Crofelemer regulatory update

FDA accepted and granted Priority Review to an NDA from Salix Pharmaceuticals Ltd. (NASDAQ:SLXP, Morrisville, N.C.) for crofelemer to treat diarrhea in HIV/AIDS patients on antiretroviral therapy. The PDUFA date is June 5. Crofelemer is a purified proanthocyanidin oligomer extracted from the bark latex of the Amazonian tree Croton lechleri that acts as a partial antagonist of cystic fibrosis transmembrane conductance regulator (CFTR) and calcium-activated chloride channel. The compound has Fast Track designation in the U.S. for HIV/AIDS-related diarrhea and diarrhea-predominant irritable bowel syndrome (D-IBS). Luye has Chinese rights to the compound (see BioCentury, Jan. 16).

In November, Napo said it terminated a 2008 deal that gave Salix rights to crofelemer in North America, Japan and Europe, excluding Liechtenstein, Norway and Switzerland. At the time, Napo claimed Salix breached the deal by "unnecessarily stalling the advancement" of crofelemer. Napo said Salix failed to submit an NDA 1 year after the report of Phase III data in November 2010 and did not prepare for commercialization. Salix said Napo's termination of the deal is "groundless and without merit" (see BioCentury, Nov. 21, 2011). ...