NAPL Napo Pharm.Regs

    
  Napo Pharmaceuticals Inc
  19 September 2008
   

 For immediate release  19 September 2008



    Napo Pharmaceuticals, Inc
    ("Napo" or "the Company")


    NOVEL DRUG DEVELOPMENT ALLIANCE BETWEEN NAPO pHARMACUETICALS AND DIRECT RELIEF INTERNATIONAL TARGETS GLOBAL IMPLICATIONS OF PEDIATRIC
DIARRHEA

    Napo Pharmaceuticals, Inc., of South San Francisco, California and Direct Relief International ("DRI") of Santa Barbara, California have
allied in a novel for- profit/not-for-profit effort to provide a development stage pharmaceutical product to pediatric populations in
disaster situations and resource-constrained geographies, termed the Crofelemer Access Program ("CAP").  

    Crofelemer is a late-stage gastro-intestinal agent which treats watery diarrhea.  The product targets dangerous dehydration and health
implications by decreasing flow of fluid into the intestines of infected patients, regardless of the cause of the infection or diarrhea.  

    As part of the CAP, Napo has committed to sustainably provide the drug at cost to DRI, for distribution to developing countries where
cholera and other gastro-intestinal diseases are prevalent.   DRI's commitment to distribute the product will depend upon the successful
registration of crofelemer as an FDA approved product, any local registration requirements, adequate formulation for distribution to
resource-constrained areas, and cost-effectiveness.

    "There are no safe and effective anti-diarrheal therapies for use in the pediatric populations", commented Lisa Conte, CEO of Napo
Pharmaceuticals, Inc. "Napo felt it was unacceptable to develop crofelemer for medical indications in the lucrative western market without a
business model to provide access to global populations in need. We are energized by our relationship with DRI, and hopeful that resources
from stakeholders who care about global health and HIV will help accelerate the development of and access to CRO-PED."  

    Thomas Tighe, President and CEO of Direct Relief International, added: "We've received very positive reports from our field partners
about the health benefits of crofelemer. From a humanitarian perspective, we could not be more pleased that the objectives of Napo's CAP
align with our own humanitarian mission to help people in poverty areas who face tremendous challenges to their health."

    Crofelemer is currently in final Phase 3 clinical development for chronic diarrhea in people living with HIV/AIDS in adults in the US,
and has been tested for safety in children as young as three months of age. In the approximately 1700 patients tested to date, there have
been no drug-related adverse events.  Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which
can be sustainably harvested from several countries in South America. Napo has exclusive worldwide rights to synthetic compounds in
pre-clinical development which act by the same mechanism of action.

    It is estimated that 4 billion episodes of acute diarrhea occur among children under five in developing countries each year, resulting
in two to three million deaths per annum. Research has demonstrated lasting, long-term morbidity due to persistent diarrhea in young
children, including effects on growth, fitness, and cognitive function.

    Chronic diarrhea is also a persistent problem in children born with HIV infection, and dehydration is the cause of death for most of the
young patients.  Untreated chronic diarrhea can also interfere with the body's ability to absorb the drugs used to treat HIV infection,
particularly anti-retroviral therapy.

    Napo's commitment is part of a program to attract socially responsible investors and donors to support the acceleration of development
of an FDA approved pediatric product. While return would be based on royalties on western market sales, Napo's commitment is to develop an
FDA approved pediatric formulation of crofelemer ("CRO-PED") for distribution to DRI's medical partner network.  Napo is currently seeking
other NGO (non-governmental) aid organizations for further reach to resource-constrained situations.  

    Napo expects to formalize this commitment in a to be formed B corporate subsidiary structure, which institutionalizes company
commitments which create benefit for all stakeholders.  Legislation establishing B corporations is currently pending in California.  Napo's
operating procedures and practices already established for the B corporation subsidiary have passed certification requirements to qualify as
a B corporation.

    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 
    Buchanan Communications 
    Tim Anderson, Mary-Jane Johnson
     (44) + 020 7466 5000 


    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. 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

    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. 

This information is provided by RNS
The company news service from the London Stock Exchange
 
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