Shionogi eyes overseas clinical trials of oral COVID-19 drug early next year

The Yomiuri Shimbun

10:27 JST, December 15, 2021

OSAKA — Pharmaceutical company Shionogi and Co. aims to have the oral COVID-19 drug it is currently developing used both at home and abroad, its president said during a recent interview with The Yomiuri Shimbun.

President Isao Teshirogi also said the company will select its partners for clinical trials and production in foreign countries within this year.

Trials of the drug on COVID-19 patients in North America and Europe are expected to start early next year.

“We won’t change our objective of applying for approval to manufacture and sell our therapeutic drug [for patients in Japan] within this year,” he said. “We want to have an oral antiviral drug produced in Japan [and have it marketed internationally]. We will use our managerial resources and compete with our foreign rivals,” Teshirogi said.

The company is considering forming a partnership with a foreign drug maker, focusing on pharmaceutical giants in Europe and North America.

An oral drug that is effective in preventing an infected patient from developing serious symptoms is considered a game changer in coping with the coronavirus.

Shionogi is presently expediting its efforts for the final-stage clinical trial in Japan. As it is difficult to secure enough patients for trials due to a decline in the number of new infections in Japan, Shionogi plans to apply for approval following clinical trials in such countries as Singapore and South Korea, where the medical systems and people’s average weights are similar to Japan.

The company will also accelerate its efforts to conduct clinical trials and apply for approval in foreign countries.

During the interview, Teshirogi also revealed that the company started production of the oral drug on Dec. 6, ahead of its application for authorization. His company plans to produce enough of the oral drug for 100,000 people by the end of December, and to amass stock for 1 million people by the end of March.

Applying with interim data

“We want to deliver a drug people in Japan need,” Teshirogi stressed. As one option, Shionogi is even considering applying for authorization of its COVID-19 treatment with interim diagnostic trial data — on the premise that its safety is assured — so as to get the application in within this year.

The oral therapy for COVID-19 Shionogi has been developing inhibits the function of an enzyme that is essential for the replication of the virus, thus preventing an infected patient from developing serious symptoms. By taking the drug soon after the onset of symptoms, the infected patient is expected to recover early.

“An oral drug that people can easily take at home is considered to be vital,” Teshirogi said. For this reason, his company has assigned a large number of researchers to its development. It is thought to usually take five years to identify a chemical compound for the drug, but his company has succeeded in doing so within nine months. The company is speeding up its preparation for putting the drug on the domestic market once it is authorized.

Among foreign companies, MSD K.K., a Japanese subsidiary of U.S. firm Merck & Co., applied to the Health, Labor and Welfare Ministry on Dec. 3 for approval to produce and sell its oral drug Molnupiravir. The government has reached an accord with Merck, conditional on approval, for the procurement of 1.6 million doses of the drug. Pfizer Inc., also of the United States, is also said to be in discussions with the government over an application for authorization of its drug.

Vaccine for omicron

Japan has lagged behind other countries in the development of vaccines against COVID-19. “We are sorry and feel vexed [about the delay]. As a state, there was no preparation made,” said Teshirogi.

“Britain had put a lot of effort into health care, while the United States has invested a huge amount of money into measures against infectious diseases,” he added.

Prime Minister Fumio Kishida has made clear his intention to invest in the development and manufacturing of domestic vaccines and therapeutic medicines for COVID-19.

“A drug for an acute infectious disease like the one caused by this coronavirus won’t sell well unless the disease is prevalent, so it is quite difficult for commercial profit to be made,” Teshirogi said. “We would appreciate very much if the government helps us continue developing medicines, even if a disease does not become prevalent.”

Meanwhile, the new omicron variant is spreading.

“We have already started developing a vaccine to deal with it,” he said. “We will also verify the efficacy of our therapeutic drug against the omicron variant. It is necessary to hone the technology for developing domestic-made vaccines so that Japanese companies can deal even with variants.”