DOCSLIB.ORG

BRISTOL-MYERS SQUIBB COMPANY (Exact Name of Registrant As Specified in Its Charter) ______

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
BRISTOL-MYERS SQUIBB COMPANY (Exact Name of Registrant As Specified in Its Charter) ______ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________ FORM 10-K _______________ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2016 Commission File Number 1-1136 _______________ BRISTOL-MYERS SQUIBB COMPANY (Exact name of registrant as specified in its charter) ________________ Delaware 22-0790350 (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 345 Park Avenue, New York, N.Y. 10154 (Address of principal executive offices) Telephone: (212) 546-4000 Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registered Common Stock, $0.10 Par Value New York Stock Exchange 1.000% Notes due 2025 New York Stock Exchange 1.750% Notes due 2035 New York Stock Exchange Securities registered pursuant to Section 12(g) of the Act: Title of each class $2 Convertible Preferred Stock, $1 Par Value _________________ Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x 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 x Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 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 x No ¨ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of the 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. ¨ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. Large accelerated filer x Accelerated filer ¨ Non-accelerated filer ¨ Smaller reporting company ¨ Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x The aggregate market value of the 1,669,074,782 shares of voting common equity held by non-affiliates of the registrant, computed by reference to the closing price as reported on the New York Stock Exchange, as of the last business day of the registrant’s most recently completed second fiscal quarter (June 30, 2016 ) was approximately $122,760,450,216. Bristol-Myers Squibb has no non-voting common equity. At February 1, 2017 , there were 1,672,715,340 shares of common stock outstanding. DOCUMENTS INCORPORATED BY REFERENCE: Portions of the Proxy Statement for the registrant’s Annual Meeting of Stockholders to be held May 2, 2017, to be filed within 120 days after the conclusion of the registrant's fiscal year ended December 31, 2016 , are incorporated by reference into Part III of this Annual Report on Form 10-K. BRISTOL-MYERS SQUIBB COMPANY INDEX TO FORM 10-K DECEMBER 31, 2016 PART I Item 1. Business 3 Acquisitions and Divestitures 3 Products, Intellectual Property and Product Exclusivity 3 Research and Development 8 Alliances 10 Marketing, Distribution and Customers 12 Competition 13 Pricing, Price Constraints and Market Access 13 Government Regulation 14 Sources and Availability of Raw Materials 16 Manufacturing and Quality Assurance 16 Environmental Regulation 16 Employees 17 Foreign Operations 17 Bristol-Myers Squibb Website 17 Item 1A. Risk Factors 18 Item 1B. Unresolved Staff Comments 23 Item 2. Properties 23 Item 3. Legal Proceedings 23 Item 4. Mine Safety Disclosures 23 PART IA Executive Officers of the Registrant 24 PART II Item 5. Market for the Registrant's Common Stock and Other Stockholder Matters 25 Item 6. Selected Financial Data 27 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 28 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 52 Item 8. Financial Statements and Supplementary Data 53 Consolidated Statements of Earnings and Comprehensive Income 53 Consolidated Balance Sheets 54 Consolidated Statements of Cash Flows 55 Notes to the Financial Statements 56 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 101 Item 9A. Controls and Procedures 101 Item 9B. Other Information 101 PART III Item 10. Directors and Executive Officers of the Registrant 