Jazz Pharmaceuticals Plc Proxy Statement 2017 Annual Report
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Alkermes Public Limited Company
ALKERMES PUBLIC LIMITED COMPANY Directors’ Report and Consolidated Financial Statements For the Year Ended March 31, 2013 ALKERMES PLC Table of Contents Page Directors’ Report .......................................................... 2 Statement of Directors’ Responsibilities .......................................... 56 Independent Auditors’ Report—Group ........................................... 57 Consolidated Profit and Loss Account ........................................... 59 Consolidated Statement of Comprehensive Income (Loss) ............................. 60 Consolidated Balance Sheet ................................................... 61 Consolidated Statement of Cash Flows ........................................... 63 Consolidated Reconciliation of Shareholders’ Funds ................................. 62 Notes to the Consolidated Financial Statements .................................... 64 Independent Auditors’ Report—Company ......................................... 111 Company Balance Sheet ..................................................... 113 Notes to the Company Financial Statements ....................................... 114 1 DIRECTORS’ REPORT For the Year Ended March 31, 2013 The directors present their report and audited consolidated financial statements for the fiscal year ended March 31, 2013. The directors have elected to prepare the consolidated financial statements in accordance with section 1 of the Companies (Miscellaneous Provisions) Act, 2009, which provides that a true and fair view of the state of -
In Re: Alkermes Securities Litigation 03-CV-12091-Consolidated
Case 1:03-cv-12091-RCL Document 39 Filed 07/12/2004 Page 1 of 49 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS In re ALKERMES SECURITIES ) Master Docket No. 03-CV-12091-RCL LITIGATION ) ) CLASS ACTION This Document Relates To: ) ) ALL ACTIONS. ) ) ) CONSOLIDATED COMPLAINT FOR VIOLATION OF THE FEDERAL SECURITIES LAWS Case 1:03-cv-12091-RCL Document 39 Filed 07/12/2004 Page 2 of 49 SUMMARY AND OVERVIEW 1. This is a securities class action on behalf of all purchasers of the common stock of Alkermes, Inc. (“Alkermes” or the “Company”) between April 22, 1999 and July 1, 2002 (the “Class Period”), against Alkermes and certain of its officers and directors for violations of the Securities Exchange Act of 1934 (the “Exchange Act”). 2. Alkermes is a biopharmaceutical company focused on the development of controlled- release drug delivery technologies and their application to existing or new drug therapies. Among the drug delivery technologies defendants seek to develop are sustained-release systems based on biodegradable polymeric microspheres, including those based on Medisorb polymers. 3. In 1996, Alkermes entered into an agreement with JPI Pharmaceutical International (“Janssen”), an affiliate of pharmaceutical giant Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (“Johnson & Johnson”), to develop an injectable form of the schizophrenic drug Risperdal, based upon the Medisorb polymer technology, called Risperdal Consta. Janssen has marketed the oral form of Risperdal since 1993, with sales of $2.3 billion in 2003. According to a December 12, 2001 report by analysts Thomas Weisel Partners, LLC (“Thomas Weisel”), during the Class Period, oral Risperdal was the most prescribed drug in the $5.3 billion atypical antipsychotic market. -
Explanation of Conflict of Interest Disclosure Parts: Part One: All
Explanation of Conflict of Interest Disclosure Parts: Part One: All Financial Involvement with a pharmaceutical or biotechnology company, a company providing clinical assessment, scientific, or medical companies doing business with or proposing to do business with ACNP over past 2 years (Jan. 2011-Present) Part Two: Income Sources & Equity of $10,000 or greater Part Three: Financial Involvement with a pharmaceutical or biotechnology company, a company providing clinical assessment, scientific, or medical products or companies doing business with or proposing to do business with ACNP which constitutes more than 5% of personal income (Jan. 2011-Present): Part Four: Grants from pharmaceutical or biotechnology company, a company providing clinical assessment, scientific, or medical products directly, or indirectly through a foundation, university, or any other organization (Jan. 2011-Present) Part Five: My primary employer is a pharmaceutical/biotech/medical device company. 