Crofelemer regulatory update

Salix Pharmaceuticals Ltd. (NASDAQ:SLXP, Morrisville, N.C.) said FDA extended the PDUFA date by 3 months for an NDA for crofelemer to treat diarrhea in HIV/AIDS patients on antiretroviral therapy. The new date is Sept. 5; it was June 5. The application has Priority Review. According to Salix, FDA needed more time to review the submission, but did not request additional studies. 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.

In November, Napo 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). ...