Commercial COVID-19 Drug Production In India

Biocon Biologics, a subsidiary of the Bengaluru-based pharmaceutical firm Biocon has received an "exclusive license" from the US-based Adagio Therapeutics to manufacture and commercialize an antibody-based treatment for the coronavirus disease (Covid-19) in India and select markets.

Adagio is currently conducting two global Phase 2/3 clinical trials of ADG20, a novel monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses as a single agent for the treatment and prevention of Covid-19.

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‘Biocon Biologics gets license to manufacture and commercialize the ADG20, a novel monoclonal antibody-based treatment in India.’

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Biocon claimed that ADG20 can effectively neutralize a broad range of coronavirus and its emerging variants of concern including the dominant Delta variant.

Adagio has published preliminary data from its ongoing Phase 1 trial in healthy volunteers, which supports ADG20’s safety and pharmacokinetic profile and SARS-CoV-2 neutralizing activity.

With its potential to address resistant variants, including the Delta variant, and its ability to be administered easily as a single, intramuscular injection in the outpatient setting, ADG20 is uniquely poised to address the current need for an effective, safe and convenient therapy for COVID-19.

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“This partnership with Adagio aligns our joint vision of bringing superior biologic therapies to millions of patients in low- and middle-income countries," said Kiran Mazumdar-Shaw, Executive Chairperson Biocon Biologics.

"Vaccines alone will not protect and make the world safer. Biologic therapies that arrest the virus in its path of devastation are a necessity for sustainable protection and safety,” Mazumdar-Shaw added.

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Under the terms of the deal, Biocon can seek clinical and nonclinical data from Adagio's emergency use authorisation (EUA) to the US Food and Drug Administration (USFDA). Adagio is likely to seek EUA in the US by as early as the first quarter of 2022.

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Source-Medindia