Valeant And Actavis Agree To Stay Litigation Relating To Valeant's Top-selling Drug Xifaxan

Salix Pharmaceuticals Inc. and its parent Valeant Pharmaceuticals International Inc. and Actavis Laboratories Inc., at Actavis' request, have agreed to stay outstanding litigation regarding Actavis' application for approval of a generic version of Xifaxan, a treatment for irritable bowel syndrome. The parties have also agreed to extend the 30-month stay on the litigation, which was brought by Valeant against Actavis on March 23, 2016. Valeant said it also filed a Citizen Petition with the U.S. Food and Drug Administration in October, seeking changes to previously recommended standards for approval of generic versions of Xifaxan, Valeant's best-selling drug, and one that has chalked up annual sales of $1 billion in the past. A Citizen Petition is a process that enables drug companies and individuals to seek changes in FDA health policy. "On March 16, 2017, the FDA answered the Citizen Petition and issued its revised draft guidance regarding the recommended standards for approval of ANDAs for generic versions of Xifaxan," Valeant said in a statement. Legal action is now stayed through April of 2018 and cannot be lifted before October 31 of 2017, said the statement. "Valeant remains confident in the strength of the Xifaxan patents and will defend its intellectual property vigorously," said the statement. Valeant shares fell 1.3% in premarket trade, and have fallen 3% in 2017 so far, while the S&P 500 has gained 7%.