DOCSLIB.ORG

Focused on the Next Generation

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Focused on the Next Generation SEPRACOR focused on the next generation 1999 Annual Report Sepracor Sepracor is a leading specialty pharmaceutical company focused on developing safer, purer and more effective drugs, which are improved versions of widely-prescribed pharmaceutical compounds. These focused on the next generation improved chemical entities, Sepracor ICE™ Pharmaceuticals, are proprietary, single-isomer or active-metabolite versions that may offer therapeutic advantages over existing drugs. The Company selects for development compounds with the potential to offer improvements over existing of icetm pharmaceuticals therapies with respect to efficacy, side effect profile, or both. Sepracor’s drug development program has yielded an extensive portfolio of ICE Pharmaceutical candidates that are concentrated in three major therapeutic categories: allergy and asthma, urological and gastroenterological disorders, and central nervous system disorders. Earliest Potential Compound Parent Drug Preclinical Phase I Phase II Phase III NDA Filed Launch Launched Levalbuterol (XOPENEX™) VENTOLIN®/ PROVENTIL® of patients Launched Fexofenadine (ALLEGRA®)* SELDANE® 2000 Desloratadine CLARITIN® 2001 Norastemizole HISMANAL® 2001 Levocetirizine ZYRTEC® Europe 2002 (R,R)-formoterol FORADIL®/ ® Respiratory Care–Allergy/Asthma ATOCK 2002 (R)-fluoxetine PROZAC® (depression) 2002 (+)-zopiclone IMOVANE® of sepracor 2003 (+)-desmethylzopiclone, (+)-DMZ IMOVANE® Many of Sepracor’s ICE Pharmaceutical candidates are (anxiety) being developed at lower cost and in less time than new chemical entities (NCEs). 2003 (S)-fluoxetine PROZAC® (migraine) Central Nervous System In its ICE Pharmaceutical development program, Sepracor identifies existing drugs that 2004 (+)-didesmethylsibutramine, (+)-DDMS MERIDIA® (CNS indications) potentially, in single-isomer or active-metabolite forms, provide significant therapeutic 2002 (+)-norcisapride PROPULSID® advances over existing therapies. ICE Pharmaceuticals are designed to offer benefits such as 2003 (S)-oxybutynin DITROPAN® 2003 (S)-doxazosin CARDURA® reduced side effects, improved therapeutic efficacy, improved dosage, or the opportunity for ® 2004 (–)-didesmethylsibutramine, (–)-DDMS MERIDIA new indications. Worldwide 1999 sales for the parent drugs of ICE Pharmaceuticals under (urology indications) 2005 (–)-pantoprazole PANTOZOL™ development by Sepracor and its partners totaled almost $20 billion. Urology/Gastroenterology 2007 (S)-lansoprazole PREVACID® *Fexofenadine product developed and marketed by Hoechst Marion Roussel, Inc. (“HMRI”) as ALLEGRA® brand fexofenadine hydrochloride. Sepracor has licensed or assigned its related patents worldwide to HMRI. 1 To Our Shareholders: Nineteen Hundred and Ninety- Sepracor and Abbott’s Ross Products Division heartburn due to gastroesophageal reflux disease. Sepracor Marketed Products ™ Nine was a momentous year for Co-Promote XOPENEX (+)-Norcisapride is currently in Phase II clinical trials. Ten Potential Launches Over Four Years Sepracor. With the launch of Sepracor will receive royalties on (+)-norcisapride sales Rep Details Percent of Physicians Covered Earliest Potential Year of Launch XOPENEX™ (levalbuterol HCl) upon launch in countries where patents have been issued. 188,000 Pediatricians 100% ’01 ’02 ’03 ’04 inhalation solution sold through Ross Norastemizole Sepracor’s specialty sales force, 165,000 Primary Care 49% • Schering-Plough has licensed desloratadine, an active- (+)-zopiclone metabolite form of loratadine marketed as CLARITIN®, (R,R)-formoterol we began the transition to a Sepracor 45,000 Pulmonologists 97% (S)-doxazosin the world’s leading nonsedating antihistamine. In (S)-oxybutynin fully-integrated pharmaceutical 16,000 Allergists 86% October 1999, Schering‘s New Drug Application (NDA) (+)-DMZ (Anxiety) company. The success of (+)-DDMS (ADHD) ™ Total = 414,000 Details for desloratadine was filed with the U.S. Food and Drug (+)-DDMS (Depression) XOPENEX demonstrates our (—)-DDMS (Stress Incontinence) capability as an organization to Administration (FDA) and it is currently under review. (—)-DDMS (Erectile Dysfunction) co-promotion approach to sales and marketing makes it execute in the areas of preclinical Sepracor will receive royalties on sales upon launch of Respiratory