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Napo Pharmaceuticals Announces License of Crofelemer to Salix Pharmaceuticals
Date:12/10/2008

SAN FRANCISCO, Dec. 10 /PRNewswire/ -- Napo Pharmaceuticals, Inc. ("Napo") is pleased to announce a collaboration with Salix Pharmaceuticals, Inc. ("Salix") for the license of crofelemer for all indications in North America, Europe (excluding certain smaller countries), and Japan, and certain indications worldwide. Crofelemer is Napo's novel anti-secretory, gastrointestinal agent currently in a final Phase 3 trial for the treatment of chronic diarrhea in people living with HIV/AIDS (the "ADVENT" program) under fast-track status and Special Protocol Assessment agreement with the FDA. This is the first indication targeted for approval and commercialization, with a market opportunity in the US of approximately $300 million.

The terms of the deal include an up-front license fee for the crofelemer intellectual property of $4.5 mm and an equity investment of $500,000 for the purchase of 250,000 shares of Napo common stock; as well as regulatory and sales milestone(s) payments tailored to the significance of the indication and performance of the product; and tiered royalty rates ascending to a $400 million annual sales threshold. The terms provide for full funding by Salix of the on-going ADVENT program, some of which costs will be off-set against future milestone payments to Napo.

Salix, a leading U.S. specialty pharmaceutical company focusing on products to treat gastro-intestinal disorders, will have the commercialization rights to an agent with potential application -- to a broad range of indications. Crofelemer is currently in clinical development for three additional indications: adult acute infectious diarrhea, including cholera -- in Phase 2; irritable bowel syndrome (IBS) -- in Phase 2; and pediatric diarrhea -- in Phase 1.

The FDA has granted fast-track status to crofelemer for the indications of chronic diarrhea in people living with HIV/AIDS and IBS. Positive clinical data in the treatment
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SOURCE Napo Pharmaceuticals, Inc.
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