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news.Napo Pharmaceuticals has entered into a collaboration agreement with Glenmark Pharmaceuticals to develop and commercialize crofelemer, Napo's novel anti-diarrhea compound, for India and 140 countries mainly in the developing world.
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Under the terms of the agreement, Napo has granted development and commercialization rights to Glenmark in their territories for pediatric diarrhea, acute infectious diarrhea and AIDS-related diarrhea.
Glenmark will exclusively supply Napo’s global active pharmaceutical ingredient requirements for development and commercial sales including manufacturing to satisfy FDA requirements. In addition, Glenmark will pay Napo royalties on its net sales of crofelemer and help Napo finance the product.
Crofelemer, derived from the latex of Croton lecheri, a plant that grows along the Napo River and in several countries in South America, is currently in advanced clinical development in the US to treat chronic diarrhea in people living with HIV and diarrhea-predominant irritable bowel syndrome.
The compound has received fast-track designation for AIDS-related diarrhea from the FDA. Napo expects to file crofelemer as a new drug in 2007. Additional indications currently under investigation include pediatric diarrhea and acute infectious diarrhea.
“This collaboration is the beginning of our plan to complement our generic development efforts for India and less regulated markets with proprietary products. It illustrates the benefit of being an integrated company,” said Glenn Saldanha, managing director and CEO of Glenmark.