Napo seeks FDA OK of disputed drug for dog diarrhea

Napo CEO Lisa Conte.

Napo Pharmaceuticals Inc. hopes its experimental diarrhea drug goes to the dogs. The San Francisco company will ask the Food and Drug Administration to approve the drug, called crofelemer, for use in chemotherapy-induced diarrhea in dogs. Salix Pharmaceuticals Inc. (NASDAQ: SLXP), Napo's former partner, is seeking approval for crofelemer for HIV/AIDS patients with chronic diarrhea, but the FDA last week delayed action on Salix's application until the first quarter of 2013.

Napo rainforest drug surrounded by legal vines

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Lisa Conte’s dream of tapping rainforest plants to create human drugs may be about to emerge from the legal jungle.
Crofelemer, a highly purified form of red, sappy bark latex from an Amazonian tree, could be approved in early June by the Food and Drug Administration to treat diarrhea in AIDS patients on antiretroviral drug therapy. Her Napo Pharmaceuticals Inc., based in San Francisco, has said the drug eventually could hit hundreds of millions of dollars in annual sales.
Approval would seemingly cap a 20-year journey wending through a handful of partnership deals, failed trials and a bankruptcy filing by Conte’s earlier company, Shaman Pharmaceuticals Inc
But Napo and Conte will have to cut through legal filings — in large part instigated by Napo — for the company to bring crofelemer to market.

Napo Pharma, ex-partner battle over control of diarrhea drug

Nearly four months after a key partnership blew up, Napo Pharmaceuticals Inc . said Tuesday that the Food and Drug Administration will decide by June 5 whether to approve its drug to treat chronic diarrhea in HIV/AIDS patients on antiretroviral therapy.
The FDA will give priority review, but that does nothing to clear up just who controls the drug, called crofelemer, whose active ingredient comes from the South American medicinal plant Croton lechleri.
The new drug application was filed by Salix Pharmaceuticals (NASDAQ: SLXP) in December, a month after Napo ended a three-year collaboration with the Raleigh, N.C.-based company.