Psoriasis

Canada’s Valeant Pharmaceuticals International is buying the rights to develop and commercialise AstraZeneca‘s late-stage experimental psoriasis drug, brodalumab.

An IL-17 receptor monoclonal antibody, brodalumab is currently being developed to treat patients with moderate-to-severe plaque psoriasis and psoriatic arthritis.

In May, Amgen terminated its participation in the co-development and commercialisation of brodalumab with AstraZeneca.

Amgen pulled out of the project based on events of suicidal ideation and behaviour in the brodalumab programme.

As part of the deal, Valeant would make an upfront payment of $100m to AstraZeneca, and additional pre-launch milestone payments of up to $170m and sales-related milestone payments of up to $175m following the launch.

The deal will see Valeant hold the exclusive rights to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin under a prior arrangement with Amgen.

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AstraZeneca chief executive officer Pascal Soriot said: "Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant’s expert focus on dermatology."

"Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant’s expert focus on dermatology."

Under this agreement, Valeant will assume all development costs associated with the regulatory approval for brodalumab.

Regulatory submissions in the US and Europe for brodalumab in moderate-to-severe psoriasis are planned for the fourth quarter of this year.

Brodalumab is supported by data from the three Amagine Phase III pivotal studies, which showed that the drug 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.

Subject to customary closing conditions, the deal is expected to complete in the fourth quarter of this year.


Image: A person’s arm covered with plaque psoriasis. Photo: courtesy of en:User:Marnanel.