103 Item 11. Executive Compensation 103 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 103 Item 13. Certain Relationships and Related Transactions 103 Item 14. Auditor Fees 103 PART IV Item 15. Exhibits and Financial Statement Schedule 103 Item 16. Form 10-K Summary 103 SIGNATURES 104 SUMMARY OF ABBREVIATED TERMS 105 EXHIBIT INDEX 106 * Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index. PART I Item 1. BUSINESS. General Bristol-Myers Squibb Company was incorporated under the laws of the State of Delaware in August 1933 under the name Bristol-Myers Company, as successor to a New York business started in 1887. In 1989, Bristol-Myers Company changed its name to Bristol-Myers Squibb Company as a result of a merger. We are engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis. Refer to the Summary of Abbreviated Terms at the end of this 2016 Form 10-K for terms used throughout the document. We operate in one segment—BioPharmaceuticals. For additional information about business segments, refer to “Item 8. Financial Statements—Note 2 . Business Segment Information.” We compete with other worldwide research-based drug companies, smaller research companies and generic drug manufacturers. Our products are sold worldwide, primarily to wholesalers, retail pharmacies, hospitals, government entities and the medical profession. We manufacture products in the U.S., Puerto Rico and in five foreign countries. Most of our revenues come from products in the following therapeutic classes: oncology; cardiovascular; immunoscience; and virology, including HIV infection. The percentage of revenues by significant region/country were as follows: Year Ended December 31, Dollars in Millions 2016 2015 2014 United States 55% 49% 49% Europe 22% 21% 23% Japan 7% 10% 6% Other 16% 20% 22% Total Revenues $ 19,427 $ 16,560 $ 15,879 Acquisitions and Divestitures Acquisitions in the last five years include Cormorant and Padlock in 2016, Cardioxyl and Flexus in 2015, iPierian in 2014 and Amylin and Inhibitex in 2012 and we also entered into several license and other collaboration arrangements. Divestitures in the last five years include certain OTC products and investigational HIV medicines businesses in 2016, Erbitux* in North America and certain mature and other OTC product businesses in 2015 and our diabetes business in 2014. These transactions continue to allow us to focus our resources behind growth opportunities which drive the greatest long-term value. Products, Intellectual Property and Product Exclusivity Our pharmaceutical products include chemically-synthesized drugs, or small molecules, and products produced from biological processes, called “biologics.” Small molecule drugs are typically administered orally, e.g., in the form of a pill or tablet, although other drug delivery mechanisms are used as well. Biologics are typically administered to patients through injections or by intravenous infusion. Below is a product summary including approved indications. For information about our alliance arrangements for the products below, refer to “—Alliances" below and "Item 8. Financial Statements—Note 3 . Alliances.” Empliciti Empliciti , a biological product, is a humanized monoclonal antibody for the treatment of multiple myeloma. Opdivo Opdivo , a biological product, is a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. Opdivo has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo + Yervoy regimen also is approved in multiple markets for the treatment of melanoma. There are several ongoing potentially registrational trials for Opdivo across other tumor types and other disease areas. Sprycel Sprycel is a multi-targeted tyrosine kinase inhibitor approved for the first-line treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate). Yervoy Yervoy , a biological product, is a monoclonal
