Markers Associated
    E7080             with Response
 
    Abstract No: 5518 Poster Discussion
    Lenvatinib        A Phase II Trial of the Multitargeted Kinase Inhibitor
                      Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer
    (E7080)           (MTC)
 
    Abstract No: 5591 Poster Session
                      A Phase I Dose-Finding Study of of Golvatinib (E7050) a
                      cMET and Eph Receptor Targeted Multi-Kinase Inhibitor,
                      Administered Orally QD to Patients with Advanced Solid
    E7050             Tumours
 
    Abstract No: 3030 Poster Discussion
                      A Phase I Dose-Finding Study of Golvatinib (E7050), a
                      c-Met and EPH Receptor Targeted Multi-Kinase Inhibitor
                      Administered Orally BID to Patients with Advanced Solid
    E7050             Tumours
 
    Abstract No: 3079 Poster Session
                      Phase I Safety Study of Farletuzumab, Carboplatin and
                      Pegylated Liposomal Doxorubicin (PLD) in Patients with
    Farletuzumab      Platinum-Sensitive Epithelial Ovarian Cancer (EOC)
    MORAb-003
    Abstract No: 5062 Poster Session
                      Phase I and Pharmacokinetic Study of Farletuzumab in
    Farletuzumab      Solid Tumours
    MORAb-003
    Abstract No: 3084 Poster Session
                      Amatuximab, A Chimeric Monoclonal Antibody to
    Amatuximab        Mesothelin, in Combination with Pemetrexed and Cisplatin
                      in Patients with Unresectable Pleural Mesothelioma
    MORAb-009         Results of a Multicentre Phase II Clinical Trial
 
    Abstract No: 7030 Poster Discussion
                      A First-in-Human Phase I Study of MORAb-004 (M4), a
                      Humanised Monoclonal Antibody Recognising Endosialin
    MORAb-004         (TEM-1), in Patients with Solid Tumours
 
    Abstract No: 3016 Poster Discussion

Notes to Editors

Eisai in Oncology

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

Halaven^® (eribulin)

Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane.^[1] Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.

Lenvatinib (E7080)

Lenvatinib is an orally active inhibitor of multiple receptor tyrosine kinases (RTKs), including KDR (VEGFR-2), Flt-1 (VEGFR-1), FGFR1, PDGFR-β and c-kit involved in angiogenesis and tumour proliferation.^[2^,3^]

It is currently being investigated as a treatment for thyroid, hepatocellular, endometrial and other solid tumour types.

Farletuzumab (MORAb-003)

Farletuzumab is an investigational, humanized IgG1 monoclonal antibody targeting folate receptor alpha which is over-expressed on a number of epithelial-derived cancers, but largely absent in normal tissue. It is currently being developed as a potential treatment for ovarian and lung cancers. Significantly, farletuzumab has received orphan drug designation for ovarian cancer in the US, EU and Switzerland.

MORAb-004

MORAb-004 is an investigational humanized IgG1 monoclonal antibody that recognizes a cell surface protein, endosialin, also called Tumour Endothelial Marker-1 (TEM1) and CD248, which is expressed on tumour associated pericytes, tumour stromal cells and directly on a subset of malignant cells. Pericytes are specialised cells that support the formation of blood vessels that support blood to tumours for their growth and survival. Expression of endosialin in tumours has been observed by several independent laboratories and experiments, and blocking endosialin function has been shown to inhibit tumour growth and metastasis. MORAb-004 is currently being investigated as a monoclonal antibody for its potential treatment of many types of cancer. An Investigational New Drug <http://www.morphotek.com/pipeline/Definitions-(1).aspx> application was opened for MORAb-004 in 2009. MORAb-004 has received US FDA orphan drug designation <http://www.morphotek.com/pipeline/Definitions-(1).aspx> for sarcoma.

Amatuximab (MORAb-009)

Amatuximab (MORAb-009) is an investigational chimeric IgG1 antibody that targets a cell surface glycoprotein, mesothelin, which is over-expressed on a number of cancers. Mesothelin is thought to be involved in cell adhesion. Its presence is associated with a range of cancers, including pancreatic ductal adenocarcinoma, mesothelioma, epithelial ovarian cancer, and lung adenocarcinoma. Researchers at the National Cancer Institute (NCI) and the Johns Hopkins University have independently validated mesothelin as a potential target of immuno-based therapies. Amatuximab is currently being investigated clinically as a monoclonal antibody for its potential treatment of mesothelioma.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc). Eisai recently expanded their UK Hatfield facility which now supports the company's growing European, Middle Eastern and African (EMEA) business.

Eisai concentrates its R&D activities in three key areas:

Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression
Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, and Belgium.