2012 Program Committee Disclosures Anissa Abi-Dargham: Part 1: Pfizer; Otsuka; Takeda; Sunovion; Shire; Roche; Pierre Favre; Part 2: Pierre Favre William Carlezon: Part 1: Referring to 2010-2011: Scientific Advisory Board, Myneurolab.com; Consultant, Concert Pharmaceuticals; Consultant, Lantheus Medical Imaging; Consultant, Transcept Pharmaceuticals, (Spouse) Senior Scientist, EMD Serono; Part 2: (Spouse) Senior Scientist, EMD Serono, Part 3: (Spouse) Senior Scientist, EMD Serono Cameron Carter: Part1: GlaxoSmithKline research; Part 4: GlaxoSmithKline Karl Deisseroth: Part -
2012 Financial Markets Preview Living Creatively
REPRINT FROM JANUARY 2, 2012 BioCentury ™ THE BERNSTEIN REPORT ON BIOBUSINESS Article Reprint • Page 1 of 8 2012 Financial Markets Preview Living creatively By Stacy Lawrence “As the capital markets Viren Mehta of Mehta Partners. “Many Senior Writer companies don’t have any option but to For small, early stage biotech compa- continue to be difficult, raise at lower valuations.” nies, 2012 could be the year of living traditional investors are able He added: “Many companies are not creatively. able to defer any longer. The moment Although public biotechs raised more to extract terms that are comes for many companies when they funds last year than ever before, the vast have to swallow hard and accept painful majority of the money was debt financing more and more onerous.” dilution.” by established companies with marketed products. Thus while the overall numbers Todd Wyche, Brinson Patrick look good and are likely to continue to do Cash on hand so, precommercial companies will have to large and mid-cap companies (see “The Market volatility and macroeconomic get creative with their financings. 1% Effect,” page 2). risk had most buysiders sitting on the Many of these companies avoided rais- In 2011, public biotechs raised $43 sidelines through the back half of 2011. ing money in 2011 because they didn’t billion, easily eclipsing the record $33.1 Bankers are hopeful that this year will be like the valuations, but Wall Streeters say billion in 2000. But debt accounted for more stable, in which case investors might they are now running out of cash. As a 82% of the total dollars raised, compared be willing to support more deal flow dur- result, they will have to use the tricks at to only 19% in 2000 (see “Debt Domi- ing 1H12 (see “Fear Factor,” page 5). -
Amgen Inc. V. Sanofi, No
No. IN THE Supreme Court of the United States ———— AMGEN INC., AMGEN MANUFACTURING LIMITED, AND AMGEN USA, INC., Petitioners, v. SANOFI, AVENTISUB LLC, REGENERON PHARMACEUTICALS INC., AND SANOFI-AVENTIS U.S., LLC, Respondents. ———— On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit ———— PETITION FOR A WRIT OF CERTIORARI ———— STUART L. WATT JEFFREY A. LAMKEN WENDY A. WHITEFORD Counsel of Record ERICA S. OLSON MICHAEL G. PATTILLO, JR. EMILY C. JOHNSON SARAH J. NEWMAN AMGEN INC. MOLOLAMKEN LLP One Amgen Center Drive The Watergate, Suite 660 Thousand Oaks, CA 91320 600 New Hampshire Ave., NW (805) 447-1000 Washington, D.C. 20037 (202) 556-2000 [email protected] Counsel for Petitioners :,/621(3(635,17,1*&2,1&± ±:$6+,1*721'& QUESTION PRESENTED The 1952 Patent Act requires patents to “contain a written description of the invention, and of the manner and process of making and using it.” 35 U.S.C. §112(a). The “written description” must be “in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” Ibid. “The object of the statute is to require the patentee to describe his invention so that others may construct and use it after the expiration of the patent.” Schriber-Schroth Co. v. Cleveland Tr. Co., 305 U.S. 47, 57 (1938). The Federal Circuit has construed §112(a) as impos- ing separate “written description” and “enablement” re- quirements subject to different standards. -
Corporate Responsibility Report