CNS Urology possible for us to achieve the required detailing levels need- and clinical development, desloratadine. ed to successfully market and sell pharmaceutical products. process development, manufacturing, regulatory, as well as • Sepracor has licensed to UCB Farchim SA all of Sepracor’s Drug Discovery at Sepracor direct marketing and sale of a proprietary drug. As additional ICE Pharmaceuticals reach the market, issued patents and pending patent applications covering We believe that our near-term growth will come from Sepracor hopes to: (1) expand the focus of its primary care Direct Sales and Marketing of ICE™ Pharmaceuticals levocetirizine in Europe and other countries, except the commercialization of the ICE Pharmaceuticals currently sales organization; (2) add additional sales representatives; ® Last May, Sepracor launched its first directly-marketed U.S. and Japan. Levocetirizine is an isomer of ZYRTEC , under development. However, in the future, Sepracor and (3) attract new co-promotion partners. drug, XOPENEX™ (levalbuterol HCl) inhalation solution, Europe’s leading antihistamine. UCB intends to file a will need new drug opportunities to complement its ICE in two dosage strengths for nebulizer use. XOPENEX™ is The earliest potential product launch dates for Sepracor ICE Marketing Authorization Application (MAA), the European Pharmaceutical portfolio. The Company has been broaden- currently indicated for the treatment or prevention of Pharmaceutical direct sale candidates are as follows: 2001 equivalent of a New Drug Application (NDA), in the first ing its focus to include discovery and development of new bronchospasm in patients 12 years of age and older with for norastemizole; 2002 for (+)-zopiclone and (R,R)-for- half of 2000. UCB will pay Sepracor royalties upon first chemical entities. The focus of this discovery effort is to reversible obstructive airway disease, such as asthma. moterol; 2003 for (S)-doxazosin, (+)-desmethylzopiclone, product sale. identify new drug candidates directed toward serving unmet ™ medical needs. The Company is pursuing compounds in XOPENEX is a proprietary, single-isomer version of the and (S)-oxybutynin; and 2004 for (+)-didesmethyl- • ALLEGRA® brand fexofenadine hydrochloride is Hoechst the area of central nervous system disorders, including best-selling bronchodilator, racemic albuterol. sibutramine for depression, (+)-didesmethylsibutramine Marion Roussel’s nonsedating antihistamine ALLEGRA®. for attention deficit hyperactivity disorder (ADHD), behavioral disorders and pain management. XOPENEX™ is commercialized through a co-promotion Sepracor and Hoechst Marion Roussel (now Aventis) have (-)-didesmethylsibutramine for erectile dysfunction, and Continued Financial Strength agreement with the Ross Products Division of Abbott settled their patent interference and Sepracor is currently (-)-didesmethylsibutramine for urinary incontinence. Laboratories. Sepracor’s 65-person respiratory sales receiving royalties on sales in Europe of the fexofenadine For the year ended December 31, 1999, the Company Sepracor’s direct sales and marketing organization has the force calls on pulmonologists, allergists and primary care product. Sepracor will receive royalties on sales in the U.S. had $336 million in cash and marketable securities. In the potential to launch ten ICE Pharmaceuticals over the next physicians in U.S. hospitals and clinics. Ross adds over beginning mid-February 2001. first quarter of 2000, the Company issued $460 million in four years. 300 product specialists providing coverage to pediatric 5 percent Convertible Subordinated Debentures due in physicians in the U.S. The Sepracor sales force is also Sepracor Out-licensing Agreements 2007. Sepracor’s consolidated cash position, as of the first complemented in the field by a dedicated contract sales The Company believes that certain compounds are more Sepracor Primary Care Sales Force Could Be quarter of 2000, has never been stronger. Supported By Co-Promotion Specialty Sales Forces force of 155 territory representatives from Innovex, a appropriate for out-licensing arrangements. Sepracor’s We believe that we have a winning business strategy based division of Quintiles Transnational Corporation. existing agreements include the following: 1500 upon a proven innovative approach to drug development Women’s and commercialization. I would like to