Valeant Pharma International acquires rights from AstraZeneca to brodalumab, a potential treatment for psoriasis and psoriatic arthritis

Valeant Pharmaceuticals International, Inc. announced that its affiliate has entered into a collaboration agreement with AstraZeneca under which Valeant was granted an exclusive license to develop and commercialise brodalumab. Brodalumab is an IL-17 receptor monoclonal antibody 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 commercialise brodalumab globally, except in Japan and certain other Asian countries (including China) where rights are held by Kyowa Hakko Kirin under a prior arrangement with Amgen Inc., the originator of brodalumab.

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.

Comment: The drug originated with Amgen which shared rights with AstraZeneca and Kyowa Hakko Kirin. Despite positive trial data for psoriasis and psoriatic arthritis, Amgen withdrew from the collaboration after reports of "suicidal ideation and behaviour events" appeared in the programme which it felt could restrict labelling. The drug is currently in Phase III studies for psoriasis and psoriatic arthritis and in early trials for ankylosing spondylitis.