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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
The investigational monoclonal antibody targets interleukin-17 and is in clinical trials for the treatment of plaque psoriasis.
Valeant announced on Sept. 1, 2015 that it has entered into an agreement to develop and commercialize brodalumab. The company will license the novel, investigational product from AstraZeneca for an upfront payment of $100 million, and will also pay AstraZeneca pre-launch milestone payments of up to $170 million and post-launch fees of up to $175 million. According to Evercore ISI analyst Umer Raffat, the deal marks Valeant’s “first foray into biologics.”
Although J. Michael Pearson, chairman and CEO of Valeant, said in a press release that the monoclonal antibody (mAb) is “potentially the most efficacious therapy yet for moderate-to-severe plaque psoriasis,” Amgen-who was a co-developer of the drug with AstraZeneca-essentially abandoned the project earlier in the year because of reports of suicidal ideation and behavior in the program. Amgen thought the risks would likely “necessitate restrictive labeling,” and would effectively limit the patient population that could receive the drug, according to an Amgen press release.
Valeant will hold exclusive rights to brodalumab, except in Japan and certain other Asian countries, where rights are held by Kyowa Hakko Kirin under a prior arrangement with Amgen. Other potential competitors in the interleukin-17 (IL-17) space include Lilly’s ixekizumab and Novartis’ Cosentyx (secukinumab), but as Raffat points out, brodalumab is an antibody to the IL-17 receptor, while ixekizumab and secukinumab work by targeting the IL-17 ligand.
Despite the apparent risks involved with the novel mAb, brodulumab did demonstrate in a head-to-head clinical trial that it was more successful in clearing skin plaques than Johnson & Johnson's Stelara (ustekinumab).