Valeant Pharma: FDA Approves BLA For Brodalumab Injection - Quick Facts

(RTTNews) - Valeant Pharmaceuticals International (VRX, VRX.TO) announced the U.S. FDA has approved the Biologics License Application for SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis. Valeant expects to commence sales and marketing of SILIQ in the U.S. in the second half of 2017.

The Marketing Authorisation Application for brodalumab in moderate-to-severe psoriasis was accepted by the European Medicines Agency in the fourth quarter of 2015. In August 2015, Valeant entered into a collaboration agreement with AstraZeneca (AZN) granting Valeant an exclusive license to develop and commercialize SILIQ globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd. In July 2016, AstraZeneca and Valeant amended Valeant's license for brodalumab to terminate Valeant's right to develop and commercialize brodalumab in Europe. LEO Pharma currently holds exclusive rights to develop and commercialize brodalumab in Europe, and Valeant holds the license to develop and commercialize SILIQ in the U.S and other territories, other than Japan and certain other Asian countries.