Under the terms of the deal, Biocon Biologics will get access to the clinical and non-clinical data from Adagio’s EUA submission to the US Food and Drug Administration to seek approvals in the emerging markets.
New Delhi: Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has said US-based Adagio Therapeutics has granted an exclusive licence to the company to manufacture and commercialise an antibody treatment based on ADG20 for India and select emerging markets.
The financial terms and conditions of the deal were not disclosed by the company.
Adagio plans to seek emergency use authorization (EUA) in the US as early as the first quarter of 2022. Under the terms of the deal, Biocon Biologics will get access to the clinical and non-clinical data from Adagio’s EUA submission to the US Food and Drug Administration to seek approvals in the emerging markets.
ADG20, a novel monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is in global clinical development by Adagio as a single agent for both the treatment and prevention of covid-19, the disease caused by the SARS-CoV-2 virus, its variants, as well as future variants that may emerge.
The covid-19 pandemic continues to be a major health crisis worldwide, and even with emergency use authorizations for vaccines and antibody-based therapies, there remains a significant need for medications to treat and prevent covid-19 infection. Initial data indicate that ADG20, Adagio’s lead clinical development candidate, could provide both rapid and durable protection against covid-19 for up to one year. This could make it an ideal agent to prevent infections and significantly reduce covid-19 related hospitalizations and death.
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.
“This partnership with Adagio aligns our joint vision of bringing superior biologic therapies to millions of patients in low and middle income countries. 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" Kiran Mazumdar-Shaw, executive chairperson of Biocon Biologics Ltd, said.
Biocon Biologics has a comprehensive covid-19 portfolio that addresses the needs of patients at different stages of the disease spectrum -- mild, moderate, severe and critical. During the pandemic in India, over 50,000 patients benefited from its covid-19 drugs that included remdesevir, itolizumab and cytosorb.
ADG20 is differentiated from other antibody treatments targeting SARS-CoV-2 as it is able to effectively neutralize a broad range of sarbecoviruses, including SARS-CoV-2 and its emerging variants, with high potency. Preclinical data generated by Adagio and validated by the University of Oxford in a series of recent cell manuscripts, show that ADG20 uniquely combines potency, breadth and complete neutralization of SARS-CoV-2 and all currently known variants of concern.
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