Appendix 4: Detail Expenditures by Sponsor (Award Categories) Sponsor Name FY12 Exp
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Faculty Disclosure
Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences, -
Manufacturers and Wholesalers Street
Nevada AB128 Code of Conduct Compliant Companies Manufacturers and Wholesalers Street City ST Zip 10 Edison Street LLC 13 Edison Street LLC Abbott Diabetes Care Division Abbott Diagnostic Division Abbott Electrophysiology (including Kalila Medical 2- 2016)) Abbott Laboratories 100 Abbott Park Road, Dept. EC10, Bldg. APGA-2 Abbott Park IL 60064 Abbott Medical Optics Abbott Molecular Division Abbott Nutrition Products Division Abbott Vascular Division (includes Tendyne 9-2015) AbbVie, Inc. 1 N. Waukegan Road North Chicago IL 60064 Acadia Phamaceuticals 3611 Valley Centre Drive, Suite 300 San Diego CA 92130 Accelero Health Partners, LLC Acclarent, Inc. 1525-B O'Brien Dr. Menlo Park CA 94025 Accuri Cyometers, Inc. Ace Surgical Supply, Inc. 1034 Pearl St. Brockton MA 02301 Acorda Therapeutics, Inc. 420 Sawmill River Road Ardsley NY 10532 AcriVet, Inc. Actavis W.C. Holding, Inc. Morris Corporate Center III, 400 Interpace Parkway Parsippany NJ 07054 Actavis , Inc. Actelion Pharmaceuticals US, Inc. 5000 Shoreline Court, Suite 200 S. San Francisco CA 94080 Activis 400 Interpace parkway Parsippany NJ 07054 A-Dec, Inc. 2601 Crestview Dr. Newberg OR 97132 Advanced Respiratory, Inc. Advanced Sterilization Products 33 Technology Drive Irvine CA 92618 Advanced Vision Research, Inc., dba Akorn Consumer Health Aegerion Pharmaceuticals, Inc. 101 Main Street, Suite 1850 Cambridge MA 02142 Aesculap Implant Systems, Inc. Aesculap, Inc. 3773 Corporate Parkway Center Valley PA 18034 Aesthera Corporation Afaxys, Inc. PO Box 20158 Charleston SC 29413 AGMS, Inc. Akorn (New Jersey) Inc. Page 1 of 23 Pages 2/15/2017 Nevada AB128 Code of Conduct Compliant Companies Akorn AG (formerly Excelvision AG) Akorn Animal Health, Inc. -
OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration
OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration July 21, 2009 9:24 PM ET MELVILLE, NY and CAMBRIDGE, Mass., July 21, 2009 – OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and AVEO Pharmaceuticals, Inc. today announced that they have expanded the drug discovery and translational research collaboration announced in October of 2007. The alliance is anchored around developing molecular targeted therapies to target the underlying mechanisms of epithelial-mesenchymal transition (EMT) in cancer and to develop proprietary datasets of associated patient selection biomarkers to support OSI’s targeted medicine pipeline. EMT is a process of emerging significance in tumor development and disease progression and the focal point of OSI’s proprietary oncology research efforts. The companies are expanding their efforts to validate cancer targets and to deploy key elements of AVEO’s proprietary translational research platform in support of OSI’s clinical development programs. Under the terms of the expanded discovery and research agreement, OSI will pay AVEO a total of $20 million at closing, $5 million of which is an upfront cash payment and $15 million of which is the purchase of additional equity in AVEO. OSI will also provide AVEO research funding over the next two years to support the collaboration, and the potential to achieve additional royalties and milestones. In return, OSI will immediately receive rights beyond the original collaboration including rights to additional EMT targets (including up to 4 antibody targets) and increased access to AVEO technology (i.e. tumor models, archives and biomarkers). OSI is also acquiring non-exclusive access to AVEO’s proprietary bioinformatics platform. -
IPR2016-01284 Patent 6,900,221 B1 ______
