SGIOF - Shionogi faces setback for COVID pill as Japan delays authorization again

A group of health experts in Japanese health ministry delayed emergency approval on Wednesday for the COVID-19 pill developed by Osaka-based drugmaker Shionogi & Co. ( OTCPK:SGIOF ) ( OTCPK:SGIOY ), citing the need to continue discussions on the drug.

The delay marks the latest setback for the Japanese drugmaker after the panel postponed its decision on the drug known as S-217622 last month due to concerns over effectiveness and animal data indicating a potential risk to pregnancies.

The panelists didn’t recommend the emergency use authorization as there was a need to continue discussions on the therapy, Hiroshi Kiyota, chairman of the expert committee, noted. The panel's endorsement paves the way for the Japanese health ministry to approve the drug.

Consisting of a five-day course of seven pills, Shionogi’s ( OTCPK:SGIOF ) treatment is far more convenient than the rival oral COVID-19 drugs developed by Pfizer ( PFE ) and Merck ( MRK )/ Ridgeback Biotherapeutics, which require 30 pills and 40 pills over the same period, respectively.

The Japanese government has agreed to procure 1M doses of the drug from Shionogi ( OTCPK:SGIOF ), subject to regulatory clearance.

In April, London-based data analytics firm Airfinity projected that the company generate as much as $2.5B in sales from its COVID-19 pill in 2022.

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