Date: 2016-07-01
Type of information: Licensing agreement
Compound: tralokinumab, brodalumab
Company: AstraZeneca (UK) Leo Pharma (Denmark)
Therapeutic area: Autoimmune diseases - Dermatological diseases
Type agreement: collaboration licensing
Action mechanism: monoclonal antibody. Tralokinumab is an anti-IL-13 monoclonal antibody, that has completed a Phase IIb study for the treatment of patients with atopic dermatitis. Brodalumab is an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis.
Disease: atopic dermatitis, psoriasis
Details: * On July 1, 2016, Leo Pharma announced the signing of a strategic partnership with AstraZeneca. The partnership covers potential new medicines for atopic dermatitis and psoriasis. With the partnership, LEO Pharma enters into biological medicines within dermatology and expects to significantly expand the company's future treatment offering. The deal is expected to secure an entirely new foothold in the dermatology market for LEO Pharma, a global healthcare company dedicated to helping people achieve healthy skin. In the partnership with AstraZeneca, LEO Pharma acquires the global licence to tralokinumab in skin diseases and the exclusive licence to brodalumab in Europe. Tralokinumab completed a Phase IIb trial in atopic dermatitis in Q1 2016. Top-line results from the trial showed that at week 12, a statistically significant improvement from baseline in EASI score (Eczema Area and Severity Index) was observed in the two highest tralokinumab dosage arms tested compared to the placebo arm. Significant improvements in DLQI (Dermatology Life Quality Index) were also observed. AstraZeneca will manufacture and supply tralokinumab to LEO Pharma. AstraZeneca will retain all rights to tralokinumab in respiratory disease and any other indications outside of dermatology. 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." AstraZeneca and an affiliate of Valeant Pharmaceuticals International have agreed to terminate the licence for 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. 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.
Brodalumab is supported by data from the three AMAGINE Phase III pivotal studies. The results highlight that brodalumab's mechanism of action delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. Brodalumab has been submitted for regulatory approval in moderate-to-severe plaque psoriasis in Europe and an EMA decision is anticipated no later than Q1 2017.
The agreement with LEO Pharma for tralokinumab is subject to customary closing conditions and is expected to complete in the third quarter of 2016.
Financial terms: 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.
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