ACORDA THERAPEUTICS, INC. (Exact Name of Registrant As Specified in Its Charter)
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United States Court of Appeals for The
Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page1 of 37 14‐4353‐cv Apotex Inc., et al., v. Acorda Therapeutics, Inc. UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT August Term, 2015 (Argued: November 12, 2015 Decided: May 16, 2016) Docket No. 14‐4353‐cv ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x APOTEX INC., et al., Plaintiffs‐Appellants, ‐ v.‐ ACORDA THERAPEUTICS, INC., Defendant‐Appellee. ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x Before: JACOBS, LIVINGSTON and DRONEY, Circuit Judges. This appeal concerns two distinct questions: the circumstances under which the filing of a citizen petition with the Food and Drug Administration provides grounds for an antitrust claim, and the scope of false advertising Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page2 of 37 liability under the Lanham Act. Plaintiffs Apotex Incorporated and Apotex Corporation appeal from the judgment of the United States District Court for the Southern District of New York (Swain, J.) that granted defendant Acorda Therapeutics, Inc.’s motion to dismiss plaintiffs’ Sherman Act claim and that granted summary judgment in favor of defendant on the Lanham Act claims (Torres, J.). Because each of these conclusions was sound, we affirm. KEITH D. PARR (with Joseph N. Froehlich, Scott B. Feder, Hugh S. Balsam, James T. Peterka, and Andy J. Miller on the brief), Locke Lord LLP, Chicago, Illinois, for Appellants Apotex Incorporated & Apotex Corporation. JOHN W. NIELDS, JR. (with Jason C. Raofield and Colin P. Watson on the brief), Covington & Burling LLP, Washington, D.C. for Appellee Acorda Therapeutics, Inc. DENNIS JACOBS, Circuit Judge: The parties are rival manufacturers of tizanidine, a drug for treating spasticity. -
Acorda Announces a Recommended Cash Tender Offer for All Shares, Adss and Other Equity Instruments in Biotie
NEWS RELEASE Acorda Announces a Recommended Cash Tender Offer for All Shares, ADSs and Other Equity Instruments in Biotie 1/19/2016 ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (“Acorda”) and Biotie Therapies Corp. (“Biotie” or the "Company") have today entered into a combination agreement ("Combination Agreement") whereby Acorda, either directly or through a wholly-owned subsidiary (jointly the "Offeror"), will make a public tender offer in Finland and in the United States to purchase all of the issued and outstanding shares, American Depositary Shares ("ADSs"), stock options, share units and warrants in Biotie that are not owned by Biotie or any of its subsidiaries (the “Tender Offer”). The price offered for each share validly tendered into the Tender Offer will be EUR 0.2946 in cash, representing a premium of approximately 95 per cent compared to the closing price of the Biotie shares on Nasdaq Helsinki Ltd. (“Nasdaq Helsinki”) on 18 January 2016, the last trading day on Nasdaq Helsinki preceding this announcement. This represents a premium of approximately 84 per cent compared to the 3 month volume-weighted average trading price on Nasdaq Helsinki and approximately 56 per cent compared to the 6 month volume-weighted average trading price on Nasdaq Helsinki. The price offered for each ADS will be EUR 23.5680 in cash, payable in the equivalent amount of U.S. dollars determined as near to the payment date as reasonably practicable based on the U.S. dollar spot rate against the euro exchange rate on the nearest practicable day to the closing date of the Tender Offer. -
Biotie Therapies Annual Report 2006
