September 1, 2015
By Alex Keown, BioSpace.com Breaking News Staff
LAVAL, Quebec – Valeant Pharmaceuticals International, Inc. struck a $445 million drug pact with AstraZeneca PLC to acquire a psoriasis drug linked to suicidal tendencies during clinical trials. Valeant acquired AstraZeneca’s brodalumab, a drug that had once been a joint project between AstraZeneca and Amgen , although Amgen stepped away from the project in May after patients showed signs of suicidal tendencies.
Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. The drug blocks the binding of several IL-17 cytokines to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestations of plaque psoriasis. During late-stage clinical trials, brodalumab taken at a dose of 210 milligrams, was shown to be effective in treating psoriasis. J. Michael Pearson, chief executive officer of Valeant, said brodalumab 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,” Pearson said in a statement.
Brodalumab was originally a joint project between AstraZeneca and Amgen, Inc. However, on May 22, Amgen stepped away from the agreement concerning Brodalumab after patients showed signs of suicidal tendencies, which would require a stringent warning label if the drug achieved regulatory approval. During trials, four patients showed suicidal tendencies and two patients committed suicide. When Amgen announced it was terminating the collaboration, the company also said there were additional suicides in the open label extension studies, beyond the two reported in the Phase III studies.
After Amgen stepped away from the collaboration, Pascal Soiriot, AstraZeneca’s chief executive officer, said the company wanted to take some time to look at the data and talk things over with regulatory authorities and see if there is a clear path forward to bringing the drug to market. That path seemed to be selling the drug to deal-hungry Valeant.
The drug is expected to be submitted for regulatory approval in the United States and Europe by the end of 2015, Valeant said.
Under terms of the deal, Valeant will provide $100 million in an upfront payment to London-based AstraZeneca. Additionally, the Canadian-company will provide an additional $170 million in pre-launch milestone payments. Additional milestone payments up to $175 million will be made to AstraZeneca following the commercial launch of brodalumab. Valeant will be able to market the drug globally, with the exception of Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd under a prior arrangement with Amgen Inc., the originator of brodalumab.
Analysts sad the drug could earn as much as $1.5 billion annually, Reuters reported reported. However, a warning label could limit revenues, especially considering Novartis AG already markets a similar psoriasis drug called Cosentyx that does not come with suicidal side effects. Eli Lilly and Company is also developing a psoriasis drug, ixekizumab. Although still in Phase III trials, ixekizumab patients have not shown an increase in suicidal thoughts, analysts said.
