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Napo Announces Successful Clinical Results in Phase 2 Study of Crofelemer in Acute Adult Infectious Diarrhea
Date:4/10/2008

f as observed by the reduction in stool weight, stool frequency and passage of formed stools. Crofelemer was well tolerated and most adverse events were mild to moderate in severity and not different from the placebo group. Furthermore, the adverse events disappeared with continued therapy and causality was not attributed to the treatment.

Glenmark is Napo's exclusive licensee for crofelemer in over 140 countries for the indications of CRO-HIV, CRO-ID and CRO-PED. Glenmark anticipates it will begin another dose-ranging trial for CRO-ID in 2008, investigating the opportunity to treat with lower doses and lower frequency of dosing.

In combination with previous success in treating infectious diarrhea in travelers in Mexico and Jamaica with crofelemer, Napo is investigating the regulatory pathway to file an NDA for acute infectious diarrhea treatment with crofelemer coincident with its on-going Phase 3 program in chronic diarrhea in people living with HIV/AIDS (CRO-HIV). Napo is targeting an NDA filing for CRO-HIV around the end of the year. Napo has exclusive worldwide rights to crofelemer in all western territories.

Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc, said, "Napo is extremely pleased to see the achievement of statistical significance in this trial and that once again, crofelemer's safety profile has been confirmed. The success of this study is a very important step for Glenmark in its goal to develop crofelemer for CRO-ID in its territories. For Napo, it represents a significant step toward the realization of royalties from sales of crofelemer by Glenmark in over 140 countries, and may address the devastating morbidity and mortality issues associated with the billions of episodes of diarrhea in developing countries with a novel anti-secretory mechanism of action."

Pravin Chaturvedi, PhD, President and Chief Scientific Officer of Napo added, "The effects of crofelemer in this study of secretory diarrhea caused by infectious path
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SOURCE Napo Pharmaceuticals, Inc.
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