Both companies have given a commitment to conduct clinical trials and submit data, following approval
Cipla and its partner BDR Pharmaceuticals have written to the India drug regulator requesting approval of anti-viral drug Favipiravir under restricted emergency use, considering the unmet need for treating mild and moderate novel coronavirus, or COVID-19, patients.
Both companies have given a commitment to conduct clinical trials and submit data, following approval.
"We are now ready with Favipiravir, where we are second applicant after Glenmark Pharmaceuticals. Our file should be coming up soon. Our clinical protocol is approved by subject expert committee. We have already uploaded on CMC (Chemistry, Manufacturing and Control) data. We are awaiting possible news in the next few days," Dharmesh Shah, Chairman of BDR Pharmaceuticals, said.
Drug maker Glenmark became the first Indian company to receive approval from Drug Controller General of India (DCGI) under emergency use. The approval was based on evaluation of interim data, and in consultation with the subject expert committee. The company is currently testing the drug on patients in a randomised multi-centric study across 11 sites across India. The sample size of the trial is 150 patients.
Glenmark launched the drug, pricing it at Rs 103 per tablet of 200mg dosage. Patients need to take about 18 tablets on day one and eight tablets thereafter for up to 13 days. A total of 122 tablets in 14 day course would cost about Rs 12,566. This makes the overall cost of the treatment on higher side for most Indians.
In addition to cost, taking 18 tablets on day one and eight tablets daily for 13 days would be inconvenient for the patient.
BDR and Cipla have suggested the regulator to use tablet of 600 mg dose that would reduce the number of pills a patient has to take to one-third compared to Glenmark.
"This protocol was deliberated. There were some deliberations on it. We have re-submitted our response to the regulators," Shah said.
Analysts say Favipiravir has a revenue potential of Rs 200-300 crore, with Glenmark having first mover advantage.
BDR and Cipla have partnered for Remdesivir, where the former will exclusively make the active pharmaceutical ingredient (API) for the latter. Cipla and Hetero last week received approvals to market Remdesivir for COVID-19 patients with moderate disease requiring oxygen support.BDR is also making other anti-viral drugs for COVID-19 such as lopinavir and ritonavir combination and oseltamivir.