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2009: Turning the Corner
data page 2009: Turning the corner Walter Yang Despite the shaky start to 2009, the biotech sector regained its financial Although initial public offerings showed signs of resuscitation (at least footing. Biotech indices were up, as were offerings and partnership mon- 13 more companies are now in the queue), follow-on financings came in ies. Excluding collaborations, the sector raised a total of $24.3 billion. above $6 billion—the second-best year over the past decade. Stock market performance Global biotech industry financing Although biotech indices were up ~16% last year, they underperformed The boost in partnership promises to US biotechs and follow-on financings other major indices. pushed industry funding to $61.3 billion, up 82% from 2008. 1,500 Swiss Market S&P 500 2009 36.9 10.0 5.1 2.2 6.0 0.9 1,400 NASDAQ Biotech Dow Jones 2008 20.0 3.2 5.3 3.1 1.9 0.1 1,300 NASDAQ BioCentury 100 2007 22.4 11.7 6.8 4.7 4.4 3.0 1,200 Partnering 2006 19.8 11.9 5.6 4.7 5.6 2.0 1,100 Year Debt and other Index 17.3 6.1 5.4 2.7 4.8 1.9 1,000 2005 Venture capital PIPEs 900 2004 10.9 8.8 5.3 2.9 3.3 2.6 Follow-ons 800 2003 8.9 9.1 4.0 2.2 3.9 0.5 IPOs 700 010203040506070 Amount raised ($ billions) 1/09 2/09 3/09 4/09 5/09 6/09 7/09 8/09 9/09 12/08 Month ending 10/09 11/09 12/09 Partnership figures are for deals involving a US company. -
Appendix a 2016 Financial Report Financial Review Pfizer Inc
Appendix A 2016 Financial Report Financial Review Pfizer Inc. and Subsidiary Companies GLOSSARY OF DEFINED TERMS Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this 2016 Financial Report (defined below) refer to Pfizer Inc. and its subsidiaries. We also have used several other terms in this 2016 Financial Report, most of which are explained or defined below: 2016 Financial Report This Financial Report for the fiscal year ended December 31, 2016, which was filed as Exhibit 13 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 2016 Form 10-K Annual Report on Form 10-K for the fiscal year ended December 31, 2016 AAV Adeno-Associated Virus ABO Accumulated postretirement benefit obligation ACA (Also referred to as U.S. U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Healthcare Legislation) Act. ACIP Advisory Committee on Immunization Practices ALK anaplastic lymphoma kinase Allergan Allergan plc Alliance revenues Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us AM-Pharma AM-Pharma B.V. Anacor Anacor Pharmaceuticals, Inc. Astellas Astellas Pharma U.S. Inc. ASU Accounting Standards Update ATM-AVI aztreonam-avibactam Bamboo Bamboo Therapeutics, Inc. Baxter Baxter International Inc. BMS Bristol-Myers Squibb Company CDC U.S. Centers for Disease Control and Prevention Cellectis Cellectis SA Celltrion Celltrion Inc. and Celltrion Healthcare, -
[Docket No. FDA-2017-N-3203] Wyeth Pharmaceutical
This document is scheduled to be published in the Federal Register on 06/21/2017 and available online at https://federalregister.gov/d/2017-12908, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3203] Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: The withdrawal is effective on [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. 2 Table 1 Application No. -
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. -
Overview of Ftc Antitrust Actions in Pharmaceutical Services and Products
OVERVIEW OF FTC ANTITRUST ACTIONS IN PHARMACEUTICAL SERVICES AND PRODUCTS Health Care Division Bureau of Competition Federal Trade Commission Washington D.C. 20580 Markus H. Meier Assistant Director Bradley S. Albert Deputy Assistant Director Saralisa C. Brau Deputy Assistant Director September 2009 TABLE OF CONTENTS Page I. INTRODUCTION. ........................................................... 1 II. CONDUCT INVOLVING PHARMACEUTICAL SERVICES AND PRODUCTS. 3 A. Monopolization. ...................................................... 3 B. Agreements Not to Compete. ............................................ 8 C. Agreements on Price or Price-Related Terms. 14 D. Agreements to Obstruct Innovative Forms of Health Care Delivery or Financing. 20 E. Illegal Tying and Other Arrangements. .................................... 20 III. PHARMACEUTICAL MERGERS. ........................................... 20 A. Horizontal Mergers Between Direct Competitors. 20 B. Potential Competition Mergers. ......................................... 44 C. Innovation Market Mergers. ............................................ 47 D. Vertical Mergers...................................................... 49 IV. INDUSTRY GUIDANCE STATEMENTS...................................... 50 A. Advisory Opinions. ................................................... 50 B. Citizen Petition to the Food and Drug Administration. 51 V. AMICUS BRIEFS. ......................................................... 51 VI. INDICES. ............................................................ -
