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Napo Pharmaceuticals Will Provide Pediatric Formulation of Crofelemer at Cost to Developing Nations to Help Treat Life-Threatening Diarrhoel Diseases (Subject to FDA Approval)
Date:9/25/2008

Total Value of the Commitment to the CGI is an Estimated $210 Million

Crofelemer, Once Approved for Children, Could Aid in Treating Diarrhoel Diseases That Kill An Estimated 2.5 million Children Each Year

NEW YORK, Sept. 25 /PRNewswire-USNewswire/ -- Napo Pharmaceuticals, Inc., ("Napo") of South San Francisco, California, whose novel anti-diarrheal compound crofelemer is currently in development, has agreed to provide access to crofelemer for pediatric populations in disaster situations and resource-constrained geographies, pending successful registration of crofelemer as an FDA approved product (and any local registration requirements). The commitment is being made as part of the Clinton Global Initiative.

Crofelemer is a late-stage gastro-intestinal agent which treats watery diarrhea, and is sustainably harvested from Amazonian rain forests and manufactured in India in accordance with FDA Good Manufacturing Practices. According to the World Health Organization, up-to approximately 2.5 million children die from diarrhea each year. Crofelemer in clinical trials has demonstrated the ability to decrease the loss of fluid from the intestines of infected patients regardless of the infectious agent causing the watery diarrhoea. Crofelemer has recently demonstrated efficacy in clinical trials in acute infectious diarrhea of multiple etiologies including severely ill cholera patients. CRO-PED is a pediatric formulation of crofelemer currently under development.

Persistent acute diarrhea in children can have significant and devastating impairment of growth, fitness, school performance and cognitive function. Additionally, chronic diarrhea is a common problem for people living with HIV/AIDS, often leading to death in children. The Crofelemer Access Program ("CAP") announced September 19, 2008, aims to provide CRO-PED to millions of children in geographies hard-hit by diseases such as HIV/AIDS and cholera.

As part of the CAP, Napo a
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SOURCE Napo Pharmaceuticals, Inc.
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