congratulate Today, over 500 sales representatives are promoting • Eli Lilly and Company plans to develop and globally Health/Urology ™ Sepracor’s shareholders and employees on beginning the XOPENEX to physicians in offices, clinics and hospitals commercialize (R)-fluoxetine, a single-isomer form of 1200 in the U.S. At the end of the first quarter 2000, we are the active ingredient in PROZAC®, subject to approval of transition to a fully-integrated pharmaceutical company. Psychiatrists approaching a 10 percent market share of new prescriptions the Federal Trade Commission. (R)-Fluoxetine is currently In the coming year, I look forward to reporting on 900 Sepracor’s continuing progress. written for beta-agonist unit dose vials. in large-scale clinical trials. Sepracor will receive royalties ENT 700 on the (R)-fluoxetine product upon launch. Pediatricians Commercialization
Load more

Recommended publications
  • Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs
    International Journal of Business and Social Science Vol. 9 • No. 8 • August 2018 doi:10.30845/ijbss.v9n8p2 Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs Richard J. Hunter, Jr. Professor of Legal Studies Seton Hall University United States John H. Shannon Professor of Legal Studies Seton Hall University United States Henry J. Amoroso Associate Professor of Legal Studies Seton Hall University United States Abstract A spirited public policy debate has raged in the United States for more than four decades revolving around the responsibility of drug manufacturers for their products that cause injury to unsuspecting plaintiffs. An important part of the debate centers around a drug—DES—that was marketed as a benefit to women in preventing miscarriages. Some interesting or "alternate" theories for assessing liability have received attention in the generic area of products liability. This article will discuss three of the most prominent and still controversial theories—alternative liability, enterprise liability, and market share liability. In addition, the article will include several case studies exemplifying the legal principles discussed — some coming to very difficult conclusions — regarding the efficacy and application of these theories to particular facts developed during litigation. Keywords: Alternative Liability; Enterprise Liability; Market Share Liability 1. Introduction DES (Diethylstilbestrol, a synthetic form of the female hormone estrogen) litigation in the United States has been both extensive and controversial. Forty years ago, at the height of the DES crisis, in a seminal law review article in the Fordham Law Review, Sheiner (1978) estimated that the number of women who took DES during pregnancy ranged from 1 1/2 million to 3 million.
    [Show full text]
  • V. : Civil Action No. DKC 14-3607
    Case 8:14-cv-03607-DKC Document 47 Filed 07/29/15 Page 1 of 73 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND : MALLINCKRODT INC. : v. : Civil Action No. DKC 14-3607 : UNITED STATES FOOD AND DRUG ADMINISTRATION, et al. : MEMORANDUM OPINION Plaintiff Mallinckrodt Inc. (“Mallinckrodt”), a pharmaceutical manufacturer, brings this action seeking judicial review of actions taken by the United States Food and Drug Administration (“FDA”), regarding its methylphenidate hydrochloride extended-release tablets, a generic version of the brand-name drug Concerta. Presently pending and ready for review in this action are several motions: (1) a motion to dismiss filed by Defendants FDA and United States of America (“Defendants”) (ECF No. 30); (2) a motion to compel production of the administrative record filed by Mallinckrodt (ECF No. 31); (3) a motion for summary judgment filed by Mallinckrodt (ECF No. 34); and (2) two motions to seal filed by Mallinckrodt (ECF Nos. 4 and 20). The relevant issues have been briefed, and the court now rules, no hearing being deemed necessary. Local Rule 105.6. For the following reasons, Defendants’ motion to dismiss will be granted in part, and summary judgment will be granted in part Case 8:14-cv-03607-DKC Document 47 Filed 07/29/15 Page 2 of 73 against Plaintiff. Mallinckrodt’s motion to compel production of the administrative record will be denied as moot, and Mallinckrodt’s motions to seal will be denied. I. Background A. Statutory and Regulatory Background The FDA regulates the approval, manufacture, sale, and labeling of prescription drugs.
