Press Release: Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines
23 December 2024 - 5:00PM
Sanofi initiates phase 3 program for PCV21 and
expands collaboration with SK bioscience for next-generation
pneumococcal conjugate vaccines
- Pneumococcal disease remains a major
global health challenge despite the availability of current
vaccines
- This 21-valent pneumococcal conjugate
vaccine (PCV21) is the first pneumococcal conjugate vaccine
candidate with more than 20 serotypes to enter phase 3 in infants
& toddlers
Paris, December 23, 2024.
Sanofi and SK bioscience have entered into a new chapter of their
collaboration in pneumococcal vaccines with an expanded agreement
to develop, license and commercialize next-generation PCVs for both
pediatric and adult populations, reaffirming their commitment to
fighting pneumococcal disease.
Despite decades of public health vaccination
programs, invasive pneumococcal disease (IPD) continues to
inflict a substantial burden of disease, primarily due to
Streptococcus pneumoniae serotypes that are not included in
currently available conjugate vaccines. Next-generation PCVs have
the potential to extend vaccine coverage of disease-causing
serotypes.
This expansion builds on the companies’ existing
collaboration to develop and commercialize a PCV21 pediatric
vaccine, for which the phase 3 clinical program commenced last
week. This vaccine candidate is the first-ever PCV containing more
than 20 serotypes to enter a phase 3 clinical study in infants and
toddlers.
Thomas Triomphe Executive Vice
President, Vaccines, Sanofi“Given the vast unmet public health
needs in IPD, we’re delighted to expand this collaboration and
continue our pursuit of innovative work in PCV. Our collaboration
leverages SK bioscience’s capabilities and Sanofi’s expertise in
developing and bringing innovative vaccines to people worldwide
with the collective aim of reducing the global impact of
pneumococcal disease.”
Jaeyong AhnCEO and President of
SK bioscience “We’re thrilled about the expansion of our
collaboration with Sanofi, which serves as the core of our strategy
to develop new solutions to combat pneumococcal disease. The
ongoing expansion of our state-of-the-art manufacturing base,
cofinanced by Sanofi, will support launch of PCV21 and future next
generation vaccines.”
The PCV21 phase 3 program is based on positive
phase 2 results communicated last year and will include more than
7,700 infants, toddlers, young children and adolescents across
multiple geographies, including the US, Europe, Australia, Asia,
and Latin America.
Under the terms of their expanded agreement,
both companies will co-fund research and development costs. Sanofi
will pay EUR 50M upfront to SK bioscience, followed by development
and commercial milestone payments. Once registered, Sanofi will
commercialize the vaccines worldwide except for South Korea, where
SK bioscience will have commercial exclusivity. SK bioscience will
receive royalty payments on product sales outside South Korea.
About Sanofi We are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across the world, 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.com Nicolas
Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.com Léo Le Bourhis | + 33 6
75 06 43 81 | leo.lebourhis@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.com Keita
Browne | + 1 781 249 1766 |
keita.browne@sanofi.comNathalie Pham | +
33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik
Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.com
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