[email protected] Paper No. 49 571.272.7822 Filed: January 8, 2018 UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS HOLDINGS INC., AND APOTEX HOLDINGS, INC., Petitioner, v. OSI PHARMACEUTICALS LLC, Patent Owner. ____________________ Case IPR2016-01284 Patent 6,900,221 B1 ____________ Before LORA M. GREEN, RAMA G. ELLURU, and ZHENYU YANG, Administrative Patent Judges. GREEN, Administrative Patent Judge. FINAL WRITTEN DECISION Determining That Claims 44‒46 and 53 Are Shown to Be Unpatentable 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 IPR2016-01284 Patent 6,900,221 B1 I. INTRODUCTION Apotex Inc., Apotex Corp., Apotex Pharmaceuticals Holdings Inc., and Apotex Holdings, Inc., (“Apotex” or “Petitioner”) filed a Petition requesting an inter partes review of claims 44–47 and 53 of U.S. Patent No. 6,900,221 B1 (Ex. 1001, “the ’221 patent”). Paper 3 (“Pet.”). OSI Pharmaceuticals LLC1 (“OSI” or “Patent Owner”) filed a Preliminary Response to the Petition.2 Paper 7 (“Prelim. Resp.”). We determined that the information presented in the Petition and the Preliminary Response demonstrated that there was a reasonable likelihood that Petitioner would prevail in challenging claims 44–47 and 53 as unpatentable under 35 U.S.C. § 103(a). Pursuant to 35 U.S.C. § 314, we instituted trial on January 9, 2017, as to all of the challenged claims of the ’221 patent. Paper 8 (“Institution Decision” or “Dec. Inst.”). On February 8, 2017, the parties filed a Joint Motion to Limit Petition Under 37 C.F.R. -
In the United States District Court for the District of Delaware
Case 1:15-cv-01063-UNA Document 1 Filed 11/17/15 Page 1 of 17 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE OSI PHARMACEUTICALS, LLC, PFIZER ) INC., and GENENTECH, INC., ) ) Plaintiffs, ) ) v. ) C.A. No. ) BRECKENRIDGE PHARMACEUTICAL, ) INC. and NATCO PHARMA LTD., ) ) Defendants. ) COMPLAINT FOR PATENT INFRINGEMENT Plaintiffs OSI Pharmaceuticals, LLC (“OSI”), Pfizer Inc. (“Pfizer”) and Genentech, Inc. (“Genentech”) (collectively, “Plaintiffs”), by their undersigned attorneys, bring this action against Defendant Breckenridge Pharmaceutical Inc., (“Breckenridge”), and Natco Pharma Ltd. (“Natco”) (collectively, “Breckenridge/Natco”) for patent infringement and allege as follows: NATURE OF THE ACTION 1. This is an action for patent infringement under the patent laws of the United States, Title 35 of the United States Code, the Federal Food, Drug, and Cosmetic Act, Title 21 of the United States Code, and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 et seq., arising from Breckenridge/Natco’s filing of an Abbreviated New Drug Application No. 208488 (“Breckenridge/Natco ANDA” or “ANDA No. 208488”) with the United States Food and Drug Administration (“FDA”) seeking approval to commercially market generic versions of TARCEVA® (“Breckenridge/Natco’s Proposed Generic Products”) prior to the expiration of certain patents that relate to that product, United States Reissued Patent No. RE 41,065 (“the RE ‘065 patent”), and United States Patent No. 6,900,221 (“the ‘221 patent”). Case 1:15-cv-01063-UNA Document 1 Filed 11/17/15 Page 2 of 17 PageID #: 2 THE PARTIES 2. Plaintiff OSI is a limited liability company organized and existing under the laws of the State of Delaware, with a principal place of business at 1 Astellas Way, Northbrook, IL 60062. -
Salix Pharmaceuticals, Inc. 2007 Annual Report and Form 10-K
