DOCSLIB.ORG

Clinical Investigators Provide Perspectives on the Treatment of Metastatic Non-Small Cell Lung Cancer in Patients Without Targetable Tumor Mutations

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Clinical Investigators Provide Perspectives on the Treatment of Metastatic Non-Small Cell Lung Cancer in Patients Without Targetable Tumor Mutations CONSENSUS OR CONTROVERSY: Clinical Investigators Provide Perspectives on the Treatment of Metastatic Non-Small Cell Lung Cancer in Patients without Targetable Tumor Mutations CME Information TARGET AUDIENCE • Devise an evidence-based approach to the selection of This activity is intended for hematologists, medical oncologists induction and maintenance systemic therapy for patients and other healthcare providers involved in the treatment of with NSCLC without a targetable mutation. non-small cell lung cancer (NSCLC). • Consider biologic and patient-related factors in the selection of second- and later-line therapy for patients with OVERVIEW OF ACTIVITY progressive NSCLC without a targetable mutation. Lung cancer is a devastating disease with broad-reaching • Describe available and emerging data on the efficacy and impact on public health, as it accounts for 13% of all new safety of tumor immunotherapy directed at the PD-1/PD-L1 cancer cases in the United States and the most cancer- pathway in lung cancer, and consider this information when related deaths among both men and women. A major focus counseling patients regarding protocol and nonresearch of recent lung cancer research has been the development — options. and subsequent approval — of a number of molecular-targeted agents and the identification of related biomarkers to help • Educate patients about the potential side effects associated guide treatment selection for those individuals who harbor with commonly employed chemotherapeutic, biologic specific oncogenic alterations. Despite these groundbreaking and immunotherapeutic agents, and provide preventive scientific advances, the truth is that only 15% to 20% of strategies to reduce or ameliorate these toxicities. patients harbor abnormalities that are truly “actionable” in • Describe ongoing trials evaluating novel applica- the clinic today based on FDA approvals. Fortunately for tions of immune checkpoint inhibitors alone (eg, these individuals and their caregivers, over the past several anti-PD-L1 antibodies) or in combination with other years major clinical trials in patients with advanced NSCLC systemic approaches (eg, anti-PD-1/ PD-L1 with without a targetable mutation have witnessed unprece- anti-CTLA-4 antibodies, anti-PD-1/PD-L1 antibodies with dented successes that will challenge the cancer commu- chemotherapy), and counsel appropriately selected patients nity’s collective understanding of the diagnosis and optimal about potential participation. management of this disease. These video proceedings from a CME symposium held during ACCREDITATION STATEMENT the 2017 Multidisciplinary Thoracic Cancers Symposium Research To Practice is accredited by the Accreditation feature discussions with leading researchers with an expertise Council for Continuing Medical Education to provide in the management of lung cancer about clinical research continuing medical education for physicians. findings relevant to treatment for patients without a targetable tumor mutation to address existing uncertainties and help CREDIT DESIGNATION STATEMENT keep clinicians up to date and informed. Research To Practice designates this enduring material for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians LEARNING OBJECTIVES should claim only the credit commensurate with the extent of • Recognize available and emerging research information their participation in the activity. validating the utility of diagnostic assays designed to measure PD-L1 status, assess which testing platforms AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — should be used and appropriately employ the results to MAINTENANCE OF CERTIFICATION (MOC) identify potential candidates for front-line treatment with an Successful completion of this CME activity enables the partic- anti-PD-1 antibody. ipant to earn up to 1.75 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification • Review published research data documenting the safety (MOC) program. Participants will earn MOC points equivalent and efficacy of available anti-PD-1 antibodies for patients to the amount of CME