Full Press Release Details
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Please find enclosed a Press Release on
"Dr. Reddy's initiates process for Emergency Use Authorization of Sputnik V."
This is for your information.
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | AMIT AGARWAL amita@drreddys.com (Ph: +91-40-49002135) | APARNA TEKURI aparnatekuri@drreddys.com (Ph: +91-40- 49002446) |
initiates process for Emergency Use Authorization of Sputnik V
Hyderabad, India. February 19, 2021- Dr. Reddy's
Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as "Dr.
Reddy's") today announced that it has initiated the process with the Drugs Controller General of India (DCGI)
for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V.
As part of the review process, Dr. Reddy's will present
the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21st
In September 2020, Dr. Reddy's partnered with the Russian
Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine
is currently undergoing the phase 3 clinical trial in India. Sputnik V has demonstrated an efficacy rate of 91.6% in the interim
analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second
doses of the vaccine. Sputnik V maintained a consistent efficacy at 91.8% even among the group of 2,144 volunteers over 60 years
G V Prasad, Co-chairman and Managing Director, Dr.
Reddy's Laboratories said, "The efficacy of Sputnik V was reported to be 91.6 % by the Lancet, which is an
impressive development in the fight against COVID-19. The initiation of the EUA process will be a critical step forward for
us in ensuring speedy access to the Sputnik V vaccine in India."
Sputnik V developed by the Gamaleya National Research Institute
of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on 11th August 2020 and became the
World's first registered vaccine against COVID-19 based on the human adenoviral vector platform. More than 250 clinical studies
over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines. Sputnik V is
one of only three vaccines in the world with an efficacy of 91.6% and has most authorizations granted with 26 countries globally.
The vaccine has already been administered to more than 2 million people worldwide.
About Dr. Reddy's: Dr. Reddy's Laboratories
Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing
affordable and innovative medicines for healthier lives. 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. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets
across the globe. Our major markets include - USA, India, Russia & CIS countries, and Europe. For more information,
log on to: www.drreddys.com
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on the management's current views and assumptions and involve
known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those
expressed or implied in such statements. In addition to statements which are forward-looking by reason of
context, the words "may",
"will", "should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking
statements. Actual results, performance or events may differ materially from those in such statements due to without limitation,
(i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates,
persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing
levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks
and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi)
the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic
downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19),
and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including
those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2020. The company assumes no obligation to update any information contained herein."