For further information please visit our web site http://www.eisai.com

About Morphotek

Morphotek^®, Inc., a subsidiary of Eisai, is a biopharmaceutical company specialising in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease.

For more information, please visit http://www.morphotek.com.

1. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377: 914 -923.

2. Matsui J et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumour MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008; 14: 5459-65.

3. Matsui J et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumour activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008; 122: 664-71.

Leading Researchers Address Hope For Early Detection and Treatments For Lung Cancer

Thu, 17 May 2012 19:19:23 +0000

Leading Researchers Address Hope For Early Detection and Treatments For Lung Cancer

PR Newswire

LUNGevity, Nation's Largest Lung Cancer-focused Nonprofit, Funds Critical, Encouraging Research

WASHINGTON, May 17, 2012 /PRNewswire-USNewswire/ -- LUNGevity Foundation, the nation's largest lung cancer-focused nonprofit, is pleased to note promising updates in researchers' quest for early detection and treatments for lung cancer during May, Lung Cancer Hope Month. Renowned researchers and LUNGevity Science Board Members, including Dr. Pierre Massion, Vanderbilt University Medical Center; and Dr. Martin "Mac" Cheever, Fred Hutchinson Cancer Research Center, University of Washington; as well as LUNGevity grant awardees including Dr. John V. Heymach, University of Texas M.D. Anderson Cancer Center, see progress and promise in the ongoing quest for early detection protocols and treatment.

"The research that is giving us reason to be hopeful—from identifying biomarkers for the early detection of the disease, to tumor genomic changes for targeted therapies—is possible in no small part because of the commitment and funding of LUNGevity Foundation and other private sources of funding, which are working to help fill the gap in public sector funding," said Dr. Pierre Massion, Chair of LUNGevity's Science Board.

"I'm a two time lung cancer survivor and without advancements in lung cancer research that lead to new and effective treatment options, the odds are not in my favor," said Matt Ellefson, who started targeted gene therapy for the treatment of his lung cancer in October 2011. "Lung cancer patients rely on the hope that we will live long enough to allow for the development of a new treatment that will extend our lives. Thanks to funding and grants from organizations like LUNGevity, cancer research has made some great strides in the last five years."

The nation's largest nonprofit funder of lung cancer research, LUNGevity is part of a network of lung cancer nonprofits, pharmaceutical companies and government agencies that is funding research already making a difference in the lives of lung cancer patients, with great potential for the future. In 2011 alone, the Foundation awarded $2 million to fund nine of the most promising lung cancer research proposals in the areas of early detection and targeted therapeutics.

"LUNGevity Foundation is pleased that progress in research gives reason to be hopeful about the quest for treatments and earlier diagnosis for lung cancer patients," said LUNGevity Foundation President Andrea Stern Ferris. "We just concluded an update meeting from our 2011 research grant awardees, and it's encouraging to see what an impact funding for research can have on saving lives. Lung cancer is the nation's number one cancer killer, but compared to other cancers, it receives relatively little government funding. Progress in research is showing that with proper funding, we can make a difference, there is hope."

LUNGevity's Science Board Members and grantees report progress and reasons to be hopeful in areas of early detection and treatments as noted below.

Early detection:
According to Dr. Massion, the National Cancer Institute's 2011 report of the results of the National Lung Screening Trial, using a CT scan for the screening of the disease, marked huge progress for lung cancer's early detection in current and heavy smokers, ages 55-74. For the first time, researchers were able to demonstrate that screening this population with low dose CT screening showed a 20 percent decrease in mortality rates related to lung cancer. If the same guidelines were extended to the entire at risk population, as many as 11,000 lives per year could be saved, as lung cancer detected early is highly treatable.

Promising research is being funded by LUNGevity to help non-invasively determine whether nodules identified on a CT scan are cancerous and malignant, using blood and sputum biomarkers.

LUNGevity believes in the importance of early detection and is working to ensure that a cost effective, widely available test is developed and available to all at risk, smokers and nonsmokers alike. Foundation funded researchers are reporting progress in the creation of new tools that are helping researchers learn more about the some 30,000 never smokers who are diagnosed with lung cancer each year, as well as the current or former smoker population. Progress is being made in research for the development of blood biomarkers, molecular technology and imaging technologies.

In addition to early detection, with newly developed genome sequencing capabilities, researchers are now able to profile tumor genes for mutations, which will help doctors develop greater targeted therapies for lung cancer in the future.

Therapeutics:
"The rate of progress in treating lung cancer is only accelerating," said Dr. Heymach, who received a 2011 LUNGevity research grant to help determine which non-small cell lung cancer patients are most likely to benefit from a VEGF inhibitor. "The advances we've seen in the past couple of years are just the tip of the iceberg. There is very little doubt that even five years from now, the way we treat lung cancer will be unrecognizable to today's clinicians," Heymach noted.

