Leo Pharma to market brodalumab in Europe for psoriasis and psoriatic arthritis.- Valeant Pharma

Valeant Pharmaceuticals International, Inc. announced that its affiliate and AstraZeneca have amended Valeant's license for brodalumab, an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis, to terminate Valeant's right to develop and commercialize brodalumab in Europe. Under the terms of the amended agreement, Valeant will continue to hold the license to develop and commercialize brodalumab in the U.S, as well as the remainder of the territory outside of Europe. As consideration for the termination of the European rights, AstraZeneca will pay to Valeant an upfront payment and certain sales-based milestone payments and, in addition, one of the pre-launch milestones payable by Valeant to AstraZeneca under the original license has been reduced.

With the termination of Valeant's licensing rights to brodalumab in Europe, AstraZeneca has entered into an agreement granting LEO Pharma the exclusive rights to develop and commercialize brodalumab in Europe.

On January 25, 2016, Valeant announced that the FDA had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant for brodalumab injection for the treatment of moderate-to-severe plaque psoriasis and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016. In addition, the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant's BLA on July 19, 2016.