Following the news that 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.
Prashant Khadayate, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:
“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.
“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.
“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.
“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.”
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