Napo Pharmaceuticals Will Provide Pediatric Formulation of Crofelemer at Cost to Developing Nations to Help Treat Life-Threatening Diarrhoel Diseases (Subject to FDA... (fileits first New Drug Application for c...)

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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

file its first New Drug Application for crofelemer - CRO-HIV - in mid-2009, subject to the receipt of further funding. In the approximately 1700 patients tested to date, the medication has been well-tolerated. Napo has exclusive worldwide rights to synthetic compounds in pre-clinical development which act by a similar mechanism of action.

Napo's opportunity costs over the course of the CAP are estimated to be approximately $200 million over five years. Napo is also seeking an additional $10 million in investments at the CGI conference this week to accelerate the development of CRO-PED. With appropriate funding, Napo anticipates FDA approval and distribution of CRO-PED will begin in 2011.

For more information please contact:

Napo Pharmaceuticals, Inc.

Lisa Conte, Chief Executive Officer

+001 (650) 616-1902

Charles Thompson, Chief Financial Officer

+001 (650) 616-1902

About Napo Pharmaceuticals, Inc.

Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. Napo was founded in November 2001, and is based in California, USA with a subsidiary in Mumbai, India.

Napo's late-stage proprietary gastro-intestinal compound, crofelemer, is in various stages of clinical development for four distinct product indications, including a late-stage Phase 3 program:

-- CRO-HIV for AIDS diarrhoea, Phase 3

-- CRO-IBS for diarrhoea irritable bowel syndrome ("D-IBS"), Phase 2

-- CRO-ID for acute infectious diarrhoea (including cholera), Phase 2

-- CRO-PED for paediatric diarrhoea, Phase 1

The FDA has granted fast-track status to CRO-IBS and CRO-HIV.

Napo has partnerships with Glenmark Pharmaceuticals Limited of India and AsiaPharm Group Ltd. of China. The Company has also established an alliance with Direct Relief International to provide access to and distribution o
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SOURCE Napo Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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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...(fileits first New Drug Application for c...)