Load more

Recommended publications
  • Downloads but Many Other Countries — Such As the RCMP Said the Policy Revisions /JJ Release on April30.Pdf)
    CMAJ News For the record Published at www.cmaj.ca between Apr. The new warning letter regards in persistent or significant disability or 20 and May 18 breaches uncovered during a July– incapacity, be life-threatening or result August 2009 FDA inspection of an in death. Apotex receives second FDA Apotex facility located at 150 Signet The report indicates that there has Drive in Toronto, during which “sev- been a steady increase of adverse reac- warning eral violations that are identical” to tion reports since 2001, when roughly those found during the inspection of the 11 000 incidents were reported (www.hc he United States Food and Drug Etobicoke facility were discovered. -sc.gc.ca/dhp-mps/alt_formats/pdf/med Administration (FDA) has “These identical CGMP violations eff/bulletin/carn-bcei_v20n2-eng.pdf). T issued a second warning letter demonstrated a lack of adequate Roughly 70% (18 301) of 2009 inci- in a year to Toronto, Ontario-based process controls and raised serious dents involved pharamaceuticals, while generic drug manufacturer Apotex Inc. questions regarding your corporation’s 23% (5998) involved biotechnology for lapses in good manufacturing prac- quality and production systems,” the products. There were 833 adverse reac- tices. warning letter states. tion reports involving biologics, 516 The violations cause Apotex drug The violations included contamina- involving natural health products, 379 products to be considered “adulterated” tion of a diabetes drug with an “active involving radiopharmaceuticals and 34 within US regulations
    [Show full text]
  • DCAT MEMBER COMPANY MEETING LOCATOR V. 6 the BENJAMIN Sri Krishna Pharmaceuticals Ltd
    DCAT MEMBER COMPANY MEETING LOCATOR v. 6 THE BENJAMIN Sri Krishna Pharmaceuticals Ltd. Zydus Pharmaceuticals (USA) Inc. Amino Chemicals Ltd. Apogee Pharma, Inc. INTERCONTINENTAL BARCLAY C2 PHARMA AbbVie* Calyx Chemicals & Pharmaceuticals Ltd. ACIC Pharmaceuticals Inc. ChemCon GmbH Advitech SA Concord Biotech Limited Amneal Pharmaceuticals LLC Dipharma Francis Srl ALP Pharm DSM Sinochem Pharmaceuticals AMRI Emergent BioSolutions Asymchem Inc. F.I.S. - Fabbrica Italiana Sintetici S.p.A. Capsugel, Now a Lonza Company* Indena S.p.A. CBC AMERICAS Corp. Jost Chemical Co. CellMark USA, LLC Jubilant Pharma Charioteer Pharmaceutical Co., Ltd., Zhejiang PharmSource, A GlobalData Company Chemical and Pharmaceutical Solutions PolyPeptide Group Chiral Quest Corp. ROHNER Inc. Croda, Inc. SST Corporation DFE Pharma HOTEL 48LEX DPL-US EQ Esteve AB BioTechnologies, Inc. Evonik Corporation AGC Biologics FAREVA SA AiPing Pharmaceutical, Inc. Flavine North America, Inc. Almac Formosa Laboratories, Inc. Aptuit LLC Grifols International S.A. AZAD Fine Chemicals Ltd. Hainan Poly Pharm. Co., Ltd. Cambridge Isotope Laboratories, Inc. Harris Pharmaceutical Groupe Parima Helm AG Navin Fluorine International Limited Hetero USA, Inc. Qualicaps, Inc. Hikal, Ltd. RC2 Pharma Connect LLC Interchem Corporation Recipharm Inventia Healthcare PVT LTD Recro Gainesville LLC Johnson Matthey Reed-Lane, Inc. Kingchem Life Science LLC Sancilio Pharmaceuticals Company, Inc. Please note: Some DCAT member companies have requested not to be listed in the locator. (*) indicates member companies with Business Meeting Spaces in more than one hotel. INTERCONTINENTAL BARCLAY CONT'D LOTTE NY PALACE Legacy Pharmaceutical Packaging AbbVie* Lonza AG* Acella Pharmaceuticals Neuland Laboratories Ltd. Alcami Corporation Orion Group Alembic Pharmaceuticals Limited Par Pharmaceutical, Inc. Aphena Pharma Solutions PCI Pharma Services Aptar Pharma PHF SA Aristo Pharma Polymed Therapeutics, Inc.
