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2017-05-19

AstraZeneca: Brodalumab receives positive CHMP opinion for the treatment of adult patients with moderate-to-severe plaque p...

AstraZeneca today announced that its partner LEO Pharma has received a
positive opinion from the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) recommending the
approval of brodalumab for the treatment of adult patients with
moderate-to-severe plaque psoriasis who are candidates for systemic
therapy.

Brodalumab is the first and only fully human monoclonal antibody that
selectively targets the IL-17 receptor. By binding to the receptor,
brodalumab effectively blocks the biological activity of several
pro-inflammatory IL-17 cytokines, which are important in psoriasis, a
chronic, debilitating skin disease that causes red patches of skin
covered with silvery scales.

In July 2016, AstraZeneca announced an agreement
(https://www.astrazeneca.com/media-centre/press-releases/2016/astrazeneca...)
granting LEO Pharma, a specialist in dermatology, exclusive rights
to develop and commercialise brodalumab in Europe. Today's
announcement follows the approval of brodalumab
(https://www.astrazeneca.com/media-centre/press-releases/2017/Siliq-broda...)
by the US Food and Drug Administration (FDA) (brand name Siliq) in
February 2017 and the approval by the Japanese Pharmaceuticals and
Medical Devices Agency, in 2016.

The CHMP's positive opinion on brodalumab will now be reviewed by the
European Commission, which has the authority to approve medicines for
the European Union (EU). The final decision is applicable to all EU
and European Economic Area countries (Iceland, Liechtenstein and
Norway).

- ENDS -

NOTES TO EDITORS

About brodalumab

Brodalumab is a novel human monoclonal antibody that binds to the
interleukin-17 (IL-17) receptor and inhibits inflammatory signalling
by blocking the binding of several types of IL-17 to the receptor. By
stopping IL-17 from activating the receptor, brodalumab prevents the
body from receiving signals that may lead to inflammation. The IL-17
pathway plays a central role in inducing and promoting inflammatory
disease processes.

The CHMP positive opinion is based on data from the three AMAGINE
Phase III pivotal studies that demonstrated that brodalumab has an
effective mechanism of action that delivers clinical benefit and
could help a significant number of moderate-to-severe plaque
psoriasis patients achieve total clearance of their skin disease. At
the 210mg dose, brodalumab was shown to be efficacious in total skin
clearance of psoriasis with approximately twice as many patients on
brodalumab achieving total skin clearance compared to ustekinumab at
week 12 in two replicate comparator trials involving over 2,400
patients.

LEO Pharma has exclusive rights to develop and commercialise
brodalumab in Europe.

Valeant Pharmaceuticals has the global exclusive licence to develop
and commercialise brodalumab, except in Europe, Japan and certain
other Asian countries where rights are held by Kyowa Hakko Kirin Co.,
Ltd through an agreement with Amgen.

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, visit www.leo-pharma.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 - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. 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 and follow us on Twitter @AstraZeneca.

Media Enquiries
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US toll free +1 866 381 7277

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