Sanofi expands collaboration with SK Bioscience

Sanofi SA and SK Bioscience Co. Ltd 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.

Under the terms of the expanded agreement, both companies will co-fund research and development costs. Sanofi will pay €50m upfront to SK Bioscience, which is set to cash in success-dependent development and commercial milestone payments. Once registered, Sanofi will commercialise 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.

The expansion builds on the companies’ existing collaboration to develop and commercialize a PCV21 pediatric vaccine. Next week, Sanofi will kickoff Phase III testing of its 21-valent pneumococcal conjugate vaccine (PCV21) against more than 20 serotypes infants & toddlers. The PCV21 Phase III programme is based on positive Phase II results announced last year and will include more than 7,700 infants and adolescents across multiple geographies, including the US, Europe, Australia, Asia, and Latin America.

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 covered bn currently available conjugate vaccines. According to data from Evaluate Pharma, the global pneumococcal vaccine market is projected to grow from €7.85bn in 2024 to €9.1bn in 2028, with an average annual growth rate (CAGR) of 4.7%. The pediatric market represents 65 to 70 % of the pneumococcal vaccine market.