Salix files Crofelemer NDA as spat with Napo moves to Glenmark

USA-based Salix Pharmaceuticals (Nasdaq) said yesterday that it has submitted a New Drug Application to the US Food and Drug Administration for Crofelemer, a proprietary proanthocyanidin, for the proposed treatment of HIV-associated diarrhea, just as there were more revelations on its arguments with the drug’s originator, California-based Napo Pharmaceuticals. 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.