Blockbuster Drugs

"This book uses the cases of several landmark drugs to discuss the history of the pharmaceutical industry, and discusses what could be next"--Provided by publisher.

For the world's largest prescription drug manufacturers, the last few years have been a harrowing time. Recently, Pfizer's Lipitor, GlaxoSmithKline's Advair, AstraZeneca's Seroquel, and Sanofi-Aventis and Bristol-Myers Squibb's Plavix all came off patent in the crucial U.S. market. This so-called "patent cliff" meant hundreds of billions of dollars in lost revenue and has pharmaceutical developers scrambling to create new drugs and litigating to extend current patent protections. Having spent most of his career in drug discovery in "big pharma," Dr. Li now delivers an insider's account of how the drug industry ascended to its plateau and explores the nature of the turmoil it faces in the coming years. He begins with a survey of the landscape before "blockbuster drugs," and proceeds to describe how those drugs were discovered and subsequently became integral to the business models of large pharmaceutical companies. For example, in early 1980s, Tagamet, the first "blockbuster drug," transformed a minor Philadelphia-based drug maker named SmithKline & French into the world's ninth-largest pharmaceutical company in terms of sales. The project that delivered Tagamet was nearly terminated several times because research efforts begun in 1964 produced no apparent results within the first eleven years. Similar stories accompany the discovery and development of now-ubiquitous prescription drugs, among them Claritin, Prilosec, Nexium, Plavix, and Ambien. These stories, and the facets of the pharmaceutical industry that they reveal, can teach us valuable lessons and reveal many crucial aspects about the future landscape of drug discovery. As always, Dr. Li writes in a readable style and intersperses fascinating stories of scientific discovery with engaging human drama.

Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies. The authors focus on three sources of pharmaceutical innovation: new management methods, new technologies, and new forms of internationalization. Their findings are illustrated in the case of the Swiss pharmaceutical industry, the leading exporter of pharmaceutical products in percentage of GDP, and some of its main pharmaceutical firms such as Novartis and Hoffmann-La Roche.

"Beginning in the 1970s, several scientific breakthroughs promised to transform the creation of new medicines. As investors sought to capitalize on these Nobel Prize-winning discoveries, the biotech industry grew to thousands of small companies around the world. Each sought to emulate what the major pharmaceutical companies had been doing for a century or more, but without the advantages of scale, scope, experience, and massive resources. How could a large collection of small companies, most with fewer than 50 employees, compete in one of the world's most breathtakingly expensive and highly regulated industries? This book shows how biotech companies have met the challenge by creating nearly 40% more of the most important treatments for unmet medical needs. Moreover, they have done so with much lower overall costs. The book focuses on both the companies themselves and the broader biotech ecosystem that supports them. Its portrait of the crucial roles played by academic research, venture capital, contract research organizations, the capital markets, and pharmaceutical companies shows how a supportive environment enabled the entrepreneurial biotech industry to create novel medicines with unprecedented efficiency. In doing so, it also offers insights for any industry seeking to innovate in uncertain and ambiguous conditions. Looking to the future, it concludes that biomedical research will continue to be most effective in the hands of a large group of small companies as long as national healthcare policies allow the rest of the ecosystem to continue to thrive"--

For decades, medical professionals have been betraying the public's trust by accepting various benefits from the pharmaceutical industry. Drug company representatives and doctors alike have promulgated creative rationalizations to portray this behavior positively, as if it really serves the interest of the public. In Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, Howard Brody claims that we can neither understand the problem, nor propose helpful solutions until we fully recognize the many levels of activity that connect these two industries. Then, for real improvement to occur, the doctors themselves need to not only change their behavior, but also change how they view the actions of their peers and colleagues. We can pass laws and enact regulations, so that those physicians that do choose to focus on ethics won't be in an environment where they feel as if they are swimming against too strong a current to make meaningful change, but ultimately a profession has to take responsibility for its own integrity.

The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.

The pharmaceutical industry faces a well-documented perfect storm: on the one hand, the patent cliff; the lack of new blockbusters and, on the other, economic pressure on pricing from markets with growing expectations and shrinking budgets. In the face of such pressure, traditional health economics models no longer seem appropriate and yet what do we have to replace them? The growing focus on 'value' and 'cost effectiveness' are evidence of new emerging thinking although, even here, with the shift from medicine as cure to medicine as palliative, as a treatment for chronic illness and with the growing emphasis on preventative approaches, the landscape is complex and challenging. The Future of Health Economics offers a window into some of the most influential emerging issues in pharmacoeconomics; issues such as risk-sharing and alternative pricing models or the potential impact of radical new approaches such as personalized medicine; as well as exploring the changing role of government and regulators. Ulf Staginnus and Olivier Ethgen, themselves two of the most well-regarded practitioners in this field, have brought together some leading-edge thinkers from industry and academia around the world to provide the industry, policy-makers, regulators, health practitioners and academics with the raw material for their future scenarios.

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