Under the terms of the agreement, the pair will globally co-commercialize Novavax’s COVID-19 vaccine, NVX-CoV2373 (approved by the European Medicines Agency (EMA) in 2021). However, countries who have existing Advance Purchase Agreements (APA) and partnership agreements (Kapan, India, and South Korea) are exempt.
Sanofi gains sole license to Novavax’s COVID-19 vaccine for use in combination with its flu vaccines, and a non-exclusive license to leverage the Matrix-M adjuvant in vaccine productions. Additionally, Sanofi will take a roughly 5% stake in Novavax.
“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,” said John Jacobs, CEO of 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.”
Novavax will receive an upfront payment of $500 million and has the potential to gain up to $700 million if specific milestones are met. The agreement will commence in 2025 and Sanofi said it will book sales of Novavax’s COVID-19 vaccine and support its development, regulatory, and commercial costs.
“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, global head of vaccines R&D at Sanofi.
“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.”
Both parties have the option to develop and commercialize their own flu-COVID-19 vaccines and adjuvanted products at their own cost.
Novavax was one of the frontrunners of the COVID-19 vaccine pioneers, trying to bring its adjuvant vaccine to market with support from $1.6 million of US government assistance through the ‘Operation Warp Speed’ program.
While Moderna, Pfizer/BioNTech, Johnson & Johnson (J&J) and other companies received approval for their relative vaccines and were distributing billions of doses worldwide, Novavax suffered from manufacturing issues, which delayed approval and led then-CEO Stan Erck to tell investors back in August 2022 that his company was “late to the market.”
By the end of Q2 2022, Novavax had delivered over 73 million doses of its vaccine. However, in comparison to the billions of doses administered of rival vaccines, and the dwindling demand for COVID-19 products, the firm’s share priced decreased to a fraction of what it was in December 2021.
In October 2022, contract development manufacturing organization (CDMO) Fujifilm Diosynth Corporation said it will receive up to $185 million after Novavax cancelled a Commercial Supply Agreement relating to its COVID-19 vaccine.
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