Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN™ for the US market.
COVAXIN™ received EUA (Emergency Use Authorization) in India in January and is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients.
COVAXIN™ (whole-virion inactivated COVID-19 vaccine candidate) effectively neutralizes UK variant of SARS-Cov-2 reducing the possibility of mutant virus escape.
today announced they have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN™, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.
Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA ) and commercialization for the US market.
Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of an EUA . In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN™ in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.
In preparation for the development of COVAXIN™ in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application ( BLA ) approval in the US market for COVAXIN™. Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN™ to support its US immunization program.
H.C. Wainwright analyst Swayampakula Ramakanth raised his rating on Ocugen’s stock on Thursday from neutral to buy and placed a $4.50 price forecast on its shares. Ramakanth cheered Ocugen’s recent deal with India-based vaccine developer Bharat Biotech to potentially bring Covaxin, a COVID-19 vaccine candidate, to the U.S. market.
Ramakanth posits that Covaxin could induce broader immunity and better protection against new coronavirus strains than the COVID-19 vaccines that have received emergency use authorization in the U.S. He also highlighted Covaxin’s potential logistical advantages, due to its less onerous temperature storage requirements.
Roth Capital analyst Zegbeh Jallah, meanwhile, believes Ocugen’s share price could rise to as high as $8. Jallah applauded the structure of the deal, which gave Ocugen a 45% share of the potential profits from Covaxin’s U.S. sales without requiring it to make an upfront payment to Bharat Biotech. Jallah’s price target represents potential gains for investors of roughly 52% from Ocugen’s closing price on Friday.
Much of Ocugen’s future growth prospects now rest on its ability to obtain emergency use authorization for Covaxin in the U.S. Thus, investors should brace for in Ocugen’s stock price as it advances toward clinical trials.
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