Corporate Responsibility Report October 2019 ©2019 Alkermes. All rights reserved. Table of Contents Section 1: Introduction . 2 Section 2: About Our Company . 3 Section 3: Our Approach to Corporate Responsibility . 4 Section 4: Environment . 6 Section 5: Social . 15 Section 6: Governance . 23 Section 7: The Future of Corporate Responsibility at Alkermes and About This Report . 27 ALKERMES • CORPORATE RESPONSIBILITY REPORT 1 SECTION 1 INTRODUCTION A Message from Our CEO Alkermes was founded by pioneers in the field of Inspired by the courage and determination of individuals neuroscience, and their legacy of innovation and in these frequently underserved and marginalized scientific excellence — applied to the real-world needs communities, we are driven to develop medicines and of patients — remains central to our mission. Alkermes contribute to systemic solutions that we hope will have technologies and discoveries have contributed to a meaningful impact on the lives of patients. important medicines that continue to shape the treatment landscape in many disease areas. Today, Our Commitment we are distinguished from other biopharmaceutical As we look toward building our business for the companies by our core focus on serious mental illness future, we are guided by the opportunity — and what and addiction — chronic, highly prevalent conditions we believe is our responsibility — to help address the that affect millions of people and represent some of unmet needs of patients and to operate in a sustainable, the most challenging public health issues of our time. socially responsible manner. We firmly believe that doing so is best for our business, our employees, for Great science. Deep compassion. -
Medicaid System (Mmis) Illinois Department of Run Date: 08/08/2015 Provider Subsystem Healthcare and Family Services Run Time: 21:25:58 Report Id 2794D052 Page: 01
MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 08/08/2015 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 21:25:58 REPORT ID 2794D052 PAGE: 01 ALPHA COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 10/01/2015 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 68782 (OSI) EYETECH 65162 AMNEAL PHARMACEUTICALS LLC 00074 ABBOTT LABORATORIES 69238 AMNEAL PHARMACEUTICALS, LLC 68817 ABRAXIS BIOSCIENCE, LLC 53150 AMNEAL-AGILA, LLC 16729 ACCORD HEALTHCARE INCORPORATED 00548 AMPHASTAR PHARMACEUTICALS, INC. 42192 ACELLA PHARMACEUTICALS, LLC 66780 AMYLIN PHARMACEUTICALS, INC. 10144 ACORDA THERAPEUTICS, INC. 55724 ANACOR PHARMACEUTICALS 00472 ACTAVIS 10370 ANCHEN PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 62559 ANIP ACQUISITION COMPANY 45963 ACTAVIS INC. 54436 ANTARES PHARMA, INC. 46987 ACTAVIS KADIAN LLC 52609 APO-PHARMA USA, INC. 49687 ACTAVIS KADIAN LLC 60505 APOTEX CORP. 14550 ACTAVIS PHARMA MFGING PRIVATE LIMITED 63323 APP PHARMACEUTICALS, LLC. 67767 ACTAVIS SOUTH ATLANTIC 42865 APTALIS PHARMA US, INC 66215 ACTELION PHARMACEUTICALS U.S., INC. 58914 APTALIS PHARMA US, INC. 52244 ACTIENT PHARMACEUTICALS 13310 AR SCIENTIFIC, INC. 75989 ACTON PHARMACEUTICALS 08221 ARBOR PHARM IRELAND LIMITED 76431 AEGERION PHARMACEUTICALS, INC. 60631 ARBOR PHARMACEUTICALS IRELAND LIMITED 50102 AFAXYS, INC. 24338 ARBOR PHARMACEUTICALS, INC. 10572 AFFORDABLE PHARMACEUTICALS, LLC 59923 AREVA PHARMACEUTICALS 27241 AJANTA PHARMA LIMITED 76189 ARIAD PHARMACEUTICALS, INC. 17478 AKORN INC 24486 ARISTOS PHARMACEUTICALS, INC. 24090 AKRIMAX PHARMACEUTICALS LLC 67877 ASCEND LABORATORIES, L.L.C. 68220 ALAVEN PHARMACEUTICAL, LLC 76388 ASPEN GLOBAL INC. 00065 ALCON LABORATORIES, INC. 51248 ASTELLAS 00998 ALCON LABORATORIES, INC. 00469 ASTELLAS PHARMA US, INC. 25682 ALEXION PHARMACEUTICALS 00186 ASTRAZENECA LP 68611 ALIMERA SCIENCES, INC. -
ENDO INTERNATIONAL PLC (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of the earliest event reported): January 16, 2015 ENDO INTERNATIONAL PLC (Exact name of registrant as specified in its charter) Ireland 001-36326 Not Applicable (State or other jurisdiction of (Commission (I.R.S Employer incorporation or organization) File Number) Identification No.) Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland Not Applicable (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code 011-353-1-268-2000 Not Applicable Former name or former address, if changed since last report Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: x Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 8.01 Other Events. This Current Report on Form 8-K is being filed pursuant to a memorandum of understanding regarding the settlement of certain litigation relating to the proposed merger (the “Merger”) between Auxilium Pharmaceuticals, Inc. (“Auxilium”) and Avalon Merger Sub Inc. (“Merger Sub”) pursuant to that certain Amended and Restated Agreement and Plan of Merger, dated as of November 17, 2014 (the “Merger Agreement”), by and among Auxilium, Endo International plc (“Endo”), Endo U.S. -
