AMGEN INC. V. SANOFI
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Mark One) (X) QUARTERLY REPORT PURSUANT to SECTION 13 OR 15(D) of the SECURITIES EXCHANGE ACT of 1934
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) (X) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 1997 ------------------ 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 0-19034 ------- REGENERON PHARMACEUTICALS, INC. ------------------------------------------------------ (Exact name of registrant as specified in its charter) New York 13-3444607 ------------------------------- ------------------------------------ (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 777 Old Saw Mill River Road Tarrytown, New York 10591-6707 ---------------------------------------- ---------- (Address of principal executive offices) (Zip code) (914) 347-7000 ---------------------------------------------------- (Registrant's telephone number, including area code) 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 the number of shares outstanding of each of the issuer's classes of common stock as of November 3, 1997: Class of Common Stock -
Sixth Circuit I.O.P
RECOMMENDED FOR FULL-TEXT PUBLICATION Pursuant to Sixth Circuit I.O.P. 32.1(b) File Name: 15a0199p.06 UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT _________________ DINO RIKOS et al., ┐ Plaintiffs-Appellees, │ │ │ No. 14-4088 v. │ > │ THE PROCTER & GAMBLE COMPANY, │ Defendant-Appellant. │ ┘ Appeal from the United States District Court for the Southern District of Ohio at Cincinnati. No. 1:11-cv-00226—Timothy S. Black, District Judge. Argued: June 16, 2015 Decided and Filed: August 20, 2015 Before: MOORE and COOK, Circuit Judges; COHN, District Judge.* _________________ COUNSEL ARGUED: Brian J. Murray, JONES DAY, Chicago, Illinois, for Appellant. Timothy G. Blood, BLOOD HURST & O’REARDON, San Diego, California, for Appellees. ON BRIEF: Brian J. Murray, JONES DAY, Chicago, Illinois, D. Jeffrey Ireland, FARUKI IRELAND & COX P.L.L., Cincinnati, Ohio, Joanne Lichtman, BAKER & HOSTETLER LLP, Cleveland, Ohio, Chad A. Readler, Rachel Bloomekatz, JONES DAY, Columbus, Ohio, for Appellant. Timothy G. Blood, Leslie E. Hurst, Thomas J. O’Reardon II, BLOOD HURST & O’REARDON, San Diego, California, for Appellees. MOORE, J., delivered the opinion of the court in which COHN, D.J., joined. COHN, D.J. (pg. 37), delivered a separate concurring opinion. COOK, J. (pp. 38–40), delivered a separate dissenting opinion. *The Honorable Avern Cohn, United States District Judge for the Eastern District of Michigan, sitting by designation. 1 No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 2 _________________ OPINION _________________ KAREN NELSON MOORE, Circuit Judge. The named plaintiffs-appellees (“Plaintiffs”) are three individuals who purchased Align, Procter & Gamble’s (“P&G”) probiotic nutritional supplement, and found that the product did not work as advertised—that is, it did not promote their digestive health. -
BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant
Case: 20-1373 Document: 41 Page: 1 Filed: 04/21/2020 United States Court of Appeals for the Federal Circuit ______________________ BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant v. BANNER LIFE SCIENCES LLC, Defendant-Appellee ______________________ 2020-1373 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-02054-LPS, Chief Judge Leonard P. Stark. ______________________ Decided: April 21, 2020 ______________________ JAMES B. MONROE, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, for plaintiff-ap- pellant. Also represented by PAUL WILLIAM BROWNING, J. MICHAEL JAKES, LAURA POLLARD MASUROVSKY, JASON LEE ROMRELL. KYLE MUSGROVE, Parker Poe Adams & Bernstein LLP, Charlotte, NC, for defendant-appellee. Also represented by JOHN WORTHINGTON BATEMAN, ELIZABETH CROMPTON, SCOTT