From the 1970s until the early part of this decade, lung cancer was treated with chemotherapy and thought to be essentially untreatable. Now, through tumor mutation discoveries, researchers believe that lung cancer is best understood as a collection of different diseases, each requiring a different treatment approach. According to Dr. Heymach, key advancing treatment areas include: targeting and treating specific mutations and tumor cells; immunotherapy; and antiangiogenic therapy (cutting off the blood supply to lung cancer tumors).

Lung cancer tumors often develop resistance to treatments. Researchers are creating better tools to help overcome this. Heymach's LUNGevity funded VEGF inhibitor research could in fact provide critical insights into some of these tumors' methods of resisting treatment, helping guide treatment options. Researchers have gained understanding from treatments of diseases such as HIV, which mutate often, and are developing combinations of different drugs to help treat lung cancer mutations. Though there is not yet a cure for lung cancer, research progress to date means there are now patients whose lives are being greatly extended.

Immunotherapy:
Immunotherapy, using special drugs to help the body's own immune system fight the disease, is at an exciting stage of development according to Dr. Cheever. There is very good preliminary evidence that indicates lung cancer may be an immunologically responsive cancer.

The body has a group of cells called T cells, a type of white blood cell that normally fights infection, but can also recognize and kill cancer cells. New cancer vaccines and immunotherapy drugs are able to increase the number of T cells in patients that are capable of killing cancer cells. In the past decade, scientists have made tremendous progress in their knowledge of how to educate T cells to recognize and kill cancer cells and how to stimulate T cells to grow and increase in number.

Immunotherapy drugs that have been invented and are now being developed for other cancers could be useful for treating lung cancer. There are several lung cancer vaccines in development that are designed to help prevent lung cancer from returning in patients in remission as well as very strong early evidence that some lung cancers respond to a new category of immunotherapy drug that "unleashes" patients' own T cells.

"LUNGevity is heartened by the progress being made in research for treatment and cures for lung cancer, and we are committed to helping it continue," said Ferris.

About LUNGevity Foundation
The mission of LUNGevity Foundation is to have a meaningful impact on improving lung cancer survival rates, ensure a higher quality of life for lung cancer patients, and provide a community for those impacted by lung cancer.

LUNGevity seeks to inspire the nation to commit to ending lung cancer.

For more information, please visit www.lungevity.org.

About Lung Cancer

1 in 14 Americans is diagnosed with lung cancer in their lifetime
Lung cancer is the leading cause of cancer death, regardless of gender or ethnicity
Lung cancer kills almost twice as many women as breast cancer and more than three times as many men as prostate cancer
About 55% of all new lung cancer diagnoses are among people who have never smoked or are former smokers
Only 16% of all people diagnosed with lung cancer will survive 5 years or more, BUT if it's caught before it spreads, the chance for 5-year survival improves dramatically

To schedule an interview with Dr. Cheever, Dr. Massion, or Dr. Heymach, as well as with a LUNGevity Foundation representative, contact Victoria Shapiro at (202) 414-0774 or vshapiro@susandavis.com

SOURCE LUNGevity Foundation

Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor

Thu, 17 May 2012 12:00:00 +0000

Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor

-- Parallel publication of two manuscripts describing the discovery and in vivo characterization of anti-tumor activity of CEP-32496 and benchmarking versus other kinase inhibitors --

PR Newswire

SAN DIEGO and JERUSALEM, May 17, 2012 /PRNewswire/ -- Ambit Biosciences and Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") today announced the clearance of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for CEP-32496, a novel BRAF (V600E) kinase inhibitor.

The IND filing was based upon promising therapeutic potential for this agent, as evidenced by data revealed in recent publications in the Journal of Medicinal Chemistry and Molecular Cancer Therapeutics characterizing the preclinical properties of CEP-32496. The two publications feature results that demonstrate CEP-32496 is a selective and potent inhibitor of BRAF (V600E) in cells. The published preclinical findings also demonstrate that CEP-32496 possesses potent and sustained anti-tumor activity in xenograft models of melanoma and colon carcinoma. CEP-32496 possesses attractive pharmacokinetic properties upon oral administration and benchmarks favorably with respect to other kinase inhibitors that have activity at the BRAF (V600E) mutated kinase.

"The data that we have generated to date in these preclinical studies lead us to believe that we have a promising drug candidate with CEP-32496 and is further validation of our successful drug discovery collaboration with Ambit," said Bruce Ruggeri, Ph.D., Senior Director, Oncology and Inflammation Discovery Research of Teva. "We look forward to exploring the full potential of this drug candidate to improve outcomes in patients with tumors possessing the BRAF(V600E) mutation."

