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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

nd Direct Relief International ("DRI") have formed an alliance whereby Napo will provide CRO-PED at cost for distribution through DRI's network. Initially, the program is expected to reach 1.1 million children per year in sub-Saharan Africa who lack access to clean water. Ultimately, it is anticipated that an estimated 38 million people per year, including caregivers and the families of those children with diarrheal diseases, may be positively affected through this partnership. Napo is seeking additional NGO partners for similar programs.

"Napo is committed to a business model that not only reaches the lucrative Western markets, but will also allow us to serve global populations in need. The investment we are seeking as part of the CGI pledge would have a return based on those Western market sales," commented Lisa Conte, CEO of Napo Pharmaceuticals. "Due to the excellent safety profile of crofelemer in all clinical trials and its positive antidiarrhoeal activity, we believe crofelemer, once approved, can help save lives and improve the health of millions of children in resource constrained areas around the world ."

In addition to the CAP, Napo's CGI commitment also includes the sustainable harvesting of Croton lechleri, the raw material source of crofelemer, from rain forest areas of South America. The agroforestry will provide income to more than 5000 individuals upon the approval of crofelemer across the range of its intended indications, helping to conserve valuable forest land. Napo is committed to adhering to fair trade practices in sourcing the raw material from the suppliers in rain forest areas.

Crofelemer is currently in final Phase 3 clinical development for chronic diarrhea in people living with HIV/AIDS in adults in the US (CRO-HIV), and has been tested for safety in children as young as three months of age. The approval of CRO-PED by the FDA is subject to the prior approval of an adult formulation of crofelemer. The Company plans to
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SOURCE Napo Pharmaceuticals, Inc.
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