Sanofi launches phase 3 trials for PCV21 and expands SK bioscience partnership for advanced pneumococcal vaccines

PARIS, France | December 23, 2024 – Sanofi and SK bioscience have announced the expansion of their collaboration to develop, license, and commercialize advanced pneumococcal conjugate vaccines (PCVs) aimed at both children and adults. This strategic move is a reaffirmation of their dedication to addressing the challenges of pneumococcal disease.

Despite extensive efforts through public health vaccination initiatives, invasive pneumococcal disease (IPD) remains a significant health burden. This is largely due to the existence of Streptococcus pneumoniae serotypes that are not covered by the conjugate vaccines currently available. The development of next-generation PCVs offers hope to broaden the protection against these disease-causing serotypes.

The recent expansion of the collaboration builds upon the ongoing efforts of both companies to produce a PCV21 pediatric vaccine. This vaccine, which recently entered its phase 3 clinical trials, is notable for being the first PCV to include over 20 serotypes and reach this stage of development in infants and young children.

Thomas Triomphe, Sanofi's Executive Vice President of Vaccines, expressed enthusiasm about the partnership's growth, emphasizing the critical need for innovative solutions in the fight against IPD. He highlighted the synergy between SK bioscience's capabilities and Sanofi's extensive expertise in vaccine development. Triomphe noted that their combined efforts aim to mitigate the impact of pneumococcal disease on a global scale.

Jaeyong Ahn, CEO and President of SK bioscience, also expressed excitement about the expanded collaboration with Sanofi. He stressed that this partnership is central to their strategy to develop innovative approaches to combat pneumococcal disease. Ahn also highlighted the ongoing expansion of their advanced manufacturing facilities, financially supported by Sanofi, which will be essential for the launch of the PCV21 vaccine and future advancements in vaccine technology.

The phase 3 trials for the PCV21 vaccine, which follow promising phase 2 results disclosed last year, will involve over 7,700 participants, including infants, toddlers, young children, and adolescents. These trials will be conducted across a diverse range of regions including the United States, Europe, Australia, Asia, and Latin America.

As part of the expanded agreement, Sanofi and SK bioscience will jointly fund the research and development efforts. Sanofi has agreed to provide an upfront payment of EUR 50 million to SK bioscience, along with subsequent payments tied to development and commercial milestones. Upon regulatory approval, Sanofi will take charge of the global commercialization of the vaccines, except in South Korea where SK bioscience will retain exclusive commercial rights. Additionally, SK bioscience will benefit from royalty payments on international sales outside South Korea.

Sanofi is an innovative global healthcare company committed to using scientific advancements to improve lives. Their international team focuses on transforming medical practices and offering potentially life-changing treatments and vital vaccine protections to millions worldwide. The company prioritizes sustainability and social responsibility as core elements of its mission.

Overall, the expanded collaboration between Sanofi and SK bioscience marks a significant step forward in their shared mission to tackle pneumococcal disease and improve public health outcomes on a global scale.