credits claimed for the activity. It is the with newly diagnosed metastatic NSCLC. ResearchToPractice.com/ThoracicCancers17/Nontargeted 1 CME activity provider’s responsibility to submit participant Vice Chair, Radiation Therapy Oncology Group completion information to ACCME for the purpose of granting Philadelphia, Pennsylvania ABIM MOC credit. Advisory Committee: Abbott Laboratories, AstraZeneca Please note, this program has been specifically designed for Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals the following ABIM specialty: medical oncology. Inc, Bristol-Myers Squibb Company, Celgene Corporation, Personal information and data sharing: Research To Practice EMD Serono Inc, Genentech BioOncology, GlaxoSmithKline, aggregates deidentified user data for program-use analysis, ImClone Systems, a wholly owned subsidiary of Eli Lilly and program development, activity planning and site improvement. Company, Lilly, Merck, Novartis Pharmaceuticals Corpo- We may provide aggregate and deidentified data to third ration, Pfizer Inc;Consulting Agreements: AstraZeneca parties, including commercial supporters. We do not share Pharmaceuticals LP, Boehringer Ingelheim Pharmaceu- or sell personally identifiable information to any unaffiliated ticals Inc, Bristol-Myers Squibb Company, Celgene Corpo- third parties or commercial supporters. Please see our privacy ration, Genentech BioOncology, GlaxoSmithKline, ImClone policy at ResearchToPractice.com/Privacy-Policy for more Systems, a wholly owned subsidiary of Eli Lilly and Company, information. Lilly, Merck, Novartis Pharmaceuticals Corporation, Pfizer Inc; Contracted Research: Advantagene Inc, Celgene Corpo- HOW TO USE THIS CME ACTIVITY ration, GlaxoSmithKline, Merck, Inovio Pharmaceuticals; Data This CME activity consists of a video component. To receive and Safety Monitoring Board: Abbott Laboratories, Amgen Inc, credit, the participant should watch the video, complete Lilly, Peregrine Pharmaceuticals Inc, Synta Pharmaceuticals the Post-test with a score of 80% or better and fill out Corp. the Educational Assessment and Credit Form located at Naiyer Rizvi, MD ResearchToPractice.com/ThoracicCancers17/Nontargeted/ Professor of Medicine CME. Director of Thoracic Oncology and Phase I Immunotherapeutics CONTENT VALIDATION AND DISCLOSURES Price Chair in Clinical Translational Research Research To Practice (RTP) is committed to providing its Columbia University Medical Center participants with high-quality, unbiased and state-of-the- New York, New York art education. We assess conflicts of interest with faculty, Advisory Committee and Consulting Agreements: AstraZeneca planners and managers of CME activities. Conflicts of interest Pharmaceuticals LP, Merck, Novartis Pharmaceuticals Corpo- are identified and resolved through a conflict of interest ration, Roche Laboratories Inc; Ownership Interest: Gritstone resolution process. In addition, all activity content is reviewed Oncology. by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific Heather Wakelee, MD objectivity of studies referenced and patient care recommen- Associate Professor of Medicine dations. Division of Oncology Stanford University School of Medicine FACULTY — The following faculty (and their spouses/partners) Stanford Cancer Institute reported relevant conflicts of interest, which have been Stanford, California resolved through a conflict of interest resolution process: Consulting Agreements: ACEA Biosciences Inc, Genentech Julie R Brahmer, MD BioOncology, Helsinn Group, Peregrine Pharmaceuticals Inc, Director, Thoracic Oncology Program Pfizer Inc;Contracted Research: AstraZeneca Pharmaceu- Interim Director ticals LP, Bristol-Myers Squibb Company, Celgene Corporation, Johns Hopkins Kimmel Cancer Center at Bayview Clovis Oncology, Exelixis Inc, Genentech BioOncology, Gilead Associate Professor of Oncology Sciences Inc, Lilly, Novartis Pharmaceuticals Corporation, Sidney Kimmel Comprehensive Cancer Center Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Roche Johns Hopkins School of Medicine Laboratories Inc, Xcovery; Grants: Clovis Oncology, Exelixis Baltimore, Maryland Inc, Gilead Sciences Inc, Pharmacyclics LLC, an AbbVie Advisory Committee: Bristol-Myers Squibb Company, Merck; Company, Xcovery. Consulting Agreements: Bristol-Myers Squibb Company, MODERATOR — Dr Love is president and CEO of Research Celgene Corporation, Lilly, Merck; Contracted Research: To Practice, which receives