Dr. Reddy’s Laboratories Ltd. has embraced the Russian COVID-19 vaccine known as Sputnik V after receiving approval by the Drug Controller of India (DCGI) to conduct an adaptive Phase 2/3 clinical trial vaccine in India. A multicenter and randomized controlled study, the team seeks to test safety, efficacy and immunogenicity. This follows a strategic alliance inked between the Russia Direct Investment Fund (RDIF) and the Indian generic drug producer in September. As part of this deal, RDIF will supply 100 million doses of Sputnik V to Dr. Reddy’s if India’s regulatory authority approves of the vaccine candidate.
Sputnik V Status
As TrialSite has reported recently, Sputnik V was “Registered” in Russi,a meaning it was approved for commercialization. This was an unorthodox move described in other articles. Since then, the vaccine candidate has moved into Phase 3 clinical trials both in Russia and abroad. The proposed number of subjects in Russia is 40,000 while a Phase 3 trial started in the UAE last week reported RDIF’s press release.
Sputnik V Background
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.
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
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
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