    [Show full text]
  • Brief of Consumers Union of United States, Inc., As Amicus Curiae in Support of Petitioners, Riegel & Riegel V
    Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2007 Brief of Consumers Union of United States, Inc., as Amicus Curiae in Support of Petitioners, Riegel & Riegel v. Medtronic, Inc., No. 06-179 (U.S. Aug. 27, 2007) Lisa Heinzerling Georgetown University Law Center Docket No. 06-179 This paper can be downloaded free of charge from: http://scholarship.law.georgetown.edu/scb/40 This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: http://scholarship.law.georgetown.edu/scb Part of the Consumer Protection Law Commons, and the Torts Commons No. 06-179 ~ ~!~! GLE~a~K IN THE £ upreme ¢£ourt of nite tate CHARLES R. RIEGEL AND DONNA S. RIEGEL, Petitioners V. MEDTRONIC, INC., Respondent ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT BRIEF OF CONSUMERS UNION OF UNITED STATES, INC., AS AMICUS CURIAE IN SUPPORT OF PETITIONERS LISA HEINZERLING Counsel of Record 600 New Jersey Ave., N.W. Washington, D.C. 20001 (202) 662-9115 MARK SAVAGE Consumers Union of United States, Inc. 1535 Mission Street San Francisco, CA 94103-2512 Counsel for Amicus Consumers Union of United States, Inc. WILSON-EPES PRINTINGCO., INC. - (202) 789-0096 - WASHINGTON, D. C. 20002 QUESTION PRESENTED Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.
    [Show full text]
  • The Life Cycle of Sterling Drug, Inc.*
    22 Bull. Hist. Chem., VOLUME 25, Number 1 (2000) THE LIFE CYCLE OF STERLING DRUG, INC.* Joseph C. Collins and John R. Gwilt The foundations of Sterling Drug were laid by William partners were bought out. Weiss and Diebold realized E. Weiss and Albert H. Diebold, boyhood friends in that expansion required more product lines and that these Canton, Ohio. Weiss graduated from the Philadelphia would best be obtained by acquisition. This policy con- College of Pharmacy in 1896 and went to work in a tinued throughout the life of the organization, at least drug store in Sistersville, West Virginia. Diebold raised 130 companies being acquired, directly or indirectly, funding from his father’s company, Diebold Safe and Lock, and in 1901 the friends set up business together in Wheeling, WV. In fact, Sterling operated a plant in that town until 1962. The history of the Corporation can conveniently be divided into five periods: 1901-1917 The Neuralgyline Period 1917-1928 Sterling Products I 1928-1933 Drug Inc. 1933-1942 Sterling Products II 1942-1988 Sterling Drug, Inc. The Neuralgyline Period On May 4, 1901, Weiss and Diebold, with three local business men as partners, established the Neuralgyline Company with the sole purpose of manufacturing and Figure 1. Where it all began: in 1901 the selling a pain-relieving preparation which they called Neuralgyline Company occupied two upstairs rooms “Neuralgine.” There is now no company record of its in this house in Wheeling, WV. composition, but it seems to have been a mixture of ac- from 1902 through 1986. Ironically, the eventual fate etanilide, caffeine, and sodium salicylate.
    [Show full text]
  • Pharmaceutical Sector
    MARKET REVIEW ON PRIORITY SECTOR UNDER COMPETITION ACT 2010 PHARMACEUTICAL SECTOR Malaysia Competition Commission (MyCC) 27 December 2017 TABLE OF CONTENTS Executive Summary 2 List of Abbreviations 7 Glossary 9 Introduction 16 Methodology and Limitations 18 Policy Context for the Review 24 PART ONE: OVERVIEW OF MALAYSIA’s PhARMACEUTICAL SECtor Chapter 1: Overall Growth of the Healthcare and Pharmaceutical Sectors 28 Chapter 2: Market Structure and Supply Chain 41 Chapter 3: Market Share and Market Concentration 69 Chapter 4: Market Dominance and Impact on Availability, Affordability and Accessibility of Medicines 93 PART TWO: COMPETITION CONCERNS IN THE PHARMACEUTICAL SECtor Chapter 5: Key Existing Laws and Regulations and An Assessment of Impacts 118 Chapter 6: Competition Concerns Among Industry Players 148 Chapter 7: Selected Case Studies on Anti-Competitive Conduct 177 PART THREE: CONCLUSION AND RECOMMENDatIONS Chapter 8: Conclusion and Recommendations 208 APPENDICES Appendix 1: Guiding Questions for Interviews with Industry Players 224 Appendix 2: Malaysian Organization of Pharmaceutical Industries (MOPI) Members 229 Appendix 3: Brief Profiles of Top 6 Malaysian Local/Joint Venture Pharmaceutical Companies 230 Appendix 4: Pharmaceutical Association of Malaysia (PhAMA) Members 232 Appendix 5: Malaysian Association of Pharmaceutical Suppliers (MAPS) Members 233 Appendix 6: Drug Registration Process 234 References 236 EXECUTIVE SUMMARY The aims of Malaysia’s National Medicines Policy are to promote equitable access to, and rational use of, safe, effective and affordable medicines by its population. In order to maximize social welfare, this policy is strengthened by Malaysia’s Competition Act of 2010 and the establishment of the Malaysia Competition Commission (MyCC) to bring about allocation, production and innovation efficiencies.
    [Show full text]
  • Case No COMP/M.2192 - 3* SMITHKLINE BEECHAM / BLOCK DRUG
    EN Case No COMP/M.2192 - 3* SMITHKLINE BEECHAM / BLOCK DRUG Only the English text is available and authentic. REGULATION (EEC) No 4064/89 MERGER PROCEDURE Article 6(1)(b) NON-OPPOSITION Date: 11/01/2001 Also available in the CELEX database Document No 301M2192 Office for Official Publications of the European Communities L-2985 Luxembourg COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 11.01.2001 SG(2000)D/285020 In the published version of this decision, some PUBLIC VERSION information has been omitted pursuant to Article 17(2) of Council Regulation (EEC) No 4064/89 concerning non-disclosure of business secrets and other confidential information. The omissions are MERGER PROCEDURE shown thus […]. Where possible the information ARTICLE 6(1)(b) DECISION omitted has been replaced by ranges of figures or a general description. To the notifying party Dear Sir/Madam, Subject: Case No COMP/M.2192 – SmithKline Beecham/Block Drug Notification of 17.11.2000 pursuant to Article 4 of Council Regulation No 4064/89 1. On 17 November, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EEC) No 4064/89 (“the Merger Regulation”), by which the UK company, SmithKline Beecham plc (“SB”) notified its intention to acquire sole control over the US company, Block Drug Company Inc. (“Block Drug”), through purchase of shares. 2. Following examination of the notification, the Commission has concluded that the notified operation falls within the scope of the said Council Regulation and does not raise serious doubts as to its compatibility with the common market and the EEA agreement.
    [Show full text]
  • Preliminary Guide to the Parke, Davis Research Laboratory Records
    Preliminary Guide to the Parke, Davis Research Laboratory Records NMAH.AC.0001 Robert Harding 1983 Archives Center, National Museum of American History P.O. Box 37012 Suite 1100, MRC 601 Washington, D.C. 20013-7012 [email protected] http://americanhistory.si.edu/archives Table of Contents Collection Overview ........................................................................................................ 1 Administrative Information .............................................................................................. 1 Biographical / Historical.................................................................................................... 3 Arrangement..................................................................................................................... 3 Scope and Contents........................................................................................................ 3 Names and Subjects ...................................................................................................... 4 Container Listing ............................................................................................................. 5 Series 1: Corporate Materials, 1887-1951............................................................... 5 Series 2: Financial Materials, 1880-1970............................................................... 11 Series 3: Employee/Personnel Materials, 1900-1989............................................ 12 Series 4: Advertising/Sales Materials, 1868-1980.................................................