funds in the form of educa- AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb tional grants to develop CME activities from the following Company, Merck. commercial interests: AbbVie Inc, Acerta Pharma, Agendia Corey J Langer, MD Inc, Amgen Inc, Ariad Pharmaceuticals Inc, Array BioPharma Director of Thoracic Oncology Inc, Astellas Pharma Global Development Inc, AstraZeneca Abramson Cancer Center Pharmaceuticals LP, Baxalta Inc, Bayer HealthCare Pharma- Professor of Medicine ceuticals, Biodesix Inc, bioTheranostics Inc, Boehringer Perelman School of Medicine Ingelheim Pharmaceuticals Inc, Boston Biomedical Pharma University of Pennsylvania Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, CTI BioPharma Corp, Daiichi Sankyo Inc, ResearchToPractice.com/ThoracicCancers17/Nontargeted 2 Dendreon Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Food and Drug Administration. Research To Practice does not
Load more

Recommended publications
  • Fully Human Domain Antibody Therapeutics: the Best of Both Worlds
    Drug Discovery Fully Human Domain Antibody Therapeutics: The Best of Both Worlds By combining the therapeutic benefits of small molecule drugs with those of fully human antibodies, Domain Antibodies are expected to have strong therapeutic and commercial potential. By Robert Connelly at Domantis Robert Connelly is Chief Executive Officer of Domantis. He has over 22 years’ commercial experience of the life science sector, including that gained in the fields of diagnostics, drug discovery technologies and antibody therapeutics. Prior to joining Domantis, he was CEO of Veritas Pharmaceuticals (Los Angeles, USA), an in vivo imaging start-up company. He spent over five years with IGEN International, latterly as Senior Vice President and General Manager, Life Sciences, where he took part in the company’s IPO and financing rounds, raising $130 million. The first 11 years of his career were spent at Abbott Laboratories in sales, marketing and management positions. Domain Antibodies (dAbs) are the smallest functional variable regions of either the heavy (VH) or light (VL) binding units of antibodies. At Domantis, we are chains of human antibodies. Domantis scientists applying our proprietary know-how in dAbs to deliver have used the variable domains sequences of human human therapies that address large, unmet medical antibodies to create a series of large and highly needs in areas such as inflammation, cancer and functional libraries of fully human dAbs, with each autoimmune diseases. Three and a half years after library comprising at least 1010 different dAbs. The opening our laboratories, we have a dozen proprietary dAbs selected from these libraries are both specific therapeutic programmes underway, and an additional for their biological target and are well folded and eight therapeutic programmes with partners.
    [Show full text]
  • Lilly to Acquire Imclone Systems in $6.5 Billion Transaction
    Lilly to Acquire ImClone Systems in $6.5 Billion Transaction Creates a Global Leader in Oncology Biopharmaceuticals Boosts Oncology Pipeline With Up to Three Promising Targeted Therapies in Phase III in 2009 INDIANAPOLIS and NEW YORK, Oct 06, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Eli Lilly and Company (NYSE: LLY) and ImClone Systems Inc. (Nasdaq: IMCL) today announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion. The offer represents a premium of 51 percent to ImClone's closing stock price on July 30, 2008, the day before an acquisition offer for ImClone was made public. ImClone's board recommends that ImClone's shareholders tender their shares in the tender offer. Additionally, certain entities associated with ImClone's chairman, Carl C. Icahn, holding approximately 14 percent of ImClone's outstanding common stock, have agreed to tender their shares in the tender offer. This strategic combination will create one of the leading oncology franchises in the biopharmaceutical industry, offering both targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combined oncology portfolio will target a broader array of solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic, positioning Lilly to pursue treatments of multiple cancers. Combining with ImClone will further strengthen Lilly's growing portfolio of first-in-class and best-in-class pharmaceutical products, enabling Lilly to better support oncologists, with the ultimate goal of delivering better outcomes for cancer patients.
