Valeant to buy rights to AstraZeneca's psoriasis drug
01 September 2015
Canada's Valeant Pharmaceuticals International Inc would buy rights to AstraZeneca Plc's late-stage experimental psoriasis drug brodalumab Amgen Inc dropped it in May.
Amgen pulled out of the project due to some patients getting suicidal thoughts after taking the medicine, which clouded its prospects.
Valeant today said it would make an upfront payment of $100 million to AstraZeneca, additional pre-launch milestone payments of up to $170 million and sales-related milestone payments of up to $175 million subsequent to the launch.
Regulatory submissions in the US and Europe for brodalumab in moderate-to-severe psoriasis had been planned for the fourth quarter of 2015.
The arrangement is not applicable in Japan and certain other Asian countries where Kyowa Hakko Kirin Co hold rights to the drug.
Brodalumab is part of a family of drugs called IL-17 inhibitors that block a signalling pathway, which plays a key role in inducing and promoting inflammatory diseases.
In psoriasis a chronic autoimmune disease, the growth cycle of skin cells is accelerated.
According to AstraZeneca, the deal, which was expected to complete in the fourth quarter of 2015, would not materially impact its financial forecasts for 2015.
Income from the upfront and milestone payments would be reported as "externalization revenue".
Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis.
Valeant will assume all development costs associated with the regulatory approval for brodalumab.
Brodalumab is supported by data from the three AMAGINE Phase III pivotal studies.
The results highlighted that brodalumab 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.
At the 210 mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis compared to placebo and superior to ustekinumab at week 12 in two replicate comparator trials involving over 3,500 patients.
Pascal Soriot, chief executive officer of AstraZeneca, said, "Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant's expert focus on dermatology."
J Michael Pearson, chairman and chief executive officer of Valeant, said, "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. We remain fully committed to dermatology and will continue to advance our pipeline of internally developed and acquired products."