Biocon Ltd, an innovation-led global biopharmaceuticals company, presenting its key insights into the results of the Itolizumab for treating patients with moderate to severe COVID-19 complications informed that per vial is priced at Rs 7950 in a virtual press conference.
The biotechnology major informed that each ALZUMAb® (Itolizumab) injection is presented as a 25mg/5mL solution, per vial to cost Rs 7,950. Based on an average body weight of 60 kg, the therapy cost of a single dose comprising four vials is estimated to be ~Rs 32,000 (MRP).
The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
“Until the vaccine comes, we certainly need life saving drugs. I think what we are doing across the world is to see how we can either repurpose drugs or develop new drugs to treat this pandemic,” Kiran Mazumdar-Shaw, Biocon Executive Chairperson said in a virtual press conference.
“Even if we get a vaccine by the end of this year or early next year, there is no guarantee that there will not be reinfection, there is no guarantee that it will work the way we expect it to work, so we must be in a state of preparedness,” she added.
Asked if the company is ramping up the capacity to manufacture more vials on account of the pandemic, she said: “The Biocon has been successful in making adequate supplies available to patients in the multi-centric clinical trial that just concluded in India. The company has the manufacturing capacity and the supply and distribution network in place, which they are looking to ramp up further to reach a larger number of patients across the country.”
The drug will be manufactured and formulated as an intravenous injection at the company’s bio-manufacturing facility at Biocon Park, Bengaluru.
“Currently, there is a huge demand and Biocon wants to ensure Itolizumab first reaches those patients who need them the most. Concurrently, we are ramping up production capacity to meet surging demand,” she added.
Giving detail about the Itolizumab she said, “Itolizumab is a ‘Made in India,’ ‘Innovated in India,’ first-in-class anti-CD6 monoclonal antibody, which has a seven-year proven track record of safety as doctors in India have been prescribing this biologic therapy to treat acute psoriasis. As Itolizumab has been approved in India and given that we are in the middle of a medical emergency, we went ahead with a pivotal clinical trial involving a cohort of 30 patients. The two-arm, randomized study met both the primary and secondary endpoints, with the Itolizumab arm demonstrating statistically significant advantage over the control arm, culminating in the drug’s approval for restricted emergency use by the DCGI. The study results show that Itolizumab’s unique mechanism of action can bring down mortality in moderate to severe ARDS patients due to COVID-19.”
Dr Rahul Pandit, Director of Critical Care Services, Fortis Hospital, Mumbai, said, “There are not many drugs currently available to block the COVID-19-induced cytokine release syndrome (CRS), which patients typically experience at the start of the second week of the viral infection. I used only a single dose of Itolizumab on my patients at the onset of CRS and the drug’s mechanism of action of immunomodulation suppressed the pro-inflammatory cytokines, and the patients showed clinical improvement.”
Dr Vishal Gore, Physician and Intensivist, Markandeya Hospital and CNS Hospital, Solapur, said: “COVID-19 patients who present co-morbidities such as diabetes and hypertension have a higher chance of experiencing the ‘cytokine storm’ as a result of the novel coronavirus infection. I administered Itolizumab to a few of my patients who were showing serious COVID-19 complications, and this drug has by far given the best experience. None of the patients treated with Itolizumab suffered from sepsis or other bacterial infections after using the drug. The drug is also affordable considering that it can reduce three to four days in ICU on a ventilator, which can be far more expensive.”
Dr. Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said: “We have seen promising efficacy in over 150 patients treated under compassionate use by many doctors. We Will be publishing the trial data as well as real world data to further strengthen the body of evidence for Itolizumab. We hope to reach all the patients who need this product in time and are now working towards ramping up to meet those needs.”
In the virtual conference the experts informed that the clinical trial showed that if Itolizumab is best administered in the pulmonary phase of the COVID-19 infection when the cytokine build-up is starting, and the patient is experiencing shortness of breath and exhibiting abnormal chest images. It prevents progression to the hyperinflammation phase (cytokine storm) and other complications such as coagulation and organ failure.
Further the company informed that partner Equillium plans global clinical trial of Itolizumab in COVID-19.Equillium, Biocon’s commercial partner for Itolizumab in the U.S., Canada, Australia and New Zealand, is moving quickly to initiate a global study of Itolizumab that would support approval of the therapeutic in the U.S. and elsewhere so that the therapy may become available in the shortest time possible to the greatest number of patients worldwide.