Valeant, AstraZeneca In Brodalumab Pact

Valeant Pharmaceuticals’ affiliate has entered into a collaboration agreement with AstraZeneca under which Valeant was granted an exclusive license to develop and commercialize brodalumab, an IL-17 receptor monoclonal antibody in development for moderate-to-severe plaque psoriasis and psoriatic arthritis.

Valeant has exclusive rights to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries, and is responsible for all development costs associated with the regulatory approval. Regulatory submission in the U.S. and EU for brodalumab in moderate-to-severe psoriasis is planned for 4Q15.

Valeant will make an up-front payment to AstraZeneca of $100 million, as well as pre-launch milestones of as much as $170 million and sales milestones of as much as $175 million. Once approved, the companies will share profits.

Three Phase III studies support that brodalumab has an effective mechanism of action that delivers clinical benefit in moderate-to-severe plaque psoriasis patients. Brodalumab was shown to be efficacious in total skin clearance of psoriasis compared to placebo and superior to ustekinumab at week 12 in two replicate comparator trials involving over 3,500 patients.
Pascal Soriot, chief executive officer of AstraZeneca, said, “Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant’s expert focus on dermatology.”

J. Michael Pearson, chairman and chief executive officer of Valeant, said, “We are delighted we were able to reach a licensing agreement with AstraZeneca to commercialize brodalumab, which is potentially the most efficacious therapy yet for moderate-to-severe plaque psoriasis. We remain fully committed to dermatology and will continue to advance our pipeline of internally developed and acquired products.”

The transaction, subject to customary closing conditions, is expected to complete in 4Q15.