    [Show full text]
  • Robert J. Desalvo Papers Business Combinations in the Cosmetic and Pharmaceutical Industries 1944
    Robert J. DeSalvo Papers Business Combinations in the Cosmetic and Pharmaceutical Industries 1944 - 1990 Collection #107 Abstract Robert J. DeSalvo’s research focused on business combinations (acquisitions, mergers, and joint ventures in the cosmetic and pharmaceutical industries. This topic was the basis for his master’s thesis in pharmacy administration at the University of Pittsburgh and continued as a life-long interest. This collection consists of two series of notebooks that Dr. DeSalvo developed to record relevant business combinations. The first series records acquisitions, proposed acquisitions, mergers, and joint ventures for the period of 1944 –1990 in an alphabetical arrangement. The information on these entries is cumulative so that the history of an organization is collected in one place. The second series of notebooks is arranged in chronological blocks. The information is arranged alphabetically by the name of the acquirer. The name of the acquired (merged), type of combination (acquisition, proposed acquisition, joint venture) and the date is also provided. The information is cross-referenced between the two series so that the researcher can approach the information by the name of the parent company or chronologically. Dr. DeSalvo used this resource for many of his publications as well as his master’s thesis. A copy of these publications and his thesis make up the remainder of the collection. Donor Gift of Barbara DeSalvo, 2000 Biography Robert James DeSalvo was born on July 20, 1933 in Toledo, OH. He died on January 23, 1993 in Cincinnati, OH. DeSalvo graduated from high school in Toledo and attended pharmacy school at the University of Toledo where he received his B.S.
    [Show full text]
  • The Societal Value of Prescription Drug Advertisements in the New Millenium: Targeted Consumers Become the Learned, 9 J
    Journal of Law and Policy Volume 9 Issue 2 SYMPOSIUM: Article 9 Constitutional Lawyering in the 21st Century 2001 The oS cietal Value of Prescription Drug Advertisements in the New Millenium: Targeted Consumers Become the Learned Caroline L. Nadal Follow this and additional works at: https://brooklynworks.brooklaw.edu/jlp Recommended Citation Caroline L. Nadal, The Societal Value of Prescription Drug Advertisements in the New Millenium: Targeted Consumers Become the Learned, 9 J. L. & Pol'y (2001). Available at: https://brooklynworks.brooklaw.edu/jlp/vol9/iss2/9 This Note is brought to you for free and open access by the Law Journals at BrooklynWorks. It has been accepted for inclusion in Journal of Law and Policy by an authorized editor of BrooklynWorks. THE SOCIETAL VALUE OF PRESCRIPTION DRUG ADVERTISEMENTS IN THE NEW MILLENNIUM: TARGETED CONSUMERS BECOME THE LEARNED Caroline L. Nadal* INTRODUCTION In a majority of jurisdictions throughout the United States, a prescription drug manufacturer will not be liable to the ultimate drug consumer when it has heavily advertised its product to that consumer yet failed to provide adequate warnings of the dangers associated with its use.' Under the learned intermediary doctrine,2 the manufacturer absolves itself from liability by providing *Brooklyn Law School, Class of 2002; B.A. Davidson College 1994. The author would like to thank Professor Aaron Twerski for his guidance. The author would also like to thank her husband for his continuing support. See, e.g., In re Norplant Contraceptive Prod. Litig., 165 F.3d 374 (5th Cir. 1999) (affirming summary judgment for defendant manufacturer despite its aggressive marketing of contraceptive devices to consumers); Skill v.
