US Pharma's Financialized Business Model William Lazonick, Matt
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Resource #350932
−This Clinical Resource gives subscribers additional insight related to the Recommendations published in− September 2019 ~ Resource #350932 Anticipated Availability of First-Time Generics ―To help explain the benefits of generic drugs to your patients, the FDA has patient education materials available at https://www.fda.gov/drugs/generic-drugs/patient-education ― Branda Generic Name Generic Manufacturer(s)b,1 Anticipated Availabilityc (Manufacturer) Acanya Benzoyl peroxide 2.5%/ Teva Generic now available (Valeant) Clindamycin phosphate 1.2% Cuprimine Penicillamine capsule Amerigen, Teva Generic now available (Bausch Health) Delzicol Mesalamine delayed-release Teva Generic now available (Warner Chilcott) capsule Diclegis Doxylamine/Pyridoxine Teva Generic now available (Duchesnay) Exjade Deferasirox tablets for oral Teva Generic now available (Novartis) suspension Fareston Toremifene Rising (EirGen Pharma Limited) Generic now available (Kyowa Kirin) Faslodex Fulvestrant Sandoz Generic now available (AstraZeneca) Firazyr Icatibant Teva Generic now available (Shire Orphan Therapies) Gablofen Baclofen 1 mg/mL single dose Mylan Institutional Generic now available (Piramal) vial Hemabate Carboprost tromethamine Dr. Reddy’s Generic now available (Pharmacia & Upjohn) Letairis Ambrisentan Cipla, Mylan, Par, Sigmapharm, Sun, Teva, Generic now available (Gilead) Zydus Lexiva Fosamprenavir Mylan Generic now available (Viv) More. Copyright © 2019 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com ~ nursesletter.therapeuticresearch.com (Clinical Resource #350932: Page 2 of 24) Branda Generic Name Generic Manufacturer(s)b,1 Anticipated Availabilityc (Manufacturer) Lotemax Loteprednol ophthalmic Hi-tech Generic now available (Bausch & Lomb) suspension Lyrica Pregabalin capsule Alembic, Amneal, Ascend (Alkem), Cipla Generic now available (PF Prism CV) (InvaGen), Dr. -
Gilead Sciences, Inc. November 13, 2016
Student Investment Management Gilead Sciences, Inc. November 13, 2016 Gilead Sciences, Inc. NASDAQ: GILD BUY $92.00 The Fisher College of Business Student Investment Management Program is initiating coverage on Gilead Sciences with a BUY rating. Our target price is $92.00. Our implied P/E for 2016E is 7.9x versus consensus 6.5x. Our 2017 and 2018 estimates are 8.8x and 9.5x, respectively. Company overview Gilead Sciences, Inc. is a research-based biopharmaceutical Fund Manager company that discovers, develops and commercializes innovative Royce West, CFA medicines in areas of unmet medical need. Gilead strives to 614-227-2948 transform and simplify care for people with life-threatening illnesses [email protected] around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, liver Analyst diseases, cancer, inflammatory and respiratory diseases, and Andrew Jasen cardiovascular conditions. 301-300-0702 [email protected] 12-Month trading performance 10.0% S&P Current share price: $72.64 7.0% 52 wk range: $71.76 - $108.13 0.0% S5HLTH Market cap: $99.9bn 1.4% P/E: 6.8x (10.0%) XBI (3.0%) Diluted shares out.: 1.3bn Last dividend (9/4/2016): $0.47 (20.0%) GILD Dividend yield: 2.4% (25.5%) Beta: 0.94 (30.0%) EV/EBITDA: 4.8x EV/Sales: 3.1x (40.0%) Nov-15 Jan-16 Mar-16 May-16 Jul-16 Sep-16 Nov-16 Investment thesis We are placing a BUY rating on GILD with a price target of $92.00, a 20.4% upside to the current trading price. -
Amgen-Opinion-Jan-7-2021.Pdf
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELA WARE AMGEN INC. and AMGEN MANUFACTURING, LIMITED, Plaintiffs, v. Civil Action No. 20-0561-CFC HOSPIRA, INC. and PFIZER INC. Defendants. MEMORANDUM ORDER Having considered the merits of Defendants Hospira, Inc. and Pfizer Inc.' s Motion to Stay (D.I. 19) and the briefs filed by the parties in connection with that motion, it is HEREBY ORDERED that Defendants' motion to stay is GRANTED IN PART for the following reasons: 1. Plaintiffs Amgen Inc. and Amgen Manufacturing, Limited make and sell the biologic filgrastim under the brand name Neupogen®. Filgrastim, like many biologics, is a protein. Plaintiffs own two patents generally related to methods of purifying such proteins. These two patents are U.S. Patent Nos. 10,577,392 (the #392 patent), and 9,643,997 (the #997 patent). The #392 patent issued in March of 2020. 