Biocon eyes international markets to supply Itolizumab for Covid-19 therapy

While Biocon has received the Drugs Controller General of India’s (DCGI) approval to market its novel biologic drug Itolizumab in India for treatment of patients with moderate to severe Covid-19 complications, its partner Equillium is planning to carry out a clinical trial in the US, which could lead to huge spike in demand for the product. 

While the US has over 3 million cases, it has reported more than 132,000 deaths to date in the country. 

Currently, there are more than 280,000 active cases in India. According to the World Health Organization, 80 per cent cases are mild, 15 per cent are severe that require oxygen support and 5 per cent are critical which require ventilation. 

“By that estimate, the patient pool would range from 42,000-56,000 for Itolizumab, which would translate into an addressable market of Rs 39 crore not incorporating the international market,” according to an ICICI Securities estimate.

Biocon and Equillium had last year expanded an exclusive licensing agreement for Itolizumab to include Australia and New Zealand. Equillium had originally secured exclusive rights to develop and commercialise the novel biologic for the US and Canada markets in 2017.

Biocon executive chairperson Kiran Mazumdar-Shaw said the company will also be looking at enquiries for the drug from other parts of the world.

She said Biocon currently has the capacity to address the present size of the serious population in India. “But we do realise that this is a much bigger challenge not only for India, but the world so we are going to ramp up capacity as much as possible and as fast as possible to make sure that we can make it available for India first and of course globally,” said Shaw.

In India, Itolizumab, known by the brand name ALZUMAb, has been priced at Rs 8,000 per vial, with most patients requiring four vials, taking the total cost of the therapy to Rs 32,000. In a few cases, however, a patient might need an additional two more. The drug will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility in Bengaluru.