2 min read.Updated: 25 May 2020, 02:11 PM ISTLeroy Leo
Gilead had signed a voluntary licensing pact with four companies -- Cipla, Hetero Drugs, Jubilant Life Sciences and Mylan -- for manufacturing the drug and its sale in India and 126 other countries
NEW DELHI: Gilead Sciences Inc is eyeing studies on use of remdesivir with other drugs to understand if such combinations would aid patient recovery.
“Beyond the ongoing studies of remdesivir, we look forward to the initiation of combination studies of remdesivir to understand whether the addition of other drugs may enhance patient outcomes," Gilead Sciences Inc said in a statement on Monday.
The statement comes on the back of the preliminary results from the National Institute of Allergy and Infectious Diseases’ (NIAID) study on use of remdesivir for the treatment of covid-19 were published in the peer-reviewed New England Journal of Medicine.
The study of 1,100 adult patients, hospitalized with covid-19 and evidence of lower respiratory tract infection, had shown that remdesivir was superior in shortening the recovery time to 11 days as compared to 15 days for patients treated with placebo.
Apart from helping patients recover quickly, use of the drug in combination with other medicines is likely to also be an important commercial objective for Gilead.
In India, Gilead had signed a voluntary licensing pact with four companies -- Cipla, Hetero Drugs, Jubilant Life Sciences and Mylan -- for manufacturing the drug and its sale in India and 126 other countries.
Under the pact, Gilead would also transfer the technology for the complex manufacturing process of the intravenous drug to these, and the sale would be royalty-free till an alternative medicine for covid-19 is found or if the World Health Organisation were to withdraw the status of ‘public health emergency of an international concern’ for the disease.
An expert committee advising to the apex regulator, Central Drugs Standards Control Organisation, has also recommended that a waiver be given to the clinical trial for drug manufactured by Cipla and Hetero Drugs, two sources in the know told Mint. A formal approval from the Drug Controller General of India (DCGI) V.G. Somani is expected soon, the sources said.
Apart from these four companies, Gilead had also inked the voluntary licensing pact with Pakistan-based Ferozsons Laboratories.
The preliminary trial results were disclosed by Gilead late last month, based on which the US Food and Drug Administration had on 1 May given an emergency use authorisation for the drug to treat hospitalized patients with severe covid-19.
About a week later, the Japanese government had also granted regulatory approval of remdesivir, which will be sold under the brand Veklury, as a treatment for covid-19 under an exceptional approval pathway.
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