UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of February 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: February 3rd 2021, London UK / Tübingen, Germany
/ Boston, USA
GSK and CureVac to develop next generation mRNA COVID-19
vaccines
● Companies aim to develop a multi-valent candidate
vaccine to address emerging variants for pandemic and endemic
use
● Development to begin immediately targeting vaccine
availability in 2022, subject to regulatory
approval
● GSK will also support manufacture of up to 100
million doses of CureVac's first generation COVID-19 vaccine CVnCoV
in 2021
GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC)
today announced a new €150m collaboration, building on their
existing relationship, to jointly develop next generation mRNA
vaccines for COVID-19 with the potential for a multi-valent
approach to address multiple emerging variants in one
vaccine.
GSK will also support the manufacture of up to 100 million doses of
CureVac's first generation COVID-19 vaccine candidate CVnCoV in
2021
Through this new exclusive co-development agreement, GSK and
CureVac will contribute resources and expertise to research,
develop, and manufacture a number of novel mRNA vaccine candidates,
including multi-valent and monovalent approaches. The aim of this
work is to offer broader protection against a variety of different
SARS-CoV2 variants, and to enable a quick response to new variants
potentially emerging in the future. The development programme will
begin immediately, with the target of introducing the vaccine in
2022, subject to regulatory approval.
The increase in emerging variants with the potential to reduce the
efficacy of first generation COVID-19 vaccines requires
acceleration of efforts to develop vaccines against new variants to
keep one step ahead of the pandemic. These next generation COVID-19
vaccines may either be used to protect people who have not been
vaccinated before, or to serve as boosters in the event that
COVID-19 immunity gained from an initial vaccination reduces over
time. In addition, the collaboration will assess the
development of novel mRNA vaccines to protect against multiple
respiratory viruses, including COVID-19.
This collaboration will build on CureVac's first generation
COVID-19 vaccine candidate CVnCoV, which is currently in Phase 2b/3
clinical trial and on CureVac's ability to optimise mRNA for a
strong immune response, manufacturability, and stability at
standard 2-8°C cold chain conditions for vaccines. CureVac's
platform is uniquely adapted to designing multi-valent vaccines
with a balanced immune response and a low dose of
mRNA.
Emma Walmsley, Chief Executive Officer, GSK, said: "We believe that next generation
vaccines will be crucial in the continued fight against COVID-19.
This new collaboration builds on our existing relationship with
CureVac and means that together, we will combine our scientific
expertise in mRNA and vaccine development to advance and accelerate
the development of new COVID-19 vaccine candidates. At the same
time, we will also support the production of CureVac's first
generation vaccines with the manufacture of 100 million doses in
2021."
Franz-Werner Haas, Chief Executive Officer of
CureVac, said: "We are very
pleased to build on our existing relationship with GSK with a new
agreement to jointly develop next generation mRNA-based vaccines,
in addition to our current candidate CVnCoV. With the help of GSK's
proven vaccine expertise, we are equipping ourselves to tackle
future health challenges with novel vaccines."
As part of the new collaboration, GSK will also support manufacture
of CureVac's first-generation COVID-19 vaccine candidate CVnCoV
which is currently in Phase 2b/3 trials. Using its established
manufacturing network in Belgium, GSK aims to support manufacturing
of up to 100 million doses of the vaccine in 2021.
Under the terms of the new collaboration agreement, GSK will be the
marketing authorisation holder for the next generation
vaccine, except in Switzerland, and will have exclusive rights
to develop, manufacture, and commercialise the next generation
COVID-19 vaccine in all countries with the exception of Germany,
Austria and Switzerland. GSK will make an upfront payment of
€75m and a further milestone payment of €75m,
conditional on the achievement of specific milestones.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com/about-us.
About CureVac
CureVac is a global biopharmaceutical company in the field of
messenger RNA (mRNA) technology, with more than 20 years of
expertise in developing and optimizing the versatile biological
molecule for medical purposes. The principle of CureVac's
proprietary technology is the use of non-chemically modified mRNA
as a data carrier to instruct the human body to produce its own
proteins capable of fighting a broad range of diseases. Based on
its proprietary technology, the company has built a deep clinical
pipeline across the areas of prophylactic vaccines, cancer
therapies, antibody therapies, and the treatment of rare diseases.
CureVac had its initial public offering on the New York Nasdaq in
August 2020. In January 2021 the company entered into a
collaboration and services agreement with Bayer. CureVac is
headquartered in Tübingen, Germany, and employs more than 500
people at its sites in Tübingen, Frankfurt, and Boston, USA.
Further information can be found at www.curevac.com.
GSK enquiries:
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Media
enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Simon
Moore
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+44 (0)
20 8047 5502
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(London)
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Kristen
Neese
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+1 804
217 8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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Danielle
Smith
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+44 (0)
20 8047 0932
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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CureVac enquiries:
Media enquiries:
Thorsten Schüller, Corporate Communications
CureVac AG, Tübingen, Germany
T: +49 7071 9883-1577
Investor enquiries:
Dr. Sarah Fakih, Vice President Investor Relations
CureVac AG, Tübingen, Germany
T: +49 7071 9883-1298
Cautionary statement regarding forward-looking
statements
GSK
cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
CureVac Forward-Looking Statements
This press release contains statements that constitute "forward
looking statements" as that term is defined in the United States
Private Securities Litigation Reform Act of 1995, including
statements that express the opinions, expectations, beliefs, plans,
objectives, assumptions or projections of CureVac (the "company")
regarding future events or future results, in contrast with
statements that reflect historical facts. Examples include
discussion of the potency efficacy of the company's vaccine
candidate and the company's strategies, financing plans, growth
opportunities and market growth. In some cases, you can identify
such forward-looking statements by terminology such as
"anticipate," "intend," "believe," "estimate," "plan," "seek,"
"project," or "expect," "may," "will," "would," "could,"
"potential," "intend," or "should," the negative of these terms or
similar expressions. Forward-looking statements are based on
management's current beliefs and assumptions and on information
currently available to the company. However, these forward-looking
statements are not a guarantee of the company's performance, and
you should not place undue reliance on such statements.
Forward-looking statements are subject to many risks, uncertainties
and other variable circumstances, including negative worldwide
economic conditions and ongoing instability and volatility in the
worldwide financial markets, ability to obtain funding, ability to
conduct current and future preclinical studies and clinical trials,
the timing, expense and uncertainty of regulatory approval,
reliance on third parties and collaboration partners, ability to
commercialize products, ability to manufacture any products,
possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition
and consolidation in the company's industry, the effects of the
COVID-19 pandemic on the company's business and results of
operations, ability to manage growth, reliance on key personnel,
reliance on intellectual property protection, ability to provide
for patient safety, and fluctuations of operating results due to
the effect of exchange rates or other factors. Such risks and
uncertainties may cause the statements to be inaccurate and readers
are cautioned not to place undue reliance on such statements. Many
of these risks are outside of the company's control and could cause
its actual results to differ materially from those it thought would
occur. The forward-looking statements included in this press
release are made only as of the date hereof. The company does not
undertake, and specifically declines, any obligation to update any
such statements or to publicly announce the results of any
revisions to any such statements to reflect future events or
developments, except as required by law.
For further information, please reference the company's reports and
documents filed with the U.S. Securities and Exchange Commission
(SEC). You may get these documents by visiting EDGAR on the SEC
website at www.sec.gov.
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 authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: February
03, 2021
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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