LegalReader.com  ·  Legal News, Analysis, & Commentary

Drugs & Medical Devices

Valeant Strikes Collaboration Deal with AstraZeneca over Experimental Psoriasis Drug


— September 1, 2015

The terms of the agreement include Valeant paying AstraZeneca $100 million up front, adding another $170 million depending on pre-launch benchmarks, as well as up to $175 million depending upon sales benchmarks. After the product’s launch, the two companies will share profits. Valeant will handle the regulatory submission processes and the associated costs. In return, Valeant will retain the commercialization rights to brodalumab in all markets except in Japan and some Asian countries, where Amgen, the originator of the drug, had made a pre-existing agreement with Japanese biotech firm Kyowa Hakko Kirin.


Canadian drugmaker Valeant is continuing its purchasing frenzy, announcing early Tuesday morning that it has purchased the development and marketing rights from pharmaceutical giant AstraZeneca for the psoriasis drug brodalumab. The announcement comes less than two weeks after agreeing to purchase the “female Viagra” drug Addyi from Sprout Pharmaceuticals for $1 billion. The generic version of the drug, flibanserin, had only been approved by the Food and Drug Administration for two days before that purchase was announced. Similarly, AstraZeneca had been looking for a partner for brodalumab after San Francisco-based Amgen dropped its collaborative efforts in May due to side-effect concerns. Amgen representatives had said “events of suicidal ideation and behavior” during clinical trials would lead to restrictive labeling of the drug.

Brodalumab is part of a drug class known as IL-17 inhibitors, which help block the signal that causes inflammatory diseases like psoriasis, a chronic disease which accelerates the life-cycle of skin cells. AstraZeneca decided to continue the development of Brodalumab despite the hazardous side-effects due to successful phase-three clinical trials. Valeant CEO J. Michael Pearson believes that brodalumab is “potentially the most efficacious therapy yet for moderate-to-severe plaque psoriasis.” Valeant plans to submit the drug for Food and Drug Administration (FDA) approval, along with submitting filings for EU regulation later this year. This is roughly the same time that the collaborative agreement is expected to be finalized. Valeant has increasingly sought to increase its impressive dermatology treatment portfolio. AstraZeneca CEO Pascal Soriot noted the benefits of collaborating with Valeant, saying “Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant’s expert focus on dermatology.”

The terms of the agreement include Valeant paying AstraZeneca $100 million up front, adding another $170 million depending on pre-launch benchmarks, as well as up to $175 million depending upon sales benchmarks. After the product’s launch, the two companies will share profits. Valeant will handle the regulatory submission processes and the associated costs. In return, Valeant will retain the commercialization rights to brodalumab in all markets except in Japan and some Asian countries, where Amgen, the originator of the drug, had made a pre-existing agreement with Japanese biotech firm Kyowa Hakko Kirin. In addition to this deal and the Addyi purchase from Sprout, Valeant has spent $14.9 billion on 12 acquisitions since last year, including the $11 billion purchase of Salix Pharmaceuticals in 2014. Valeant also purchased eye-care leader Bausch & Lomb in 2013.

 

Sources:

Pharma Times – Selina McKee

Reuters – Ben Hirschler and Supriya Kurane

Wall Street Journal – Denise Roland

Join the conversation!