Added Michael A. Martino, Ambit's President and Chief Executive Officer, "The filing of this IND represents a significant milestone for the Teva-Ambit collaboration and for the CEP-32496 program, and we look forward to advancement of the molecule into the clinic. The demonstrated selectivity and anti-tumor activity of this kinase inhibitor give it real promise in tumors that express the mutated BRAF gene and is further validation of Ambit's distinct competencies in kinase inhibitor drug discovery and optimization.

The manuscript published in Journal of Medical Chemistry describes the process that was employed to identify CEP-32496 as a clinical candidate. The publication includes data from preclinical models that highlight the selectivity and pharmacokinetic profile of the drug candidate.

The manuscript published in Molecular Cancer Therapeutics describes the pharmacokinetic profile and anti-tumor activity of CEP-32496 in preclinical models. In these studies, CEP-32496 demonstrated tumor stasis and regressions with favorable activity compared to other kinase inhibitors, including sorafenib and RAF-265, at doses that were well tolerated.

About CEP-32496

CEP-32496 is a small molecule kinase inhibitor of V600E mutated BRAF that is being developed as part of a collaborative agreement with Teva, initiated in 2006. This mutation in the BRAF gene has been identified in forms of melanoma, thyroid, colon, ovarian, and lung cancers. In addition to targeting mutations in BRAF, CEP-32496 targets other select kinases of interest in oncology with potentially desirable clinical application. Animal models in multiple cancer types suggest CEP-32496 may possess best-in-class potential. The CEP-32496 program is testament to the successes that can be achieved when two companies leverage their respective strengths in collaboration.

About BRAF Kinase in Cancer

Mutations in the BRAF gene have been identified in approximately seven percent of all cancers, including 60 percent to 70 percent of melanoma cases, four to 16 percent of colorectal cancer cases, 29 to 83 percent of papillary thyroid carcinomas and to a lesser extent in serous ovarian cancer and non-small lung cancer. The BRAF gene is a key component of a pathway involved in normal cell growth and survival. Mutations such as BRAF (V600E) are believed to be drivers of disease and can lead to uncontrolled cell growth and disease progression, and therefore represent a promising target for pharmacological intervention.

Melanoma is the most serious type of skin cancer and is growing at a rate of approximately five to six percent annually. More than 75,000 people in the U.S. plus an additional 85,000 people worldwide are diagnosed with melanoma each year. Patients with melanoma have limited treatment alternatives and experience some of the poorest outcomes, with 5-year survival rates of less than 20 percent for people with advanced (Stage IV) melanoma, according to the American Cancer Society.

About the Ambit-Teva Collaboration

In November 2006, Ambit and Cephalon Inc (acquired by Teva) entered into an exclusive collaboration agreement with multiple parts: (i) a drug discovery and development collaboration aimed at identifying and developing a clinical candidate for the BRAF(V600E) mutated kinase, and a separate effort for identifying and developing a clinical candidate for a second undisclosed kinase, and (ii) kinase screening services for Cephalon's small molecule library of kinase inhibitors. Cephalon paid Ambit an upfront fee of $15.5 million as partial consideration for access to Ambit's kinase profiling technology and licenses contributed by Ambit to the drug discovery part of the collaboration. Ambit may be entitled to receive greater than $45 million in development and commercial milestone payments if CEP-32496 is successful, and may receive further milestones if a compound is successfully developed and commercialized against the second target in the collaboration. In addition, Ambit may receive tiered royalty payments on net sales of the collaboration compounds.

About Ambit Biosciences

Ambit Biosciences is a privately held biopharmaceutical company engaged in the development of a robust pipeline of small molecule kinase inhibitors for the treatment of cancer, inflammatory disease and other indications. Ambit's lead compound, quizartinib (AC220), is a novel, potent, highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor, and is currently under clinical investigation in patients with relapsed or refractory AML and treatment-naive AML. Ambit is developing quizartinib in collaboration with Astellas Pharma Inc. as part of a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications. In addition to quizartinib, Ambit's clinical pipeline includes AC430, an oral JAK2 inhibitor, and CEP-32496, a BRAF inhibitor licensed to Teva. Ambit's preclinical portfolio includes a proprietary CSF1R inhibitor program. For more information, visit www.ambitbio.com.

About Teva

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.

