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7 Aug 2020

Novavax and Serum Institute of India – licensing agreement for Development and Commercial Collaboration

Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a license agreement with Serum Institute of India Private Limited (SIIPL) for the development and commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate, in low- and middle-income countries (LMIC) and India. This agreement excludes major upper-middle and high-income countries, for which Novavax continues to retain rights. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

“Novavax is strongly committed to ensuring a global supply of NVX‑CoV2373, including for low- and middle-income countries that are also significantly impacted by coronavirus,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “As the world’s largest vaccine manufacturer in terms of doses delivered, Serum Institute is the ideal partner to advance NVX‑CoV2373 throughout India and the LMIC countries. This partnership continues to build on our companies’ collaborative history.”

For LMICs and India, Novavax and SIIPL are partnering on clinical development, co-formulation, filling and finishing and commercialization of NVX-CoV2373. SIIPL will be responsible for regulatory submissions and marketing authorizations. Novavax will provide to SIIPL both vaccine antigen and Matrix‑M adjuvant, and Novavax and SIIPL are in discussions to have SIIPL manufacture vaccine antigen in India. Novavax and SIIPL will split the revenue from the sale of product, net of agreed costs.

“We believe that Novavax’ NVX-CoV2373 has significant potential to successfully prevent COVID-19. Given our experience with Novavax on the development of a malaria vaccine, we know the power of their vaccine technologies,” said Adar Poonawalla, Chief Executive Officer of Serum Institute of India. “We will work urgently together to bring this vaccine to patients in these geographies.”

This agreement further boosts the global supply of the NVX-CoV2373 vaccine and builds on and complements Novavax’ collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). Through that partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, if proved safe and effective, to be procured and distributed equitably by the COVAX Facility through a globally fair allocation framework.

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