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Ocugen, Bharat in Agreement for Commercialization of Covaxin in U.S.
9:46 am ET February 2, 2021 (Dow Jones) Print
By Michael Dabaie
Ocugen Inc. said it agreed a commercialization deal for Bharat Biotech's Covaxin, an advanced stage Covid-19 vaccine candidate, for the U.S. market.
Shares of Ocugen were up 15% to $2.08 in early trading Tuesday.
Ocugen will have U.S. rights to the vaccine candidate and will be responsible for clinical development, regulatory approval and commercialization for the U.S. market.
Bharat Biotech will supply initial doses to be used in the U.S. upon Ocugen's receipt of an emergency use authorization. Bharat Biotech will also support the technology transfer for manufacturing in the U.S.
Ocugen will share the profits from the sale of Covaxin in the U.S. market with Bharat Biotech, with Ocugen retaining 45% of the profits.
Covaxin received emergency use authorization in India in January and is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients.