India-based Sun Pharmaceutical Industries Ltd (Sun Pharma) has received Indian regulatory approval to start clinical trials of pancreatitis drug nafamostat mesylate in COVID-19 patients. GlobalData, a leading data and analytics company, offers an overall review based on this development.

“Sun Pharma being the leading player in India seems to be slightly lagging in its efforts for COVID-19 repurposed drug research compared to other leading Indian companies. Nafamostat is the second repurposed drug that the company is evaluating for COVID-19 treatment. Earlier, the company received Indian regulatory approval to conduct clinical trials for plant-based dengue drug. However, the company is yet to initiate clinical trials" says Prashant Khadayate, Pharma Analyst at GlobalData.

“According to GlobalData’s Pharma Intelligence Center, nafamostat is approved only in Japan for pancreatitis. Six trials of nafamostat are under investigation for COVID-19 with five trials in planned stages across various phases and one phase III trial ongoing in Japan in combination with favipiravir by The University of Tokyo Hospital. Sun Pharma is expected to be the second pharma company expected to initiate trials on nafamostat mesylate following US-based Ensysce Biosciences" adds Prashant.

He further explains that “The race towards identifying COVID-19 treatments has made all of the companies’ focus on repurposed drugs. Indian companies are taking their chance to grab the opportunity where risk is undoubtedly high, but if successful returns would be even higher".

“Sun Pharma has initiated the manufacturing of active pharmaceutical ingredients and the formulation using technology from its Japanese Subsidiary Polo. Research at the University of Tokyo and Leibniz Institute for Primate Research, Germany demonstrated that nafamostat at very low concentrations suppresses a protein (TMPRSS2) that the COVID-19 virus uses to enter human lung cells" concludes Prashant.

“Sun Pharma is putting its energy on repurposed drug candidates like nafamostat and plant-based dengue drug where the focus by commercial companies is much less. Hence, if the COVID-19 clinical trial results for nafamostat are encouraging in India, then Sun Pharma could initiate trials in other geographies and will make every attempt to gain regulatory approval for those regions as well.”

Recently Sun Pharma launched world's cheapest Favipiravir , FluGuard (Favipiravir 200 mg) at an economical price of Rs. 35 per tablet, for the treatment of mild to moderate cases of Covid-19 in India. Favipiravir is the only oral anti-viral treatment approved in India for the potential treatment of patients with mild to moderate Covid-19 disease.

Commenting on the launch, Kirti Ganorkar, CEO of India Business, Sun Pharma said, “With over 50,000 Covid-19 cases being reported daily in India, there is an urgent need to provide more treatment options to healthcare professionals. We are launching FluGuard at an economical price to make the drug accessible to more and more patients thereby reducing their financial burden. This is in line with our continuous efforts to support India’s pandemic response.”

The company will work closely with the government and medical community to ensure the availability of FluGuard to
patients across the country. The stocks of FluGuard will be available in the market from this week.

Sun Pharma is the world's fourth-largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enable it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D.