ASTRAZENECA ENTERS LICENSING AGREEMENTS WITH LEO PHARMA IN SKIN DISEASES
Agreement for development and commercialisation of tralokinumab for atopic
dermatitis supports sharper focus on main therapy areas
AstraZeneca also licenses European rights to LEO Pharma for brodalumab, a
potential new medicine for psoriasis
AstraZeneca today announced that it has entered into agreements that support its
strategic focus on three main therapy areas; Respiratory, Inflammation and
Autoimmunity, Cardiovascular and Metabolic disease and Oncology. The agreements
include two of AstraZeneca’s potential new medicines for dermatitis and
psoriasis, allowing the Company to further simplify and sharpen focus on
innovative new medicines in the main therapy areas.
Agreement for tralokinumab for dermatology
AstraZeneca has entered into an agreement with LEO Pharma A/S (LEO Pharma), a
specialist in dermatology care, for the global licence to tralokinumab in skin
diseases. Tralokinumab is a potential new medicine (an anti-IL-13 monoclonal
antibody) that has completed a Phase IIb trial for the treatment of patients
with atopic dermatitis, an inflammatory skin disease resulting in itchy, red,
swollen and cracked skin.
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. Tralokinumab is also in
Phase III development for patients with severe asthma. 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.”
Agreements for brodalumab in Europe
AstraZeneca and an affiliate of Valeant Pharmaceuticals International, Inc.
(Valeant) 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. Brodalumab is an IL-17 receptor monoclonal antibody under regulatory
review for patients with moderate-to-severe plaque psoriasis (a skin disease
that causes red patches of skin covered with silvery scales) and in development
for psoriatic arthritis (inflammation of the joints associated with psoriasis).
In September 2015, AstraZeneca and Valeant entered an
agreement (https://www.astrazeneca.com/media-centre/press
-releases/2015/astrazeneca-valeant-pharmaceuticals-brodalumab-dermatology
-psoriasis-01092015.html) granting Valeant an exclusive licence to develop and
commercialise brodalumab globally, outside Japan and certain other Asian
countries where the rights are held by Kyowa Hakko Kirin Co., Ltd. Valeant will
continue to lead development and commercialisation of brodalumab in the US and
all other markets included in the original agreement.
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.
Luke Miels added: “These agreements allow us to capitalise on LEO’s strong track
record of bringing new dermatological treatments to patients in Europe, while
enabling Valeant to focus on bringing brodalumab to market in the US and other
key markets. We are confident that working with both partners, we can maximise
the reach of this potential new medicine to help psoriasis patients across the
globe.”
Gitte Aabo, President and CEO, LEO Pharma, said: “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.”
Financial considerations
The agreement with LEO Pharma for tralokinumab is subject to customary closing
conditions and is expected to complete in the third quarter of 2016. As
AstraZeneca will retain a significant ongoing interest in dermatology
indications for tralokinumab, the upfront consideration of $115 million, future
commercial milestone and royalty payments will be reported as Externalisation
Revenue in the Company’s financial statements.
The agreements with Valeant and LEO Pharma for brodalumab became effective at
signing and incremental payments received from LEO Pharma will be reported as
Externalisation Revenue, in line with the prior arrangement.
The agreements do not impact AstraZeneca’s financial guidance for 2016.
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. For more
information please visit: www.leo-pharma.com
About Valeant
Valeant (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that
develops, manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, gastrointestinal disorder, eye health,
neurology and branded generics. More information about Valeant can be found at
www.valeant.com
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 –
Respiratory and Autoimmunity, Cardiovascular and Metabolic disease, and
Oncology. We are also active in inflammation, infection and neuroscience through
collaborations. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com
CONTACTS
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Investor Enquiries
UK
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US
Lindsey Trickett CVMD +1 240 543 7970
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Dial / Toll-Free +1 866 381 7277
Key: RIA – Respiratory, Inflammation and Autoimmunity, CVMD – Cardiovascular and
Metabolic Disease, ING – Infection, Neuroscience and Gastrointestinal
01 July 2016
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