2007 Annual Report and Form 10-K Advancing Treatment in GastroenterologyTM Corporate Mission Statement Salix is committed to being the leading U.S. specialty pharmaceutical Company licensing, developing and marketing innovative products to health care professionals to prevent or treat gastrointestinal disorders in patients while providing rewarding opportunities for our employees and creating exceptional value for our stockholders. To Our Stockholders Despite the December 28, 2007 approval of three generic delivery of mesalamine, or 5-ASA, beginning in the small balsalazide products by the Office of Generic Drugs, Salix bowel and continuing throughout the colon. Wilmington succeeded in making substantial advances in its business Pharmaceuticals, which licensed metoclopramide-ZYDIS to during 2007. From a product development standpoint we us, is moving forward in seeking FDA approval to market made impressive strides toward accessing both the multi- this fast-dissolving formulation. At this time, Wilmington is billion dollar irritable bowel syndrome market as well as targeting a fourth quarter 2008 approval. We believe that the hepatic encephalopathy market. We also progressed in our specialized sales force is positioned to effectively our effort to expand our presence in the inflammatory commercialize this patient-friendly formulation of this bowel disease market. On the marketing and sales side, widely-prescribed agent, if and when approved. we grew OSMOPREP® and MOVIPREP® to command a 25% We expect the product development success share of the prescription bowel cleansing market and we achieved during 2007 to be followed by commercial continued to grow XIFAXAN. On the business development success during 2008, as we anticipate receiving responses front we broadened our portfolio with the acquisitions of from the Food and Drug Administration during 2008 PEPCID OS® and metoclopramide-ZYDIS®. -
Spec Pharma M&A Transaction Multiples
SECTOR REPORT FOURTH QUARTER 2016 Disclaimer All information set forth in this report (the “Overview”) has been synthesized by Bourne Capital Partners, L.L.C. (“BP”) or was obtained from publicly available sources. BP makes no express or implied representation or warranty as to the accuracy or completeness of the information contained herein. BP expressly disclaims any and all liability that may be based on all information set forth in the Overview, errors therein, or omissions therefrom. This Overview includes certain statements, estimates and projections provided by BP with respect to anticipated future performance. Such statements, estimates and projections reflect various assumptions made by BP concerning anticipated results, which reflect significant subjective judgments made by BP and as a result, may or may not prove to be correct. There can be no assurance that such projected results are attainable or will be realized. No express or implied representations or warranties are made as to the accuracy of such statements, estimates or projections. In furnishing the Overview, BP does not undertake any obligation to provide the recipient with access to any additional information, to correct any inaccuracies that may become apparent or to update or otherwise revise this Overview. This Overview is not an offer to sell or a solicitation of an offer to purchase securities or to engage in any other transaction. BP is a North Carolina (USA) limited liability company doing business as Bourne Partners with divisions in Healthcare Merchant Banking, Alternative Assets, Management Consulting and Investment Banking. Investment Banking services are offered by Bourne Partners Securities, LLC, a registered broker dealer, Member FINRA and SIPC. -
17TH ANNUAL PHARMACEUTICAL and MEDICAL DEVICE COMPLIANCE CONGRESS Office of Inspector General Update
17TH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS Office of Inspector General Update Mary E. Riordan, Senior Counsel Office of Counsel to the Inspector General October 19, 2016 AGENDA FOR TODAY Update on recent enforcement activity Update on OIG reports and other publications Lessons/suggestions for consideration ISSUES IN RECENT SETTLEMENTS Settlements addressed a variety of areas: Kickback issues Marketing and sales issues Medicaid drug rebate program issues Drug price reporting issues FALSE CLAIM ACT SETTLEMENTS Kickback-related settlements Salix Pharmaceuticals, Inc. Olympus Corporation of the Americas Novartis Pharmaceuticals