1st July 2016, Ballerup, Denmark – The partnership covers potential new medicines for atopic dermatitis and psoriasis, two of the world’s major skin diseases where a significant unmet medical need remains. 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.
“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. 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,” says Gitte Aabo, President and CEO, LEO Pharma.
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 is a potential new medicine, 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.
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. 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.”
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.footnote 11 The safety and efficacy of tralokinumab are still under investigation.
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 diseasefootnote 22. 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. The agreement for brodalumab became effective at signing and LEO Pharma’s payments to AstraZeneca are not disclosed and are in line with the arrangement with the previous licence holder for Europe. Additionally, Amgen will continue to receive a low single-digit inventor royalty in relation to brodalumab.
LEO Pharma is currently the world leader in topical psoriasis treatment and has significantly expanded its portfolio over recent years to cover several dermatology indications.
- Lebwohl M. et al. N Engl J Med. 2015 Oct;373(14):1318-28