Twenty Years of Change in Pharmaceutical R&D

By Ian Lloyd, Pharmaprojects

Twenty years may not seem such a long period, but in fact, it can represent generations of compounds in the pharmaceutical industry. A good example is in the treatment of peptic ulcer. The first edition of Pharmaprojects, in 1980, reflected the treatment modalities of the time, with products in development including antacids and prostaglandins. But the first of a new kind of antiulcer drug, the histamine H₂ antagonist Tagamet, had just come onto the market, and within a few years this class had become the drug of choice, with Glaxo's version, Zantac, becoming the biggest selling prescription drug in the world. However, in 1988, the Swedish company Astra launched Losec, the first of a new kind of antiulcer drug, the proton pump inhibitors, and by the late '90s, Losec had itself become the world's biggest selling drug and spawned a number of big-selling imitators.

Now, with both drugs available over the counter, a further change in therapy is underway, with the discovery that most ulcers are caused by the bacterium, Helicobacter pylori. A short course of combination therapy with antibiotics is becoming the gold standard in treating ulcers. That's three complete revolutions in antiulcer therapy within 20 years.

Cardiovascular therapy was also on the brink of major change in 1980. Calcium channel antagonists and b-blockers were still pre-eminent, but that year saw the launch of the first of a new kind of agent—captopril, the first ACE inhibitor. ACE inhibitors went on to become massive sellers in the eighties before they themselves were eclipsed by the angiotensin II antagonists in the latter half of the '90s.

An even more stark illustration of the rate of change of pharmaceutical development can be seen by looking at the huge change in antiviral therapy. Twenty years ago, viral diseases were difficult, if not impossible, to treat. Then, in 1981, the anti-herpes drug aciclovir reached the market and has now not only become one of the most widely prescribed drugs in the world, but has also been followed a number of similar drugs, and is considered so safe that it is sold over the counter. In 1980, AIDS had not even been heard of, never mind HIV identified; now there are 14 antiviral drugs on the market to treat the condition. There are also drugs available to treat hepatitis-B, cytomegalovirus, and human papillomavirus infections. And the turn of the millennium has seen the introduction of the first drugs targeted specifically against influenza. The cure for the common cold, however, has proved more elusive.

The major change that the time traveller arriving from 1980 would observe would be the proliferation of biotechnology products. Twenty years ago, biotech was a long way from making a significant mark on medicine. Then, the first recombinant therapeutic, Genentech's human insulin, was launched in 1982, and now there are over 100 biotech drugs on the market. Gene therapy and genomics were merely speculative concepts in 1980; now, Pharmaprojects reports that approval for the first Phase III clinical trial of a gene therapy has been received, and a drug acting on a target identified via genomics is in Phase II trials.

The structure of the industry is also almost unrecognisable, with the emergence of many small niche companies reflecting the rise of new technologies complementing the numerous megamergers. Household names in 1980 such as Fisons, Cyanamid, Sandoz, and Hoechst have all disappeared, and Beecham and Wellcome are about to be consigned to history, too

As well its core function of tracking the developments and successes of the last 20 years, Pharmaprojects also, and uniquely, contains 20 years of data on compounds and projects which have been discontinued, withdrawn, or whose development has lapsed, the number of which has now grown to 17,270. This provides a wealth of information on failed drugs, all of which can provide invaluable clues towards new drug development and how to avoid the mistakes of the past. The database is also tracking 5,995 drugs in current development, and holds details on 1,658 whose development has been successfully completed since 1980.

The development of Pharmaprojects itself also reflects the vast technological changes which have occurred since 1980. Although designed as a database from the outset, it was available as a print publication only initially until made available online in 1985. The first CD-ROM presentation was launched in 1994, with a Windows version following rapidly in 1995. Last November saw the launch of a completely redesigned version of the database that can be networked. The Pharmaprojects team is currently engaged in further developments to enable the publication to track the even more extraordinary developments which will doubtless occur over the next 20 years. The team is also available for comment or to provide presentations on trends in pharmaceutical R&D. For details, please contact Ian Lloyd, Managing Editor.

About Pharmaprojects
Pharmaprojects is a leading database tracking pharmaceutical development from early preclinical study through to launch or failure. The completely redesigned version of its CD-ROM product includes a number of new features, such as a graphing facility and the ability to analyse trends over six years (as from June 2000). The data is also available online via PJB Publications, Dialog and DataStar, Ovid Technologies, STN International, NewsEdge Corp., and in Lotus Notes and print formats.

For more information: Ian Lloyd, Managing Editor, Pharmaprojects, 18/20 Hill Rise, Richmond, Surrey TW10 6UA, UK. Tel: +44 020-8332-8877. Fax: +44 020-8332-8994.