BioCentury
ARTICLE | Clinical News

Fulyzaq crofelemer regulatory update

January 7, 2013 8:00 AM UTC

Salix is engaged in litigation over crofelemer with Napo. In 2011, Napo terminated a 2008 deal giving Salix rights to the drug in North America, Japan and Europe, excluding Liechtenstein, Norway and Switzerland. Napo claimed Salix breached the deal by "unnecessarily stalling the advancement" of crofelemer and filed suit seeking damages. Salix has said Napo's allegations are "without merit" and in its most recent 10-Q said it is "moving forward" with the development of crofelemer under the 2008 deal. Napo could not be reached for comment (see BioCentury, Nov. 21, 2011). Luye has Chinese rights to crofelemer, which has Fast Track designation in the U.S. for HIV/AIDS-related diarrhea and diarrhea-predominant irritable bowel syndrome (D-IBS). ...