Sanofi, GlaxoSmithKline Ink Coronavirus Vaccine Deal With U.S. -- Update
July 31 2020 - 3:18PM
Dow Jones News
By Joseph Walker
The U.S. government will pay up to $2.1 billion to Sanofi SA and
GlaxoSmithKline PLC to fund the development of a coronavirus
vaccine and guarantee supply of 100 million doses, if proven safe
and effective in clinical trials, the companies said Friday.
Paris-based Sanofi is leading development of the vaccine, the
companies said, and plans to start initial clinical trials in
September and move into late-stage studies by the end of this
year.
If the studies are positive, the companies said they could seek
U.S. regulatory approval in the first half of 2021.
The contract is the latest in a series of deals -- potentially
worth more than $8 billion -- struck by the U.S. government aimed
at accelerating development of Covid-19 vaccines and securing large
supplies before potential product approvals.
The U.S. has reached deals worth over $1 billion each with
vaccine makers including Pfizer Inc. and partner BioNTech SE,
AstraZeneca PLC and its partner the University of Oxford, and
Novavax Inc., a biotech company in Gaithersburg, Md. Each of the
deals guarantees the U.S. 100 million doses or more, if the
vaccines are approved by regulators.
The government is also helping to fund drugs that can treat
infected patients. Regeneron Pharmaceuticals Inc. has received
about $618 million to develop an antibody drug and provide the U.S.
with thousands of doses, if the drug is authorized by
regulators.
As in earlier deals, the contract with Sanofi and
GlaxoSmithKline was made under the auspices of the Trump
administration's "Operation Warp Speed," which aims to secure 300
million vaccine doses for the U.S. by January 2021.
The European Commission said on Friday it had reached a
preliminary agreement with Sanofi for the sale of 300 million doses
of a potential vaccine.
"Today's step with Sanofi is a first important cornerstone of a
much broader European Vaccines Strategy," European Commission
President Ursula von der Leyen said in a statement. "We are in
advanced discussions with several other companies," she added.
The companies said they would also "provide a significant
portion of total world-wide supply" in 2021 and 2022 to an
initiative led by the World Health Organization and other
nongovernmental organizations to supply low- and middle-income
countries with drugs, vaccines and other supplies to fight
Covid-19.
Under the U.S. contract with Sanofi and GlaxoSmithKline, more
than half of the $2.1 billion is earmarked for clinical trials and
other development costs. The remainder will go toward scaling up
manufacturing of the vaccine and delivery of an initial 100 million
doses.
The U.S. also has an option to secure an additional 500 million
doses over the long-term, Sanofi said.
The companies don't yet know how many doses will be needed to be
effective, a Sanofi spokeswoman said. Other leading vaccine makers
are moving into Phase 3 studies using two-shot regimens.
Sanofi, which will receive the bulk of the U.S. funding,
developed the vaccine candidate. London-based GlaxoSmithKline is
responsible for making a so-called "adjuvant" substance that helps
to make vaccines work better.
Sanofi earlier received about $30 million from the Department of
Health and Human Services in February for early-stage development
of the vaccine.
Also on Friday, Pfizer said it had reached a deal with Japan to
provide the country with 120 million vaccine doses beginning in
2021. Financial terms weren't disclosed.
Noemie Bisserbe contributed to this article.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
July 31, 2020 15:03 ET (19:03 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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