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. -
Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines
Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S. -
Manufacturers with Signed Rebate Agreements February 1 , 2011
Wisconsin Medicaid Pharmacy Data Table Manufacturers with Signed Rebate Agreements February 1 , 2011 NEWLABELER NAME START END SC NEW LABELER NAME START END SC 00002 ELI LILLY AND COMPANY 1/1/1991 Y 00126 COLGATE ORAL PHARMACEUTICAL 1/1/1991 Y 00003 E R SQUIBB AND SONS INC. 1/1/1991 Y 00131 SCHWARZ PHARMA, INC. 1/1/1991 Y 00004 HOFFMANN LAROCHE INC 1/1/1991 00132 C B FLEET COMPANY INC. 1/1/1991 00005 LEDERLE LABORATORIES 1/1/1991 Y 00135 SMITHKLINE BEECHAM 1/1/1995 Y 00006 MERCK SHARP & DOHME 1/1/1991 Y 00143 WEST-WARD PHARMACEUTICAL C 1/1/1991 Y 00007 SMITHKLINE BEECHAM CORPORATI 1/1/1991 Y 00145 STIEFEL LABORATORIES INC. 1/1/1991 Y 00008 WYETH AYERST LABORATORIES 1/1/1991 Y 00149 PROCTER & GAMBLE PHARMACEU 1/1/1991 Y 00009 PHARMACIA AND UPJOHN 1/1/1991 Y 00168 E FOUGERA AND CO, DIV OF ALTAN 1/1/1991 Y 00013 PHARMACIA AND UPJOHN 1/1/1991 Y 00169 NOVO NORDISK PHARMACEUTICAL 1/1/1991 Y 00015 INVAMED, INC 1/1/1991 Y 00172 ZENITH LABORATORIES, INC 1/1/1991 Y 00023 ALLERGAN INC. 1/1/1991 Y 00173 GLAXOSMITHKLINE 1/1/1991 Y 00024 SANOFI SYNTHELABO 1/1/1991 Y 00178 MISSION PHARMACAL COMPANY 1/1/1991 Y 00025 PHARMACIA CORPORATION 1/1/1991 Y 00182 GOLDLINE LABORATORIES INC 1/1/1991 Y 00026 BAYER CORP PHARMACEUTICAL DI 1/1/1991 Y 00185 EON LABS MANUFACTURING, INC. 1/1/1991 Y 00028 NOVARTIS PHARMACEUTICALS 1/1/1991 Y 00186 ASTRAZENECA LP 1/1/1991 Y 00029 SMITHKLINE BEECHAM CORPORATI 1/1/1991 Y 00187 ICN PHARMACEUTICALS INC. -
AILERON THERAPEUTICS, INC. (Name of Registrant As Specified in Its Charter)
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy Statement ☐ Definitive Additional Materials ☐ Soliciting Material Pursuant to §240.14a-12 AILERON THERAPEUTICS, INC. (Name of Registrant as Specified in Its Charter) (Name of Person(s) Filing Proxy Statement, if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box): ☒ No fee required. ☐ Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. (1) Title of each class of securities to which transaction applies: (2) Aggregate number of securities to which transaction applies: (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): (4) Proposed maximum aggregate value of transaction: (5) Total fee paid: ☐ Fee paid previously with preliminary materials. ☐ Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount previously paid: (2) Form, Schedule or Registration Statement No.: (3) Filing Party: (4) Date Filed: Table of Contents AILERON THERAPEUTICS, INC. -
Reporter's Handbook
2O14 RE POR TER’ S HANDBOOK for the biopharmaceutical research industry Member Companies 1 Research Associates 2 U.S. Health-Related Trade and Professional Organizations 3 Government Medical and Health Contacts 4 Voluntary Health Agencies 5 International Pharmaceutical Associations/Health Care Groups 6 Key Facts/About PhRMA 7 Company Products by Category 8 Member Companies 1 Member Companies Abbott Dept 383, AP6D 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: (847) 937-6100 Fax: (847) 937-1511 Website: www.abbott.com Melissa Brotz, Corporate Public Affairs Office: (847) 935-3456 E-Mail: [email protected] Kelly Morrison, Corporate Public Affairs, Science/Policy Office: (847) 937-3802 E-Mail: [email protected] Scott Stoffel, Corporate Public Affairs, Financial Office: (847) 936-9502 E-Mail: [email protected] Steve Chesterman, Medical Optics Office: (714) 247-8711 E-Mail: [email protected] Jonathon Hamilton, Vascular Devices 3200 Lakeside Drive, Suite 355 Santa Clara, CA 95054 Office: (408) 845-3491 E-Mail: [email protected] AbbVie 1 North Waukegan Road North Chicago, IL 60064 Phone: (847) 932-7900 Website: www.abbvie.com Gulden Mesara, Vice President, Global Commercial and Health Communications Office: (847) 938-2804 E-Mail: [email protected] Angela Sekston, Vice President, Leadership and Employee Communications Office: (847) 937-6636 E-Mail: [email protected] Morry Smulevitz, Head of U.S. Public Affairs Office: (847) 937-2152 E-Mail: [email protected] 1-1 -
UNITED STATES SECURITIES and EXCHANGE COMMISSION Form
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Form 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☒ 1934 For the fiscal year ended December 31, 2008 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ☐ OF 1934 Commission file number 000-12477 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Amgen Center Drive, 91320-1799 Thousand Oaks, California (Zip Code) (Address of principal executive offices) (805) 447-1000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(g) of the Act: Common stock, $0.0001 par value; preferred share purchase rights (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. -
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.