Biocon Biologics  /  COVID-19

United Agaınst Covid-19- Together Let’s Combat The Novel Coronavirus

Biocon is responding to the COVID-19 outbreak, consistent with our belief that the pharmaceuticals industry has a humanitarian responsibility to serve patients who are in need. Our people across various functions are committed to ensuring the continuity of the production and supply of our life-saving medicines and we are committed to ensuring their personal health and safety.

Our scientific teams are also engaged in finding solutions to combat the COVID -19 pandemic.
– We are repurposing our products to benefit patients with COVID -19
– We are repurposing our novel drugs to find treatment for COVID -19
– We are developing tech platforms for testing COVID 19

Biocon Group’s initiatives to tackle Covid-19

Meeting our business commitments amid unprecedented challenges has not deterred the Biocon Group of Companies from contributing to global efforts to tackle COVID-19 through innovative science.

1. Biocon’s repurposed novel drug Itolizumab

A. How has Biocon repurposed its novel drug Itolizumab?

As the COVID-19 pandemic swept through India, Biocon responded to the need of the hour and repurposed its novel biologic ALZUMAb® (Itolizumab) for COVID-19 patients. It is a ‘first-in-class,’ anti-CD-6 IgG1 monoclonal antibody, which has shown promising results in treating cytokine release syndrome (CRS) in COVID-19 patients experiencing acute respiratory distress syndrome (ARDS).

Itolizumab is an approved and in-market drug that has been available in India under the trade name ALZUMAb® for the treatment of chronic plaque psoriasis since 2013 and has been used safely in thousands of patients.

We received permission from the Drugs Controller General of India in April 2020, to conduct a clinical trial for this novel drug in patients with COVID-19 complications.

The Drugs Controller General of India (DCGI), acting on a recommendation from the Subject Expert Committee (SEC), granted ‘Restricted Emergency Use’ approval to Itolizumab in July 2020 for treating Cytokine Release Syndrome (CRS) in acute respiratory distress syndrome (ARDS) patients due to COVID-19.

Download: Committed to Innovative Solutions to Transform Patients’ Lives

B. Can you provide details on the clinical trials conducted?

We have concluded a multi-centre, open label, two-arm, randomised Phase 2 clinical trial in 30 eligible patients, to study the efficacy and safety of Itolizumab in COVID-19 complications.

The primary objective of the trial was to study the efficacy and safety of Itolizumab in patients with moderate to severe COVID-19 complications.

The secondary objective was to study the effect of immunomodulation by Itolizumab and its correlation to clinical improvement, by evaluating biomarker data (IL6, TNF-a, IL17, IL1, Interferon-A etc.) before and after Itolizumab treatment.

This trial was conducted at multiple hospitals in Mumbai and Delhi.

C. How does Itolizumab work?

Itolizumab’s unique mechanism of action of immunomodulation involves binding to the CD6 receptor and blocking the activation of T lymphocytes, which in turn suppresses the pro-inflammatory cytokines, thus reducing inflammation.

Studies have shown that COVID-19 patients who develop serious complications experience a ‘cytokine storm,’ also known as Cytokine Release Syndrome (CRS), which leads to excessive inflammation, organ failure and death. Itolizumab reduces cytokine storm and the deadly inflammatory response.

2. Caring for critically ill patients

Biocon Biologics is supplying CytoSorb 300 ®, an in-licensed unique device that reduces cytokine storm in critically ill patients. The Company received the Drugs Controller General of India’s (DCGI) approval for this extracorporeal blood purification (EBP) device to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. We have been granted licence for emergency use of CytoSorb 300 ® in public interest by the Indian health regulator to treat COVID-19 patients who are 18 years of age or older. The licence will be effective until the COVID-19 outbreak is under control across the country.

3. Helping scale up testing capacity

Syngene has repurposed one of its laboratories to set up a RT-PCR-based COVID-19 testing facility in record time and a dedicated team of specially trained scientists have been testing thousands of samples received from hospitals across Karnataka, a gesture that has been recognised and appreciated by the Government of Karnataka.

The RT-PCR method is currently the definitive method for testing, approved by the Indian Council of Medical Research (ICMR). Syngene’s facility was approved by ICMR and a dedicated team of specially trained scientists test the samples free of charge, as per the guidelines prescribed by national and global regulatory authorities. Research efforts also focussed on development of RT-PCR reagents to reduce the cost per test.

Syngene has also indigenously developed an ELISA kit that is highly reliable and identifies the presence of SARS-COV-2 antibodies in blood samples and confirms if a patient has been exposed to the coronavirus. It has collaborated with HiMedia Laboratories to manufacture and distribute these ELISA kits. The Company has also partnered with Pune-based Mylab Discovery Solutions, to supply reagents for use in their indigenously developed testing kits.

4. Contributing to research in vaccines, therapeutics

Syngene is also collaborating with a number of biotech companies, both nationally and internationally, in supplying them with reagents or research support to develop diagnostic testing kits, therapeutics and vaccines.

5. Serving the underprivileged

Through Biocon Foundation, we are addressing the needs of daily wage earners and migrant labourers affected by the economic fallout of the COVID-19 crisis. The Foundation’s COVID-19 relief effort is ongoing, as the pandemic continues to affect people. This includes the distribution of several thousand dry ration kits, each comprising of 14 kg of basic items such as grains, pulses, spices and vegetables, among daily wage earners and the underprivileged. Biocon and its employees have also contributed to the PM Fund, as well as several states’ CM Fund for offering relief to the needy during this pandemic.

Business Continuity Statement

Biocon & Biocon Biologics ensuring manufacturing of life-saving medicines for patients, partners and customers

Essential Staffing Ensures Business Continuity, Rest ‘Work from Home’ in Compliance with the Government of India directive for COVID-19

Biocon Ltd. and Biocon Biologics have activated business continuity plans across their functions to prepare for unforeseen events, in light of the evolving COVID-19 situation and to meet the needs of patients, partners, customers and other stakeholders who depend on our products.

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