Valeant Pharmaceuticals International, Inc. reports that J. Michael Pearson has returned as Valeant’s chief executive officer following his recovery from severe pneumonia and other complications, effective immediately. Howard B. Schiller, Valeant’s interim chief executive officer, will transition out of his current duties but will continue as a member of Valeant’s Board of Directors. Robert A. Ingram has been appointed Chairman of the Board as the company has separated the roles of chairman and chief executive officer.

Given the timing of Mr. Pearson’s return, the company will be rescheduling its previously announced call to discuss preliminary fourth quarter 2015 results, deliver a business review, and provide updated guidance for 2016. In the interim, the company is withdrawing its prior financial guidance. The company expects to provide preliminary financial information for the fourth quarter of 2015, and 2016 guidance, in the near term. As previously announced, the company will delay filing its 2015 10-K pending completion of the review of certain accounting matters by the Ad Hoc Committee, with the assistance of its independent advisors, and the company’s ongoing assessment of the impact on financial reporting and internal controls. The Ad Hoc Committee is continuing its review of the circumstances relating to those accounting matters and appropriate actions to be taken.

In addition, Valeant confirms that its wholly owned subsidiary, Salix Pharmaceuticals, has received a notice letter dated February 11, 2016 from Actavis Laboratories FL, Inc. stating that the US Food and Drug Administration (FDA) has received Actavis’ abbreviated new drug application (ANDA) containing a “Paragraph IV” patent certification seeking approval to market a generic version of Salix’s Xifaxan (rifaximin) 550 mg tablets. Valeant has 22 Orange Book-listed patents covering Xifaxan 550 mg tablets that are scheduled to expire between August 2019 and October 2029. “Valeant is highly confident in its intellectual property rights relating to Xifaxan 550 mg tablets and intends to vigorously enforce such rights in all applicable venues,” said the company in a statement.

Source: Valeant Pharmaceuticals