    [Show full text]
  • [ Biopharmaceuticals ] Support Programs Invest in Canada to and Innovation Achieve Global Excellence
    [ BIOPHARMACEUTICALS ] SUPPORT PROGRAMS INVEST IN CANADA TO AND INNOVATION ACHIEVE GLOBAL EXCELLENCE A DYNAMIC RESEARCH AND INNOVATION NETWORK A WELCOMING BUSINESS ENVIRONMENT FINANCIAL STABILITY Canada is ranked as the best country for For six consecutive years, the World Economic Canada’s research excellence is recognized in cardiovascular and metabolic disorders, neuroscience, oncology business in the G-20. Forum has declared Canada’s banking system and infectious diseases and vaccines. Canada is a leader in the development of key technology platforms, Source: Forbes and Bloomberg to be the soundest in the world. including stem cells and regenerative medicine, genomics and antibody technologies. Source: World Economic Forum (WEF) ■ British Columbia’s Centre for Drug Research and Development addresses the challenge of fi nding how A HIGHLY EDUCATED WORKFORCE promising health research conducted at the university level can be translated into commercially viable Canada’s workforce is the most highly UNPARALLELED MARKET ACCESS solutions; educated among members of the OECD, Canada’s NAFTA advantage gives investors with half of its working-age population access to 470 million consumers. Many Canadian ■ Genome Alberta, a public not-for-profi t corporation, initiates, funds and manages genomics research having a tertiary-level education. production hubs are actually closer to U.S. markets and partnerships; Source: Organisation for Economic Co-operation than American production sites—of Canada’s and Development (OECD) ■ Saskatoons Vaccine and
    [Show full text]
  • SANOFI DECISION: THREE YEARS LATER* Patrick S
    THE SUPREME COURT’S SANOFI DECISION: THREE YEARS LATER* Patrick S. Smith and Donald M. Cameron** ABSTRACT In 2008, the Supreme Court of Canada’s decision in Apotex Inc. v. Sanofi-Synthelabo Canada Inc. restated the test for anticipation under Canadian patent law to expressly include enablement. Sanofi also provided an analytical approach for obviousness and provided the option of using the “obvious to try” test in areas where inventions are often won by experimentation. This article reviews the most important cases from 2008 to 2011 that have applied the Sanofi decision. The Supreme Court’s Sanofi Decision: Three Years Later* Patrick S. Smith and Donald M. Cameron** . 281 RÉSUMÉ 1.0 Introduction . 282 En 2008, la décision de la Cour suprême du Canada dans l’affaire Apotex Inc. c. 1.1 The New Anticipation Test . 282 Sanofi-Synthelabo Canada Inc. a reformulé le critère de l’antériorité en vertu de la loi 1.2 The New Obviousness Test . 283 canadienne sur les brevets de façon à y inclure la notion de « caractère réalisable ». 1.3 How We Conducted the Review . 283 Elle a aussi établi la méthode analytique à adopter concernant l’évidence, et a offert la 2.0 Anticipation . 284 possibilité d’appliquer le critère de l’« essai allant de soi » dans les domaines où les 2.1 What Did Sanofi Do Regarding Enablement? . 284 inventions sont souvent le fruit de l’expérimentation. L’article passe en revue les plus 2.2 Post-Sanofi Enablement Decisions . 285 importantes causes qui ont utilisé la décision Sanofi entre 2008 et 2011.
    [Show full text]
  • Biomedical Conflicts of Interest: a Defence of the Sequestration Thesis
    Biomedical Conflicts of Interest: a defence of the sequestration thesis Learning from the cases of Nancy Olivieri and David Healy Arthur Schafer, Centre for Professional and Applied Ethics, University of Manitoba, Canada Abstract No discussion of academic freedom, research integrity and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self-examination within the biomedical research community. The first part of the essay analyses this pair of recent academic scandals. The two case studies are then placed in their historical context – that context being the transformation of the norms of science through increasingly close ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticized and the radical approach defended. Two case studies: Olivieri and Healy The leading individual roles in this diptych are taken by two internationally eminent medical researchers, haematologist Nancy Olivieri and psychiatrist David Healy. The institutional players include one research-intensive university (the University of Toronto) and two affiliated research-intensive teaching hospitals (the Hospital for Sick Children, referred to as “Sick Kids” and the Centre for Addiction and Mental Health, referred to as “CAMH”).
