LEO Pharma Enters Biologics Through Strategic Partnership With AstraZeneca

Ballerup, Denmark (ots/PRNewswire) - 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

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

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