LAVAL, Quebec—Valeant Pharmaceuticals International Inc. has announced the beginning of a collaboration agreement between its affiliate and AstraZeneca, under which Valeant has received an exclusive license for the development and commercialization of brodalumab, an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis.
Per the terms of the agreement, Valeant will have exclusive rights to develop and commercialize the compound globally, excluding Japan and certain other Asian countries where Kyowa Hakko Kirin Co. Ltd. holds the rights under a prior agreement with Amgen Inc., brodalumab's originator. Valeant will be responsible for all development costs associated with the products regulatory approval, the submission for which is planned for the fourth quarter of this year in moderate-to-severe psoriasis. Valeant will pay AstraZeneca $100 million up front, in addition to pre-launch milestone payments of up to $170 million and sales-related milestone payments of up to $175 million after product launch. The companies will share profits after brodalumab gains approval.
"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," J. Michael Pearson, chairman and CEO of Valeant, said in a press release.
Brodalumab has undergone three AMAGINE Phase 3 pivotal studies, the results of which showed that the compound has an effective mechanism of action that offers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. Brodalumab was shown to be efficacious in total skin clearance of psoriasis at the 210 mg dose compared to placebo, and superior to ustekinumab at week 12 in two replicate comparator trials consisting of over 3,500 patients.
"Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant's expert focus on dermatology," added Pascal Soriot, CEO of AstraZeneca.
Amgen terminated its part in the development and commercialization of brodalumab in May in the wake of suicidal ideation and behavior in the program, noting that "During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," according to Dr. Sean E. Harper, executive vice president of Research and Development at Amgen.
Valeant has also announced a definitive agreement to acquire Synergetics USA Inc., a leading supplier of precision surgical devices with a focus on ophthalmology and neurosurgery. Valeant will acquire the company for $6.50 per share in cash as well as additional cash payments to Synergetics shareholders of up to $1 per share if certain sales milestones are reached following the closing of the deal, which is expected in the fourth quarter of this year.