2. Defendants manufacture and sell a biosimilar version Neupogen® called Nivestym®. Nivestym® has been available since 2018 and is the third biosimilar version ofNeupogen® launched in the United States since Neupogen® became available almost thirty years ago. 3. Both the #392 patent and #997 patent have been asserted against the Defendants-albeit in different actions-for the manufacture ofNivestym®. The #392 patent has been asserted in this case (C.A. 20-0561 ), which was filed on April 24, 2020. The #997 patent has been asserted in the related case Amgen Inc. et al. v. Hospira, Inc. et al., No. 18-cv-1064-CFC-CJB (D. Del. 2018). That case is scheduled for a jury trial to begin on May 17, 2021. -
XCHANGE COMMISSION Washington, D.C
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) (X) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1999 ( ) 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) Securities registered pursuant to Section 12(b) of the Act: None (Title of Class) Securities registered pursuant to Section 12(g) of the Act: Common Stock - par value $.001 per share (Title of Class) Preferred Share Purchase Rights expiring October 18, 2006 (Title of Class) 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 if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (ss. 229.405 of this chapter) 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. -
Virginia: in the Circuit Court of Pittsylvania County
VIRGINIA: IN THE CIRCUIT COURT OF PITTSYLVANIA COUNTY PITTSYLVANIA COUNTY, Plaintiff, v. PURDUE PHARMA, L.P.; PURDUE PHARMA, INC.; THE PURDUE FREDERICK COMPANY, INC.; RHODES PHARMACEUTICALS, L.P.; ABBOTT LABORATORIES; ABBOTT LABORATORIES, INC.; MALLINCKRODT PLC; MALLINCKRODT LLC; ENDO HEALTH SOLUTIONS, INC; ENDO PHARMACEUTICALS, INC.; PAR Case No. CL18 - __________ PHARMACEUTICAL COMPANIES, INC.; PAR PHARMACEUTICAL, INC.; TEVA Jury Trial Demanded PHARMACEUTICALS USA, INC.; CEPHALON, INC.; BARR LABORATORIES, INC.; JANSSEN PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICA, INC.; WATSON LABORATORIES, INC.; ALLERGAN PLC; ACTAVIS PHARMA, INC.; ACTAVIS, LLC; INSYS THERAPEUTICS, INC.; KVK-TECH, INC.; AMNEAL PHARMACEUTICALS LLC; IMPAX LABORATORIES, LLC; AMNEAL PHARMACEUTICALS, INC.; AMNEAL PHARMACEUTICALS OF NEW YORK, LLC; MYLAN PHARMACEUTICALS, INC.; MCKESSON CORPORATION; MCKESSON MEDICAL-SURGICAL INC.; CARDINAL HEALTH, INC.; AMERISOURCEBERGEN DRUG CORPORATION; HENRY SCHEIN, INC.; GENERAL INJECTABLES & VACCINES, INC.; INSOURCE, INC.; CVS HEALTH CORPORATION; CVS PHARMACY, INC.; CVS TN DISTRIBUTION, L.L.C.; WALGREENS BOOTS ALLIANCE, INC.; WALGREEN CO.; EXPRESS SCRIPTS HOLDING COMPANY; EXPRESS SCRIPTS, INC; CAREMARK RX, L.L.C.; CAREMARKPCS HEALTH, L.L.C.; CAREMARK, L.L.C.; UNITEDHEALTH GROUP INCORPORATED; OPTUM, INC.; OPTUMRX, INC.; and DOES 1-100, Defendants. PLAINTIFF’S ORIGINAL COMPLAINT Plaintiff, Pittsylvania County, Virginia, by and through the undersigned attorneys, (hereinafter “Plaintiff,” “Pittsylvania -
Surescripts, Llc As Amicus Curiae in Support of Petitioners in No
Nos. 19-508 and 19-825 In the Supreme Court of the United States ———————————— AMG CAPITAL MANAGEMENT, LLC, ET AL., Petitioners, v. FEDERAL TRADE COMMISSION, Respondent. ———————————— FEDERAL TRADE COMMISSION, Petitioner, v. CREDIT BUREAU CENTER, LLC, ET AL., Respondents. ———————————— ON WRITS OF CERTIORARI TO THE UNITED STATES COURTS OF APPEALS FOR THE SEVENTH AND NINTH CIRCUITS ———————————— BRIEF OF SURESCRIPTS, LLC AS AMICUS CURIAE IN SUPPORT OF PETITIONERS IN NO. 19-508 AND RESPONDENTS IN NO. 19-825 ———————————— ALFRED C. PFEIFFER, JR. ROMAN MARTINEZ LATHAM & WATKINS LLP Counsel of Record 505 Montgomery Street AMANDA P. REEVES Suite 2000 ALLYSON M. MALTAS San Francisco, CA 94111 DOUGLAS C. TIFFT BLAKE E. STAFFORD JAMES A. TOMBERLIN* LATHAM & WATKINS LLP 555 Eleventh Street, NW Suite 1000 Washington, DC 20004 (202) 637-2200 [email protected] Counsel for Amicus Curiae Surescripts, LLC TABLE OF CONTENTS Page TABLE OF AUTHORITIES ...................................... ii INTEREST OF AMICUS CURIAE ............................1 SUMMARY OF ARGUMENT .....................................3 ARGUMENT ...............................................................5 I. The FTC Has Increasingly Wielded Section 13(b) To Obtain Monetary Relief In Antitrust Cases ................................................5 II. The FTC’s Antitrust Authority Confirms That Section 13(b) Does Not Authorize Monetary Relief ..................................................22 CONCLUSION ..........................................................32 ii TABLE OF AUTHORITIES Page(s) CASES Apple Inc. v. Pepper, 139 S. Ct. 1514 (2019) .......................................... 13 Armstrong v. Exceptional Child Center, Inc., 575 U.S. 320 (2015) .............................................. 23 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) .............................................. 26 In re Cardinal Health, Inc., No. 101-0006, 2015 WL 1849040 (F.T.C. Apr. 17, 2015) ........................ 19, 20, 28, 30 Credit Suisse Securities (USA) LLC v. Billing, 551 U.S. -
In the Supreme Court of the United States ACORDA THERAPEUTICS, INC., Petitioner
NO. 181280 In the Supreme Court of the United States ACORDA THERAPEUTICS, INC., Petitioner, v. ROXANE LABORATORIES, INC., MYLAN PHARMACEUTICALS, INC., and TEVA PHARMACEUTICALS USA, INC., Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit BRIEF OF AMICUS CURIAE BOSTON PATENT LAW ASSOCIATION IN SUPPORT OF NEITHER PARTY SOPHIE F. WANG COUNSEL OF RECORD BRYANA T. MCGILLYCUDDY NATALIA SMYCHKOVICH CHOATE HALL & STEWART LLP TWO INTERNATIONAL PLACE BOSTON, MA 02110 (617) 248-5000 [email protected] MAY 8, 2019 COUNSEL FOR AMICUS CURIAE SUPREME COURT PRESS ʕ (888) 958-5705 ʕ BOSTON, MASSACHUSETTS i TABLE OF CONTENTS Page TABLE OF AUTHORITIES ....................................... ii INTEREST OF THE AMICUS CURIAE ................... 1 SUMMARY OF ARGUMENT .................................... 1 ARGUMENT ............................................................... 3 I. THE FEDERAL CIRCUIT’S DECISION CREATES SIGNIFICANT UNCERTAINTY CONCERNING THE SCOPE AND APPLICABILITY OF THE BLOCKING PATENT DOCTRINE. ............................................ 3 A. Clarification Is Needed as to the Definition of a “Blocking Patent.” .............. 3 B. Clarification Is Also Needed as to Whether and How the Blocking Patent Doctrine Should Be Applied to Objective Indicia of NonObviousness. ...................... 8 II. ABSENT CLARIFICATION, THE EXPANDED BLOCKING PATENT DOCTRINE HAS A CHILLING EFFECT ON INNOVATION AND INVESTMENT. .................. 11 A. Improvement Innovations Are Critical and Require Significant Investment. ....... 11 B. Objective Indicia Matter. .......................... 13 CONCLUSION .......................................................... 16 ii TABLE OF AUTHORITIES TABLE OF AUTHORITIES Page CASES Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310 (Fed. Cir. 2018) ......... passim Apple v. ITC, 725 F.3d 1356 (Fed. Cir. 2013) ......................... 14 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) ............................................. 6 Galderma Labs., L.P. -
Complaint, “Chronic Pain” Means Non-Cancer Pain Lasting Three Months Or Longer
TABLE OF CONTENTS Page I. INTRODUCTION ...............................................................................................................1 II. JURISDICTION AND VENUE ..........................................................................................8 III. PARTIES .............................................................................................................................8 A. Plaintiff ....................................................................................................................8 B. Defendants ...............................................................................................................9 IV. FACTUAL ALLEGATIONS ............................................................................................14 A. Defendants Used Multiple Avenues To Disseminate Their False And Deceptive Statements About Opioids. ...................................................................14 1. Defendants spread and continue to spread their false and deceptive statements through direct marketing of their branded opioids. .......................................................................................................15 2. Defendants used a diverse group of seemingly independent third parties to spread false and deceptive statements about the risks and benefits of opioids.................................................................17 a. Key Opinion Leaders (“KOLs”) ....................................................19 (1) Russell Portenoy ................................................................20 -
