Sept. 1, 2015
Valeant Pharmaceuticals International, Inc.
(NYSE: VRX and TSX: VRX) today announced that its affiliate has entered into a collaboration agreement with
under which Valeant was granted an exclusive license to develop and commercialize 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 commercialize brodalumab globally, except in
and certain other Asian countries where rights are held by
Kyowa Hakko Kirin Co., Ltd
under a prior arrangement with
, 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
, as well as additional pre-launch milestones of up to
and further sales-related milestone payments of up to
following launch. After approval,
and Valeant will share profits.
Brodalumab is supported by data from the three AMAGINE Phase III 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 210 mg 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 over 3,500 patients.
Pascal Soriot, Chief Executive Officer of
, 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
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, including Hart-Scott-Rodino anti-trust clearance.