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 October 2016
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca
PLC
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AstraZeneca PLC
This announcement contains inside information
03 October 2016 07:00
MEDIMMUNE OUT-LICENSES POTENTIAL MEDICINE
FOR INFLAMMATORY DISEASES TO ALLERGAN
AstraZeneca
today announced that MedImmune, its global biologics research and
development arm, has entered into a licensing agreement with
Allergan plc for the global rights to MEDI2070. MEDI2070 is an
IL-23 monoclonal antibody currently in a Phase IIb clinical trial
for moderate-to-severe Crohn's disease (a chronic inflammatory
disease of the intestines) and is ready for Phase II for
ulcerative colitis (a chronic inflammatory condition of the colon and rectum).
These diseases are outside AstraZeneca's three main therapy areas
- Respiratory, Cardiovascular
& Metabolic Diseases, and
Oncology.
MedImmune will continue the ongoing Phase II trials until a
mutually-agreed transition date.
Under
the terms of the agreement, Allergan will make an upfront payment
to AstraZeneca of $250 million for the exclusive, worldwide licence
to develop and commercialise MEDI2070. In addition, Allergan may
make potential additional payments to AstraZeneca of up to $1.27
billion, dependent on the achievement of agreed upon success-based
development and sales-related milestones, and pay tiered royalties
on potential sales of the medicine.
MedImmune
has been leading the clinical development for MEDI2070 under a
collaboration agreement AstraZeneca entered into with Amgen Inc.
(Amgen) in March 2012. Under the conditions of this agreement,
AstraZeneca will subsequently pay Amgen one third of all payments
and royalties received from Allergan. Amgen will also receive a
single-digit percentage inventor royalty on MEDI2070.
Bahija
Jallal, Executive Vice President, MedImmune, said: "This agreement
demonstrates our sharp focus on three main therapy areas while
creating value from the increased R&D productivity and
innovative science in our pipeline through collaborations. Allergan
has significant experience in gastrointestinal and inflammatory
diseases and is the right partner to progress the development and
commercialisation of MEDI2070."
David
Nicholson, Chief Research & Development Officer, Allergan,
said: "MEDI2070 represents an exciting addition to our Open Science
pipeline, adding an important new programme currently being studied
in Crohn's disease, with potential across a number of inflammatory
and autoimmune disorders. The MEDI2070 programme also reinforces
Allergan's commitment to bringing forward important innovations in
the treatment of inflammation and autoimmune disorders where
significant unmet need exists across many of our therapeutic
areas. We look
forward to bringing our significant clinical development and
regulatory expertise to bear and maximising the potential benefit
of this possible new treatment option for patients."
Financial considerations
The
transaction is expected to close in the fourth quarter of 2016,
subject to customary closing conditions, including the expiration
or early termination of the waiting period under the Hart Scott
Rodino Act. AstraZeneca is expected to retain around $167 million
of the upfront payment and up to around $847 million in future
potential milestones, as well as the tiered royalty payments of up
to low double-digit percent, following payment to Amgen under the
provisions of the original agreement. As AstraZeneca will not
retain a significant ongoing interest in MEDI2070, any revenue will
be reported as Other Operating Income in the Company's financial
statements. The agreement does not impact AstraZeneca's financial
guidance for 2016.
About Allergan plc
Allergan
plc, headquartered in Dublin, Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model -
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan
markets a portfolio of leading brands and best-in-class products
for the central nervous system, eye care, medical aesthetics and
dermatology, gastroenterology, women's health, urology and
anti-infective therapeutic categories.
Allergan
is an industry leader in Open Science, the Company's R&D
model, which defines our approach to identifying and developing
game-changing ideas and innovation for better patient care. This
approach has led to Allergan building one of the broadest
development pipelines in the pharmaceutical industry with 65+
mid-to-late stage pipeline programs in development.
Our
Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is
right.
With
commercial operations in approximately 100 countries, Allergan is
committed to working with physicians, healthcare providers and
patients to deliver innovative and meaningful treatments that help
people around the world live longer, healthier lives every
day.
For more information, visit Allergan's website
at www.Allergan.com.
About MedImmune
MedImmune
is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Respiratory & Autoimmunity, Cardiovascular & Metabolic
Diseases, Oncology, and Infection and Vaccines. The MedImmune
headquarters is located in Gaithersburg, Md., one of AstraZeneca's
three global R&D centres, with additional sites in Cambridge,
UK and Mountain View, CA. For more information, please
visit www.medimmune.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 therapy areas - Respiratory, Cardiovascular &
Metabolic Diseases, and
Oncology. The Company is also selectively active in Neuroscience
and Autoimmunity. 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
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AstraZeneca
PLC
-ENDS-
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
|
Date:03
October 2016
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By: /s/
Adrian Kemp
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|
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Name:
Adrian Kemp
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|
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Title:
Company Secretary
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