Biotechnology firms Ocugen and Bharat Biotech on Monday said they have agreed to include Mexico in their co-development, supply and commercialisation pact for the latter’s COVID-19 vaccine, Covaxin. The two companies have entered into an amendment to their agreement to expand Ocugen’s exclusive territory to include commercialisation of Covaxin in Mexico, they said in a joint statement.
“This gives Ocugen Covaxin commercialisation rights for all of north America,” it added. The licence extension between Ocugen and Bharat Biotech with respect to commercialisation in Mexico includes the same profit sharing structure as in the US, it added.
Ocugen chairman, CEO and co-founder Shankar Musunuri said, “Covaxin is currently under review by COFEPRIS (Comisin Federal para la Proteccin contra Riesgos Sanitarios) for emergency use among children between 2 and 18 years of age, and Ocugen is prepared to collaborate with the public health community to help their efforts.” Bharat Biotech chairman and managing director Krishna Ella said, “We are fully supportive of team Ocugen in our endeavor to expedite technology transfer activities towards commercial scale manufacturing of Covaxin in north America.” Earlier this month, citing deficiencies of good manufacturing practices in Covaxin production, the World Health Organization (WHO) confirmed the suspension of the vaccine’s supply through UN procurement agencies and recommended countries that received the vaccine to take actions as appropriate. WHO had said the suspension was in response to the outcome of its post Emergency Use Listing (EUL) inspection.
Bharat Biotech had also stated that after the WHO inspection, it was working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements. The company had also announced that it was temporarily slowing down production of its Covaxin across its manufacturing units for facility optimisation, as it has already completed its supply obligations to procurement agencies, and foresees a decrease in demand.