Shionogi & Co has signed an agreement with the Japanese Ministry of Health, Labor and Welfare (MHLW) to deliver courses of the oral antiviral drug S-217622, for Covid-19, in the country.
An inhibitor of 3CL protease, S-217622 was developed under the joint research of Shionogi with Hokkaido University, in Japan.
3CL protease is vital for viral replication, and the oral antiviral stops the SARS-CoV-2 by hindering the protease.
As per the deal, Shionogi will commence the manufacturing and commercialisation of the oral drug on obtaining regulatory approval in Japan.
Shionogi noted that the agreement is the first for an oral Covid-19 drug produced in the country.
The parties will proceed with talks to conclude a purchasing contract and a distribution consignment contract, until the grant of regulatory approval.
The Japanese government is anticipated to procure one million courses of S-217622 following the approval to extend the drug to Covid-19 patients, especially in the country.
It will also progress to secure additional antiviral courses later on.
Based on the data from clinical trials collected to date, the company submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking manufacturing and sales approval in February this year.
The company is seeking review under the conditional approval system from the PMDA.
To make the antiviral available rapidly to patients, Shionogi will hold discussions relating to the deal, provide data for the PMDA review, advance manufacturing and supply activities, and expedite trials underway.
At present, the Phase III segment of the Phase II/III trial in mild-moderate Covid-19 patients, and a Phase IIb/III section in asymptomatic-mildly symptomatic subjects, are underway in the country.
Shionogi is also collaborating with The AIDS Clinical Trials Group for international Phase III trials of the oral drug.