Hyderabad: In a development that will bring the capabilities of Hyderabad pharma firms into focus, city-based Hetero will make Remdesivir, authorised for the treatment of patients with severe Covid-19 disease, at its formulation facility in Hyderabad. The facility has been approved by regulatory authorities such as USFDA and EU, among others.
Hetero, one of India’s generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, on Wednesday announced that it has entered into a licensing agreement with Gilead Sciences, Inc for manufacture and distribution of ‘Remdesivir’ for the treatment of Covid-19.
Under this licensing deal, Hetero will be supplying Remdesivir in 127 countries, including India, subject to regulatory approvals in respective countries.
Dr B Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented in a release: “Hetero is pleased to partner with Gilead to enable access for this important drug to India and other developing countries at this crucial time. This agreement also illustrates the significance of global collaboration and the need for coming together to fight the health crises impacting humanity. Hetero has developed this product in India and has already been working with the government, ICMR, and DCGI for necessary studies and approvals to bring this product to treat Covid-19 patients in India.”
Dr Vamsi Krishna Banda, MD of Hetero Labs Limited, said: “Hetero has several licensing partnerships with Gilead across key therapies such as ARV, Hepatitis etc. We have been a long-time partner for them for over a decade. The key focus is to enable access to Remdesivir to patients living in India and other developing countries.”
“We have a fully vertically integrated supply chain for this product complementing the Make in India campaign as defined by our Prime Minister. And, it is also a pride to the Telangana region that the product is being developed here in Hyderabad,” he said on the impetus the deal will give to Hyderabad. He said it is too early to comment on volumes under this agreement.
FDA has granted emergency use authorisation (EUA) for the investigational antiviral Remdesivir to treat Covid-19. Remdesivir is authorised for the treatment of hospitalised patients with severe Covid-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials, the release added.
Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. The authorisation is temporary and does not take the place of the formal new drug application submission, review and approval process, it said.
The EUA allows for the distribution and emergency use of Remdesivir only for the treatment of Covid-19. Remdesivir remains an investigational drug and is not approved anywhere globally, including US and India, it said. Gilead is also working with two other companies- Cipla and Jubilant Life Sciences on this.
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