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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Sam Citron who wrote (9742)	12/12/2003 12:11:50 PM
From: Sam Citron	Respond to of 52153

Glaxo Faces a Good Problem: High Costs for Clinical Trials [WSJ 12.12.03] Excerpt: Swelling budgets for clinical trials are turning acute not just at Glaxo, but at every company scratching to replenish its portfolio of medicines. These days, nearly all major drug makers fall in that category. These human tests vary in size and design. But the expenses for all of them are rising. The earliest and simplest studies, called Phase I, test the safety of new drugs in healthy volunteers. In the next stage, Phase II, researchers look for evidence that a drug works as expected and for information on the best dose to use. The most important trials, Phase III, are the biggest and most costly, sometimes involving tens of thousands of patients. These studies typically are designed to prove that a drug is more effective than a sugar pill or standard therapy and to collect definitive data on safety. Clinical-study costs averaged $414 million for each drug launched during the five years ended 2000, according to a recent analysis by Bain & Co., a consulting concern. The cost climbed to $860 million for each drug launched between 2000 and 2002. Bain divided spending on clinical studies on all compounds, including the duds, by the number of successful drugs launched. So the direct costs for drugs that made it to market were lower. But no matter how one adds the money up, clinical-study expenses are among the fastest-growing costs at drug companies. What's changed? Regulatory authorities are more demanding than ever in evaluating new drugs. Each year, they seek firmer proof to approve drugs, especially when it comes to their safety. That means enrolling more patients to detect uncommon but potentially serious side effects. Meanwhile, marketing mavens at many companies are demanding studies that examine multiple uses, or indications, for medicines, another factor leading to bigger, longer and more complex studies. online.wsj.com

To: Sam Citron who wrote (9742)	12/12/2003 9:07:15 PM
From: hmpa	Read Replies (1) \| Respond to of 52153

Country that might make a good candidate for large scale clinical trials is India. However, Indian legislation expressly prohibits foreign pharma's drugs to be tested there unless these tests are [not principal] part of a multi-national trial. There is certain amount of clinical testing done in Eastern Europe/former USSR; they have some FDA cleared centers. Some trials run there, however, produced poor quality data (statistics wise - e.g. CBST and EMIS trials, and probably others from the companies I don't follow), so I am not sure there is much growth despite supposedly lower costs and active promotion.