Valeant enters into partnership with AstraZeneca to develop brodalumab for psoriasis

Valeant Pharmaceuticals International announced that it has entered into a collaborative agreement through its affiliate with AstraZeneca, with Valeant being granted rights to develop and commercialize brodalumab.

Brodalumab, an IL-17 receptor monoclonal antibody, is being developed as treatment for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis, according to a press release. Valeant will hold exclusive developmental and commercialization rights to brodalumab globally, except in Japan and certain Asian countries where rights are held by Kyowa Hakko Kinn Co. Ltd. under a prior arrangement, the release stated.

Valeant announced that regulatory submission is planned for the fourth quarter of 2015 in the United States and European Union for brodalumab in moderate to severe psoriasis. Developmental costs associated with regulatory approval will be assumed by Valeant, the release stated.

Valeant will make an up-front payment of $100 million to AstraZeneca, with additional pre-launch payments of up to $170 million and sales-related milestone payment of up to $175 million after the launch, according to the release. Profits will be shared by AstraZeneca and Valeant after approval, the release stated.

Data from three phase 3 studies have supported brodalumab as treatment for moderate-to-severe psoriasis, according to the release. Brodalumab was shown to be efficacious compared to placebo in total skin clearance of psoriasis at a 210 mg dose, and superior to Stelara (ustekinumab, Janssen) at week 12 in two trials of more than 3,500 patients with psoriasis, the release stated.

“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,” J. Michael Pearson, chairman and CEO of Valeant, said in the release.

The agreement is expected to be completed in the fourth quarter of 2015, subject to closing conditions, according to the release.

Reference: www.valeant.com