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. -
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. -
The Top 15 Generic Drugmakers of 2016 by Eric Sagonowsky, Eric Palmer, Angus Liu
The top 15 generic drugmakers of 2016 by Eric Sagonowsky, Eric Palmer, Angus Liu Branded drugmakers weren’t the only ones working through a tumultuous 2016. Generics companies faced pricing pressure, too. And while branded companies suffer pricing pain on costly cutting-edge therapies, generics outfits feel the pinch with already-thin margins, making pressure all the more agonizing. How is the industry responding? By consolidating and hoping to save money, for one. Take a look at FiercePharma’s 2014 ranking, and it’s clear that some companies have made leaps too big to depend on organic growth alone. Take Teva, which topped the 2016 list as it did in 2014. It wrapped up the biggest M&A move in recent history for the generics industry, swallowing Allergan’s unbranded offerings for $40.5 billion in August. The massive move will continue to reverberate in the generics industry for years to come. Top drugmakers by 2016 generics revenue in USD billions Teva Pharmaceutical Industries 9.85 Mylan 9.43 Novartis 9 Pfizer 4.57 Allergan 4.5 Sun Pharmaceutical Industries 3.61 Fresenius 2.8 Endo International 2.57 Lupin 2.49 Sanofi 2.05 Aspen Pharmacare 2 Aurobindo Pharma 1.86 Dr. Reddy's Laboratories 1.78 Cipla 1.61 Apotex 1.6 Source: Evaluate, May 2017 Get the data Sales data for Sun Pharma, Fresenius, Lupin, Aspen Pharmacare, Aurobindo, Cipla, and Apotex are Evaluate estimates. Dr. Reddy’s data provided from company filing. Behind Teva came Mylan, which also completed a big deal last year, a $7.2 billion buyout of Sweden’s Meda. -
Views Expressed in This Publication by Any Contributor Are Not Necessarily Those of the Publisher
THOMSON REUTERS Expansion of the blocking-patent doctrine By Ha Kung Wong, Esq., and Michael Scerbo, Esq., Venable LLP APRIL 13, 2020 In 2005 the U.S. Court of Appeals for the Federal Circuit first Therefore, the law considers two factors to be probative of articulated the blocking-patent doctrine in Merck & Co. v. Teva whether or not an invention would have been obvious: evidence Pharmaceuticals USA Inc., 395 F.3d 1364 (Fed. Cir. 2005), or of (1) commercial success, and (2) a causal nexus between the Merck I. invention and commercial success of a product embodying it.4 The Federal Circuit said that under the doctrine courts may reduce The Federal Circuit in Merck I explained that the district court’s the weight given to evidence of commercial success where an finding of commercial success should be given only minimal earlier patent blocked market entry by others. weight because Merck had both (1) a preexisting patent covering the administration of alendronate sodium (a bisphosphonate) to The appellate court later explained in Acorda Therapeutics treat osteoporosis, and (2) exclusive marketing rights granted by Inc. v. Roxane Laboratories Inc., 903 F.3d 1310 (Fed. Cir. 2018), the Food and Drug Administration. that a patent is a blocking patent “where the practice of a later invention would infringe the earlier patent.” ”Because market entry by others was precluded on those bases, the inference of nonobviousness … from evidence of commercial The rationale behind the doctrine was that where others are legally success … is weak.”5 barred from commercializing a purportedly obvious idea due to a preexisting patent, the court may conclude that the inference of In the years after the Federal Circuit’s decision in Merck I, the court nonobviousness from evidence of commercial success is weak.