In an important development, drug developer Ocugen on Tuesday announced that it has partnered with Bharat Biotech to co-develop the India-based company`s COVID-19 vaccine candidate for the US market.
Under the partnership terms, Ocugen said it would have US rights to the vaccine candidate and be responsible for clinical development, registration, and commercialization for the US market.
Bharat Biotech is developing Covaxin with the government-run Indian Council of Medical Research (ICMR) and has sought emergency-use authorization from the Indian drug regulator.
Ocugen is a leading American biopharmaceutical company and the global leader in vaccine innovation and it has signed a letter of Intent (LOI) with Bharat Biotech on Tuesday.
Phase 1 of Covaxin and Phase 2 of the human trial were done on about 1,000 people. While the human trial of Phase 3 was started in November, Bharat Biotech has set a target of 26,000 volunteers for this.
According to the Letter of Intent (LOI), Ocugen will have US rights for the vaccine candidate and India will be responsible for clinical development, registration and commercialization for the US market, in collaboration with Biotech. The two companies have started collaborating and a definitive agreement will be finalized in the next few weeks.
In preparation for the development of COVAXIN in the US, Ocugen has assembled a Vaccine Scientific Advisory Board consisting of leading academic and industry experts to evaluate the clinical and regulations pathway for the US market.
Dr Shankar Mussunari, Chairman and Co-founder, Ocugen, “We are delighted to bring COVAXIN to the US market together with India Biotech. To face the coronavirus epidemic, we all have a responsibility to find solutions that make life The ability to save and normalize our day to day activities. We are very pleased with the results of COVAXIN’s Phase 1 and Phase 2 trials and are encouraged to progress the Phase 3 trials in India.”
On this occasion, Dr Krishna Alla, Chairman and Managing Director, Bharat Biotech, said that the development and clinical evaluation of COVAXIN is an important milestone for vaccination in India and COVAXIN has attracted interest from many countries around the world and we are excited to collaborate with Ocugen to bring it to market.