Decision Resources study on irritable bowel syndrome finds drug developers competing for expanding market opportunity

Decision Resources Inc.table bowel syndrome (IBS)—which experts estimate afflicts at least 10% of the world's population—is the subject of a new Decision Resources study. As awareness of IBS increases and more patients seek medical attention, we believe that a substantial market opportunity will open for pharmaceutical companies that offer safe, efficacious, multisymptom agents.

Four new 5-HT modulators will become available over the 1999-2009 forecast period of this study. Controversy surrounds this class because the first 5-HT-modulating agent for IBS, GlaxoSmithKline's alosetron, was withdrawn from the U.S. market in November 2000, and development in all countries has since halted. A large burden of proof now exists for developers of any future 5-HT modulators for IBS to demonstrate beyond a doubt that their product does not have serious or life-threatening side effects. We believe that the emerging 5-HT modulators will overcome this hurdle. In Irritable Bowel Syndrome we examine the market potential of emerging IBS therapies, including the following:

• Cilansetron, a 5-HT3 antagonist, is being developed in Phase III trials by Solvay in the United States and Europe for diarrhea-predominant IBS. Trial data published to date have not shown problematic rates of side effects, and Solvay has issued public statements that cilansetron will not have the same problems as aloestron. If late-stage trials proceed well, cilansetron has the potential to be the first in its class to establish itself in the IBS market.

• Novartis's 5-HT4 antagonist tegaserod (Zelmac) was submitted for approval for constipation-predominant IBS in both the United States and the European Union in February 2000, and it is in Phase III trials in Japan. In October 2000, Novartis and Bristol-Myers Squibb announced a strategic alliance to codevelop and copromote tegaserod worldwide, excluding Japan.

• Renzapride (formerly known as ATL 1251) is in Phase IIb development in Europe (GlaxoSmithKline licensed it to Alizyme in July 1998). Renzapride will be in direct competition with the selective 5-HT4 agonist tegaserod for the treatment of constipation-predominant IBS patients, but it may hold an advantage in that its 5-HT3 antagonist action could help mediate visceral pain.

Irritable Bowel Syndrome offers invaluable market intelligence for pharmaceutical companies competing in the IBS market. This study is part of Mosaic, one of six Pharmacor services from Decision Resources that evaluate the commercial potential of drugs in research and development.

Decision Resources, Inc., is a world leader in research publications and advisory services designed to help clients shape strategy, allocate resources, and master their chosen markets. Founded as a subsidiary of Arthur D. Little, Inc., the company has provided strategic information services for 30 years, assessing international pharmaceutical and health care industry trends. Visit Decision Resources at www.dresources.com.

Contact: Frank Sama, 781.296.2553, sama@dresources.com.

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