A. CUNNING, II, Washington, DC. ______________________ Case: 20-1373 Document: 41 Page: 2 Filed: 04/21/2020 2 BIOGEN INTERNATIONAL GMBH v. BANNER LIFE SCIENCES LLC Before LOURIE, MOORE, and CHEN, Circuit Judges. LOURIE, Circuit Judge. Biogen International GmbH (“Biogen”) appeals from a judgment of the United States District Court for the Dis- trict of Delaware that Banner Life Sciences LLC (“Banner”) does not infringe the extended portion of U.S. Patent 7,619,001 (the “’001 patent”), extended under the patent term restoration provisions of the Hatch-Waxman Act, Pub. L. No. 98-417, § 201, 98 Stat. 1585, 1598 (as codified at 35 U.S.C. § 156 (2018)). Biogen Int’l GmbH v. Banner Life Scis. LLC, No. 18-2054-LPS, 2020 WL 109499 (D. Del. Jan. 7, 2020) (“Decision”). Because the scope of a patent term extension under 35 U.S.C. -
In the United States District Court for the District of Delaware
Case 1:20-cv-00561-UNA Document 1 Filed 04/24/20 Page 1 of 27 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE AMGEN INC. and AMGEN MANUFACTURING, LIMITED, C.A. No. ________ Plaintiffs, v. HOSPIRA, INC. and PFIZER INC., DEMAND FOR JURY TRIAL Defendants. COMPLAINT Plaintiffs Amgen Inc. and Amgen Manufacturing, Limited (collectively, “Plaintiffs”), by and through their undersigned attorneys, for their Complaint against Defendants Hospira, Inc. and Pfizer Inc. (collectively, “Defendants”) hereby allege as follows: THE PARTIES 1. Amgen Inc. is a corporation existing under the laws of the State of Delaware, with its principal place of business at One Amgen Center Drive, Thousand Oaks, California, 91320. Amgen Inc. discovers, develops, manufactures, and sells innovative therapeutic products based on advances in molecular biology, recombinant DNA technology, and chemistry. Founded in 1980, Amgen Inc. is a pioneer in the development of biological human therapeutics. Today, Amgen Inc. is one of the largest biotechnology companies in the world, fueled in part by the success of NEUPOGEN® (filgrastim). 2. Amgen Manufacturing, Limited (“AML”) is a corporation existing under the laws of Bermuda with its principal place of business in Juncos, Puerto Rico. AML manufactures and sells biologic medicines for treating particular diseases in humans. AML is a wholly-owned subsidiary of Amgen Inc. Case 1:20-cv-00561-UNA Document 1 Filed 04/24/20 Page 2 of 27 PageID #: 2 3. On information and belief, Hospira, Inc. (“Hospira”) is a corporation existing under the laws of the State of Delaware, with its principal place of business at 275 North Field Drive, Lake Forest, Illinois 60045. -
Human Sequencing Resource with UK Biobank
January 8, 2018 Regeneron Forms Consortium of Leading Life Sciences Companies to Accelerate Largest Widely-Available 'Big Data' Human Sequencing Resource with UK Biobank By end of 2019, Regeneron plans to sequence the exomes of all 500,000 people within the UK Biobank resource, all with associated health records, creating an unprecedented resource linking human genetic variations to human biology and disease AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer will join Regeneron to co-fund one of the industry's most ambitious 'pre-competitive' research efforts Exome sequencing data and findings will be openly available to other researchers TARRYTOWN, N.Y., Jan. 8, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), along with new collaborators AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer Inc., today announced the formation of a major 'pre-competitive' consortium to fund the generation of genetic exome sequence data from the 500,000 volunteer participants who make up the UK Biobank health resource. The newly announced collaborators will each commit $10 million to enable a dramatic acceleration of sequencing timelines, and additional companies are considering joining the consortium. Regeneron will conduct the sequencing effort. The sequencing data will be paired with detailed, de-identified medical and health records within the UK Biobank resource, including enhanced measures such as brain, heart and body imaging, to create an unparalleled resource for linking human genetic variations to human biology and disease. It was originally planned that sequencing of all 500,000 samples in the UK Biobank would be completed by 2022, with the first 50,000 people sequenced during 2017 with funding from Regeneron and GlaxoSmithKline. -
