AstraZeneca has granted an exclusive license to develop and commercialize its registration-bound plaque psoriasis drug candidate brodalumab to Valeant Pharmaceutical International, in a deal that could generate up to $445 million-plus for AstraZeneca.
The deal, announced today by both companies, comes three months after AstraZeneca gained full control of brodalumab worldwide—except for Japan and some other Asian countries, where Kyowa Hakko Kirin holds rights. AstraZeneca gained full control in May, when Amgen halted co-development of the drug candidate, citing what it called “events of suicidal ideation and behavior,” that it believed was likely to require restrictive labeling.
But in their announcements today, the companies instead played up positive data from three Phase III pivotal studies. The companies cited findings of the AMAGINE studies that brodalumab had an effective mechanism of action that delivered 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 had been shown to be effective 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, AstraZeneca and Valeant noted.
The interleukin-17 (IL-17) inhibitor is a monoclonal antibody that has been in development for indications that include moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
By agreeing to license out development of brodalumab, AstraZeneca is further narrowing its drug development focus within its three key areas of oncology, cardiovascular and metabolic disease; and respiratory, inflammation and autoimmunity diseases.
Valeant, for its part, seeks to expand its pipeline in dermatology where in recent years, among actions, the company bought Medicis Pharmaceutical for some $2.6 billion; acquired PreCision Dermatology for up to $500 million; won FDA approval for its inflammatory acne gel Onexton™; and shelled out C$25.3 million ($17.9 million) for a portfolio of skin drugs and specialty products from Valeo Pharma.
During the second quarter, dermatology revenue jumped 55% from the year-ago quarter, to $461.8 million—the second largest increase behind the 58% of the neurological and other/generics category, Valeant reported on July 23.
“We remain fully committed to dermatology and will continue to advance our pipeline of internally developed and acquired products,” J. Michael Pearson, Valeant’s Chairman and CEO, said in a statement.
Valeant agreed to assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in the U.S. and E.U. for brodalumab in moderate-to-severe psoriasis is planned for the fourth quarter of 2015, the companies said.
Valeant also agreed to pay AstraZeneca $100 million upfront, another up to $170 million in payments tied to unspecified prelaunch milestones, and further sales-related milestone payments of up to $175 million following launch. AstraZeneca and Valeant said they will share profits following approval of brodalumab.
The deal is expected to complete in the fourth quarter, subject to customary closing conditions that include Hart-Scott-Rodino anti-trust clearance.
“Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant's expert focus on dermatology,” stated AstraZeneca CEO Pascal Soriot.