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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. Marketing of Approved Biotechnology-Derived Drugs . 81 5-5. Company Rank by Pharmaceutical Sales 1989 . 85 5-6. Merger and Acquisition Activity in the Pharmaceutical Industry . 87 Chapter 5 The Pharmaceutical Industry INTRODUCTION R&D, contributing as both a production technol- ogy and a research tool. It is particularly impor- The development of biotechnology-based phar- tant in drug discovery, as it enables scientists to maceutical products is flourishing. Since the early study the molecular basis for disease and to 1970s, independent, dedicated biotechnology com- design drugs that respond to a particular disease panies (DBCs) have been examining the technol- process. Once the drug discovery process is com- ogy’s potential for commercial development, and in pleted, the product development process and cycle more recent years, the technology has diffused into are virtually the same for biotechnology-derived research laboratories and the development processes drugs and conventionally derived drugs. The devel- of most major companies in the pharmaceutical opment process is lengthy and tightly regulated, industry. Currently, both dedicated biotechnology requiring significant investment in time and money companies and established, multinational pharma- (7). Drug development includes clinical research ceutical companies are using the tools and tech- and trials and the completion of regulatory require- niques of biotechnology in their drug discovery and ments. development efforts. Despite the strong barriers to entry, characteristic Drug Discovery of the global pharmaceutical industry, there are Pharmaceutical research began as a chemical many DBCs focusing on niche markets and develop- science, focusing on chemical structures and corre- ing biotechnology-based pharmaceutical products. sponding activity, dominated by medicinal and Established pharmaceutical companies use biotech- organic chemists. Little was known about the nology as a research tool and are increasingly biology, biochemistry, and pharmacology of early developing in-house capabilities to complement products, and drug development in the days follow- their conventional research. Strategic alliances and ing World War II was speculative, based on mass- mergers between major, multinational pharmaceuti- screening of chemical compounds (56). Since then, cal companies use biotechnology as a research tool the development of physiology, biochemistry, ge- and DBCs allow both to compete in the industry and netics, and other biological sciences—including combine their strengths-the innovative technolo- biotechnology-has provided information at the gies and products of the DBCs blended with the molecular and cellular level. This has contributed to financial and marketing power and development and increased understanding of the relationships be- regulatory experience of the major companies. tween chemical structure and biological activity This chapter examines dedicated biotechnology companies, specifically with respect to human therapeutics and the diffusion of biotechnology into established pharmaceutical companies. The chapter also discusses the dynamics and economics of the pharmaceutical industry as they influence the adop- tion and commercialization of biotechnology. RESEARCH AND DEVELOPMENT Pharmaceutical research and development (R&D) is a risky business. Scientifically, the research and discovery of new drugs is interdisciplinary, involv- ing medicinal chemistry, molecular biology, bio- chemistry, physics, pharmacology, and other sci- Photo credit: National Institutes of Hsalth ences and technologies. Biotechnology has proven Flasks filled with microbes that have been genetically to be a source of innovation in pharmaceutical engineered to produce interferon. –73– 74 ● Biotechnology in a Global Economy necessary for the discovery and development of new these methods have worked well and provided the pharmaceutical products (14). industry with many drugs. Since the 1950s and 1960s, the most fruitful period of drug discovery Pharmaceutical R&D is now an interdisciplinary using conventional screening, this traditional route process in which a rational approach to drug design, toward the discovery of new chemical entities has based on an improved understanding of the biologi- become more costly and has provided fewer drugs cal mechanisms of disease and drug interactions, is (39). increasingly used to complement conventional chemical investigation. Biotechnology is likely to Rational Drug Design be the principal scientific driving force for the Conventional screening is increasingly being discovery of new drugs as we enter the 21st augmented and complemented by biological sci- century, and the impact of biotechnology on the ences that allow a more mechanistic and physiolog- discovery of new therapeutic entities is difficult to ical approach to drug discovery and design. This underestimate (28). rational approach to drug design requires close collaboration between many scientific disciplines Conventional Screening and is characteristic of drug development efforts of Traditional approaches to discovering new drugs many biotechnology companies and, increasingly, include continued research on existing products, the established pharmaceutical companies. investigation and characterization of natural prod- Rational drug design depends on an increased ucts, and the screening of synthetic chemicals and knowledge of cellular mechanisms and control. This compounds for medicinal and pharmacologic activ- contributes not only to the discovery of new drugs, ity (14). Existing drugs will always be researched for but also improves the understanding of the mode of possible improvements, be they in terms of dosage, action of existing drugs (25). Rational drug design side effects, or increased activity. Screening com- focuses on understanding the physiological basis of pounds, both natural and synthetic, for biological disease; and research concentrates, in part, on the and pharmacological activity is the conventional activity of enzymes, hormones and hormone recep- approach to drug discovery (55). tors, cell replication and protein synthesis, and other Thousands of natural and synthetic chemicals and molecular-level aspects of disease and drug treat- compounds are screened every year for biological ment (9,14). The techniques of biotechnology, and pharmacological activity. Natural products have specifically recombinant DNA (rDNA) and hybrid- been used to develop many new medicines. Exam- oma technology, are important research tools for ples include: molds, bacteria, plant products, ven- rational drug design. Biotechnology can provide oms, and toxins. Penicillins were developed from information about both the state and mechanism of penicillium mold, and other antibiotics, including disease, allowing the discovery aspect of pharma- streptomycin and bacitracin, were discovered by ceutical research to be more specific and targeted. screening soil samples for biological activity. Plant For an in-depth discussion of the use and potential products often have pharmacological activity and of biotechnology for therapeutic development see can be used to develop medicines. Morphine and OTA’s 1988 report, U.S. Investment in Biotechnol- heroin, for example, axe derived from the opium ogy (48). poppy. The study of venoms and toxins has led to The pharmaceutical industry uses biotechnology muscle relaxants, anticoagulants, and ion-channel for both its products and techniques, and there axe blockers. Screening and modification of synthetic two basic approaches to its use in drug development. chemicals have also resulted in the development of First, biotechnology can be a production technology important drugs, including chemotherapeutic drugs, using rDNA techniques to manufacture otherwise sulphonamide antibacterial,
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