    [Show full text]
  • 11/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 20:25:21 Report Id 2794D051 Page: 01
    MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 11/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 20:25:21 REPORT ID 2794D051 PAGE: 01 NUMERIC COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 01/01/2017 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 00002 ELI LILLY AND COMPANY 00145 STIEFEL LABORATORIES, INC, 00003 E.R. SQUIBB & SONS, LLC. 00149 WARNER CHILCOTT PHARMACEUTICALS INC. 00004 HOFFMANN-LA ROCHE 00168 E FOUGERA AND CO. 00006 MERCK & CO., INC. 00169 NOVO NORDISK, INC. 00007 GLAXOSMITHKLINE 00172 IVAX PHARMACEUTICALS, INC. 00008 WYETH LABORATORIES 00173 GLAXOSMITHKLINE 00009 PFIZER, INC 00178 MISSION PHARMACAL COMPANY 00013 PFIZER, INC. 00182 GOLDLINE LABORATORIES, INC. 00015 MEAD JOHNSON AND COMPANY 00185 EON LABS, INC. 00023 ALLERGAN INC 00186 ASTRAZENECA LP 00024 SANOFI-AVENTIS, US LLC 00187 VALEANT PHARMACEUTICALS NORTH AMERICA 00025 PFIZER, INC. 00206 LEDERLE PIPERACILLIN 00026 BAYER HEALTHCARE LLC 00224 KONSYL PHARMACEUTICALS, INC. 00029 GLAXOSMITHKLINE 00225 B. F. ASCHER AND COMPANY, INC. 00032 SOLVAY PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 00037 MEDA PHARMACEUTICALS, INC. 00245 UPSHER-SMITH LABORATORIES, INC. 00039 SANOFI-AVENTIS, US LLC 00258 FOREST LABORATORIES INC 00046 AYERST LABORATORIES 00259 MERZ PHARMACEUTICALS 00049 PFIZER, INC 00264 B. BRAUN MEDICAL INC. 00051 UNIMED PHARMACEUTICALS, INC 00281 SAVAGE LABORATORIES 00052 ORGANON USA INC. 00299 GALDERMA LABORATORIES, L.P. 00053 CSL BEHRING 00300 TAP PHARMACEUTICALS INC 00054 ROXANE LABORATORIES, INC. 00310 ASTRAZENECA LP 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00327 GUARDIAN LABS DIV UNITED-GUARDIAN INC 00062 ORTHO MCNEIL PHARMACEUTICALS 00338 BAXTER HEALTHCARE CORPORATION 00064 HEALTHPOINT, LTD. 00378 MYLAN PHARMACEUTICALS, INC.
    [Show full text]
  • Active Labelers Run Date : Feb 19, 2018
    Active Labelers Run Date : Feb 19, 2018 Labeler ID Labeler Name Contract Begin Date Contract End Date 00002 ELI LILLY AND COMPANY 01/01/1991 01/01/3000 00003 E.R. SQUIBB & SONS, LLC. 01/01/1991 01/01/3000 00004 HOFFMANN-LA ROCHE 01/01/1991 01/01/3000 00006 MERCK & CO., INC. 01/01/1991 01/01/3000 00007 GLAXOSMITHKLINE 01/01/1991 01/01/3000 00008 WYETH LABORATORIES 01/01/1991 01/01/3000 00009 PFIZER, INC 01/01/1991 01/01/3000 00013 PFIZER, INC. 01/01/1991 01/01/3000 00014 PFIZER, INC 01/01/1991 01/01/3000 00015 MEAD JOHNSON AND COMPANY 01/01/1991 01/01/3000 00023 ALLERGAN INC 01/01/1991 01/01/3000 00024 SANOFI-AVENTIS, US LLC 01/01/1991 01/01/3000 00025 PFIZER, INC. 01/01/1991 01/01/3000 00026 BAYER HEALTHCARE LLC 01/01/1991 01/01/3000 00029 GLAXOSMITHKLINE 01/01/1991 01/01/3000 00032 ABBVIE INC. 01/01/1991 01/01/3000 00037 MEDA PHARMACEUTICALS, INC. 01/01/1991 01/01/3000 00039 SANOFI-AVENTIS, US LLC 01/01/1991 01/01/3000 00046 AYERST LABORATORIES 01/01/1991 01/01/3000 00049 PFIZER, INC 01/01/1991 01/01/3000 00051 ABBVIE INC 10/01/1997 01/01/3000 00052 ORGANON USA INC. 01/01/1991 01/01/3000 00053 CSL BEHRING LLC 01/01/1991 01/01/3000 00054 WEST-WARD PHARMACEUTICALS CORP. 01/01/1991 01/01/3000 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 01/01/1991 01/01/3000 00062 ORTHO MCNEIL PHARMACEUTICALS 01/01/1991 01/01/3000 00064 HEALTHPOINT, LTD.