Surprises in the Industry's Most Profitable Companies
June 20, 2008 Surprises in the industry's most profitable companies Evaluate Vantage An analysis of the industry’s most profitable companies last year throws up some surprising names within the top ten – ViroPharma tops the league table with a net income margin of 47%, generating all its profits from sales of anti-bacterial agent Vancocin. Interestingly, two Indian generic firms feature, Sun Pharmaceutical Industries and Glenmark Pharmaceuticals, perhaps dispelling the notion that margins from selling generics are always low. Of the big pharma players, only those US groups with mature product portfolios, namely Pfizer, Merck & Co and Amgen, make it into the list. However, looking at forecast margins for the current year, the table below also reveals that Merck & Co drops out of the top ten, impacted by significantly lower sales from its cholesterol franchise. Alcon replaces Merck, suggesting one good reason why Novartis recently decided to fork out $11bn to acquire a 25% stake in the eye-care company. This analysis from EvaluatePharma is based on dividing normalised net income (excluding exceptional items) by the total revenues, to generate a net margin percentage. It only includes companies that have reported two consecutive years of profit, with incomes in excess of $50m in both 2007 and 2008. 2007 - top 10 companies Net Margin Net Income - Normalised ($m) Total Revenues ($m) 2007 2006 2007 2007 ViroPharma 47% 66 95 204 Sun Pharmaceutical Industries 44% 159 371 837 Gilead Sciences 38% 1,204 1,615 4,230 Biovail 35% 428 293 843 OSI Pharmaceuticals -
Cell and Gene Therapy Gathers Pace
Next-generation therapeutics: cell and gene therapy gathers pace At one of its most exciting phases of growth, the cell and gene therapy market has gained momentum in dealmaking, product sales and big Brain light/Alamy Stock Photo Stock Brain light/Alamy pharma interest, all of which are analyzed in this feature. feature Paul Verdin and Lisa Urquhart Therapeutic approaches employing whole cells are not new—for is substantial ongoing work in oncology, the majority of programs example, techniques based on cultured autologous epidermal cells (65%) across the combined pipeline are in non-oncology indications. for burn treatment and chondrocytes for knee cartilage repair have The value picture reveals a similar overall distribution—indications been available for more than a decade. Gene therapy and other gene outside oncology account for 76% of the 2024 forecasted sales transcription and translation-targeted approaches such as RNA inter- value, and only three oncology indications are included in the top ference (RNAi) are a much more recent addition to the therapeutic 20 indications by 2024 forecast sales (Fig. 2). The top 20 list reveals a arsenal, and coupled with the high-profile arrival of chimeric antigen wide variety of indications, including SMA, amyloidosis, hemophilia receptor (CAR)-T cells are ushering in a new era for cell-based and A and B, sickle cell disease, Huntington’s disease and amyotrophic gene-based medicine. lateral sclerosis. Logically, nucleic acid approaches are on the whole These groundbreaking scientific advances have also brought with focused on those diseases with a clearer genetic basis, whereas cell them intense debate about payment models and affordability, add- therapies are being explored in oncology and those indications with ing fuel to the broader fire raging around drug pricing. -
