Dr Reddy’s expects to launch Remdesivir in August

Dr Reddy’s is expecting to launch a generic version of anti-viral drug Remdesivir next month. It has a voluntary license from Gilead Sciences to manufacture and distribute the drug in 127 countries including India.

The company has sought approval from the Drug Controller General of India (DCGI), the application is currently under review.

On supply capacity, Erez Israeli, Chief Executive Officer (CEO) of Dr. Reddy’s hinted at substantial Remdesivir supply capacity.

“(We have capacities) as much as India needs and beyond,” Israeli said, a company’s post earnings media briefing.

Cipla, Hetero and Mylan have till now launched the generic versions of Remdesivir in India. Jubilant Life Sciences, also has approval and is expected to launch the drug in August. Both Cipla and Hetero can produce up to 2 lakh doses a month; the production capacity of Mylan is not known. Dr Reddy’s, Zydus Cadila and Syngene are other companies that have licenses from Gilead to manufacture and distribute Remdesivir generic versions but are yet to get approval from DCGI.

Pankaj Patel, Chairman of Zydus Cadila in an interview to Moneycontrol earlier this month told Moneycontrol said that the company has the potential to produce as high as 3-4 lakh doses a month, and it plans to launch the drug by August.

Remdesivir is prescribed for hospitalised patients who are on oxygen. The drug has to be taken for five days, with 200 mg IV (intravenous) on day 1 followed by 100 mg IV daily for four days.

With a rising number of confirmed COVID-19 cases, the demand for Remdesivir is also soaring, but the current capacity is still way short than the demand. Prices of the drug in the black market have soared many times its MRP.

To go ahead on Favipiravir

On another antiviral Favipiravir, which is prescribed for mild COVID-19 cases, Dr Reddy’s said it will be going ahead with the product, despite Glenmark’s clinical trial data being statistically significant. The DCGI along with Glenmark has approved Favipiravir versions of half a dozen companies including Cipla, Hetero, Brinton Pharmaceuticals and Jenburkt.

Dr. Reddy’s has earlier signed with the innovator company Fujifilm, which offered the company exclusive rights to develop, produce, and sell Avigan (Favipiravir) overseas in combination with Dubai-based Global Response Aid. The new agreement covers all countries other than Japan, China and Russia.

“We have the brand product, as well as access to all relevant clinical trials, may be others can not,” said Israeli.

Currently, a clinical trial on 1000 patients is underway in Kuwait to investigate if the antiviral drug can work as a treatment for COVID-19, he added.

The trial was to be conducted in Japan originally. It was designed to involve 96 people through late March to June. The trial reportedly ran out of patients, due to containment of COVID-19 in Japan.

Kuwait had a large number of COVID-19 cases compared to Japan, so Fujifilm is hoping there will be a steadier stream of participants for the trialIf the trial proves successful, Fujifilm will use the data to show that the treatment can be used in Japan.- Moneycontrol