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Two Indian firms to produce United Nations-backed Coronavirus antiviral medicine

The UN-backed Medicines Patent Pool and the Japanese company Shionogi said India’s Hetero Labs and Laurus Labs are among seven firms with sublicense agreements for Shionogi’s ensitrelvir

G.S. Mudur New Delhi Published 27.06.23, 05:17 AM

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Two Indian companies can produce under a UN-backed public health initiative an antiviral medicine found effective against mild and moderate Covid-19 in vaccinated people, the UN organisation and the Japanese drug maker announced on Monday.

The UN-backed Medicines Patent Pool (MPP) and the Japanese company Shionogi said India’s Hetero Labs and Laurus Labs are among seven firms with sublicense agreements for Shionogi’s ensitrelvir, an antiviral approved in Japan and under clinical trial evaluation outside Japan.

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Ensitrelvir’s developers have described it as the first antiviral compound to show both clinical symptomatic efficacy for five typical omicron-related symptoms and antiviral efficacy in a predominantly vaccinated population of patients with mild and moderate Covid-19.

The compound, developed by researchers at Hokkaido University and Shionigi, is administered as a once-daily oral pill for five days and works by suppressing the replication of the coronavirus. Health authorities in Japan had granted emergency authorisation for the use of ensitrelvir against Covid-19 in November 2022 on the basis of clinical trials in Japan, South Korea and Vietnam.

Public health experts believe the demand for antivirals against Covid-19 will grow in the future as the coronavirus continues to circulate worldwide and population immunity against Covid-19 acquired through natural infections or vaccines wanes over time.

“Even though Covid-19 is no longer classified as a public health emergency of international concern, we see numbers ebb and flow across the continents as we learn to live with the disease,” Charles Gore, executive director of MPP, said in a media release. “We look forward to working with all seven generic manufacturing partners on developing generic versions of ensitrelvir.”

Under the sublicensing pacts, India’s Hetero and Laurus, three companies in China, and one each in Ukraine and Vietnam will be able to manufacture and supply ensitrelvir to 117 low- and middle-income countries after the antiviral is authorised for use in those countries.

Infectious disease specialists who had reviewed work on candidate antiviral agents had cautioned last year that while antivirals provide an opportunity to manage Covid-19 without the need for hospital admission, the timing of the initiating treatment is crucial.

“It is pivotal to initiate the administration of oral antivirals no later than five days after the onset of Covid-19 symptoms,” a 14-member group of medical researchers from Asia, Africa and Europe had asserted last year in Pharmacological Reports, a research journal.

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