LEO Pharma Enters Biologics through Strategic Partnership with AstraZeneca

PR64987

BALLERUP, Denmark, 1 July 2016 /PRNewswire=KYODO JBN/ --

    LEO Pharma is a significant step closer to realising its vision of becoming

the preferred dermatology care partner following a strategic partnership with

AstraZeneca announced today.

    (Logo: http://photos.prnewswire.com/prnh/20130221/595427 )

    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.[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

[https://clinicaltrials.gov/ct2/show/NCT02347176?term=Tralokinumab+atopic&rank=1

]

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

SOURCE: LEO Pharma A/S