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Vaccines alone will not protect and make the world safer: Biocon chief

K Giriprakash Bengaluru | Updated on July 30, 2021

Says antibody therapies that arrest the virus in its path of devastation are a necessity

Biocon Biologics, a fully integrated biosimilars company, has partnered with the US-based Adagio Therapeutics for an exclusive licence to manufacture and commercialise an antibody treatment based on ADG20 for India and select 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 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.

In an interview with BusinessLine, Kiran Mazumdar Shaw, Executive Chairperson, Biocon Biologics, shares the developments regarding the new alliance: Excerpts:

What kind of demand do you foresee for this antibody product?

We believe that Covid-19 will become an endemic disease requiring a variety of effective, safe and convenient treatment and prevention options for years to come. Even with emergency-use authorisations for vaccines and antibody-based therapies, there remains a significant need for medications to treat and prevent Covid.

Vaccines alone will not protect and make the world safer. Antibody therapies that arrest the virus in its path of devastation are a necessity for sustainable protection and safety. This partnership with Adagio aligns our joint vision of bringing superior biologic therapies to millions of patients in low- and middle-income countries.

ADG20, a broadly neutralising, novel antibody therapy targeting the spike protein of SARS-CoV-2 and related Coronaviruses, could provide both rapid and durable protection against Covid for up to one year.

This could make it an ideal agent to prevent infections and significantly reduce Covid-related hospitalisations and death.

Other companies are also working on antibody cocktails. How is this product different?

The ADG20 asset is differentiated from other antibody treatments targeting SARS-CoV-2 as it is able to effectively neutralise a broad range of sarbecoviruses, including the SARS-CoV-2 virus, its variants, as well as future variants that may emerge.

This drug, which is being developed as a single agent for both the treatment and prevention of Covid, can be administered easily as a single, intramuscular injection in an outpatient setting. Engineered to have a long half-life, this asset can allow immediate and durable protection against Covid for up to one year.

Also, ADG20 is a mono-therapy versus approved combination therapy for neutralising mAbs. Moreover, Adagio is advancing ADG20 through multiple clinical trials on a global basis.

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 neutralisation of SARS-CoV-2 and all currently known variants of concern.

At what stage of clinical development is

the asset currently in?

Adagio has published preliminary data from its ongoing Phase 1 trial in healthy volunteers, which support ADG20’s safety and pharmacokinetic profile and SARS-CoV-2-neutralising activity. Adagio is currently conducting two global Phase 2/3 clinical trials, which will support an emergency-use authorisation submission in the US.

When do you expect

to launch this drug

in the market?

Adagio Therapeutics has granted Biocon Biologics an exclusive licence to manufacture and commercialise this antibody treatment for India and select emerging markets. Adagio plans to seek emergency-use authorisation 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.

How much will Biocon Biologics pay Adagio

to licence the drug?

The financial terms and conditions of the deal are not disclosed.

How do you explain the lower-than-expected Q1 earnings for Biocon? How does the company plan to improve the performance

of the generics business?

Biocon’s consolidated Q1 FY22 revenue at ₹1,808 crore saw a muted growth on account of a subdued performance in the generics business as the second wave resulted in operational and supply chain challenges that impacted API manufacturing.

Biocon’s Q1 P&L was largely impacted by a share of loss in our Boston-based associate start-up entity, Bicara Therapeutics. With the number of Covid cases starting to decline, we expect operational and supply chain challenges in the generics business to normalise in the coming quarter. We are confident that our strong foundation in fermentation technology, coupled with several initiatives undertaken during the past year, including digitalisation, cost improvement and measures to boost operational efficiencies, will help us to significantly improve our generics business performance in the coming quarters.

Published on July 29, 2021

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