Contacts:

Ambit Biosciences:
Alan Fuhrman
Chief Financial Officer
(858) 334-2133

Ian Stone or David Schull (Media)
Russo Partners
(619) 308-6541
(212) 845-4271
ian.stone@russopartnersllc.com
david.schull@russopartnersllc.com

Cindy McGee (Investors)
Russo Partners
(619) 308-6538
cindy.mcgee@russopartnersllc.com

SOURCE Ambit Biosciences

Varian Medical Systems to Showcase Radiosurgery Technology for Non-invasive Treatment of Early Stage Inoperable Lung Cancer

Thu, 17 May 2012 12:00:00 +0000

Varian Medical Systems to Showcase Radiosurgery Technology for Non-invasive Treatment of Early Stage Inoperable Lung Cancer

PR Newswire

SAN FRANCISCO, May 17, 2012 /PRNewswire/ -- Varian Medical Systems (NYSE: VAR) will showcase radiosurgery technologies for treating early-stage inoperable lung cancer and other conditions non-invasively at the 2012 International Conference of the American Thoracic Society (ATS) later this week in San Francisco.

"We're excited about putting our technology in front of pulmonologists who may not be familiar with radiosurgery as a treatment option for early-stage, inoperable lung cancer," said Calvin Huntzinger, M.S., senior director of surgical sciences at Varian. "Research has been accruing to show that radiosurgery can be a viable option for these patients.[1] In addition, a major NCI-funded study is under way to see if that viability extends to high-risk operable Stage I lung cancer patients." [2]

Varian will exhibit RapidArc® Radiosurgery on its TrueBeam™ STx system at the meeting. The technology enables clinicians to precisely target and rapidly treat tumors using finely shaped high-energy X-ray beams. Clinicians who are gaining early experience in the clinical use of RapidArc® Radiosurgery are reporting that this approach can be performed quickly and accurately in the treatment of many thoracic tumors.[3],[4],[5],[6]

The TrueBeam STx system was engineered to enable precise, efficient treatment, two to eight times faster than other radiosurgery machines. A high-definition multileaf collimator, or beam-shaping device, shapes the dose so that it closely matches the shape of the targeted tumor to minimize exposure of delicate healthy lung tissues and of other nearby organs, such as the heart or spinal cord.

"Radiosurgery procedures in the body have been made possible by a fairly recent convergence of technological innovations that enable precise beam shaping, real-time image guidance, and motion management," says Robert Timmerman, M.D., professor of radiation oncology at the University of Texas Southwestern Medical Center in Dallas. Dr. Timmerman will be speaking at the conference on the role of stereotactic body radiation therapy in the treatment of lung cancer.

"Radiosurgery for lung cancer, which historically has been very difficult to treat, is of growing interest to the members of the American Thoracic Society, as evidenced by the rapid growth of its Section on Thoracic Oncology," Huntzinger said. "Since last year, the section went from 230 to 505 members, more than doubling in size. We're delighted to see the heightened interest in thoracic oncology because we want clinicians to know how high precision radiosurgery can be used to treat patients who would have had few or no treatment options before."

About Varian Medical Systems
Varian Medical Systems, Inc., of Palo Alto, California, is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes and digital detectors for X-ray imaging in medical, scientific, and industrial applications and also supplies high-energy X-ray devices for cargo screening and non-destructive testing applications. Varian Medical Systems employs approximately 6,000 people who are located at manufacturing sites in North America, Europe, and China and approximately 70 sales and support offices around the world. For more information, visit http://www.varian.com or follow us on Twitter. Varian's medical devices are indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. While clinical studies such as those highlighted here may support the effectiveness of Varian's technology when used for radiotherapy or radiosurgery, individual results may vary. There are no guarantees of outcome.

[1] Timmerman R et al. Stereotactic Body Radiation Therapy for Inoperable Early Stage Lung Cancer. JAMA. 2010;303(11):1070-1076. doi: 10.1001/jama.2010.261

[2]Phase III Randomized Study of Sublobar Resection With or Without Brachytherapy Versus Stereotactic Body Radiotherapy in High-Risk Patients With Stage I Non-Small Cell Lung Cancer. Information is available at the NCI website at the following URL: http://www.cancer.gov/clinicaltrials/search/view?cdrid=698986&protocolsearchid=9090456&version=patient.

[3] Palma DA, Senan S, Haasbeek CJ, Verbakel WF, Vincent A, Lagerwaard F. Radiological and clinical pneumonitis after stereotactic lung radiotherapy: a matched analysis of three-dimensional conformal and volumetric-modulated arc therapy techniques. Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):506-13.

