Coronavirus: Glenmark conducts Fabiflu trial on 1,000 patients; to compete with Gilead's Remdesivir
Drug major Glenmark Pharmaceuticals, the first Indian company to commercially launch antiviral drug Favipiravir with brand name FabiFlu, is conducting a large study involving 1,000 patients to prove the drug's efficacy in coronavirus treatment.
"We are not in a hurry to rollout and want to doubly ensure its safety and efficacy before big launch. We are conducting a 1,000 patient study across India and the results will be available in the next two--three weeks. Trial batch production was started last week and big rollout will happen depending on the results," a top level Glenmark executive told Business Today on condition of anonymity.
The company is also hopeful of supplying the drug globally after the survey. The executive said the company has created adequate end to end domestic manufacturing capacity from raw materials to finished formulations. Capacity will not be a constraint to supplying the drug globally, according to the executive.
Currently, the US-based Gilead Life Sciences' Remedesivir is the only other drug allowed as emergency drug in many countries for coronavirus treatment. Glenmark is planning to take on Remdesivir with FabiFlu. While Glenmark has priced FabiFlu at Rs 3,500 for a pack of 34 tablets (Rs 103 per tablet), Glilead's injection is likely to be priced in the range of Rs 3,000 to Rs 5,000 per dose by licensed Indian manufacturers like Cipla and Hetero Drugs. The patient requires 5 to 6 doses. So the total treatment could cost anywhere between Rs 15,000 to Rs 36,000 in India with Remdesivir, say sources.
On Saturday, Glenmark announced the launch of the drug in India at Rs 103 a tablet, following the approval from Drug Controller General of India (DCGI) through a fast track approval process. The approval was based on a 150 patient clinical trial in India and 18 global clinical trials involving 3,000 subjects in India, US, Canada, Italy, China, France, UK and other countries.
Favipiravir, sold under the brand name Avigan by Fujifilm Toyama Chemical, has been used in Japan since 2014 for influenza treatment. It is already commercially used in therapeutic management of coronavirus in Bangladesh and UAE. Russia launched it on Saturday and Japan is awaiting a large trial data result. A Russian study on 390 patients found 80 percent plus success rate, while a trial among 2,141 patients in Japan saw 88 percent success rate. The trials so far claim the drug has a success rate of 80 to 88 percent.
Meanwhile, patent experts say Favipiravir main compound has no patent protection in India and Indian companies are free to make it. Favipiravir 200 mg patent in India (IN/PCT/2001/144/KOL) and its use as antiviral for the main compound expired on 18 August 2019. Another patent application for Favipiravir tablet or granulated powder compositions in India (IN6955/DELNP/2011) was filed in 2011 and the application was rejected later by the Indian patent office. "Its patent is not enforceable in India and the company Fujifilm Toyama Chemical is not a full fledged drug maker to aggressively pursue even if it had the rights," said Gopakumar G Nair, founder and CEO of Patent Gurukul and Gopakumar Nair Associates.
Companies like Strides Pharma, Mangalam Drugs, Brinton Pharmaceuticals, Lasa Supergenerics and Optimus Pharma are among the companies preparing for launch in India. "While Glenmark and Strides have both manufacturing and marketing scale to make and distribute the drug globally, rest of the companies are either API makers or lack marketing network to take the formulations globally", say sources.