Dr. Reddy’s and RDIF receive approval to conduct clinical trial for Sputnik V vaccine in India
October 17 2020 - 6:44AM
Business Wire
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY) and Russian Direct Investment Fund (RDIF), Russia’s sovereign
wealth fund, today 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 multi-center and randomized controlled study, which will
include safety and immunogenicity study.
Earlier in September 2020, Dr. Reddy’s 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 Dr. Reddy’s upon
regulatory approval in India.
G V Prasad, Co-chairman and Managing Director, Dr.
Reddy’s Laboratories, said “This is a significant development that
allows us to commence the clinical trial in India and we are
committed to bringing in a safe and efficacious vaccine to combat
the pandemic.”
Kirill Dmitriev, CEO of the Russian Direct Investment
Fund, said, “We are pleased to collaborate with the Indian
regulators and in addition to Indian clinical trial data, we will
provide safety and immunogenicity study from the Russian phase 3
clinical trial. This data will further strengthen the clinical
development of Sputnik V vaccine in India.”
On August 11, 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.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY) 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
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. RDIF acts as a
catalyst for direct investment in the Russian economy. RDIF’s
management company is based in Moscow. Currently, RDIF has
experience of the successful joint implementation of more than 80
projects with foreign partners totaling more than RUB1.9 tn and
covering 95% of the regions of the Russian Federation. RDIF
portfolio companies employ more than 800,000 people and generate
revenues which equate to more than 6% of Russia’s GDP. RDIF has
established joint strategic partnerships with leading international
co-investors from more than 18 countries that total more than $40
bn. Further information can be found at www.rdif.ru
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version on businesswire.com: https://www.businesswire.com/news/home/20201017005007/en/
Dr. Reddy’s Laboratories Ltd. Amit Agarwal, Investor Relations /
Aparna Tekuri, Media Relations E-mail: amita@drreddys.com /
aparnatekuri@drreddys.com
Russian Direct Investment Fund Arseniy Palagin, Press Secretary
Tel: +44 (0) 20 7796 4133 Tel: +7 495 644 34 14, ext. 2395 Mobile:
+7 916 110 31 41 E-mail: arseniy.palagin@rdif.ru
Andrew Leach / Maria Shiryaevskaya Tel: +44 (0) 20 7796 4133
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