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. -
The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry
The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry By: Maitri Punjabi Honors Thesis Economics Department The University of North Carolina at Chapel Hill March 2016 Approved: ______________________________ Dr. Jonathan Williams Punjabi 2 Abstract This paper analyzes the effect of the changing nature of innovation on pharmaceutical firm market value from the years 1987 to 2010 by using U.S. patent and claim data. Over the years, firms have started shifting focus from primary innovation to secondary innovation as new ideas and new compounds become more difficult to generate. In this study, we analyze the impact of this patent portfolio shift on the market capitalization of pharmaceutical firms. After using firm fixed effects and the instrumental variable approach, we find that there exists a strong positive relationship between secondary innovations and the market value of the firm– in fact, we find a stronger relationship than is observed between primary innovation and market value. When focusing on the different levels of innovation within the industry, we find that this relationship is stronger for less-innovative firms (those that have produced fewer patents) than it is for highly- innovative firms. We also find that this relationship is stronger for firms that spend less on research and development, complementing earlier findings that research productivity is declining over time. Punjabi 3 Acknowledgements I would primarily like to thank my adviser, Dr. Jonathan Williams, for his patience and constant support. Without his kind and helpful attitude, this project would have been a much more frustrating process. Through his knowledge of the industry, I have gained valuable insight and have learned a great deal about a unique and growing field. -
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. -
US Pharma's Business Model
INNOVATION-FUELLED, SUSTAINABLE, INCLUSIVE GROWTH Working Paper US Pharma’s Business Model: Why It Is Broken, and How It Can Be Fixed William Lazonick Matt Hopkins Ken Jacobson Mustafa Erdem Sakinç Öner Tulum The Academic-Industry Research Network 13/2017 May This project has received funding from the European Union Horizon 2020 Research and Innovation action under grant agreement No 649186 US Pharma’s Business Model: Why It Is Broken, and How It Can Be Fixed William Lazonick Matt Hopkins Ken Jacobson Mustafa Erdem Sakinç Öner Tulum The Academic-Industry Research Network (www.theAIRnet.org) Revised, May 22, 2017 Chapter for inclusion in David Tyfield, Rebecca Lave, Samuel Randalls, and Charles Thorpe, eds., The Routledge Handbook of the Political Economy of Science The contents of this chapter are drawn from two contributions by the Academic- Industry Research Network to the United Nations Secretary-General’s High-Level Panel on Access to Medicines: http://www.unsgaccessmeds.org/list-of-contribution/ William Lazonick is Professor of Economics, University of Massachusetts Lowell; Visiting Professor, University of Ljubljana; Professeur Associé, Institut Mines- Télécom; and President, The Academic-Industry Research Network (theAIRnet); Matt Hopkins, Ken Jacobson, Mustafa Erdem Sakinç, and Öner Tulum are researchers at theAIRnet. Jacobson is also theAIRnet communications director. Sakinç has just completed a PhD in economics at the University of Bordeaux. Tulum is a PhD student at the University of Ljubljana. Funding for this research came from the Institute for New Economic Thinking (Collective and Cumulative Careers project), the European Union Horizon 2020 Research and Innovation Programme under grant agreement No.