With Itolizumab life-saving drug, Biocon in an Atma Nirbhar Bharath moment

Anil Urs Bengaluru | Updated on July 13, 2020 Published on July 13, 2020

Kiran Mazumdar Shaw , CMD, Biocon

Biocon, which is under criticism from several quarters for fast-tracking its Itolizumab drug to treat coronavirus patients, said that such a step was necessary as the initial response to the drug was extremely encouraging.

“The drug had already received necessary approvals. So, we went ahead with it as it has already saved lives during the clinical trials in treating Covid-19 patients,” said a spokesperson for the company. Each vial costs ₹8,000 and the full course will cost ₹32,000.

DGCI approval

The company received the Drugs Controller General of India’s (DCGI) approval to market Itolizumab (ALZUMAb) Injection 25mg/5mL solution for emergency use in India for treating cytokine release syndrome (CRS) in moderate-to-severe ARDS (acute respiratory distress syndrome) patients.

“Until the vaccine comes out, we need life-saving drugs. I think what we are doing across the world is either repurpose the drugs to treat this pandemic. When we started on this journey of developing the drug or repurposing the Itolizumab for Covid-19, it was based on a very strong hypothesis that it was related to cytokine storm or cytokine syndrome as we call it in medical terms. This was identified as the leading cause of deaths by the end of March 2020,” said Kiran Mazumdar Shaw, executive chairperson, Biocon.

Active Covid infections

As per the Union Ministry of Health and Family Welfare Statistics, India currently has more than 283,400 documented active coronavirus infections and more than 22,100 deaths.

Krishna Kumar, a professor with IIT Madras, who has been involved with such trials, told BusinessLine that Simon’s two-stage test is a well-established drug trial algorithm for the phase II trial. The number involved in carrying out the trials being small is not the criteria, but whether it is statistically significant or not is the criteria in a stage II trial.

Mazumdar-Shaw said this drug was basically developed in India for treating psoriasis as it is a autoimmune condition that sees a large release of cytokine, and the ability of Itolizumab that regulates cytokine made it compelling to develop it for psoriasis.

“But instead of developing it in India which does not appreciate this kind of path-breaking innovation and innovative mechanisms, we felt it was going to be better understood in other parts of the world. And, therefore, we licensed it to a US company, which started developing new indications for this drug again using the same hypothesis of cytokines regulation and modulation. They have begun studies on a host of diseases like rejection when transplant patients face or take place (acceptor and donor), also looking at immune modulation in acute asthma and other diseases,” she added.

Mazumdar-Shaw said this positions India among the leading global innovators in their effort to overcome the Covid-19 pandemic. “The randomised control trial indicated that all patients treated with Itolizumab responded positively and recovered. The control arm that did not receive Itolizumab, unfortunately, had deaths. Itolizumab is now approved for the treatment of CRS in patients with moderate-to-severe ARDS due to Covid-19. We plan to take this therapy to other parts of the world impacted by the pandemic,” said Mazumdar Shaw.

“Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm’, which is a leading cause of death in Covid patients. I am pleased that our R&D and clinical teams delivered on this promising hypothesis in such a short period of time.

The application of drugs is seeing much lower deaths levels. We should aim that the mortality rates should be less than 1 per cent, that should be our objective in dealing with the pandemic,” said the Biocon chief.

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Published on July 13, 2020
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