Press Release: Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines
December 23 2024 - 12:00AM
UK Regulatory
Press Release: Sanofi initiates phase 3 program for PCV21 and
expands collaboration with SK bioscience for next-generation
pneumococcal conjugate vaccines
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 Ahn
CEO 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 Relations
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| victor.rouault@sanofi.com
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