Warner Chilcott Omnicare, Inc. FALSE CLAIM ACT SETTLEMENTS Settlements involving sales and marketing issues Acclarent, Inc. Genentech Inc. and OSI Pharmaceuticals LLC Paradigm Spine Qualitest Pharmaceuticals Settlement involving Medicaid drug rebate issues Wyeth/Pfizer Settlements involving other issues Imported and compounded drugs CIVIL MONETARY PENALTY SETTLEMENTS Drug Price Reporting CMP Settlements Nephron Pharmaceuticals Corporation Cipher Pharmaceuticals US, LLC Coloplast Corp. OIG REPORTS Drug pricing issues “Average Manufacturer Prices Increased Faster Than Inflation for Many Generic Drugs” – December 2015 (A-06-15-00030) 340B program issues “Part B Payment for 340B Purchased Drugs” - Nov. 2015 (OEI-12-14-00030) “State Efforts to Exclude 340B drugs from Medicaid Managed Care Rebates” – June 2016 (OEI-05-14- 00430) OIG REPORTS Reports relating to the Medicaid -
OSI Pharmaceuticals and AVEO Pharmaceuticals Enter Into an Oncology Drug Discovery and Translational Research Collaboration | Busi…
3/9/2019 OSI Pharmaceuticals and AVEO Pharmaceuticals Enter into an Oncology Drug Discovery and Translational Research Collaboration | Busi… 111.92.25.247 OSI Pharmaceuticals and AVEO Pharmaceuticals Enter into an Oncology Drug Discovery and Translational Research Collaboration - OSI to Host Conference Call / Webcast - October 02, 2007 07:30 AM Eastern Daylight Time MELVILLE, N.Y. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and AVEO Pharmaceuticals, Inc. announced today that they have entered into a small molecule drug discovery and translational research collaboration. The alliance is anchored around developing molecular targeted therapies that target the underlying mechanisms of epithelial-mesenchymal transition (EMT) in cancer, a process of emerging significance in tumor development and disease progression and the focal point of OSI’s proprietary oncology research efforts. The companies will collaborate to develop proprietary target-driven tumor models for use in drug screening and biomarker validation, and intend to deploy these systems in support of OSI drug discovery and clinical programs. Under the terms of the agreement, OSI will pay AVEO a total upfront of $10 million in cash and purchase equity valued at approximately $5 million. OSI will also pay AVEO research funding, and milestones and royalties upon successful development and commercialization of products from the collaboration. “We are delighted to announce this collaboration with AVEO,” stated Colin Goddard, Ph.D., Chief Executive Officer -
Clinical Research Services
Clinical Research Services Advancing the future of medicine through research. Who We Are Experience Clinical Research Services is a department within Clinical Research Services has been involved CHI St. Alexius Health in Bismarck, ND. We are fully in clinical research since 1987. Our professional dedicated to providing research support services staff has more than 180 years of combined to physicians within our region and the valued experience in clinical trials. We are committed patients they serve. to providing outstanding service to ensure the success of every project. CHI St. Alexius Health is a tertiary care facility affiliated with PrimeCare, a health group which Our involvement in inpatient and outpatient combines the most experienced, trusted, and phase II-IV clinical and device research studies has proven medical leaders in the area. PrimeCare is contributed substantially to the approval of new comprised of a network which includes more than drugs and treatments. You should carefully consider 190 physicians in private and institutional practice, both the benefits and the risks of participation including: CHI St. Alexius Health, Mid Dakota Clinic, before enrolling in a study. The Bone & Joint Center, and other affiliated area physicians. Many of these physicians are actively Previous clinical