Annual Report 2006 Biotie Therapies Contents President’s Review 2 Partnering Agreements 3 Information for Shareholders 4 Management Team 7 Research and Product Development 8 Projects: Nalmefene for dependence disorders 10 Partnering agreements for nalmefene 12 First-in-class therapeutics for inflammatory diseases 14 Two innovative therapeutics for thrombosis 16 Corporate Governance 18 Board of Directors 20 Report from the Board of Directors 21 Financial Statements Consolidated Income Statement, IFRS 26 Consolidated Balance Sheet, IFRS 26 Shareholders’ Equity Statement, IFRS 27 Consolidated Cash Flow Statement, IFRS 27 Notes to the Consolidated Financial Statements 28 Parent Company Income Statement, FAS 40 Parent Company Balance Sheet, FAS 40 Parent Company Cash Flow Statement, FAS 41 Notes to the Parent Company Financial Statements 41 Signatures, Report from the Board of Directors and Financial Statements 46 Auditors’ Report 46 Main Stock Exchange Releases in Brief 47 Formulas for the Calculation of the Financial Ratios 48 Key Figures 49 First-in-class pharmaceuticals BioTie in Brief 1 The year 2006 in brief The 2006 financial statement has been prepared in accordance with IFRS recognition and measurement Nalmefene for alcoholism VAP-1 therapeutics for inflam- In November, BioTie and H. Lundbeck A/S signed an agreement on worldwide rights for nalmefene, principles, and applying the same accounting policy Marketing Authorisation matory diseases excluding North America, Mexico, UK, Ireland, Turkey, as for the 2005 financial statements. Application submitted in the UK and South Korea which have already been licensed. The net loss in financial year 2006 stood at EUR First-in-class In total, BioTie is eligible for up to EUR 88 million in –9.0 million (in 2005 EUR –7.9 million). -
Companies in Attendance
COMPANIES IN ATTENDANCE Abbott Diabetes Care Archbow Consulting LLC Business One Technologies Abbott Laboratories ARKRAY USA BusinessOneTech AbbVie Armory Hill Advocates, LLC CastiaRX ACADIA Artia Solutions Catalyst Acaria Health Asembia Celgene Accredo Assertio Therapeutics Celltrion Acer Therapeutics AssistRx Center for Creative Leadership Acorda Therapeutics Astellas Pharma US Inc. Cigna Actelion AstraZeneca Cigna Specialty Pharmacy AdhereTech Athenex Oncology Circassia Advantage Point Solutions Avanir Coeus Consulting Group Aerie Pharmaceuticals Avella Coherus Biosciences AGIOS AveXis Collaborative Associates LLC Aimmune Theraputics Bank of America Collegium Akcea Therapeutics Bausch Health Corsica Life Sciences Akebia Therapeutics Bayer U.S. CoverMyMeds Alder BioPharmaceuticals Becton Dickinson Creehan & Company, Inc., an Inovalon Company Alexion Biofrontera CSL Behring Alkermes Biogen Curant Health Allergan Biohaven CVS Health Almirall BioMarin D2 Consulting Alnylam BioMatrix Specialty Pharmacy Daiichi Sankyo Amarin BioPlus Specialty Pharmacy DBV Technologies Amber Pharmacy Bioventus Deloitte Consulting LLP AmerisourceBergen Blue Cross Blue Shield Association Dendreon Amgen Blue Fin Group Dermira Amicus Therapeutics bluebird bio Dexcom Amneal Boehringer Ingelheim Diplomat Pharmacy Anthem Boston Biomedical Dova Applied Policy Bowler and Company Decision Resources Group Aquestive Therapeutics Braeburn Eisai Arbor Pharmaceuticals Bristol-Myers Squibb 1 electroCore Indivior Merz Pharmaceuticals EMD Serono Inside Rx Milliman Encore Dermatology, -
FDA Listing of Authorized Generics As of July 1, 2021
FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc. -
Biotie Interim Report 1 January - 31 March 2012
