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Sanofi SNY and its partner SK bioscience announced that they have expanded their agreement to develop, license and commercialize next-generation pneumococcal conjugate vaccines (PCVs) for treating invasive pneumococcal disease (“IPD”) in pediatric and adult patient populations.
The latest deal builds on the existing collaboration between SNY and SK bioscience to develop and commercialize a 21-valent PCV (PCV21) for the pediatric patient population.
Sanofi also said that the companies commenced a phase III program for the PCV21 pediatric vaccine last week. Per management, this is the first-ever PCV containing more than 20 serotypes to enter a phase III study targeting infants and toddlers.
Year to date, shares of Sanofi have lost 4% against the industry’s growth of 1.4%.
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SNY's Expanded Deal for Developing PCV21
Per the expanded collaboration agreement, Sanofi and SK bioscience will jointly fund all research and development costs to support the launch of PCV21 and next-generation vaccines.
Sanofi will make an upfront payment of €50 million to SK bioscience while the latter will also be eligible to receive certain development and commercial milestone payments.
Once the vaccine is registered, Sanofi will commercialize the same across the world except for South Korea, where SK bioscience will hold commercial exclusivity.
Outside South Korea, SK bioscience will be entitled to receive royalty payments on the net product sales of the vaccines.
Other Drugmakers in the PCV Space
Pfizer PFE is a key player in the PCV vaccine space.
PFE markets Prevnar 20, which is approved for the prevention of IPD caused by 20 serotypes in individuals aged six weeks and older. PFE also markets Prevnar 13, which contains 13 serotypes and has the FDA’s approval for use in individuals aged six weeks and older.
In the first nine months of 2024, Pfizer recorded $4.8 billion from combined sales of Prevnar 13 and Prevnar 20.
Merck MRK also markets two PCV vaccines — Capvaxive and Vaxneuvance.
MRK received FDA approval for Vaxneuvance in 2021 for 15 serotypes in older adults. Merck generated $647 million from Vaxneuvance in the first nine months of 2024.
The FDA approved Capvaxive for 21 serotypes, which account for 84% of all IPDs in older adults in June 2024. Per Merck, Capvaxive launch is off to an encouraging start.
Small vaccine maker, Vaxcyte, Inc. PCVX is developing its investigational 31-valent PCV, VAX-31, which is in mid-to-late-stage studies, for preventing IPD in both pediatric and adult patient populations.