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 2021
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 supply agreement for additional AZD7442 doses
16 March 2021 07:00 GMT
AstraZeneca to supply the US with up to half a million
additional
doses of the potential COVID-19 antibody treatment
AZD7442
Agreement builds on an earlier announcement that
included
support for the clinical development and supply of the
treatment
AstraZeneca has modified an existing agreement with the US
Government to supply up to 500,000 additional doses of AZD7442, a
long-acting antibody (LAAB) combination which is in late-stage
development for the prevention and treatment of
COVID-19.
Today's agreement with the Department of Health and Human Services
(HHS) and the Department of Defense (DoD) builds
on an agreement from
October 2020 for the
support of the late-stage development of AZD7442 and for the supply
of an initial 100,000 doses of the LAAB combination. It included
the option to acquire additional doses in 2021. The Company also
has a separate agreement to supply the DoD with 100,000 doses,
bringing potential US supplies of AZD7442 to 700,000 in
2021.
Pascal Soriot, Chief Executive Officer, said: "The long-acting
antibody combination has the potential to offer almost immediate
protection to those who are not able to be vaccinated, to both
prevent infection or treat the disease in patients already infected
with the virus. The US Government's support is critical in helping
accelerate the development of AZD7442, which we believe will be an
important tool in the fight against COVID-19."
AZD7442 is currently being evaluated for the prevention and
treatment of COVID-19 in late-stage trials in more than 9,000
participants around the world. The two-LAAB combination has been
engineered with AstraZeneca's proprietary half-life extension
technology which triples the durability of its action compared to
conventional antibodies. The combination of LAABs is also designed
to reduce the risk of resistance developed by the SARS-CoV-2 virus
and its variants.
Financial considerations
The value of the extended agreement is $205m and is contingent on
AZD7442 receiving Food and Drug Administration Emergency Use
Authorisation in post-exposure prophylaxis - the ability to prevent
COVID-19 in people who have confirmed exposure to the SARS-CoV-2
virus. The Biomedical Advanced Research and Development Authority
(BARDA), which is part of the HHS office of the Assistant Secretary
for Preparedness and Response, worked with the DoD Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND) and the Army Contracting Command to provide
funding to purchase the additional doses. Together, the total value
of current agreements with the US Government for the development
and supply of AZD7442 in 2021 is about $726m. The extended
agreement is not anticipated to impact the Company's financial
guidance for 2021.
AZD7442
AZD7442 is a combination of two LAABs derived from convalescent
patients after SARS-CoV-2 infection. Discovered by Vanderbilt
University Medical Center and licensed
to AstraZeneca in June 2020, the human monoclonal antibodies
were optimised by AstraZeneca with half-life extension and reduced
Fc receptor binding. The half-life extension should afford six to
12 months of protection from COVID-19 following a single
administration.1-4 The
reduced Fc receptor binding aims to minimise the risk of
antibody-dependent enhancement of disease - a phenomenon in which
virus-specific antibodies promote, rather than inhibit, infection
and/or disease.5
AZD7442 is currently being assessed in five late-stage prevention
and treatment trials. The STORM
CHASER7 Phase
III trial is assessing the safety and efficacy of AZD7442 compared
to placebo for the prevention of COVID-19 in about 1,125
participants after exposure to a specific identified individual
with laboratory-confirmed SARS-COV-2 infection (post-exposure
prophylaxis). PROVENT6 is
a Phase III trial assessing the safety and efficacy of AZD7442
compared to placebo for the prevention of COVID-19 in approximately
5,000 adults who are at increased risk for SARS-CoV-2 infection due
to living or work situations, or who are at increased risk of
responding inadequately to vaccines, such as those with compromised
immune systems.
TACKLE COVID-198 is
an AstraZeneca-sponsored Phase III trial evaluating the safety and
efficacy of AZD7442 compared to placebo in treating
non-hospitalised patients with mild to moderate COVID-19. AZD7442
is also being studied as a potential treatment as part of the
National Institute of Health's Phase II/III ACTIV-2 (outpatient)
and ACTIV-3 (hospitalised) trials. All five trials are assessing
intramuscular (IM) administration, with ACTIV-2 evaluating both IM
and intravenous administration routes.
Data published in Nature in
July 2020 showed that in pre-clinical experiments the LAABs were
able to block the binding of the SARS-CoV-2 virus to host cells and
protect against infection in cell and animal models of
disease.9
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) 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
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Robbie, G.J., et al., A novel investigational
Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an
extended half-life in healthy adults. Antimicrob Agents
Chemother, 2013. 57(12): p.
6147-53.
2. Griffin, M.P., et al., Safety, Tolerability,
and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus
Prefusion F-Targeting Monoclonal Antibody with an Extended
Half-Life, in Healthy Adults. Antimicrob Agents
Chemother, 2017.
61(3).
3. Yu, X.Q., et al., Safety, Tolerability, and
Pharmacokinetics of MEDI4893, an Investigational,
Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human
Monoclonal Antibody, in Healthy Adults. Antimicrob Agents
Chemother, 2017.
61(1).
4. Domachowske, J.B., 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. Pediatr Infect Dis
J, 2018. 37(9): p.
886-892.
5. Van Erp EA, Luytjes W,
Ferwerda G and van Kasteren PB. Fc-Mediated Antibody Effector
Functions During Respiratory Syncytial Virus Infection and
Disease. Front.
Immunol. 2019. https://doi.org/10.3389/fimmu.2019.00548.
6.ClinicalTrias.gov
NCT04625725. https://clinicaltrials.gov/ct2/show/NCT04625725
7.ClinicalTrials.gov
NCT04625972. https://clinicaltrials.gov/ct2/show/NCT04625972
8.ClinicalTrials.gov
NCT04723394. https://clinicaltrials.gov/ct2/show/NCT04723394
9. Zost SJ et al. Potently neutralizing human
antibodies that block SARS-CoV-2 receptor binding and protect
animals. Nature. 2020. DOI:
10.1038/s41586-020-2548-6.
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.
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AstraZeneca
PLC
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Date:
16 March
2021
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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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