    [Show full text]
  • Boot Camp Roster Through July 2015
    Participants in our GMP Boot Camps have come from these companies AB Biotechnologies Irisys, Inc. Abbott Vascular IVX Animal Health Acacia Biomedical Pte Ltd. J & J Packaging Actavis Pharmaceuticals Johnson Matthey Adhesives Research Karl Storz Endovision AHC Products, Inc. Kenco Management Services Alcon Labs King Pharmaceuticals Alk-Abello Source Materials Kleen Test Products Allergan, Inc. Kosan Amax Nutrasource KV Pharmaceutical American Red Cross La Jolla Pharmaceuticals Aptalis Pharmaceuticals Label World Artes Medical Labortorios Sophia Astellas Pharma Technologies Leica Microsystems Astra Zeneca Mayo Clinic Atex Technologies, Inc. Medicomp Inc. Auer Precision Co. Merck Avail Medical Metor-Logics Avema Pharma Solutions NBTY B. Braun Medical Nexgen Pharma BASF Nitto Denko Technical Inc. Baxa Corp. Norwich Pharmaceuticals Baxter Healthcare Novartis Animal Health US, Inc. Bayer Nuskin Enterprises Beckman Coulter Nutri-Mack Beiersdorf Inc. NuWorld Beauty Bend Research Oakley Biovail Ohm Laboratories Block Medical Organogenesis Inc. Boston Scientific Pacira Pharmaceuticals Bradley Corp. Palm Beach Pharmaceuticals Bristol-Myers Squibb Par Pharmaceutical Inc. CAMAG Pennakem LLC Carl Zeiss Meditec, Inc. Peter Cremer North America Cepheid Pfizer Church & Dwight Co. Philip Morris USA Cornerstone Research and Development Philliips Medisize GMP Training Systems, Inc. P.O. Box 2585 Orange, CA 92859 714-289-1233 www.GMPTrainingSystems.com Participants in our GMP Boot Camps have come from these companies CR Bard PL Developments Daiichi Sankyo Pharma Development Protab Laboratories Danisco USA Purdue Pharmaceuticals Dial Eisai Qm5 DSI, Inc. Ranbaxy Labs DSM Pharmaceuticals Raptor Pharmaceuticals Earthwise Nutritionals Regeneron Pharmaceuticals Edwards Lifesciences RJ Reynolds Co. Elan Robinson Pharma Co. Endosonics Romark Labs Eurand, Inc. Rosendin Electric Flextronics, Inc. Sanofi aventis FMI Schick, division of Energizer Forest Labs Sensible Organics Foster Corporation Shire Pharmaceuticals Garmon Corp.
