TIDMGSK
RNS Number : 7863U
GlaxoSmithKline PLC
31 July 2020
Issued: 31 July 2020, London, UK and Paris, France - LSE
announcement
GlaxoSmithKline plc
Sanofi and GSK selected for Operation Warp Speed to supply
United States Government with 100 million doses of COVID-19
vaccine
-- Promising vaccine candidate selected by U.S. government's Operation Warp Speed
-- U.S. government to provide funding up to $2.1 billion for
development including clinical trials, manufacturing, scale-up and
delivery of an initial 100 million doses
-- Ongoing discussions with European Commission - with France
and Italy on the negotiation team - and other governments to ensure
global access to a novel coronavirus vaccine
Sanofi and GSK today announce a collaborative effort with the
U.S. government to accelerate the development and manufacturing of
a COVID-19 recombinant protein-based vaccine.
The vaccine candidate, developed by Sanofi in partnership with
GSK, is based on the recombinant protein technology used by Sanofi
to produce an influenza vaccine, and GSK's established pandemic
adjuvant technology.
Collaborating with the U.S. Department of Health and Human
Services (HHS) and Department of Defense will help fund the
development activities and secure scale-up of Sanofi's and GSK's
manufacturing capabilities in the United States for the recombinant
protein-based, adjuvanted vaccine, resulting in a significant
increase in capacity.
The U.S. government will provide up to $2.1 billion, more than
half of which is to support further development of the vaccine,
including clinical trials, with the remainder used for
manufacturing scale up and delivery of an initial 100 million doses
of the vaccine. Sanofi will receive the majority of the U.S.
government funding. The U.S. government has a further option for
the supply of an additional 500 million doses longer term. This
helps the U.S. government's Operation Warp Speed goals of providing
millions of doses of a safe and effective COVID-19 vaccine.
"The global need for a vaccine to help prevent COVID-19 is
massive, and no single vaccine or company will be able to meet the
global demand alone," said Thomas Triomphe, Executive Vice
President and Global Head of Sanofi Pasteur. "From the beginning of
the pandemic, Sanofi has leveraged its deep scientific expertise
and resources to help address this crisis, collaborating with the
U.S. Department of Health and Human Services to unlock a rapid path
toward developing a pandemic vaccine and manufacturing at large
scale. With our partner GSK, we expect our Phase 1/2 study for the
recombinant adjuvanted approach to start in September."
Roger Connor, President of GSK Vaccines added, "GSK is proud to
be working in partnership with Sanofi to make this vaccine
available at scale as soon as possible. We thank the U.S.
government for playing a very important role in providing early,
significant funding to enable the development and scale-up of this
potentially important vaccine."
"The portfolio of vaccines being assembled for Operation Warp
Speed increases the odds that we will have at least one safe,
effective vaccine as soon as the end of this year," said HHS
Secretary Alex Azar. "Today's investment supports the Sanofi and
GSK adjuvanted product all the way through clinical trials and
manufacturing, with the potential to bring hundreds of millions of
safe and effective doses to the American people."
Sanofi is leading the clinical development and registration of
the COVID-19 vaccine and expects a Phase 1/ 2 study to start in
September, followed by a Phase 3 study by the end of 2020. If data
are positive, the companies can request U.S. regulatory approval in
the first half of 2021. In parallel, Sanofi and GSK are scaling up
manufacturing of the antigen and adjuvant to produce up to one
billion doses per year globally.
Sanofi and GSK are committed to making the vaccine available
globally
Active discussions are ongoing with global organizations and
with the EU Commission - with France and Italy on the negotiation
team on supplying European countries from Sanofi's and GSK's
European industrial network. The partners also plan to provide a
significant portion of total worldwide available supply capacity in
2021/22 to the global initiative "Access to COVID -- 19 Tools (ACT)
Accelerator, a global collaboration of leaders of governments,
global health organizations, businesses and philanthropies to
accelerate development, production, and equitable access to
COVID-19 tests, treatments, and vaccines."
GSK commitment to tackling COVID-19
GSK is collaborating with companies and research groups across
the world working on promising COVID-19 vaccine candidates through
the use of our innovative vaccine adjuvant technology. The use of
an adjuvant is of particular importance in a pandemic situation
since it may reduce the amount of vaccine protein required per
dose, allowing more vaccine doses to be produced and therefore
contributing to protecting more people. GSK does not expect to
profit from COVID-19 vaccines during the pandemic phase and will
invest any short-term profit in coronavirus related research and
long-term pandemic preparedness, either through GSK internal
investments or with external partners.
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 Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
GSK enquiries:
Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Simon Moore +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor Sarah Elton-Farr +44 (0) 20 8047 (London)
enquiries: 5194
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
Danielle Smith +44 (0) 20 8047 (London)
0932
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
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.
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END
MSCWPUPCMUPUGUG
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