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Napo Pharmaceuticals, Inc. Will Provide Pediatric Formulation of Crofelemer at Cost to Developing Nations to Help Treat Life-Threatening Diarrhoel Diseases



9/26/2008 8:07:53 AM

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 and 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 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 of crofelemer for pediatric populations in disaster and resource-constrained geographies, if the product achieves approval and registration by the FDA. For more information please visit www.napopharma.com.

About Direct Relief International

Founded in 1948, Direct Relief International is a Santa Barbara-based nonprofit organization focused on improving the quality of life by bringing critically needed medicines and supplies to local healthcare providers worldwide. Direct Relief works in 59 countries and has delivered more than $1 billion in privately funded humanitarian medical aid to health professionals serving impoverished communities since 2000. Direct Relief is one of two charities ranked by Forbes that has received a perfect fundraising efficiency score for five consecutive years and is ranked by the Chronicle of Philanthropy as California's largest international nonprofit organization based on private support. For more information, please visit www.DirectRelief.org

About the Clinton Global Initiative (CGI)

Established in 2005 as a project of the non-partisan William J. Clinton Foundation, the Clinton Global Initiative (CGI) convenes global leaders to devise and implement innovative solutions to some of the world's most pressing challenges. Since 2005, CGI members have made nearly 1,000 Commitments to Action valued at upwards of $30 billion to improve more than 200 million lives in over 150 countries around the world. Through past Annual Meetings, CGI has brought together more than 80 current and former heads of state, hundreds of top CEOs and non-profit leaders, major philanthropists, and 10 of the last 16 Nobel Peace Laureates.

The CGI community also includes: CGI University (CGI U), a forum to engage college students in global citizenship; CGI Asia, the first in a series of regional CGI meetings; and, MyCommitment.org, an online portal where anybody can make their own Commitment to Action.

For more details on CGI and the 2008 Annual Meeting, please visit www.clintonglobalinitiative.org or contact press@clintonglobalinitiative.org.

This announcement contains forward-looking statements relating to Napo Pharmaceuticals and its products that involve risks and uncertainties, including statements regarding future products and developments that are not historical facts. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. These statements can be identified by the use of forward-looking terminology such as "believe," "expect," "may," "will," "should,'' "could," "project," "plan,'' "seek," "intend,'' or "anticipate'' or the negative thereof or comparable terminology and statements about industry trends and Napo's future performance, operations and products.

CONTACT: Lisa Conte, Chief Executive Officer, +001-650-616-1902, or
Charles Thompson, Chief Financial Officer, +001-650-616-1902, both of Napo
Pharmaceuticals, Inc.

Web site: http://www.clintonglobalinitiative.org/
http://www.DirectRelief.org/
http://www.napopharma.com/


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