Dr. Reddy's Initiates Process for Emergency Use Authorization of Sputnik V
February 19 2021 - 5:45AM
Business Wire
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 February 2021.
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 old.
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.”
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH:
+91-40-49002135) MEDIA RELATIONS APARNA TEKURI
aparnatekuri@drreddys.com (PH: +91-40- 49002446)
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