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 March 2017
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
INDEX
TO EXHIBITS
1.
ALLIANCE WITH
SANOFI PASTEUR FOR MEDI8897
This announcement contains inside information
3 March 2017 07:00 GMT
MEDIMMUNE AND SANOFI PASTEUR FORM ALLIANCE TO DEVELOP AND
COMMERCIALISE POTENTIAL NEXT-GENERATION RESPIRATORY SYNCYTIAL VIRUS
ANTIBODY MEDI8897
MedImmune,
the global biologics research and development arm of AstraZeneca,
and Sanofi Pasteur, the vaccines division of Sanofi, today
announced an agreement to develop and commercialise MEDI8897
jointly. MEDI8897 is a monoclonal
antibody (mAb) for the prevention of lower respiratory tract
illness (LRTI) caused by respiratory syncytial virus (RSV), the
most prevalent cause of LRTI among infants and young children.
MEDI8897 is currently in a Phase IIb clinical trial in pre-term
infants who are ineligible for Synagis, the current standard of care medicine, and the
development plan includes a proposed Phase III trial in healthy
full-term and late pre-term infants.
Under the terms of the global agreement, Sanofi Pasteur will make
an upfront payment of €120 million and pay up to €495
million upon achievement of certain development and sales-related
milestones. The two companies will share all costs and profits
equally. MedImmune and AstraZeneca will continue to lead all
development activity through initial approvals, and AstraZeneca
will retain MEDI8897 manufacturing activities. Sanofi-Pasteur will
lead commercialisation activities for MEDI8897.
Bahija
Jallal, Executive Vice President, MedImmune, said: "By combining
our development expertise and leadership in RSV with Sanofi
Pasteur's significant global experience in commercialising
paediatric vaccines we hope to provide an RSV disease prevention
approach for all infants, both term and pre-term. This agreement
supports our focus on our three main therapy areas, while
delivering value from the innovative science in our pipeline
through partnerships."
AstraZeneca's
commitment to the prevention of paediatric RSV disease will also
continue through Synagis,
the only medicine currently approved for the prevention of serious
lower respiratory tract disease caused by RSV in pediatric patients
at high risk of severe RSV disease.
Financial considerations
AstraZeneca will maintain a direct ongoing interest in MEDI8897
through the alliance. Revenue from the agreement, including the
upfront payment of €120 million and up to €495 million
in milestone payments, will therefore be reported as
Externalisation Revenue in the Company's financial statements. The
agreement was completed at signing and does not impact
AstraZeneca's financial guidance for 2017.
About Respiratory syncytial virus
Respiratory syncytial virus (RSV) is the most common cause of lower
respiratory tract infections among young children in the United
States and worldwide. Most infants are infected before the age of
one, and virtually everyone gets an RSV infection by the age of
two.
Each year, on average, in the United States alone, RSV leads
to:
●
57,527 hospitalisations
among children younger than 5 years old
●
2.1 million outpatient
visits among children younger than 5 years old
●
177,000 hospitalisations
and 14,000 deaths among adults older than 65
years
Source: Centres for Disease Control
and Prevention, US Department for Health and Human Services,
https://www.cdc.gov/rsv/about/infection.html
About MEDI8897
MEDI8897 is a highly potent monoclonal antibody (mAb) that
neutralises RSV by binding the RSV fusion (F) protein expressed on
virions and infected cells and has been engineered to have a long
half-life, so that only one dose will be needed for the entire RSV
season. It is being developed for the passive immunisation of a
broad infant population. MEDI8897 is currently being tested in a
Phase IIb trial in preterm infants ineligible for
Synagis. The current development plan includes a Phase
III trial in healthy full-term and late preterm infants. MEDI8897
has received Fast Track designation from the
FDA.
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
Oncology, Respiratory, Cardiovascular & Metabolic Diseases, 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 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.
Date:
03 March 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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