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
2019
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.
US FDA grants
Breakthrough Therapy Designation
5 February 2019 07:05 GMT
US FDA grants Breakthrough Therapy Designation
for potential next-generation RSV medicine MEDI8897
Designation based on positive primary analysis of the Phase
IIb
trial that demonstrated the safety and efficacy of
MEDI8897
AstraZeneca and its global biologics research and development arm,
MedImmune, today announced that the US Food and Drug Administration
(FDA) has granted Breakthrough Therapy Designation (BTD) for
MEDI8897, an extended half-life respiratory syncytial virus (RSV) F
monoclonal antibody (mAb) being developed for the prevention of
lower respiratory tract infection (LRTI) caused by
RSV.
A BTD is designed to expedite the development and regulatory review
of medicines that are intended to treat a serious condition and
that have shown encouraging early clinical results, which may
demonstrate substantial improvement on a clinically-significant
endpoint over available medicines. MEDI8897 is being developed in
partnership with Sanofi Pasteur and received Fast Track designation
from the US FDA in March 2015.
Mene Pangalos, Executive Vice-President, R&D
BioPharmaceuticals, said: "MEDI8897 is our next-generation
preventive medicine for respiratory syncytial virus, which has the
potential to address an important unmet need for infants, families
and caregivers. The Breakthrough Therapy Designation, together with
its recent PRIME eligibility from the European Medicines Agency,
will help us to bring MEDI8897 to all infants at risk for RSV as
quickly as possible."
The BTD is based on the primary analysis of
the Phase IIb
trial to evaluate the
safety and efficacy of MEDI8897, which met its primary endpoint
defined as a statistically-significant reduction in the incidence
of medically-attended LRTI caused by reverse transcriptase
polymerase chain reaction-confirmed RSV, for 150 days after dosing
in healthy preterm infants. Full results from the Phase IIb trial
will be presented at a forthcoming medical
meeting.
About MEDI8897
MEDI8897 is an extended half-life RSV F mAb being developed for the
prevention of LRTI caused by RSV. MEDI8897 is being developed
for use in a broader infant population than the current standard of
care for RSV prevention, Synagis (palivizumab), which in the US is only
approved for use in high-risk infants. Additionally, MEDI8897 is
being developed so that it may only require one dose during a
typical five-month RSV season, vs. monthly injections with current
standard of care.1
The development programme for MEDI8897 also includes a Phase III
trial in late preterm and healthy full-term infants. AstraZeneca
will also conduct a Phase II/III study in Synagis-eligible paediatric patients to generate
additional data for use in this population.
In February 2019, the EMA granted PRIME
eligibility to
MEDI8897.
In March 2017, AstraZeneca and Sanofi
Pasteur announced an agreement to
develop and commercialise MEDI8897 jointly. In November 2018,
AstraZeneca announced Swedish
Orphan Biovitrum AB (publ) (Sobi) has the right to participate in
payments that may be received from the US profits or losses for
MEDI8897.
About RSV
RSV is the most common cause of LRTI in infants and young children
worldwide, and 90% of children are infected with RSV in the first
two years of life. Of those, up to 40% will experience a LRTI with
the initial episode, making the development and availability of
effective prevention methods a critical public health
priority.2 In
the US, there is currently one approved medicine for RSV
prophylaxis, Synagis (palivizumab), indicated for high-risk
children (premature infants ≤ 35 weeks gestational age,
children with chronic lung disease of prematurity, and children
with haemodynamically significant chronic heart
disease).3
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 commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular, Renal and 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 South
San Francisco, 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 - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Media Relations
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Gonzalo
Viña
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UK/Global
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UK/Global
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Sweden
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US
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Thomas
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Henry
Wheeler
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Oncology
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Gruvris
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BioPharma - Cardiovascular; Metabolism
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+44 203 749 5711
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Nick
Stone
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BioPharma - Respiratory; Renal
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+44 203 749 5716
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Afolabi
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Other
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+44 203 749 5631
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. Domachowske JB, Khan AA, Esser MT,
et al. Safety, Tolerability, and Pharmacokinetics of MEDI8897,
an Extended Half-Life Single-Dose Respiratory Syncytial Virus
Prefusion F-Targeting Monoclonal Antibody Administered as a Single
Dose to Healthy Preterm Infants. The Pediatric Infectious
Disease Journal. September
2018:886-892. doi:10.1097/inf.0000000000001916.
2. Adamko DJ, Friesen M. Why does
respiratory syncytial virus appear to cause
asthma? Journal of Allergy and
Clinical Immunology.
2012;130(1):101-102.
doi:10.1016/j.jaci.2012.05.024.
3. Synagis Prescribing Information.
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:
05 February
2019
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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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