Blueprint
FORM
6-K
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Report
of Foreign Issuer
Pursuant to Rule
13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of February 2017
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
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assigned to the Registrant in connection with Rule
12g3-2(b): 82-_____________
16 February 2017, 12 noon GMT
SILIQ (BRODALUMAB) APPROVED BY THE US FDA
FOR ADULT PATIENTS WITH MODERATE-TO-SEVERE PLAQUE
PSORIASIS
Approval triggers $130 million milestone payment to AstraZeneca
from
US Partner Valeant Pharmaceuticals
AstraZeneca's
partner Valeant Pharmaceuticals today announced that the US Food
and Drug Administration (FDA) has approved Siliq (brodalumab) injection for the
treatment of adult patients with moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or phototherapy
and have failed to respond or have lost response to other systemic
therapies.
Siliq is an IL-17 receptor monoclonal antibody for patients
with moderate-to-severe plaque psoriasis, a chronic, debilitating
skin disease that causes red patches of skin covered with silvery
scales.
Through
a collaboration agreement,
AstraZeneca granted Valeant, an expert in dermatology, the
exclusive license to develop and commercialise Siliq globally, except in Japan and
certain other Asian countries where rights are held by Kyowa Hakko
Kirin Co., Ltd through an agreement with Amgen, and in Europe,
where LEO Pharma holds exclusive rights to develop and
commercialise brodalumab through an agreement entered
in July 2016.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer at AstraZeneca, said: "We are
pleased that our commitment to Siliq, from its development in our
biologics pipeline through to our partnership with Valeant, has led
to a new treatment option for psoriasis patients, many of whom have
previously not been able to achieve full clearance of their
skin."
Financial considerations
Under the terms of the agreement, AstraZeneca will receive a
milestone payment of $130 million from Valeant at first regulatory
approval. This milestone will be
recorded in the AstraZeneca financial statements as Externalisation
Revenue. Following the approval, AstraZeneca and Valeant will share
profits from the sale of Siliq in the US market.
Marc Dunoyer, Chief Financial Officer, AstraZeneca said: "Our
agreement with Valeant supports our externalisation strategy, which
allows us to focus on our three main therapy areas while partnering
other assets for the benefit of patients, generating sustainable
revenue for the future."
- ENDS -
NOTES TO EDITORS
About Siliq
Siliq (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 FDA approval is based on data from the three AMAGINE Phase III
pivotal studies that demonstrated that Siliq 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,
Siliq
was shown to be efficacious in total
skin clearance of psoriasis with approximately twice as many
patients on Siliq achieving
total skin clearance compared to ustekinumab at week 12 in two
replicate comparator trials involving over 2,400
patients.
About Valeant
Valeant Pharmaceuticals International, Inc. (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 disorders,
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 - 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.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AstraZeneca PLC
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Date:
16 February 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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