Sanofi Advances Phase 3 Program for PCV21
Pneumococcal disease remains a significant health threat worldwide, despite the existence of current vaccines. Sanofi is taking a bold step to address this issue by initiating phase 3 trials for its innovative 21-valent pneumococcal conjugate vaccine, known as PCV21. This groundbreaking vaccine is remarkable as it contains more than 20 serotypes, a first for such vaccines.
Expanded Collaboration with SK bioscience
Sanofi has enhanced its partnership with SK bioscience in a new agreement focusing on the development of next-generation pneumococcal conjugate vaccines (PCVs). This collaboration aims to license and commercialize these vaccines for both pediatric and adult use, further demonstrating their commitment to tackling pneumococcal disease.
Addressing Public Health Needs
Despite ongoing public health efforts, invasive pneumococcal disease (IPD) continues to impose a heavy burden on global health. The challenge arises from various serotypes of Streptococcus pneumoniae not covered by existing vaccines. The next-generation PCVs could significantly broaden vaccine coverage against these harmful strains.
Initiating the Clinical Program
This expanded collaboration builds upon an existing agreement to develop a pediatric PCV21 vaccine. Recently, the phase 3 clinical trials have commenced, aiming to include over 7,700 infants, toddlers, young children, and adolescents from diverse regions such as the United States, Europe, Australia, Asia, and Latin America.
Expert Insights on Collaboration
Thomas Triomphe, Sanofi’s Executive Vice President of Vaccines, expressed enthusiasm about this partnership, stating, “With the considerable unmet needs in the realm of invasive pneumococcal disease, we’re eager to expand our efforts in PCV development. Through our collaboration, we leverage SK bioscience’s advanced capabilities alongside Sanofi's expertise to innovate and ultimately alleviate the global impact of pneumococcal disease.”
Support for Vaccine Development
Jaeyong Ahn, CEO of SK bioscience, also shared his excitement: “The expansion of our partnership with Sanofi aligns with our strategic goal to develop new solutions against pneumococcal disease. Moreover, our state-of-the-art manufacturing facilities, co-financed by Sanofi, will be crucial in launching PCV21 and future vaccine innovations.”
Funding Structure of the Program
As part of this collaboration, both organizations are committed to sharing the research and development costs. Sanofi will provide an upfront payment of EUR 50 million to SK bioscience, along with milestone payments contingent on development and commercial achievements. Following regulatory approval, Sanofi will manage worldwide commercialization of the vaccines, aside from South Korea, where SK bioscience will hold exclusive rights. Additionally, SK bioscience will receive royalty payments based on sales outside of South Korea.
About Sanofi
Sanofi is a leading global healthcare organization focused on enhancing lives through scientific innovations. The company's mission is to transform medical practices to deliver potentially life-saving treatments and vaccinations to millions globally. Sanofi is committed to sustainability and social responsibility, integral to its overall strategy. The company is listed on EURONEXT: SAN and NASDAQ: SNY.
Contact Information
Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan 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.com
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Frequently Asked Questions
What is the primary goal of the phase 3 program for PCV21?
The primary goal is to evaluate the safety and efficacy of the PCV21 vaccine in infants and toddlers, as it aims to combat pneumococcal disease more effectively.
What does the collaboration with SK bioscience involve?
This collaboration focuses on the development, licensing, and commercialization of next-generation pneumococcal conjugate vaccines for pediatric and adult populations.
Why is the PCV21 vaccine significant?
PCV21 is noteworthy because it contains more than 20 serotypes and is designed to enhance coverage compared to existing vaccines.
How will the collaboration be funded?
Sanofi will supply an upfront payment along with milestone payments based on development and commercialization achievements, sharing the costs with SK bioscience.
What is Sanofi's mission?
Sanofi aims to improve lives through innovative science, focusing on transforming medical practices and delivering beneficial treatments to people in need.
