AstraZeneca and Valeant Pharmaceuticals International, Inc. entered into a collaboration agreement  under which AstraZeneca will grant Valeant an exclusive license to develop and commercialize brodalumab, an IL-17 receptor monoclonal antibody that is in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis.

Under the agreement, Valeant will hold the exclusive rights to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd under a prior arrangement with Amgen Inc., the originator of brodalumab. Amgen terminated its co-development and commercialization agreement with AstraZeneca for brodalumab in May following Amgen’s decision to concentrate on other portfolio priorities after observing suicidal ideation and behavior events in the brodalumab program, which may result in restrictive labelling.

Valeant will assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in US and EU for brodalumab in moderate-to-severe psoriasis is planned for the fourth quarter of 2015.

Under the terms of the agreement, Valeant will make an up-front payment to AstraZeneca of $100 million as well as additional pre-launch milestones of up to $170 million and further sales related milestone payments of up to $175 million following launch. After approval, AstraZeneca and Valeant will share profits.

Brodalumab is supported by data from the three AMAGINE phase 3 pivotal studies. The results highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210mg dose, 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 more than 3,500 patients.

Pascal Soriot, Chief Executive Officer, 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 is expected to complete in the fourth quarter of 2015, subject to customary closing conditions, and it does not materially impact AstraZeneca’s financial guidance for 2015. As AstraZeneca continues to retain a significant interest in brodalumab, the upfront payment and any potential subsequent milestone payments are expected to be reported as Externalisation Revenue.