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By Katherine Purcell
Two international pharmaceutical partnerships are working to simultaneously develop and commercialize crofelemer, which is the United States Adopted Name (USAN) for the anti-diarrheal preparation extracted from a South American tree, for use in the developing world and the United States.
Napo Pharmaceuticals Inc., a San Francisco-based, specialty pharmaceutical company, signed a partnership with Glenmark Pharmaceuticals Ltd of Mumbai, India, on July 6 to develop and commercialize the crofelemer compound for the Indian market and 140 countries,1 but exclude the U.S., Europe, Japan and China.2
Napo signed a similar deal with AsiaPharm of the People’s Republic of China (PRC) on June 15, to launch crofelemer in China, Hong Kong and Macau.3 These partnerships are part of Napo’s global strategy to expand crofelemer’s potential uses and to bring the drug to new markets.1
“This collaboration will allow Napo to bring a novel therapy to these debilitating and sometimes deadly diseases, to both traditional Western markets and resource constrained areas of the world," said Napo CEO Lisa Conte in a press release.1
The international partnerships have licensed the crofelemer compound in various countries to treat pediatric and acute infectious diarrhea and chronic diarrhea in people living with HIV/AIDS.1
According to Napo, crofelemer has shown significant anti-diarrheal activities in multiple clinical trials of over 1000 patients.1
“Crofelemer works by normalizing water flow in the gut. It is not absorbed into the blood, but acts in the intestines to treat diarrhea and prevent dehydration. Because it is not absorbed and acts locally, it has a positive safety profile,” explained Steven King, vice-president of Ethnobotany and Conservation of Napo (oral communication, July 21, 2205). (Dr. King is also a member of the American Botanical Council Advisory Board.)
The drug’s capacity to treat diarrhea, by blocking the secretion of chloride ions, and still allowing bowel movements, makes this useful for treating chronic diarrhea, explained King (oral communication, July 21, 2205).
This novel mechanism is important to people living with chronic diarrhea, so much so, that the US Food and Drug Administration (FDA) gave Napo a fast-track designation for the crofelemer drug compound for use in treating AIDS-related diarrhea.2
“The plan is to be through with clinical trials and gain the FDA approval for a new drug application (NDA), by 2007,“ King said (oral communication, July 21, 2205).
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Crofelemer is extracted and purified from the latex of a South American tree called dragon’s blood (Croton lechleri [Mull.] Arg., Euphorbiaceae).3 Each indigenous group has a different common name for this tree but the most common name is sangre de drago (dragon’s blood), because of the color of the tree sap of latex (King, oral communication, July 21, 2205).
“This is a novel mechanism of action for the treatment and management of diarrhea, and it has been brought to us by indigenous knowledge,” adds King (oral communication, July 21, 2205).
References
1. Conte L, Bertrand B. Napo Pharmaceuticals, Inc. Adds Glenmark Pharmaceuticals of India to Global Team to Develop and Commercialize a Novel Treatment for Diarrhea. [Press Release] [Press Release] San Francisco, CA: Napo Pharmaceuticals Inc; July 7, 2005.
2. Jankiraman V, Conte LA., Bertrand D. Glenmark Pharmaceuticals Ltd and Napo Pharmaceuticals Inc announce collaboration agreement on Napo’s novel anti-diarrheal product Crofelemer. [Press Release] Mumbai, India: Glenmark Pharmaceuticals Ltd.; July 7, 2005.
3. McGuffin M, Kartesz JT, Leung AY, Tucker AO. The American Herbal Product Association’s Herbs of Commerce. 2nd ed. Silver Spring, MD: American Herbal Products Association; 2000:49.
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