AstraZeneca licenses skin disease drugs to LEO Pharma

AstraZeneca has entered into an agreement with LEO Pharma for the global licence 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 terms of 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.

Commenting on the collaboration with LEO Pharma, Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “This agreement allows us to concentrate our efforts on tralokinumab’s potential for patients with severe asthma, a priority area for AstraZeneca, while benefitting from LEO Pharma’s expertise in dermatology for the continued development and commercialisation of tralokinumab in atopic dermatitis and other dermatology conditions.”

Agreements for brodalumab in Europe

In related news, AstraZeneca is to terminate Valeant’s right to develop and commercialise brodalumab in Europe. Simultaneously, AstraZeneca has entered into an agreement with LEO Pharma for the exclusive licence to brodalumab in Europe. Brodalumab is an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis (a skin disease that causes red patches of skin covered with silvery scales) and in development for psoriatic arthritis (inflammation of the joints associated with psoriasis).

In September 2015, AstraZeneca and Valeant entered an agreement granting Valeant an exclusive licence to develop and commercialise brodalumab globally, outside Japan and certain other Asian countries where the rights are held by Kyowa Hakko Kirin Co. Valeant will continue to lead development and commercialisation 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.

Luke Miels added: “These agreements allow us to capitalise on LEO’s strong track record of bringing new dermatological treatments to patients in Europe, while enabling Valeant to focus on bringing brodalumab to market in the US and other key markets. We are confident that working with both partners, we can maximise the reach of this potential new medicine to help psoriasis patients across the globe.”