study trials: involved as investigators for clinical trials. • Oncology • Orthopaedic • Rheumatology • Diabetes Our clinical research team is committed to providing: • Neurology • Weight loss • Rapid study start-up • Cardiology • Pain • Pro-active patient enrollment • Urology • Men’s Health • Clean data submission • Gastroenterology • Women’s Health • Highly experienced principal • Infectious Disease • Medical Devices investigators • Pediatric • Initial training and continuing education for all support personnel Sponsors Patient Demographics Abbott Laboratories Characteristics of our patients include Acorda Therapeutics, Inc. -
Acquisition of OSI Pharmaceuticals, Inc
Acquisition of OSI Pharmaceuticals, Inc. -Becoming a Global Category Leader in Oncology- May 17, 2010 Table of Contents I. Transaction Summary II. Strategic Rationale III. Overview of OSI Pharmaceuticals IV. Financial Impact 2 1 I. Transaction Summary 3 2 Transaction Summary ● Purchase price: $57.50 per share in cash (55% premium to the closing price on February 26, 2010, the last trading day before the announcement of tender offer) ● Acquisition amount: Approximately $4.0 Billion (Fully diluted basis) ● Tender offer period: Expires no later than 10 business days after the amendment to the Schedule TO is filed (which is expected to be filed on or before May 21st), unless extended ● Financing: Fully financed with cash and cash equivalents on Astellas’ balance sheet ● The acquisition is unanimously approved by the Board of Directors of both Astellas and OSI 4 3 II. Strategic Rationale 5 4 Business Model of Astellas GGloballobal CCategoryategory LLeadereader (GCL)(GCL) A “GCL”, by providing value-added products “globally”, takes over the position of “leader” in a “category” where high unmet medical needs exist and a high degree of expertise is required. 6 5 Becoming a GCL in Oncology ● Oncology, one of Astellas’ five focus therapeutic areas ● Acquisition of OSI significantly enhances Astellas’ oncology capabilities Current Transplantation Urology GCL Areas Immunology & Oncology Infectious Diseases Future GCL Candidates DM Complications & Neuroscience Metabolic Diseases 7 Strategic Rationale for OSI Acquisition ● Accelerates development of -
Manufacturers/Wholesalers Street City ST Zip 454 Life Sciences Branford CT A.L.I Holdings, LLC A.L.I
Manufacturers/Wholesalers Street City ST Zip 454 Life Sciences Branford CT A.L.I Holdings, LLC A.L.I. Imaging Systems Corp A.L.I. Technologies (International) LLC Abbott Diabetes Care Division Abbott Diagnostic Division Abbott Laboratories 100 Abbott Park Rd. Bldg. AP6D-1 Abbott Park IL 60064 Abbott Molecular Division Abbott Nutrition Products Division Abbott Pharmaceutical Products Group Abbott Point of Care Division Abbott Vascular Division Abraxis Bioscience, LLC. 11755 Wilshire Blvd., Suite 2000 Los Angeles CA 90025 Access Diabetic Supply, LLC Acclarent, Inc. 1525-B O'Brien Dr. Menlo Park CA 94025 Acorda Therapeutics, Inc. 15 Skyline Drive Hawthorne NY 10532 Advanced Neuromodulation Systems, Inc. Advanced Respiratory, Inc. Advanced Sterilization Products 33 Technology Drive Irvine CA 92618 Aesculap Implant Systems, Inc. 3773 Corporate Parkway Center Valley PA 18034 Aesculap, Inc. 3773 Corporate Parkway Center Valley PA 18034 Alaven Pharmaceuticals, LLC 2260 Northwest parkway Suite A Marietta GA 30067 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth TX 76134 Alexion Pharmaceuticals, Inc. 352 Knotter Drive Cheshire CT 06410 Alkermes, Inc. 88 Sidney Street Cambridge MA 02139 Allen Medical Systems, Inc. Allergan Sales, LLC Allergan USA, Inc. Allergan, Inc. 2525 Dupont Drive Irvine CA 92612 Alpharma Pharmaceuticals, Inc. Alpharma Pharmaceuticals, LLC AMAG Pharmaceuticals, Inc. 100 Hayden Avenue Lexington MA 02421 AMATECH Corporation American Medical Distributors, Inc. 100 New Highway N Amityville NY 11701 American Medical System,