AstraZeneca, LEO Pharma Sign Potential $1 Billion Licensing DealBy
AstraZeneca has entered into agreements with LEO Pharma A/S, a specialist in dermatology care, for the global license to tralokinumab in skin diseases. Tralokinumab is a potential new medicine (an anti-IL-13 monoclonal antibody) that has completed a Phase IIb trial for the treatment of patients with atopic dermatitis, an inflammatory skin disease resulting in itchy, red, swollen and cracked skin.
Under the agreement, LEO Pharma will make an upfront payment to AstraZeneca of $115 million for the exclusive, global rights to tralokinumab in atopic dermatitis and any future additional dermatology indications. LEO Pharma will also pay AstraZeneca up to $1 billion in commercially related milestones and up to mid-teen tiered percentage royalties on product sales. AstraZeneca will manufacture and supply tralokinumab to LEO Pharma.Tralokinumab is also in Phase III development for patients with severe asthma. AstraZeneca will retain all rights to tralokinumab in respiratory disease and any other indications outside of dermatology. The agreement with LEO Pharma for tralokinumab is subject to customary closing conditions and is expected to complete in the third quarter of 2016
In other news, AstraZeneca and an affiliate of Valeant Pharmaceuticals International, Inc. have agreed to terminate the licenze for Valeant's right to develop and commercialize brodalumab in Europe. Simultaneously, AstraZeneca has entered into an agreement with LEO Pharma for the exclusive licenze to brodalumab in Europe. Brodalumab is an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis and in development for psoriatic arthritis (inflammation of the joints associated with psoriasis).
In 2015, AstraZeneca and Valeant entered an agreement granting Valeant an exclusive license to develop and commercialize brodalumab globally, outside Japan and certain other Asian countries where the rights are held by Kyowa Hakko Kirin Co., Ltd. Valeant will continue to lead development and commercialization of brodalumab in the US and all other markets included in the original agreement. LEO Pharma will gain the European rights to brodalumab under similar terms to those agreed with Valeant. Additionally, Amgen will continue to receive a low single-digit inventor royalty.
The agreements with Valeant and LEO Pharma for brodalumab became effective at signing.
With the termination of Valeant’s licensing rights to brodalumab in Europe, AstraZeneca has entered into an agreement granting LEO Pharma the exclusive rights to develop and commercialize brodalumab in Europe. On January 25, 2016, Valeant announced that the US Food and Drug Administration had accepted for review the biologics license application (BLA) submitted by AstraZeneca in partnership with Valeant for brodalumab injection for the treatment of moderate-to-severe plaque psoriasis and assigned a Prescription Drug User Fee Act action date of November 16, 2016. In addition, the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant’s BLA on July 19, 2016.