[4] Ong CL, Verbakel WF, Cuijpers JP, Slotman BJ, Lagerwaard FJ, Senan S. Stereotactic radiotherapy for peripheral lung tumors: a comparison of volumetric modulated arc therapy with 3 other delivery techniques. Radiother Oncol. 2010 Dec;97(3):437-42

[5] Ong CL, Palma D, Verbakel WF, Slotman BJ, Senan S. Treatment of large stage I-II lung tumors using stereotactic body radiotherapy (SBRT): planning considerations and early toxicity. Radiother Oncol. 2010 Dec;97(3):431-6.

[6] Verbakel WF, Senan S, Cuijpers JP, Slotman BJ, Lagerwaard FJ. Rapid delivery of stereotactic radiotherapy for peripheral lung tumors using volumetric intensity-modulated arcs. Radiother Oncol. 2009 Oct;93(1):122-4.

FOR INFORMATION CONTACT:
Meryl Ginsberg, 650.424.6444
meryl.ginsberg@varian.com

SOURCE Varian Medical Systems

Children with Cancer Have Complete Responses in a Children's Oncology Group Phase 1 Trial

Wed, 16 May 2012 22:00:00 +0000

Children with Cancer Have Complete Responses in a Children's Oncology Group Phase 1 Trial

--Children's Hospital of Philadelphia Researcher Leads Trial of ALK Inhibitor in Neuroblastoma, Lymphoma--

PR Newswire

PHILADELPHIA, May 16, 2012 /PRNewswire/ -- A pill designed to zero in on abnormal genes that drive specific cancers has produced encouraging early results in children with an uncommon but aggressive type of lymphoma, as well as in children with a rare form of neuroblastoma.

To view the multimedia assets associated with this release, please visit: http://www.multivu.com/mnr/50776-childrens-hospital-philadelphia-lymphoma-neuroblastoma-oncology-gene-trial

(Photo: http://photos.prnewswire.com/prnh/20120516/MM07672 )

A phase 1 clinical trial of the drug crizotinib achieved remissions, with minimal side effects, for 10 of the children participating in a clinical study carried out by the multicenter Children's Oncology Group (COG). The results were "an exciting proof-of-principle" for the targeted treatment, said the study leader, Yael P. Mosse, M.D., a pediatric oncologist at The Children's Hospital of Philadelphia.

Mosse presented study findings today at a press program organized by the American Society of Clinical Oncology (ASCO) in advance of its annual meeting in early June. In addition, the society selected the research for its Best of ASCO program following the meeting, and has announced that Mosse will be the first recipient of its James B. Nachman ASCO Junior Faculty Award in Pediatric Oncology.

Mosse previously led a team at Children's Hospital that discovered in 2008 that aberrations in the anaplastic lymphoma kinase (ALK) gene are present in 14 percent of cases of high-risk neuroblastoma, the most common solid cancer of early childhood. The same gene is disrupted in some cases of anaplastic large cell lymphoma (ALCL), a cancer of the lymph cells, and in patients with non-small cell lung cancer. Because drug manufacturers had already developed crizotinib for use in adult lung cancer clinical trials, Mosse and colleagues were able to quickly move crizotinib into an initial pediatric trial.

"We are entering a new era of cancer therapy, in which we use knowledge of basic biology to design very specific drugs that target cancer cells with potentially less side effects on healthy tissue," said Mosse. "In addition, as we concentrate on targets in molecular pathways, we move away from an exclusive focus on one form of cancer to customizing treatments according to biological activity. Abnormal ALK activity occurs in subtypes of neuroblastoma and subtypes of lymphoma, so identifying ALK activity in individual patients may enable us to provide the most effective care."

The current trial was not restricted to patients with known ALK abnormalities, but was open to children with certain refractory or relapsed cancers. There were 62 patients enrolled who could be fully evaluated for drug toxicity. Toxic side effects were minimal, even though many of the dosages were relatively high.

For 8 children with ALCL, 7 had complete responses — no cancer could be detected with imaging scans. Within days of taking the oral medication, said Mosse, fevers and chills stopped in many children, and their pain diminished or disappeared.

Twenty-seven patients enrolled in the trial had neuroblastoma, a difficult-to-treat cancer of the nervous system. Of the two patients with known germline mutations in ALK—mutations occurring in every cell in their body, which can be found in the very rare form of neuroblastoma, familial neuroblastoma, one achieved a complete remission. Of the 19 neuroblastoma patients in the trial whose ALK status was not able to be studied in the molecular diagnostic lab at Children's Hospital, a second patient had a complete remission.

"The current study shows the great potential for targeted therapy in children with anaplastic large cell lymphoma," concluded Mosse, "and the COG is now planning a larger scale trial for these patients." Additional studies are also underway to determine whether children with forms of neuroblastoma other than familial neuroblastoma, as laboratory studies suggest, might benefit from crizotinib.

