HYDERABAD: Gland Pharma, based out of Hyderabad, has entered into an agreement with
Russian Direct Investment Fund
(RDIF), a sovereign wealth fund, to manufacture and supply 252 million (25.2 crore) doses of the Russian Covid-19 vaccine
Sputnik V.
The company said on Tuesday that it expects to commence
production
of Sputnik V at its facilities in Hyderabad from the third quarter of 2021, with deliveries estimated to start from the fourth quarter of 2021.
News of the tie-up sent the scrip of the company, which listed on Indian bourses in November 2020, soaring to a record high of Rs 2,784.45 a share on the Bombay Stock Exchange on Tuesday, before closing nearly 7% up at Rs 2,718.65 a share as compared to the previous day’s closing.“Under the terms of the agreement, Gland Pharma will first undertake
technology transfer
of the drug substance to its manufacturing facilities. After successful technology transfer, Gland Pharma will undertake manufacturing of the drug substance and drug product filling into vials under aseptic conditions,” it said in a regulatory filing.
However, it was not clear whether the Sputnik V doses that Gland Pharma will churn out are meant solely for the Indian market or for global supplies as well.
The pharma company, set up by PVN Raju in 1978 but now majority owned by Fosun Pharma of China, said it will be leveraging its expertise in manufacturing sterile injectables at scale for the production of Sputnik V and establishing a stable supply of Covid-19 vaccines.
Gland Pharma said this is the first of multiple partnerships being explored by the company to leverage its manufacturing capacity and capabilities to support the global supply of Covid-19 vaccines.
Sputnik V, which showed a 91.6% interim efficacy in global Phase 3 trials, has already applied to the Indian drug regulator for emergency use authorisation.
At the end of February, Dr Reddy’s Laboratories, which is conducting Phase II/III trials on 1,600 volunteers in India as part of a bridging study to larger global trials, was asked to submit safety and immunogenicity data. Dr Reddy’s Labs had joined hands with RDIF in September 2020 for clinical trials and distribution of 100 million doses of the vaccine in India.
In November 2020, RDIF had tied up with Hyderabad-based Hetero Drugs to manufacture 100 million doses of Sputnik V.