Schedule 14A
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 Filed by the Registrant ☑ Filed by a Party other than the Registrant o Check the appropriate box: o Preliminary Proxy Statement o Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) o Definitive Proxy Statement ☑ Definitive Additional Materials o Soliciting Material Pursuant to § 240.14a-12 BIOGEN IDEC INC. (Name of Registrant as Specified In Its Charter) N.A. (Name of Person(s) Filing Proxy Statement, if other than the Registrant) Payment of Filing Fee (Check the appropriate box): ☑ No fee required. o 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: o Fee paid previously with preliminary materials. o 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 -
13-ICML Abbvie Acerta Pharma Amgen (Europe) Gmbh Bayer
13th INTERNATIONAL CONFERENCE ON MALIGNANT LYMPHOMA Lugano, Switzerland, June 17-20, 2015 13-ICML THE CONFERENCE ORGANIZERS WISH TO THANK THE FOLLOWING SPONSORS FOR THEIR UNRESTRICTED FINANCIAL SUPPORT: Abbvie Acerta Pharma Amgen (Europe) GmbH Bayer HealthCare Pharmaceuticals, Inc. Bristol-Myers Squibb Celgene Corporation CTI Life Sciences Ltd. F. Hoffmann-La Roche Ltd . www.roche.com Gilead Sciences, Inc. Gilead Sciences Europe Ltd. Infinity Pharmaceuticals, Inc. Institut Biochimique SA – IBSA Janssen Pharmaceutical Companies of Johnson & Johnson Medicom Worldwide, Inc. Mentrik Biotech, LLC Mundipharma Oncology www.mundipharma.ch Novartis Oncology Pfizer Oncology Seattle Genetics, Inc. Servier sigma-tau Research Switzerland SA Spectrum Pharmaceuticals, Inc. Takeda Oncology Vifor SA THE CONFERENCE ORGANIZERS WISH TO THANK THE FOLLOWING CONTRIBUTORS FOR THEIR SUPPORT : American Association for Cancer Research – AACR Arcobaleno - Comunità Tariffale Ticino e Moesano CALYM, the Carnot Lymphoma Institute City of Lugano www.lugano.ch/ European School of Oncology – ESO www.eso.net European Society for Medical www.esmo.org Oncology – ESMO European Society for Radiotherapy and Oncology – ESTRO Hotel Splendide Royal www.splendide.ch International Extranodal Lymphoma Study Group - IELSG International Lymphoma Radiation Oncology Group - ILROG Kompetenznetz Maligne Lymphome e.V. – KML www.LHRM.de Leukämiehilfe Rhein-Main g.e.V. - LHRM Lugano MICE Convention Bureau www.luganomice.ch Lugano University Campus http://www.lymphomahub.co Lymphoma HUB m/search/ICML%25202015 Omega SA Repubblica e Cantone Ticino/Fondo Swisslos San Salvatore Foundation Schweizerische Patientenorganisation für Lymphombetroffene und Angehörige - ho / noho Swiss Cancer League Swiss Cancer Research Foundation Swiss International Air Lines The Leukemia Lymphoma Society Ticino Tourism www.ticino.ch . -
Biopartnering Executive Summary
BIOWORLD® BIOPARTNERING REPORT 2009: STRATEGIES AND PARADIGMS OF THE DEAL EXECUTIVE SUMMARY By Michael Harris, BioWorld Executive Editor and Amanda Lyle, BioWorld Managing Editor LIST OF CONTENTS Introduction and Analysis Trends Depressing First Half of 2008 in Worldwide Public Markets Drug/Device Combos Could Salvage Dropped Compounds A Match Made in Heaven; R&D Productivity Via Partnering Drug and Medical Device Deals: A Different Type of Partnership As Big Pharma Model Falters, Biotech Rides to the Rescue Deals to M&As: The Culture of False-Flagging, Shape-Shifting Notable Deals Autoimmune and Inflammation Deals Immunomedics Inks Potential $620M Deal with Nycomed ARYx Seeking New Partner for GI Program after P&G Bails Out UCB Licenses Keppra, Cimzia Rights in Japan Alizyme, Norgine Team Up in $67M Marketing Deal Bionomics Signs Merck Serono in MS, Autoimmune Partnership TransPharma Gets $35M in Osteo Deal with