Financial support for this Children's Oncology Group study came from the National Cancer Institute and from Pfizer, Inc. Co-authors with Mosse included researchers from The Children's Hospital of Philadelphia, C.S. Mott Children's Hospital, Children's Hospital Boston, the University of Minnesota, Minneapolis, Baylor College of Medicine, and Texas Children's Cancer Center.

"Efficacy of crizotinib in children with relapsed/refractory ALK-driven tumors including anaplastic large cell lymphoma and neuroblastoma: A Children's Oncology Group phase 1 consortium study," Abstract 9500, American Society of Clinical Oncology, 2012 Annual Meeting.

About The Children's Hospital of Philadelphia: The Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking third in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 516-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.chop.edu.

About the Children's Oncology Group: The Children's Oncology Group (childrensoncologygroup.org) unites more than 7,500 experts in childhood cancer at more than 200 leading children's hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. The COG research has turned children's cancer from a virtually incurable disease 50 years ago to one with a combined 5-year survival rate of 80% today. Our goal is to cure all children and adolescents with cancer, reduce the short and long-term complications of cancer treatments, and determine the causes and find ways to prevent childhood cancer.

Media Contact:
Rachel Salis-Silverman
The Children's Hospital of Philadelphia
Office: (267) 426-6063
Cell: (267) 970-3685
Salis@email.chop.edu

SOURCE The Children's Hospital of Philadelphia

Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012

Wed, 16 May 2012 22:00:00 +0000

Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012

LUX-Lung 3 clinical trial data selected for late-breaking oral presentation

PR Newswire

RIDGEFIELD, Conn., May 16, 2012 /PRNewswire/ -- Boehringer Ingelheim will present results from LUX-Lung 3, the company's pivotal Phase III clinical trial investigating afatinib in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation (EGFR M+), at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 1-5, 2012. LUX-Lung 3, which compares the investigational oral, once-daily therapy, afatinib, to pemetrexed/cisplatin, is the largest Phase III trial to date in first-line EGFR mutation-positive, advanced, metastatic NSCLC patients, and the first to use pemetrexed/cisplatin as a comparator in this population.

The presentation of the LUX-Lung 3 trial will shed light on a distinct and specific NSCLC patient population, those with EGFR mutations. EGFR mutations occur in 10 to 15 percent of NSCLC patients, and are well-established predictive biomarkers that provide specific targets for therapeutic intervention in NSCLC.

Title

Lead Author

Presentation details

LUX-Lung 3: A randomized,
open-label, phase III study of
afatinib versus pemetrexed and
cisplatin as first-line treatment for
patients with advanced
adenocarcinoma of the lung
harboring EGFR-activating mutations.

James Chih-Hsin Yang, MD, PhD

Oral Abstract #LBA7500

Date: Monday, June 4
Time: 3:00 PM-3:15 PM CDT

"We are excited to share the results of our pivotal LUX-Lung 3 trial, the largest and most robust ever conducted in EGFR mutation-positive patients," said Berthold Greifenberg, M.D., Vice President, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "We are continuously advancing the development of our oncology pipeline and look forward to opportunities to contribute to the body of scientific knowledge in this area."

Additional Presentations of Boehringer Ingelheim Investigational Compounds

In addition to the LUX-Lung 3 presentation, more than 15 studies of Boehringer Ingelheim's investigational therapies have been selected for inclusion at ASCO, demonstrating the company's innovative clinical development program across a variety of cancer types.

Select Poster Presentations
Title	Lead Author	Poster details
*Afatinib*
LUX-breast 3: Randomized phase II study of afatinib alone or with vinorelbine versus investigator's choice of treatment in patients (pts) with HER2-positive breast cancer (BC) with progressive brain metastases (BM) after trastuzumab or lapatinib-based therapy.	Heikki Joensuu, MD, Professor	Abstract #TPS647 Poster #15B Date: Saturday, June 2 Time: 8:00 AM - 12:00 PM CDT

LUX-breast 1: Randomized, phase III trial of afatinib and vinorelbine versus trastuzumab and vinorelbine in patients with HER2-overexpressing metastatic breast cancer (MBC) failing one prior trastuzumab treatment.	Nadia Harbeck, MD, PhD	Abstract #TPS649 Poster #15D Date: Saturday, June 2 Time: 8:00 AM - 12:00 PM CDT

LUX-breast 2: Phase II, open-label study of oral afatinib in HER2-overexpressing metastatic breast cancer (MBC) patients (pts) who progressed on prior trastuzumab (T) and/or lapatanib (L).	Tamas Hickish, MD	Abstract # TPS651 Poster #15F Date: Saturday, June 2 Time: 8:00 AM - 12:00 PM CDT

