Press Release: Nirsevimab: Sanofi, AstraZeneca and Sobi simplify contractual agreements
11 Aprile 2023 - 8:00AM
Nirsevimab: Sanofi, AstraZeneca and Sobi simplify
contractual agreements
- Modification of existing
collaboration agreement with AstraZeneca gives Sanofi full
commercial control of nirsevimab and enhanced agility in the
U.S.
- Existing collaboration agreement
with AstraZeneca remains in place for nirsevimab activities
ex-U.S.
Paris, April
11, 2023. Sanofi
has simplified its contractual arrangements relating to the
development and commercialization of Beyfortus (nirsevimab) in the
United States (U.S.).
Under the new and updated arrangements, Sobi
will terminate its participation agreement with AstraZeneca, and
Sanofi and AstraZeneca will update the Collaboration Agreement so
that Sanofi has full commercial control of nirsevimab in the U.S.
Sanofi has simultaneously entered into a direct royalty agreement
with Sobi to share a portion of U.S. net sales from nirsevimab.
With respect to territories outside the U.S.,
the existing Collaboration Agreement between AstraZeneca and Sanofi
continues to govern that relationship.
The new and updated contractual agreements do
not impact nirsevimab registration and launch in the U.S., where
all parties remain committed to making Beyfortus available for all
infants in time for the 2023/24 RSV season.
About BeyfortusBeyfortus® (nirsevimab), an
investigational long-acting antibody designed to protect all
infants against RSV infections from birth through their first RSV
viral season with a single dose, is being co-developed by Sanofi
and AstraZeneca. Beyfortus was developed to provide direct antibody
protection to newborns and infants and protect them against lower
respiratory tract infections caused by RSV. Monoclonal antibodies
do not require activation of the immune system to confer direct and
rapid protection against infection. Beyfortus has received
marketing authorization in the European Union for the prevention of
lower respiratory tract disease caused by RSV in neonates and
infants from birth during their first RSV season.
In March 2017, AstraZeneca and Sanofi announced
an agreement for the development and commercialization of
Beyfortus. Under the agreement, AstraZeneca leads all development
and manufacturing activities, while Sanofi is responsible for
marketing activities and revenue recognition. Under the terms of
the global agreement, Sanofi has made an upfront payment of €120
million, a milestone payment of €30 million and a regulatory
payment of €25 million. Sanofi shall pay up to €440 million,
subject to the achievement of a certain number of regulatory and
sales objectives. Both companies share costs and benefits related
to the Alliance in certain territories.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine
Guendoul | + 33 6 25 09
14 25 | sandrine.guendoul@sanofi.comEvan
Berland | +1 215 432 0234 |
evan.berland@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69
36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40
56 92 21 | corentine.driancourt@sanofi.comFelix
Lauscher | +
1 908 612 7239 |
felix.lauscher@sanofi.comTarik
Elgoutni| + 1 617 710 3587 |
tarik.elgoutni@sanofi.comNathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
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StatementsThis press release contains forward-looking
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AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2022. Other than as required by applicable law, Sanofi does not
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