Salix submits Crofelemer NDA to FDA for treatment of HIV-associated diarrhea

Dec 14 2011

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Crofelemer for the proposed treatment of HIV-associated diarrhea. By regulation, the FDA has 60 days from the date of submission to conduct a filing review to determine if the application is sufficiently complete to permit a substantive review.

Salix has an exclusive license to the HIV-associated diarrhea indication for Crofelemer and the additional indications of pediatric diarrhea and acute infectious diarrhea in North America, Europe (excluding Iceland, Liechtenstein, Norway and Switzerland) and Japan. Salix also has a worldwide license to all other possible human indications, including irritable bowel syndrome, for Crofelemer. Napo has purported to terminate the license due to Salix's alleged failure to develop Crofelemer and other alleged breaches of the parties' Collaboration Agreement. As Salix has previously explained, Napo's purported termination of the license is groundless and without merit.