Sanofi, Novavax to Co-Commercialize COVID-19 Vaccine

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Parties sign co-exclusive licensing agreement, which includes a minority equity investment in Novavax, who will be receiving payments totaling as high as $1.2 billion when combining upfront payment and milestones.

Image Credit: Adobe Stock Images/Orkidia.com

Image Credit: Adobe Stock Images/Orkidia.com

In an effort to continue expanding on its vaccine development portfolio, Sanofi will be entering into a co-exclusive licensing deal with Novavax.1

Per the agreement, Sanofi will own a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine across the globe (except where Novavax has existing partnership agreements, including India, Japan, and South Korea, along with nations that already have advance purchase agreements; a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products.

Further, Novavax will receive an upfront payment of $500 million and as much as $700 million in development, regulatory and launch milestones, for a total of up to $1.2 billion. Sanofi will also own a minority (<5%) equity investment in Novavax.

“With flu and COVID-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses,” said Jean-Francois Toussaint, Sanofi’s global head of vaccines R&D. “We’re excited by the prospect of combining Novavax’s adjuvanted COVID-19 vaccine that has shown high efficacy and favorable tolerability, with our rich portfolio of differentiated flu vaccines that have demonstrated superior protection against flu and its serious complications. Improved tolerability and thermostability, without compromise on efficacy, are what regulators, recommending bodies, and patients will demand.”

Other conditions of the licensing agreement include:

  • Beginning in 2025, Sanofi will book sales of Novavax’s adjuvanted COVID-19 vaccine and will support certain R&D, regulatory, and commercial expenses.
  • Sanofi will be exclusively responsible for any development and commercialization of a novel flu-COVID-19 combination vaccine that contains a Sanofi flu vaccine.

“This collaboration is important for Novavax and for global public health. Our new partnership combines Novavax’s proprietary recombinant protein and nanoparticle technologies, Matrix adjuvant, and R&D expertise with Sanofi’s world-class leadership in launching and commercializing innovative vaccines,” explained John Jacobs, CEO, Novavax. “Together, we can broaden access to both our COVID-19 vaccine and our adjuvant to ensure more individuals can benefit from the protection vaccines can provide. Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in research and development and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases.”

Pertaining to the topic of vaccines, Sanofi and manufacturing partner AstraZeneca have announced a new reservation program to address the shortages of the respiratory syncytial virus (RSV) vaccine Beyfortus (nirsevimab-alip) that plagued the 2023–2024 RSV season.2

The Beyfortus Reservation Program seeks to improve readiness for the 2024-2025 RSV season with prioritized fulfillment of requests placed through the program, according to Sanofi.

“We are focusing on how we partner with customers with the aim of protecting babies from the leading cause of infant hospitalization in the US,” said Ayanna Santos, PharmD, Sanofi head of RSV Franchise, US Vaccines. “We’re excited by the potential of the Beyfortus Reservation Program to help support planning for the next RSV season.”

Reference

1. Press Release: Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines. Sanofi. May 10, 2024. Accessed May 10, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-05-10-06-00-00-2879379

2. James D. Sanofi, AstraZeneca Launch Program to Mitigate Future RSV Vaccine Shortages. Pharmaceutical Commerce. February 2, 2024. Accessed May 10, 2024. https://www.pharmaceuticalcommerce.com/view/sanofi-astrazeneca-launch-program-to-mitigate-rsv-vaccine-shortages

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