Lilly QLT Sells Acne Gel Product Aczone for $150M to Allergan Start-up TFT Adds NF-Kappa B Decoy Program from Anesiva Early Stage Antibody Nets EUSA $44M from GSK Scil, Pfizer Enter $250M Deal for Preclinical Osteo Drug Catalyst Partners with Centocor for Engineered Protease Drugs Galapagos Inks $395M Deal with Lilly for Osteo Drugs Alba Inks Ex-U.S./Japan Deal with Shire for Celiac Drug Excaliard Snags $15.5M and Isis Fibrosis Drugs Galapagos and Janssen in RA Partnership Axcan, Cellerix Deal for Adult Stem Cell Therapy Radius Grants Novartis Option to BA058 in Potential $500M Deal Microbia, Forest Collaborate: Up to $330M for -
Summary Conflict of Interest Statements BCC 2021
Summary conflict of interest statements BCC 2021 Last name First name Type of affiliation/ financial interest Name of commercial company Aapro Matti Receipt of grants/research supports: Amgen, Eisai, Genomic Health, Helsinn, Hospira, Novartis, Merck, Mundipharma, Pfizer, Rache, Sandoz, Tesaro, Teva, Vifor Receipt of honoraria or consultation fees: Accord Pharmaceuticals, Amgen, Astellas, Bayer HealthCare Pharmaceuticals (Schering), Biocon, Boehringer Ingelheim, BMS, Celgene, Cephalon, Chugai Pharmaceutical Co. Ltd., Clinigen Group, Dr.Reddy's Laboratories, Eisai Co. Ltd., Eli Lilly, Genomic Health (Exact Sciences), GlaxoSmithKline (GSK), Glenmark Pharmaceuticals Limited, Gl Therapeutics, lnc., Helsinn Healthcare SA, Hospira (Pfizer), lpsen, Janssen Biotech, Johnson & Johnson, Kyowa Kirin Group, Merck, Merck Serono (Merck KGaA), Mundipharma International Limited, Novartis, Pfizer, Pierre Fabre, Rache, Sandoz, Sanofi, Taiho Pharmaceutical, Tesaro (GSK), Teva Pharmaceutical lndustries Ltd., Vifor Pharma Other support: European Cancer Organisation, SPCC, Cancer Center Genolier Aebi Stephan Receipt of honoraria or consultation fees: Novartis, Roche, Pfizer Other support: Support for CME lectures of the Lucerne Cancer Center: Amgen, Astellas, Bayer, Bristol-Myers Squibb, Debiopharm International SA, Eisai, Ipsen Pharma, Janssen, Merck, MSD, Pfizer, Roche, Sanofi Genzyme, Servier, Takeda André Fabrice Receipt of grants/research supports: Comepensated to the hospital: Roche, AstraZeneca, Daiichi Sankyo, Pfizer, Novartis, Lilly Barrios Carlos -
David Meline Joins Moderna As Chief Financial Officer
David Meline Joins Moderna as Chief Financial Officer June 4, 2020 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 4, 2020-- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that David Meline has joined Moderna as Chief Financial Officer, effective Monday, June 8, 2020. He will serve on Moderna’s Executive Committee and report to Chief Executive Officer Stéphane Bancel. “I am pleased to welcome David to Moderna as our Chief Financial Officer and to the Executive Committee. As we prepare for the Phase 3 studies of our SARS-CoV-2 vaccine and our CMV vaccine, we are entering another critical phase for the Company. We have started to build commercial capabilities and started to set up commercial subsidiaries in several countries,” said Stéphane Bancel, Chief Executive Officer of Moderna. “David’s global biopharmaceutical industry and commercial experience along with his track record as CFO of Amgen for the last 6 years and before that, as CFO of 3M, make him a great addition to our team. I look forward to partnering with David to grow Moderna to a global enterprise focused on development and delivery of novel therapeutics and vaccines.” Mr. Meline joins Moderna from Amgen (Nasdaq: AMGN), where he served as Chief Financial Officer and EVP from 2014 through 2019. At Amgen, he was responsible for all finance, information systems and global business services activities across 100 countries. In this role, Mr. Meline led enterprise-wide transformation while increasing growth and productivity and reducing development cycle time.