Pharmaceuticals major Biocon is “perplexed and confused” that its drug, Itolizumab, does not yet figure in the ‘Clinical Management Protocol for Covid-19’ of the Ministry of Health and Family Welfare, despite proof of the drug’s efficacy.
“But we are ramping up production anyway,” says Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, “because the demand has suddenly spiked since April”.
Itolizumab, a lab-made novel anti-CD6 antibody (monoclonal antibody, or mAb), was approved by the Drug Controller General of India (DCGI) for ‘restricted emergency use’ to treat cytokine release syndrome (CRS) in patients experiencing moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Since July last year it has been administered to thousands of patients.
A competing mAb, Tocilizumab, produced by the Swiss pharma giant Roche and distributed in India by Cipla, figures in the protocol, despite it not being approved by DCGI, noted Athalye, in a conversation with BusinessLine today. Tocilizumab, in short supply today, has been approved for use on ‘compassionate grounds’ and is used as an ‘off-label’ or unapproved drug.
If a drug is on the national protocol “doctors know about it quicker”, he said. Biocon recently completed Phase-IV trials on over 300 patients and the results will be soon published in reputed journals. The company will submit the (additional) data to the Indian Council for Medical Research, the government body that promotes medical research, he said.
Since Itolizumab is not on the protocol, Biocon initially hesitated to raise production of the drug. However, since the demand is now going through the roof, the company has taken a decision to ramp up production.
Biocon did not wish to give any volume-related numbers, but said it would produce as much of the drug as required by the market.
Typically, the lead time for the production of monoclonal antibodies is long; these are ‘biologics’ produced by living organisms, and a production cycle can be as long as 45 days. Athalye pointed out that the company had been producing Itolizumab since 2013, now repurposed for Covid-19. As such, there would be no difficulty in stepping up production.
Biocon is the largest mAb producer in India. Athalye said that Itolizumab compares favourably with Tocilizumab on economics. Biocon’s product costs around ₹32,000 and the patient needs only one dose; Roche’s costs ₹45,000 and the patient needs two doses.
Coronaviruses typically do not kill people. Usually they stop multiplying in a patient’s body in about 6-7 days after the first infection. If the viral replication doesn’t stop the patient needs hospitalisation, where he or she is treated with anti-virals (remdesirvir) and steroids (dexamethasone). At this stage, often the body’s immune system overreacts to the infection; cytokines – meant to kill off the invading pathogen – goes on a rampage and starts attacking the body’s healthy cells, too. This is the cause of most Covid-19 deaths.
Monoclonal antibodies help put down the cytokine storm. Therefore, they are useful (indispensable) to patients who are deteriorating and just about to need mechanical ventilation.
Athalye said that Itolizumab works best if given exactly at this stage – not earlier or later. It is less effective if given to a patient who is on ventilator.