Source: Biotie Therapies May 04, 2012 02:00 ET Biotie Interim report 1 January - 31 March 2012 BIOTIETHERAPIESCORP.StockExchangeRelease4May,2012at 9.00a.m. BiotieInterimreport1January-31March2012 BiotiereportsQ12012results;clinicaldevelopmentremainsontrack,with importantinflectionpointsexpectedinH22012andbeyond CompanyHighlights *SuccessfullycompletedaclinicalPETimagingstudywithSYN120 *PartnerLundbeckpresenteddataatthe2012EuropeanCongressofPsychiatry showingthatSelincroreducestotalalcoholconsumptionbytwo-thirdson averageaftersixmonthsoftreatment,furtherdatatobepresentedata medicalconferenceinthesummer *PanuMiettinenappointedChiefFinancialOfficer(CFO)andamemberofthe Group'smanagementteam,effectiveMarch15,2012 KeyFinancialsfortheperiodendingMarch31,2012 Figuresinbrackets,unlessotherwisestated,refertothesameperiodinthe previousyear(EURmillion) *RevenuesEUR0.0million(0.5) *ResearchanddevelopmentcostsEUR5.8million(4.9) *FinancialResult(Netloss)EUR-7.5million(-7.7) *Cashflowfromoperatingactivities,continuingoperationsEUR-9.3million (-4.2) *LiquidassetsattheendofperiodEUR24.7million(46.8) *Earningspershare-0.02(-0.03) Theinterimreportisunaudited.Liquidassetsarecomprisedofcash,cash equivalentsandinvestmentsheldtomaturity. TimoVeromaa,Biotie'sPresidentandCEOcommented,"Weareverypleasedwith theprogressofourclinicalstudies.Withourleadasset,Selincro,under reviewattheEuropeanMedicinesAgencywithourpartnerLundbeck,ourfocusis ondrivingforwardthenextwaveofproductsinourpipeline,forwhichwecould seeanumberofimportantdatapointsinthenext12-18months". Outlookfor2012andkeyupcomingmilestonesin2012 -
Fidelity® Nasdaq Composite Index® Fund
Fidelity® Nasdaq Composite Index® Fund Semi-Annual Report May 31, 2021 Contents Note to Shareholders 3 Investment Summary 4 Schedule of Investments 6 Financial Statements 85 Notes to Financial 89 Statements Shareholder Expense 97 Example Board Approval of 98 Investment Advisory Contracts and Management Fees Liquidity Risk 106 Management Program To view a fund’s proxy voting guidelines and proxy voting record for the 12-month period ended June 30, visit http://www.fidelity.com/proxyvotingresults or visit the Securities and Exchange Commission’s (SEC) web site at http://www.sec.gov. You may also call 1-800-544-8544 to request a free copy of the proxy voting guidelines. Nasdaq®, OMX®, NASDAQ OMX®, Nasdaq Composite®, and The Nasdaq Stock Market®, Inc. are registered trademarks of The NASDAQ OMXGroup, Inc. (which with its Affiliates are the Corporations) and are licensed for use by Fidelity. The product has not been passed on by the Corporations as to its legality or suitability. The product is not issued, endorsed or sold by the Corporations. The Corporations make no warranties and bear no liability with respect to shares of the product. Standard & Poor’s, S&P and S&P 500 are registered service marks of The McGraw-Hill Companies, Inc. and have been licensed for use by Fidelity Distributors Corporation. Other third-party marks appearing herein are the property of their respective owners. All other marks appearing herein are registered or unregistered trademarks or service marks of FMR LLC or an affiliated company. © 2021 FMR LLC. All rights reserved. This report and the financial statements contained herein are submitted for the general information of the shareholders of the Fund. -
Tuesday, November 29 Track One Villard, 2Nd Floor Track Two
Tuesday, Track One Track Two Track Three Track Four Track Five Track Six Track Seven November 29 Villard, 2nd Floor Spellman, 5th Floor Holmes 1, 4th Floor Holmes 2, 4th Floor Hubbard 1, 5th Floor Kennedy 1, 4th Floor Kennedy 2, 4th Floor Public & Private Track Private Track Registration - Villard Foyer, 2nd Floor 7:30 Continental Breakfast - Reid Salon, 2nd Floor 7:30 DentalPlans.com, Inc. SYMIC BIO, INC. Luminex Corporation Insmed Incorporated AngioDynamics Inc. Vascular Biogenics Ltd. 7:30-7:55 ConforMIS, Inc. (CFMS) (LMNX) (INSM) (ANGO) (VBLT) 7:50 OticPharma, Ltd. Accera, Inc. Gilead Sciences, Inc. Medidata Solutions, Inc. Horizon Pharma plc NxStage Medical, Inc. Acorda Therapeutics, UDG Healthcare plc 8:00-8:25 8:10 Availity, LLC (GILD) (MDSO) (HZNP) (NXTM) Inc. (ACOR) (UDG LN) MiMedx Group, Inc. 8:30 VisionGate, Inc. Boston Scientific Masimo Corporation COMPANY TO BE (MDXG) 8:30-8:55 Akorn, Inc. (AKRX) Teladoc, Inc. (TDOC) Corporation (BSX) (MASI) ANNOUNCED (JS) Anika Therapeutics Inc. 8:50 Benvenue Medical, Inc. (ANIK) Supernus Zimmer Biomet Henry Schein, Inc. Benefitfocus, Inc. Stealth BioTherapeutics 9:00-9:25 Pharmaceuticals, Inc. Ignyta, Inc. (RXDX) 9:10 EarLens Corporation Holdings, Inc. (ZBH) (HSIC) (BNFT) Incorporated (SUPN) Schedule for Tuesday, November 29, 2016 - Page 1 of 10 Schedule as of November 18, 2016. Schedule is subject to change. Tuesday, Track One Track Two Track Three Track Four Track Five Track Six Track Seven November 29 Villard, 2nd Floor Spellman, 5th Floor Holmes 1, 4th Floor Holmes 2, 4th Floor Hubbard 1, 5th Floor Kennedy 1, 4th Floor Kennedy 2, 4th Floor ProMetic Life Sciences Adamas 9:30 Graybug Vision, Inc. -
Deal Point Data Rankings Include Mergers & Acquisitions With
Public Mergers & Acquisitions (US & Non-US Targets) Deal Point Data rankings include mergers & acquisitions with a US or non-US public target and at least one SEC filer participant. Top Target and Acquirer M&A Financial Advisers Created: 10/Aug/2016 www.dealpointdata.com/ranking Search Criteria Target industry: Healthcare Include only highest bid in pending competing deals. Exclude withdrawn deals. Equity Value Equity Value Equity Value % Rank Rank Advice or Opinion $m $m Change Deal Count Deal Count 2016 2015 Financial Adviser 2016 2015 2015 to 2016 2016 2015 1 7 Evercore Partners 44,102 32,317 36 5 2 2 10 Guggenheim Partners 33,859 18,844 80 5 4 3 15 Bank of America Merrill Lynch 26,599 3,442 673 3 1 4 1 JPMorgan 23,628 68,999 -66 9 10 5 5 Centerview Partners LLC 13,542 42,693 -68 4 5 6 21 Rothschild Inc. 7,160 1,364 425 1 1 Skandinaviska Enskilda Banken 6 - AB 7,160 - - 1 0 8 8 Barclays 5,191 30,919 -83 2 1 9 4 Citigroup Inc. 4,767 46,899 -90 2 7 10 - Perella Weinberg Partners 1,891 - - 4 0 11 19 MTS Health Partners, L.P. 1,634 1,398 17 2 1 12 19 Credit Suisse 1,432 1,398 2 1 1 13 - RBC Capital Markets 1,285 - - 1 0 14 3 Goldman, Sachs & Co. 1,082 53,432 -98 1 9 15 2 Morgan Stanley 714 66,510 -99 1 4 16 - Duff & Phelps, LLC 391 - - 1 0 17 8 Lazard 349 30,919 -99 1 4 18 30 Roth Capital Partners, LLC 264 46 474 1 1 Stifel, Nicolaus & Company, 19 - Incorporated 141 - - 1 0 20 12 Jefferies LLC 85 6,750 -99 1 3 21 - PJT Partners 75 - - 1 0 22 - KPMG 60 - - 1 0 23 - Greenhill and Co 43 - - 1 0 24 - Oppenheimer & Co. -
Biotie Therapies Annual Report 2003
Annual Report 2003 Contents Information for Shareholders .......................................................3 BioTie in Brief ................................................................................4 The Year 2003 in Brief....................................................................5 President’s Review..........................................................................7 Business Model ...............................................................................8 Vision...............................................................................................9 Strategy...........................................................................................9 Research and Product Pipeline...................................................10 Nalmefene.....................................................................................12 VAP-1 as Target Molecule for Drug Development....................14 Other Research Projects .............................................................16 Network of Scientifi c Collaboration ..........................................18 Board of Directors .......................................................................20 Management Team.......................................................................20 Human Resources ........................................................................21 Report from the Board of Directors ..........................................22 Income Statement .......................................................................26 Balance -
