Regulatory Filings • Dec 23, 2024
Regulatory Filings
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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. Nextgeneration 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.
"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."
"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 stateof-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.
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
Sandrine Guendoul | + 33 6 25 09 14 25 | [email protected] Evan Berland | +1 215 432 0234 | [email protected] Nicolas Obrist | + 33 6 77 21 27 55 | [email protected] Léo Le Bourhis | + 33 6 75 06 43 81 | [email protected] Victor Rouault | + 33 6 70 93 71 40 | [email protected] Timothy Gilbert | + 1 516 521 2929 | [email protected]
Thomas Kudsk Larsen |+ 44 7545 513 693 | [email protected] Alizé Kaisserian | + 33 6 47 04 12 11 | [email protected] Felix Lauscher | + 1 908 612 7239 | [email protected] Keita Browne | + 1 781 249 1766 | [email protected] Nathalie Pham | + 33 7 85 93 30 17 | [email protected] Tarik Elgoutni | + 1 617 710 3587 | [email protected]
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the 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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forwardlooking information or statements.
All trademarks mentioned in this press release are the property of the Sanofi group.
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