AstraZeneca, Valeant Collaborate on mAb
AstraZeneca has entered into a collaboration agreement with the specialty pharmaceutical company, Valeant Pharmaceuticals International, Inc, under which it will grant an exclusive license to Valeant for developing and commercializing brodalumab, an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. 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.
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. Valeant will assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in the US and European Union for brodalumab in moderate-to-severe psoriasis is planned for the fourth quarter of 2015.
The transaction is expected to be completed in the fourth quarter of 2015, subject to customary closing conditions, 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 externalization revenue.
In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialize six monoclonal antibodies from Amgen’s clinical inflammation portfolio, including brodalumab. Following Amgen's decision to discontinue development of brodalumab in May 2015, AstraZeneca terminated its contractual relationship with Amgen with regard to brodalumab at the end of August 2015. The collaboration arrangements remain in place for the other programs.