LUX-head and neck 1: A phase III, randomized trial of afatinib versus methotrexate (MTX) in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after platinum-based therapy.	Jean-Pascal H. Machiels, MD, PhD	Abstract # PS5598 Poster #32H Date: Saturday, June 2 Time: 1:15 – 5:15 PM CDT

LUX-head and neck 2: A randomized, double- blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.	Barbara Burtness, MD	Abstract # TPS5599 Poster # 33A Date: Saturday, June 2 Time: 1:15 – 5:15 PM CDT
*Nintedanib*
TRICC-c: BIBF 1120 versus placebo in patients receiving oxaliplatin plus fluorouracil and leucovorin (mFOLFOX6) for advanced, chemorefractory metastatic colorectal cancer (mCRC)—A multicenter, randomized phase II trial in progress.	Andreas Berger, MD	Abstract # TPS3636 Poster # 39A Date: Monday, June 4 Time: 8:00 AM - 12:00 PM CDT
*Volasertib*
Phase I trial of the polo-like kinase (Plk) inhibitor volasertib (BI 6727) combined with cisplatin or carboplatin in patients with advanced solid tumors.	Herlinde Dumez	Abstract # 3018 Poster #10 Date: Saturday, June 2 Time: 1:15 – 5:15 PM CDT

About Lung Cancer

Lung cancer is the second most common cancer and kills more people than any other cancer. In 2012, approximately 226,160 new cases of lung cancer will be diagnosed in the United States, with 160,340 Americans dying from the disease. NSCLC is the most common form, accounting for about 85 percent of all lung cancers.[1] Lung cancer remains an area of high unmet need, especially in its advanced stages where it is particularly aggressive and patients have limited treatment options.

About Afatinib

Afatinib is an investigational compound. Afatinib is not approved by the FDA; its safety and efficacy have not been established.

Afatinib is an investigational oral, once-daily irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2), ErbB3 and ErbB4. It is currently in phase III clinical development in NSCLC, head and neck and breast cancer.

About the Afatinib Clinical Trial Program in Advanced NSCLC

The LUX-Lung studies evaluate the use of afatinib in various settings of advanced NSCLC, including in patients harboring EGFR mutations and those with recurrent disease. These trials include:

LUX-Lung 1, a Phase IIb/III trial investigating afatinib plus best supportive care (BSC) versus placebo plus BSC in NSCLC patients who were previously treated with first-line chemotherapy and the reversible EGFR TKIs erlotinib or gefitinib.
LUX-Lung 2, a Phase II trial evaluating afatinib in NSCLC patients with EGFR mutations (EGFR M+), either treatment-naive or after one line of treatment with chemotherapy.
LUX-Lung 3, a Phase III trial investigating afatinib as a first-line treatment in patients with advanced NSCLC with EGFR mutations.
LUX-Lung 4, a Phase I/II trial of afatinib in NSCLC patients who have progressed after conventional EGFR-TKI treatment.
LUX-Lung 5, a global Phase III trial in patients previously treated with erlotinib or gefitinib. This is the first randomized Phase III trial investigating whether patients who initially benefit from treatment with afatinib alone may further benefit from afatinib beyond progression when given in combination with chemotherapy.
LUX-Lung 6, a Phase III trial investigating the efficacy and safety of afatinib compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations.
LUX-Lung 7, a Phase IIb trial evaluating afatinib head-to-head versus gefitinib as a first-line treatment in EGFR M+ NSCLC patients. Patient recruitment for this trial has recently initiated.
LUX-Lung 8, a Phase III trial evaluating afatinib head-to-head versus erlotinib in second-line treatment of squamous cell carcinoma of the lung. Patient recruitment for this trial has recently initiated.

For more information on these trials, please visit www.clinicaltrials.gov.

About Boehringer Ingelheim in Oncology

Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world's leading cancer centers, Boehringer Ingelheim's commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers.

The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. Afatinib is an investigational orally-administered irreversible inhibitor of the ErbB family of receptor tyrosine kinases, which is currently in phase III clinical development in advanced NSCLC, head and neck cancer, and breast cancer. Nintedanib (BIBF 1120) is an investigational orally-administered triple angiokinase inhibitor that targets three of the receptor tyrosine kinases shown to aid in the regulation of angiogenesis and is currently in phase III clinical development in NSCLC and ovarian cancer. Volasertib is an investigational inhibitor of polo-like kinase that is currently being investigated in early phase trials. Boehringer Ingelheim's oncology pipeline continues to evolve and demonstrates the company's continued commitment to the disease area.

For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can visit www.inoncologyus.com for additional information.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

References

[1] American Cancer Society. Cancer Facts and Figures: 2012. Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf. Last accessed April 27, 2012.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.