    [Show full text]
  • 05/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 04:25:50 Report Id 2794D052 Page: 01
    MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 05/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 04:25:50 REPORT ID 2794D052 PAGE: 01 ALPHA COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 07/01/2016 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 68782 (OSI) EYETECH 55513 AMGEN USA 00074 ABBOTT LABORATORIES 58406 AMGEN/IMMUNEX 68817 ABRAXIS BIOSCIENCE, LLC 53746 AMNEAL PHARMACEUTICALS 16729 ACCORD HEALTHCARE INCORPORATED 65162 AMNEAL PHARMACEUTICALS LLC 42192 ACELLA PHARMACEUTICALS, LLC 69238 AMNEAL PHARMACEUTICALS, LLC 10144 ACORDA THERAPEUTICS, INC. 53150 AMNEAL-AGILA, LLC 00472 ACTAVIS 00548 AMPHASTAR PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 69918 AMRING PHARMACEUTICALS, INC. 45963 ACTAVIS INC. 66780 AMYLIN PHARMACEUTICALS, INC. 46987 ACTAVIS KADIAN LLC 55724 ANACOR PHARMACEUTICALS 49687 ACTAVIS KADIAN LLC 10370 ANCHEN PHARMACEUTICALS, INC. 14550 ACTAVIS PHARMA MFGING PRIVATE LIMITED 43595 ANGELINI PHARMA, INC. 61874 ACTAVIS PHARMA, INC. 62559 ANIP ACQUISITION COMPANY 67767 ACTAVIS SOUTH ATLANTIC 54436 ANTARES PHARMA, INC. 66215 ACTELION PHARMACEUTICALS U.S., INC. 52609 APO-PHARMA USA, INC. 52244 ACTIENT PHARMACEUTICALS 60505 APOTEX CORP. 75989 ACTON PHARMACEUTICALS 63323 APP PHARMACEUTICALS, LLC. 69547 ADAPT PHARMA INC. 43485 APRECIA PHARMACEUTICALS COMPANY 76431 AEGERION PHARMACEUTICALS, INC. 42865 APTALIS PHARMA US, INC 50102 AFAXYS, INC. 58914 APTALIS PHARMA US, INC. 10572 AFFORDABLE PHARMACEUTICALS, LLC 13310 AR SCIENTIFIC, INC. 27241 AJANTA PHARMA LIMITED 08221 ARBOR PHARM IRELAND LIMITED 17478 AKORN INC 60631 ARBOR PHARMACEUTICALS IRELAND LIMITED 24090 AKRIMAX PHARMACEUTICALS LLC 24338 ARBOR PHARMACEUTICALS, INC. 68220 ALAVEN PHARMACEUTICAL, LLC 59923 AREVA PHARMACEUTICALS 00065 ALCON LABORATORIES, INC. 76189 ARIAD PHARMACEUTICALS, INC. 00998 ALCON LABORATORIES, INC. 24486 ARISTOS PHARMACEUTICALS, INC.
    [Show full text]
  • March 24, 2009 the Honorable Harry Reid the Honorable Mitch
    March 24, 2009 The Honorable Harry Reid The Honorable Mitch McConnell Senate Majority Leader Senate Minority Leader United States Senate United States Senate Capitol Building S-221 Capitol Building S-230 Washington, DC 20510-7020 Washington, DC 20510-7010 Fax: (202) 224-7362 Fax: (202) 224-2574 The Honorable Nancy Pelosi The Honorable John A. Boehner Speaker of the House House Minority Leader United States House of Representatives United States House of Representatives Capitol Building H-232 Capitol Building H-204 Washington, DC 20515-6501 Washington, DC 20515-6537 Fax: (202) 225-4188 Fax: (202) 225-5117 Dear Congressional Leadership: The 200 undersigned companies and trade associations write today to express our strong opposition to provisions in the Administration's budget to increase taxes on U.S. companies that are competing for business in international markets. Together, we provide millions of high-paying American jobs that depend on our ability to compete in the global economy. Ninety-five percent of the world’s consumers live outside of the United States. American companies seeking to serve these consumers rely on growth in these markets to restart economic growth and create jobs for Americans. In fact, 22 million Americans work for U.S. multinationals while millions of other Americans are employed by the thousands of small and medium-sized companies that supply and service U.S. multinationals. American companies require only a level playing field in international tax policy. Unfortunately, the Administration's proposal to repeal “deferral” would impose a unilateral tax on the foreign earnings of American companies, upsetting the competitive balance between U.S.
    [Show full text]
  • Imclone and Bristol-Myers Team up for Cancer Treatment in Japan
    www.asiabiotech.com Industry Watch Japan ImClone and Bristol-Myers Team up for Erbitux mClone Systems and Bristol-Myers Squibb are working together on a lead product, Erbitux (Cetuximab), used to treat patients with colorectal disease. Erbitux is an IIgG1 monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR). They have submitted an application with the Japanese Pharmaceuticals and Medical Devices Agency for the use of Erbitux (Cetuximab). The filing in Japan leads into the development of collaboration between ImClone Systems, Bristol-Myers Squibb and Merck. The Japanese submission was based on results from studies conducted in Europe and Japan which confirm the activity of Erbitux in patients with metastatic colorectal cancer. About Imclone Systems ImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Their efforts have resulted in a broad spectrum of innovative product candidates with potential application in multiple tumor types. ImClone Systems operates in two locations. Its corporate and scientific headquarters is in New York City, which houses the company’s research and executive offices, and its campus in Branchburg, New Jersey. The Branchburg facility is home to the manufacturing, product development, finance, clinical, regulatory and quality assurance and commercial operations departments. About Bristol-Myers Squibb Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb manufactures hundreds of different products and is a leader in the discovery and manufacture of innovative therapies for cardiovascular disease, central nervous system disorders, oncology, virology, metabolics, and immunology.
