LEO Pharma Enters Biologics Through Strategic Partnership With AstraZeneca - Seite 2

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.^[1] Significant improvements in DLQI (Dermatology Life Quality Index) were also observed.^[1]

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.^[2] 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.

NOTES TO EDITORS 

About AstraZeneca 

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - oncology; respiratory and autoimmunity; and cardiovascular and metabolic disease. We are also active in infection, neuroscience and inflammatory diseases through collaborations with others. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: http://www.astrazeneca.com

About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide.

Visit us at: http://www.leo-pharma.com

Subscribe to our YouTube channel: http://www.youtube.com/leopharmaglobal

Follow us on Twitter: http://www.twitter.com/leohealthyskin

Visit us at LinkedIn: http://www.linkedin.com/company/leo-pharma

References 

^[1] https://clinicaltrials.gov/ct2/show/NCT02347176

^[2] Lebwohl M. et al. N Engl J Med. 2015 Oct;373(14):1318-28