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.

In August 2015, AstraZeneca and Valeant entered into an agreement granting Valeant an exclusive license to develop and commercialize brodalumab globally, other than in Japan and certain other Asian countries.  Under the terms of the amended agreement, Valeant will continue to hold the license to develop and commercialize brodalumab in the US, 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 US Food and Drug Administration (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.

"We are pleased with this new licensing arrangement for brodalumab, which enables us to more sharply focus our efforts on delivering this important treatment to patients in the US and other key markets, while providing us with immediate value and significant ongoing exposure to the treatment's commercialization in Europe," said Joseph C. Papa, chairman and chief executive officer of Valeant.  "Our current focus is on the upcoming advisory panel, where we will have the opportunity to discuss brodalumab treatment options for adult patients with moderate to severe plaque psoriasis and provide information about this novel antibody we are developing."

Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.

Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics.