Dr Reddy's Laboratories Ltd hopes to launch Russian Covid vaccine Sputnik V in India in March after obtaining Emergency Use Authorisation (EUA). The pharma major expects Phase 3 trials to be completed in February. "About 70% of the trials have already been completed. We hope to roll out the product in March," said Deepak Sapra, Chief Executive Office, API & Pharmaceutical Services, Dr Reddy's Laboratories Ltd.
He said that the Phase 3 trials will be completed in February after which data will be compiled and submitted to the Drug Controller General of India (DCGI) for EUA. Addressing a virtual press conference to announce third-quarter results of the company, he said that the company was also gearing up for the production of Sputnik. Initially, it will be a combination of imports and local manufacturing, the company said.
He also revealed that the company is in talks with a couple of local manufacturers. It has already signed agreements for 125 million patient doses of Sputnik V in India. The pricing of the vaccine has not been decided yet. The company plans to cater to both government and private demand.
It was on January 15 that Dr Reddy's announced that it has received approval from the DCGI to conduct Phase 3 clinical trials. The trials are to be conducted on 1,500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India.
In September 2020, Dr Reddy's partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
Sputnik V 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 established human adenoviral vector platform.
The vaccine's efficacy is confirmed at 91.4%, based on data analysis of the final control point of clinical trials in Russia. Currently, Sputnik V is being administered as part of emergency use in 12 countries.
Meanwhile, Dr Reddy's posted a consolidated net profit of Rs 20 crore during the third quarter against a loss of Rs 569.7 crore in the year-ago period. Revenues for the quarter ending December were Rs 4,930 crore which was up 12% year on year and 1% over the second quarter.
"We continued with our growth momentum...the profits were impacted due to trigger based impairment charges taken on a few acquired products including Nuvaring. We are progressing well on Phase 3 clinical trials for Sputnik V vaccine in India. We continue to focus on enhancing our product offerings to our patients to serve them better," said Dr Reddy's Co-chairman and Managing Director (MD), GV Prasad.