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Valeant Teaming with AstraZeneca on Psoriasis Drug

By Pharmaceutical Processing | September 2, 2015

(AP) — Canadian drugmaker Valeant will work with British competitor AstraZeneca on a potential treatment for psoriasis a few months after biotech giant Amgen said it was ending research on the drug because of a link to suicidal thoughts and behavior.

Valeant could pay AstraZeneca as much as $445 million if the drug is successfully developed and approved and meets sales targets. The companies will also share profits from the drug.

The companies said Tuesday they plan to file for marketing approval of the drug brodalumab in the U.S. and the European Union during the fourth quarter. They want to market it as a treatment for moderate to severe psoriasis, a chronic condition that occurs when a person’s immune system speeds up the growth cycle of skin cells.

Kyowa Hakko Kirin Co. owns the rights to the drug in Japan and some other countries in Asia.

Brodalumab is designed to bind to a receptor in the body and block signals that lead to inflammation. Novartis AG’s drug Cosentyx, which went on sale earlier this year, treats the disease the same way. Amgen originally developed brodalumab and was studying it with AstraZeneca, but stopped that work because some patients experienced suicidal thoughts or behavior after taking it. Amgen said there would be restrictions on the use of brodalumab if it were approved.

In an emailed statement, Valeant said it is “very comfortable” with the safety and effectiveness of brodalumab, adding that patients with severe psoriasis sometimes suffer from depression. The biggest-selling treatments for psoriasis include AbbVie’s Humira and Amgen’s Enbrel, both given by injection. In 2014 the Food and Drug Administration approved a tablet called Otezla as a treatment for the disease even though it can increase depression. Physicians are advised to be careful about prescribing Otezla for patients with a history of depression or suicidal thoughts or behavior.

Among other side effects, psoriasis drugs can also affect patients’ immune systems, leaving them more vulnerable to infections.

U.S. shares of Valeant Pharmaceuticals International Inc. fell $6.55, or 2.9 percent, to $223.93 as the markets slumped. AstraZeneca PLC shares lost 59 cents to $30.69.

AstraZeneca and California-based Amgen Inc. have been working together on antibody drugs since 2012, and that partnership is continuing.

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