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Biocon  /  United against COVID-19

United against 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

The pursuit of a COVID-19 treatment led Biocon to explore the science behind its existing biologic drugs to assess their potential so that they could be repurposed for treating COVID-19 patients. The unique mechanism of action of Biocon’s novel biologic, Itolizumab, made it an ideal candidate for treating the ‘cytokine storm’ (a release of pro-inflammatory cytokines into the lungs), which is one of the leading causes of death in COVID-19 patients.

Expert Panel Discussion on Itolizumab, by Vishal Dahiya, Rajya Sabha TV, July 17, 2020
Video Credit: Rajya Sabha TV

Itolizumab is a first-in-class, anti-CD6 IgG1 monoclonal antibody with a unique mechanism of action and a proven safety profile. Originally developed by scientists at Biocon as a psoriasis treatment, the molecule is manufactured at Biocon’s biologics manufacturing facilities and has been available under the brand name ALZUMAb® in India since 2013 for treating acute psoriasis.

Biocon decided to repurpose Itolizumab and conducted a Phase II clinical trial in leading hospitals in major cities in India with the hope that Itolizumab would benefit COVID-19 patients as the molecule’s unique mechanism of action works against the Cytokine Release Syndrome (CRS), which has been found to be one of the causes of mortality in COVID-19 patients.

A multi-centric, open label, two-arm randomized, controlled clinical trial was conducted to study the efficacy and safety of Itolizumab in COVID-19 patients displaying moderate to severe ARDS (acute respiratory distress syndrome) symptoms, and yielded positive results.

After review of the data from the clinical trial of Itolizumab in 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 use in treating CRS in ARDS patients due to COVID-19, in addition to already approved indications under the Drugs & Cosmetics Act.

Based on the encouraging study results in India, Biocon’s U.S.-based partner, Equilllium is planning to conduct a global randomized controlled clinical trial of Itolizumab in COVID-19 patients.

Biocon’s Cuban partner, Centre of Molecular Immunology, has also reported promising results from treating COVID-19 patients with Itolizumab.

2. Caring for critically ill patients

Biocon Biologics is supplying CytoSorb®, 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 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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