Dr. Reddy's Laboratories (DRL) and Russian Direct Investment Fund (RDIF) announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.
This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.
Earlier in September 2020, DRL and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to DRL upon regulatory approval in India.
Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors.
G V Prasad, Co-chairman and Managing Director, DRL, said this is a significant development that allows the company to commence the clinical trial in India and it is committed to bringing in a safe and efficacious vaccine to combat the pandemic.
The announcement was made on Saturday, 17 October 2020. Shares of DRL rose 0.54% to settle at Rs 5082.35 on Friday, 16 October 2020.
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On 11 August 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Sputnik V is currently undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week.
Dr. Reddy's Laboratories is an integrated pharmaceutical company. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.
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