Pharmaceutical giants Roche and Biocon have joined the race to roll out a drug to combat coronavirus. While Roche’s rheumatoid arthritis drug Actemra (tocilizumab), marketed by Cipla, is being tried to prevent extreme inflammation in gravely ill Covid-19 patients, Biocon is learnt to have been repurposing its psoriasis drug Itolizumab to treat the deadly virus.
The two biologic drugs are being tested on critically ill patients in Mumbai's Nair Hospital and King Edward Memorial (KEM) Hospital. Reports suggest that two patients at Nair Hospital, who were administered with Roche's Tocilizumab, have shown decent recovery and could be taken off ventilators. Another at KEM was given Biocon's Itolizumab.
“In Mumbai, the number of cases are soaring. Until now Tocilizumab was used as an Interleukin-6 inhibitor to stop the cytokine storm in Covid-19 patients. Currently repurposed drug Itolizumab is being tested,” said Satyanarayana Mysore, HoD, Interventional Pulmonology & Sleep Medicine at Manipal Hospitals, who is also a member of the Covid-19 taskforce formed in Karnataka.
The BMC has now decided to test these drugs on over 120 patients that it has identified and who it thinks can benefit from these drugs. One hurdle is the price, at around Rs 60,000 a dose. A patient would need three doses taking the cost of treatment to Rs 1.8 lakh only for the drug.
According to reports, biopharmaceutical major Biocon has agreed to supply the drug for free to Brihanmumbai Municipal Corporation. An email sent to Biocon remained unanswered.
While no such trials have been undertaken in any other part of the country for Itolizumab, Mysore explained if Biocon really wants to launch this drug with a new indication, it will have to undertake multicentric clinical trials. “The same trial will have to be duplicated in several other parts of India,” Mysore added.
Itolizumab was developed and launched by Biocon in 2013 in India under the brand name Alzumab to treat moderate to severe plaque psoriasis, a skin disease.
Globally it has initiated phase-3 clinical trials on hospitalised patients in advanced stages of the novel coronavirus infection, especially those who have developed pneumonia. Roche has said it is working with the Food and Drug Administration to initiate randomised, double-blind placebo controlled phase-3 clinical trial in collaboration with the Biomedical Advanced Research and Development Authority.
Sources claimed Cipla has come forward to donate drugs for patient trials in India under the World Health Organisation (WHO) solidarity trials that involve checking the efficacy of anti-HIV drugs like lopinavir and ritonavir apart from antimalarials like hydroxychloroquine and chloroquine. The same could not be verified with the company as it declined to respond citing a silent period before quarterly results.Currently, Roche is not sponsoring any trials for Tocilizumab in India with regard to COVID-19. Tocilizumab is being promoted and distributed by Cipla in India, the company said.
Apart from Biocon, several other Indian firms are stepping up efforts to start clinical trials seeking to find a breakthrough in Covid-19 treatment.
While Glenmark Pharmaceuticals is set to start clinical trials this month for antiviral drug Favipiravin on mild to moderate coronavirus-positive patients, Bengaluru’s Strides Pharma Science, which started exporting the drug to the Gulf recently, is also applying for approval for the medicine in India.
Ahmedabad-headquartered Cadila Healthcare is also gearing up to start clinical trials of Interferon alfa-2b, a biosimilar used to treat Hepatitis C, which the company already makes commercially. The trials will start sometime this month. Zydus too has approached the Department of Biotechnology to investigate the role of Pegylated Interferon alfa-2b for Covid-19.