Crofelemer, Once Approved for Children, Could Aid in Treating Diarrhoel Diseases That Kill An Estimated 2.5 million Children Each Year
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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.
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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
