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Medical Week News for August 2006
Alizyme Reaches Agreement With FDA on Phase III Trial for Diet Pill Cetilistat

The small British drug development company Alizyme PLC said it has reached agreement with the U.S. Food and Drug Administration on plans for Phase III clinical trials of the diet pill cetilistat, and expressed hope that the trial will be able to start in the first half of 2007.

Cetilistat is a lipase, or fat, inhibitor, and is in the same class of drugs as Roche's prescription diet drug Xenical. But clinical trials have demonstrated that cetilistat has fewer side effects than Xenical.

Alizyme has said, however, that it needs a partner to help pay for the remainder of the development program, and is currently engaged in talks aimed at securing such a deal.

"The scope of the FDA agreement on the development plan provides an efficient and effective pathway for approval of cetilistat for the management of obesity and related disease and will aid our discussions with potential partners for cetilistat," Alizyme chief executive Dr. Richard Palmer said in a statement.

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(c) 2005 Medical Week News, Inc. All Rights Reserved. Last Updated: 01/07/2007