    [Show full text]
  • Dances with the Pharmaceutical Industry
    Commentaire Dances with the pharmaceutical industry Elaine Gibson, Françoise Baylis, Steven Lewis n a recent commentary published in this journal, we, tent with ethical guidelines governing research in Canada,7 along with others, described the relationship of univer- the REB instructed her to disclose her concern to all re- sity-based medical researchers with industry as a risky search participants. When she moved to comply with the I 1 dance with a porcupine. Our focus was the pharmaceutical REB’s directive, Apotex terminated the 2 trials in progress industry and how its fundamental need to satisfy sharehold- in Toronto and Olivieri’s consulting contract for a third in- ers could, and at times did, conflict with a researcher’s ternational trial. As well, Apotex threatened legal action agenda to seek and unveil truth. against Olivieri should she attempt to inform patients or Now, for a close-up view of dance partners wildly out of anyone else of her concerns. Sometime after the trials were step, we turn to the case of Nancy Olivieri. Her stormy rela- terminated, Olivieri identified a second unexpected risk, tionship with Apotex Inc., Toronto’s Hospital for Sick Chil- i.e., that the drug may cause progression of liver fibrosis. dren (HSC) and the University of Toronto has been exten- Patients receiving the drug and the regulatory authorities sively reviewed, not once but twice, in reports that reach were notified directly of this additional risk by Olivieri. diametrically opposite conclusions on some of the major is- During this period, Apotex and the University of Toronto sues at stake.
    [Show full text]
  • Manufacturers That Made Paab Submissions in 2019
    MANUFACTURERS THAT MADE PAAB SUBMISSIONS IN 2019 AbbVie Corporation Medunik Canada Aequus Pharmaceuticals, Inc. Merck Frosst Canada Ltd. Akcea Therapeutics Canada Merus Labs Alk-Abello Pharmaceuticals Inc Mitsubishi Tanabe Pharma America, Inc. Allergan Canada Mylan Pharmaceuticals ULC Amgen Canada Inc. Novadaq Technologies ULC Amicus Therapeutics UK Ltd Novartis Canada Inc. ApoPharma Inc Novartis Consumer Health Apotex Inc. Novo Nordisk Canada Inc. Astellas Pharma Canada, Inc. Otsuka Canada Pharmaceutical AstraZeneca Canada Inc. Paladin Laboratories AVIR Pharma Inc. Pediapharm Bausch & Lomb Canada Inc. PendoPharm Bayer Inc. Pfizer Canada Inc. BioSyent Pharma Inc. Pharm Canada Inc. Boehringer Ingelheim Ltd. Pierre Fabre Dermo-Cosmétique Canada Inc. Boiron Canada Inc. Purdue Pharma Bristol Myers Squibb Reckitt Benckiser Canada Inc. Celgene Recordati Rare Diseases Inc. CSL Behring Canada Inc. Sandoz Canda Inc. Dr. Reddy's Lab. Can. Inc. Sanofi Consumer Health Inc. Duchesnay Inc. Sanofi Pasteur Limited Eli Lilly Canada Inc. Sanofi-Aventis Canada Inc. EMD Serono Searchlight Pharma Inc. Emergent BioSolutions Canada Inc. Seattle Genetics, Inc. Evolus, Inc. Servier Canada Ferring Inc. Shire Canada Inc. Galderma Canada Sprout Pharmaceuticals Canada, Ltd. Genzyme Canada Inc. Stallergenes Canada Inc. Gilead Sciences Canada STI Technologies Limited GlaxoSmithKline Sunovion Pharmaceuticals Inc. Hill Dermaceuticals, Inc. Taiho Pharma Canada Inc. Hoffmann-La Roche Ltd Takeda Canada Indivior Canada Ltd Teligent Canada Inc. Intercept Pharmaceuticals, Inc TerSera Canada Inc. Ipsen Limited Teva Canada Innovation Iroko International LP Teva Canada Limited JAMP Pharma Corporation Tribute Pharmaceuticals Janssen Inc. Valeant Canada Consumer Prods. Kaleo, Inc. Valeant Pharma Knight Therapeutics Inc. Valeo Pharma Inc. Leo Pharma Inc. Valneva Canada Inc. Lundbeck Canada Vertex Pharmaceuticals Inc.
