SOUTH SAN FRANCISCO, Calif., Sept. 19 /PRNewswire-USNewswire/ -- Napo Pharmaceuticals, Inc., (“Napo”) 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.
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:
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
CONTACT: Maureen Dempsey, +1-212-300-1806, mdempsey@apcoworldwide.com, for Napo Pharmaceuticals, Inc.
CONTACT: Maureen Dempsey, +1-212-300-1806, mdempsey@apcoworldwide.com, for
Napo Pharmaceuticals, Inc.
Web site: www.DirectRelief.org/
www.napopharma.com/