In the United States District Court for the District Of
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC;, et al., ) ) Plaintiffs, ) ) v. ) Civ. No. 15-960-SLR ) MYLAN INC., et al., ) ) Defendants. ) ) Jack B. Blumenfeld, Esquire and Maryellen Noreika, Esquire of Morris Nichols, Arsht & Tunnell LLP, Wilmington, Delaware. Counsel for Plaintiffs. David E. Moore, Esquire, Bindu A. Palapura, Esquire, and Stephanie E. O'Byrne, Esquire of Potter Anderson & Corroon LLP, Wilmington, Delaware. Counsel for Defendants. Of Counsel: Robert L. Florence, Esquire, Karen L. Carroll, Esquire, and Micheal L. Binns, Esquire, Melanie Black Dubis, Esquire of Parker, Poe, Adams & Bernstein LLP. MEMORANDUM OPINION Dated: August \} , 2016 Wilmington, Delaware ROBINSON~ I. INTRODUCTION On October 22, 2015, Pfizer Inc., Wyeth LLC, Pfizer Pharmaceuticals LLC, PF PRISM C.V., ~nd Pfizer Manufacturing Holdings LLC, (collectively "plaintiffs") filed a complaint alleging infringement of three patents related to its injectable antibiotic product TYGACIL ® ("Tygacil") against defendants Mylan Inc., Mylan N.V., Mylan Laboratories Ltd. ("MLL"), and Mylan Pharmaceuticals ("MPI") (collectively "defendants"). (D.I. 1) Presently before the court is defendants' motion to dismiss for lack of personal jurisdiction and improper venue. (D.I. 6) Defendants Mylan Inc., Mylan N.V., and MPI have also filed a motion dismiss for failure to state a claim. (Id.) The court has jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331 and 1338(a). II. BACKGROUND A. The parties Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of the State of Delaware with a principal place of business in New York, New York. (D.I. 1 at~ 2) Plaintiff Wyeth LLC is a Delaware limited liability company with a principal place of business in New York, New York. -
05/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 04:25:50 Report Id 2794D052 Page: 01
MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 05/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 04:25:50 REPORT ID 2794D052 PAGE: 01 ALPHA COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 07/01/2016 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 68782 (OSI) EYETECH 55513 AMGEN USA 00074 ABBOTT LABORATORIES 58406 AMGEN/IMMUNEX 68817 ABRAXIS BIOSCIENCE, LLC 53746 AMNEAL PHARMACEUTICALS 16729 ACCORD HEALTHCARE INCORPORATED 65162 AMNEAL PHARMACEUTICALS LLC 42192 ACELLA PHARMACEUTICALS, LLC 69238 AMNEAL PHARMACEUTICALS, LLC 10144 ACORDA THERAPEUTICS, INC. 53150 AMNEAL-AGILA, LLC 00472 ACTAVIS 00548 AMPHASTAR PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 69918 AMRING PHARMACEUTICALS, INC. 45963 ACTAVIS INC. 66780 AMYLIN PHARMACEUTICALS, INC. 46987 ACTAVIS KADIAN LLC 55724 ANACOR PHARMACEUTICALS 49687 ACTAVIS KADIAN LLC 10370 ANCHEN PHARMACEUTICALS, INC. 14550 ACTAVIS PHARMA MFGING PRIVATE LIMITED 43595 ANGELINI PHARMA, INC. 61874 ACTAVIS PHARMA, INC. 62559 ANIP ACQUISITION COMPANY 67767 ACTAVIS SOUTH ATLANTIC 54436 ANTARES PHARMA, INC. 66215 ACTELION PHARMACEUTICALS U.S., INC. 52609 APO-PHARMA USA, INC. 52244 ACTIENT PHARMACEUTICALS 60505 APOTEX CORP. 75989 ACTON PHARMACEUTICALS 63323 APP PHARMACEUTICALS, LLC. 69547 ADAPT PHARMA INC. 43485 APRECIA PHARMACEUTICALS COMPANY 76431 AEGERION PHARMACEUTICALS, INC. 42865 APTALIS PHARMA US, INC 50102 AFAXYS, INC. 58914 APTALIS PHARMA US, INC. 10572 AFFORDABLE PHARMACEUTICALS, LLC 13310 AR SCIENTIFIC, INC. 27241 AJANTA PHARMA LIMITED 08221 ARBOR PHARM IRELAND LIMITED 17478 AKORN INC 60631 ARBOR PHARMACEUTICALS IRELAND LIMITED 24090 AKRIMAX PHARMACEUTICALS LLC 24338 ARBOR PHARMACEUTICALS, INC. 68220 ALAVEN PHARMACEUTICAL, LLC 59923 AREVA PHARMACEUTICALS 00065 ALCON LABORATORIES, INC. 76189 ARIAD PHARMACEUTICALS, INC. 00998 ALCON LABORATORIES, INC. 24486 ARISTOS PHARMACEUTICALS, INC.