11 January 2021 - - An independent Data and Safety Monitoring Board has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continue the clinical trial without any modifications, Indian pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) said.

The phase 2 study of Sputnik V was conducted on 100 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety.

Further, the safety data has been submitted to the Drugs Controller General of India for review and approval to continue phase 3 clinical trials.

The clinical trials are being conducted by JSS Medical Research as the clinical research partner in India. Dr. Reddy's has partnered with the biotechnology Industry Research Assistance Council (BIRAC), Department of biotechnology for advisory support, THSTI (Translational Health Science and Technology Institute) for further immunogenicity data characterisation, and to use BIRAC's clinical trial centres for the vaccine.

In September 2020, Dr. Reddy's and Russian Direct Investment Fund entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution 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.

It currently ranks among top 10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Organization's list.

The vaccine's efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia.

Currently, the vaccine's clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.

Dr. Reddy's Laboratories is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives.

Through its three businesses - Pharmaceutical Services and 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.

Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe.

The company's major markets include USA, India, Russia and CIS countries, and Europe.