    [Show full text]
  • Is Lilly in Need of a Transformational Deal?
    August 20, 2010 Is Lilly in need of a transformational deal? Evaluate Vantage The future has been looking particularly bleak for Eli Lilly for some time now so recent setbacks, such as loss of patent protection for key products and major pipeline failure, has not only deepened the gloom but left many observers suggesting the company needs a major rethink of its strategy. Unsurprisingly, the suggestions box has been flooded with M&A tips. Lilly has certainly joined the trend for bolt-on acquisitions in recent years, a significant break from its long history of organically driven growth. Perhaps increasing pressure from the scale of its patent cliff and dry pipeline means the time has come for a major acquisition or merger to transform the group’s prospects. After all, despite implementing one of the most aggressive cost cutting initiatives amongst its peers, Lilly is still expected to see the biggest erosion of its bottom line over the next six years (Lilly finally bows to patent cliff pressure, September 15, 2009). Sticking to its R&D guns Since taking over as Lilly’s chief executive in 2008, John Lechleiter, previously head of R&D, has largely stuck to the theme of searching for the next blockbuster rather than diversifying into other areas, like some of his peers. New drugs were to come from the internal pipeline, facilitated by the now standard restructuring of its R&D operations, as well as licensed or acquired products or companies. Yet the internal pipeline has struggled to deliver the goods for some time now, the most recent setback just this week with the failure of semagacestat in phase III for Alzheimer’s disease (Will gamma secretase Alzheimer's class survive the fall of semagacestat? August 18, 2010).
    [Show full text]
  • FY06 Pharmaceutical Marketing Disclosures Report
    Pharmaceutical Marketing Disclosures For the period July 1, 2005 to June 30, 2006 Report of Vermont Attorney General William H. Sorrell June 26, 2007 Contact: Julie Brill Assistant Attorney General (802) 828-5479 Pharmaceutical Marketing Disclosures: Report of Vermont Attorney General William H. Sorrell on Payments to Physicians June 26, 2007 Index Page: I. Executive Summary 3 II. Description of Vermont’s Payment Disclosure Law 4 III. Amendments to Prior Pharmaceutical Marketing Disclosure Reports filed by the Vermont Attorney General's Office 5 IV. Summary of Pharmaceutical Marketing Expenditures 6 1. Total Payments of Each Pharmaceutical Manufacturer 6 2. Payments of all Manufacturers Organized by Recipient Type 7 3. Payments by Nature of Expenditure 10 4. Payments by Purpose of Expenditure 10 5. Trade Secret Declarations 11 V. Enforcement Actions 12 Appendix: Tab 1: 33 V.S.A. §2005 13 Tab 2: FY 06 Tables 17 Tab 3: FY 05 Tables as Revised 25 Tab 4: FY 04 Tables as Revised 34 Tab 5: FY 03 Tables as Revised 43 2 Pharmaceutical Marketing Disclosures: Report of Vermont Attorney General William H. Sorrell on Payments to Physicians June 26, 2007 I. Executive Summary This is the fourth report of Vermont Attorney General William H. Sorrell on Pharmaceutical Marketing Disclosures. It is based upon disclosures pertaining to payments made during the period July 1, 2005, through June 30, 2006 (FY 06) by pharmaceutical marketers, of the amount of money the companies paid during the past fiscal year on consulting and speaker fees, travel expenses, gifts, and other payments to physicians, hospitals, universities and others authorized to prescribe or dispense pharmaceutical products.
