July 1, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Valeant Pharmaceuticals International , headquartered in Laval, Quebec, announced today that the company and UK-based AstraZeneca had amended Valeant’s license for brodalumab. Brodalumab is an IL-17 receptor monoclonal antibody being evaluated in Europe in patients with moderate-to-severe plaque psoriasis.
The deal essentially ended Valeant’s rights to develop and commercialize brodalumab in Europe that it had inked a strategic partnership with AstraZeneca. LEO Pharma picked up the rights to brodalumab in Europe, although no financial figures were disclosed. And to further complicate that deal, Amgen will receive low single-digit inventory royalties connected to brodalumab.
In addition, LEO acquired the global license from AstraZeneca for tralokinumab. Tralokinumab is an anti-IL-13 monoclonal antibody that recently completed a Phase IIb trial in patients with atopic dermatitis.
As part of the tralokinumab deal, LEO made an upfront payment to AstraZeneca of $115 million. It will also pay AstraZeneca up to $1 billion in various commercial milestones and up to mid-teen tiered percentage royalties on any product sales. AstraZeneca will manufacture and supply the drug to LEO, and also retain rights to it in respiratory disease and other non-dermatology indications.
“LEO Pharma has secured a unique position to help people with skin diseases as a result of our strategic partnership with AstraZeneca, a global healthcare company at the forefront of science-led innovation,” said Gitte Aabo, president and chief executive officer of LEO Pharma, in a statement. “By expanding our portfolio to include both biologics and topicals, LEO Pharma is set to become the world dermatology leader—offering the most diverse range of treatment solutions to meet the individual needs of people with skin diseases.”
Brodalumab is expected to receive a final decision from the European Medicines Agency (EMA) no later than the first quarter of 2017.
AstraZeneca and Valeant signed the deal for brodalumab in August 2015, which gave Valeant an exclusive license to develop and commercialize the drug globally, except in Japan and other Asian countries. Under the amended deal, Valeant will still hold the license for it in the U.S. as well as the rest of the territories outside of Europe. AstraZeneca will pay Valeant an undisclosed upfront fee. Also, as part of the amendment, a pre-launch milestone payment that Valeant was to pay AstraZeneca has been reduced.
“We are pleased with this new licensing arrangement for brodalumab, which enables us to more sharply focus our efforts on delivering this important treatment to patients in the U.S. and other key markets, while providing us with immediate value and significant ongoing exposure to the treatment’s commercialization in Europe,” said Joseph Papa, chairman and chief executive officer of Valeant, in a statement. “Our current focus is on the upcoming advisory panel, where we will have the opportunity to discuss brodalumab treatment options for adult patients with moderate to severe plaque psoriasis and provide information about the novel antibody we are developing.”
Talokinumab is currently in Phase III development for patients with severe asthma.
“This agreement allows us to concentrate our efforts on tralokinumab’s potential for patients with severe asthma,” said Luke Miels, executive vice president, Global Product and Portfolio Strategy for AstraZeneca, in a statement, “a priority area for AstraZeneca, while benefitting from LEO Pharma’s expertise in dermatology for the continued development and commercialization of tralokinumab in atopic dermatitis and other dermatology conditions.”