    [Show full text]
  • Kerry Jd Winter
    SCC Court File No.: SUPREME COURT OF CANADA (ON APPEAL FROM THE COURT OF APPEAL FOR ONTARIO) B E T W E E N: KERRY J.D. WINTER, JEFFREY BARKIN, PAUL T. BARKIN and JULIA WINTER, personal representative of DANA C. WINTER, deceased Applicants (Appellant) - and - THE ESTATE OF BERNARD C. SHERMAN, deceased, MEYER F. FLORENCE, APOTEX INC. and JOEL D. ULSTER Respondents (Respondents) AMENDED APPLICATION FOR LEAVE TO APPEAL Under s. 40(1) of the Supreme Court Act and Rule 25 of the Rules of the Supreme Court of Canada CAZA SAIKALEY S.R.L./LLP 350-220, av. Laurier Ouest Ottawa, ON K1P 5Z9 Ronald F. Caza ([email protected]) Albert Brunet ([email protected]) Tel: (613) 565-2292 Fax: (613) 565-2098 McGuinty Law Offices 1192 Rockingham Ave. Ottawa, ON K1H 8A7 Gigi Constanzo ([email protected]) Dylan McGuinty Jr. ([email protected]) Tel: (613) 526-3858 Fax: (613) 526-3187 TO: The Registrar Supreme Court of Canada 301 Wellington Street Ottawa ON K1A COPIES TO: Stikeman Elliott 5300 Commerce Court West 199 Bay Street Toronto, ON M5L 1B9 Katherine L. Kay ([email protected]) Mark Walli ([email protected]) Tel: (416) 869-5277 Fax: (416) 947-0866 INDEX TAB DOCUMENT PAGE 1. Original Application for Leave to Appeal, filed October 29, 2018 1-18 and Notice of Application filed on April 23, 2019 2. Notice of Application for Leave to Appeal 19-21 3. Judgments from lower courts A. Winter v. Sherman, 2017 ONSC 5492 22-32 B. Winter v. Sherman Estate, 2018 ONCA 703 33-38 4.
    [Show full text]
  • APOTEX, INC.1 Preparation Questions: Based on Your Reading of The
    APOTEX, INC.1 500 products under development Apotex reports that it plans to spend about $200 Preparation questions: Based on your reading of the million a year on R&D (about 10% of sales); in materials, together with your understanding of 2007, the company reported R & D expenditures strategies for generic drug firms, what are the key of $181 million. challenges that Apotex faces in its market segment? Canada position (2013; IMS data) Contents Canadian sales (IMS data) A. Company overview o 2015: $1.123 billion B. Apotex generic drug approvals in the US, o 2014: $1.158 billion 2001-2016 o 2013: $1.190 billion C. Example of a successful introduction (Norvasc) o 2012: $1.265 billion D. Example of an unsuccessful introduction o 2011: $1.206 billion (Plavix) o 2010: $1.354 billion E. 2008-2016: GMP issues and litigation o 2004: $785 million o 2003: $676 million Drug store sales (2015): 98.7% (balance in A. COMPANY OVERVIEW hospitals) Top five Apotex drugs in Canada (2015, Background IMS data) o Apo-Atorvastatin (generic Lipitor): Apotex is the largest Canadian-owned $97.4 million (6.1% growth) pharmaceutical company. o Apo-Esomeprazole (generic Nexium): $89.5 million (12% decline) o Apo-Rosuvastatin (generic Crestor): Founded: 1974 $41.0 million (3.2% growth) Headquarters: 150 Signet Drive, Toronto o Apo-Mometasone (generic Nasonex): Employees (2016): About 8,000 to 10,000; $39.0 million (22.6% growth) ~4,000 outside Canada (based on CapitalIQ o Apo-Omeprazole (generic Prilosec): estimates and company reports) $33.8 million (21.4% growth) Estimated sales (2016): ~$2 billion (based o Other key drugs: Apo-Clopidogrel on company reports) (Plavix; launched 2011), Apo- Risedronate (Actonel), Apo-Furosemide Key executives (Lasix; 1976), Apo- hydro Dr.