    [Show full text]
  • The Pharmaceutical Industry
    Chapter 5 The Pharmaceutical Industry ‘‘It has now been more than fifteen years since Robert Swanson, a young man who understood both finance and science, invited Herbert Boyer, a shy molecular biologist at the University of California, San Francisco, out for a beer. Swanson described his vision to Boyer: that the techniques and ideas that Boyer had devised for manipulating DNA could be translated into products at a private company yet to be established. As a result of that meeting, Genentech, the first well-known biotechnology corporation, was founded; Swanson and Boyer made their fortunes; and profound changes ensued in academic biomedical research, ’ Robert Bazell The New Republic, April 1991. CONTENTS Page INTRODUCTION . 73 RESEARCH AND Development . 73 Drug Discovery . ...+........~”+ 73 Drug Development . 75 BIOTECHNOLOGY-DEWED DRUGS .. .. .. .. .+ . 75 COMPETITIVE FACTORS . 81 Industry Overview . ........9. 81 Dedicated Biotechnology Companies and the Pharmaceutical Industry . 87 Competitive Influence of Government policies . 89 SUMMARY . ....+. 93 CHAPTER PREFERENCES . 94 Boxes Box Page 5-A. FDA Clinical Trials . 76 5-B. Types of Biotechnology Products in Development . 79 5-C. Pharmaceuticals-A Global Industry . 82 5-D. Price and Cost Containment . 84 5-E. Japan’s Pharmaceutical Industry . 86 5-F. Effects of Regulatory Decisions on Wall Street . 90 5-G. The Drug Export Amendments Act of 1986 . 91 5-H. The Orphan Drug Act . 92 5-I. Patent Term Extension for Pharmaceuticals . 93 Tables Table Page 5-1. Approved Biotechnology Drugs/Vaccines . 77 5-2. Conditions for Which Biotechnology-Derived Drugs Are Under Development . 78 5-3. Testing for Additional Indications for Approved Drugs . 78 5-4.
    [Show full text]
  • UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C
    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 earliest event reported): August 13, 2020 Kadmon Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37841 27-3576929 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 450 East 29th Street New York, NY 10016 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code (212) 308-6000 N/A (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: 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)) 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, par value $0.001 per share KDMN The New York Stock Exchange Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
    [Show full text]
  • American Foundation for Pharmaceutical Education Box: 8
    Ronald Reagan Presidential Library Digital Library Collections This is a PDF of a folder from our textual collections. Collection: Turner, Carlton E.: Files Folder Title: American Foundation for Pharmaceutical Education Box: 8 To see more digitized collections visit: https://reaganlibrary.gov/archives/digital-library To see all Ronald Reagan Presidential Library inventories visit: https://reaganlibrary.gov/document-collection Contact a reference archivist at: [email protected] Citation Guidelines: https://reaganlibrary.gov/citing National Archives Catalogue: https://catalog.archives.gov/ .. i ! f;c~~~ I I ,J I American Foundation For Pharmaceutical Education I OIRECTOF)S RADBURN PLAZA BUILDING 14-25 PLAZA ROAD, FAIR LAWN, N.J. 07410 Ronald J. Brenner. Ph.D. (201) 791-5192 INCORPORATED 1942 Cytogen Corpnr~lion William H. Campbell. Ph .D. March 3, 1986 Unfrersity of Washington Herbert 5. Carlin OFFICERS The New York Hospital Peter G. Tombros. Chaimratt of Board Paul N. Clark Abbott Wboralories Ronald J. Brenner. Ph.D .. Via Clwimum of Board L. Jack R. Cole. Ph.D. Robert Hanson, Treasurer William F. Weigel. Coumel and S(•aetary Uni\·ersity of Ariwna Thomas M. Collins Carlton E. Turner, Ph.D. E. PresitJ,,,u SmithK/i11e Beckman Corpora/ion Richard Faust. Ph.D .. Herbert J. Conrad Deputy Assistant to the President Hoffmann-Lo Roche Inc. for Drug Abuse Policy John W. Culligan American Home Products Corporation The White House Angele C. D"Angelo Washington, DC 20001 St. John's University Robert A . Dube Owens-Illinois Dear Carlton, Frederick M. Eckel 1he University of Nonh Carolina George W. Eckelmann Thanks for your kind note just before the holidays ..
    [Show full text]