    [Show full text]
  • [ Emc-Lusinnufll'lergcrta'rgets
    US 20070255633Al (19) United States (12) Patent Application Publication (10) Pub. N0.: US 2007/0255633 A1 Kridel (43) Pub. Date: NOV. 1, 2007 (54) SYSTEMS AND METHODS FOR INVESTING (52) US. Cl. ....................................................... .. 705/35 (76) Inventor: FIVJigiam J. Kridel, New York, NY (57) ABSTRACT The present invention discloses systems and methods for Correspondence Address? creating and managing ?nancial instruments and indexes PAUL’ HASTINGS’ JANOFSKY & WALKER comprised of securities for companies in subsectors of the LLP economy. These ?nancial instruments alloW investment in R0' BOX 919092 subsectors of the economy Will still being able to minimize SAN DIEGO CA 92191-9092 ’ risk by diversi?cation. The indexes serve as benchmarks for (21) App1_ NO; 11/465,768 companies in the subsectors of the economy. A procedure may be used to identify the securities to include in the (22) Filed: Allg- 18, 2006 ?nancial instruments. This procedure may include (a) iden _ _ tifying securities for companies in a sector of the economy; Related U's‘ Apphcatlon Data (b) limiting the identi?ed securities to those for companies (60) Provisional application No. 60/778,492, ?led on Mar. in a SubSeCIOr Of the SBCIOI‘ Of the economy; (0) applying 1, 2006. focus rules to further limit the identi?ed securities to those _ _ _ _ for companies Who are focused in the subsector of the Pubhcatlon Classl?catlon economy; and (d) limiting the securities included in the (51) Int, Cl, ?nancial instrument or index to those that satisfy other G06Q 40/00 (2006.01) objective criteria. ETF RULE. SET->| APPLICATION’ ' "1 _.
    [Show full text]
  • Table of Contents
    Table of contents Executive Summary Chapter 1 – Introduction Chapter 2 – Trends in drug delivery dealmaking 2.1. Introduction 2.2. Drug delivery partnering over the years 2.3. Bigpharma drug delivery dealmaking activity 2.4. Big biotech drug delivery dealmaking activity 2.5. Most active drug delivery dealmakers 2.6 Drug delivery partnering by deal type 2.7. Drug delivery partnering by disease type 2.8. Partnering by drug delivery technology type 2.9. Average deal terms for drug delivery partnering 2.9.1 Drug delivery headline values 2.9.2 Drug delivery upfront payments 2.9.3 Drug delivery milestone payments 2.9.4 Drug delivery royalty rates 2.10. The anatomy of drug delivery partnering 2.11. Drug delivery or specialty pharma? 2.11.1. Is specialty pharma the only way for drug delivery? 2.11.2. Best practice for optimizing drug delivery program development 2.11.3. The anatomy of a drug delivery deal 2.11.3.a. Case study 1: Alpharma – Durect 2.11.3.b. Case study 2: Bayer – MDRNA 2.11.3.c. Case study 3: Endo Pharmaceuticals – BioDelivery Sciences Chapter 3 – Leading drug delivery deals 3.1. Introduction 3.2. Top drug delivery deals by value Chapter 4 – Bigpharma drug delivery deals 4.1. Introduction 4.2. How to use bigpharma drug delivery partnering deals 4.3. Big pharma drug delivery partnering company profiles Abbott Actavis Inc (formerly Watson Pharmaceuticals) Actavis (merged with Watson Pharmaceuticals Oct 2012) Actelion Allergan Amgen Astellas AstraZeneca Baxter International Bayer Biogen Idec Boehringer Ingelheim Bristol-Myers Squibb Celgene CSL Daiichi Sankyo Dainippon Sumitomo Eisai Eli Lilly Endo Pharmaceuticals Forest Laboratories Galderma Gilead Sciences GlaxoSmithKline Grifols Hospira Johnson & Johnson Kyowa Hakko Kirin Lundbeck Menarini Merck & Co Merck KGaA Mylan Novartis Novo Nordisk Otsuka Pfizer Purdue Roche Sanofi Shionogi Shire Takeda Teva UCB Valeant Warner Chilcott Chapter 5 – Bigbiotech drug delivery deals 5.1.
    [Show full text]