    [Show full text]
  • Apo-Abacavir-Lamivudine-Zidovudine
    PRODUCT MONOGRAPH Pr APO-ABACAVIR-LAMIVUDINE-ZIDOVUDINE Abacavir, Lamivudine and Zidovudine Tablets Apotex Standard 300 mg abacavir (as abacavir sulfate), 150 mg lamivudine and/ 300 mg zidovudine tablets Antiretroviral Agent APOTEX INC. DATE OF REVISION: 150 Signet Drive September 7, 2017 Toronto, Ontario M9L 1T9 Submission Control No: 208712 Page 1 of 55 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND PRECAUTIONS ....................................................................................... 4 ADVERSE REACTIONS .....................................................................................................12 DRUG INTERACTIONS ......................................................................................................16 DOSAGE AND ADMINISTRATION .....................................................................................22 OVERDOSAGE ...................................................................................................................23 ACTION AND CLINICAL PHARMACOLOGY ......................................................................24 STORAGE AND STABILITY
    [Show full text]
  • The Drug Trial: Nancy Olivieri and the Science Scandal That Rocked the Hospital for Sick Children
    The Drug Trial: Nancy Olivieri and the Science Scandal that Rocked the Hospital for Sick Children Miriam Shuchman, Random House, 451 pp., $34.95. Review written by: Arthur Schafer Nancy Olivieri is famous for raising doubts about an experimental drug with which she was treating thalassemia patients. Her principled stand, and the resulting scandal, led universities to offer researchers some protection against illegitimate drug company pressure. Medical journals changed their publication rules. Research hospitals changed their policies. She became an international icon. Apotex, the drug company which tried to silence her, has attracted international opprobrium. The company threatened to sue Olivieri if she publicly revealed her fears about the inadequacy of their drug, deferiprone. She sued them for libeling her; they sued her ($20 million) for libeling their drug. Apotex claims still to believe in the virtue of deferiprone, but the company has been heavily criticized for conduct which many have interpreted as placing profits ahead of patient safety. Apotex is not alone in the dock of public opinion. Every week seems to bring some new scandal involving drug company suppression of negative data: think Prozac [Eli Lilly], Vioxx [Merck] and Celebrex [Pfizer]. Big Pharma is facing a crisis. Public trust in drug company sponsored research is plummeting. Olivieri’s hospital, Sick Kids, and her university, the U of T, have also taken a public drubbing for failing to provide her with effective support as she struggled with Apotex. Actually, not only was Olivieri denied effective support, she was fired from her position and experienced harassment of almost every kind.
    [Show full text]
  • Bristol-Myers Squibb Company
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________ FORM 10-K ___________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to _______ Commission File Number 001-01136 ___________________________ BRISTOL-MYERS SQUIBB COMPANY (Exact name of registrant as specified in its charter) ___________________________ Delaware 22-0790350 (State or other jurisdiction of (I.R.S Employer incorporation or organization) Identification No.) 430 E. 29th Street, 14FL, New York, NY 10016 (Address of principal executive offices) (212) 546-4000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.10 Par Value BMY New York Stock Exchange 1.000% Notes due 2025 BMY25 New York Stock Exchange 1.750% Notes due 2035 BMY35 New York Stock Exchange Celgene Contingent Value Rights CELG RT New York Stock Exchange Securities registered pursuant to Section 12(g) of the Act: Title of each class $2 Convertible Preferred Stock, $1 Par Value ___________________________ 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.
    [Show full text]