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 Shares of Fujifilm hit record highs in early April, fueled by
optimism for the drug, but have since lost a quarter of their value,
highlighting the risks of betting on experimental COVID-19 vaccines
and treatments that are often politically promoted early in their
development process.
Prime Minister Shinzo Abe previously touted Avigan's potential as
Japan's contribution to a global race for coronavirus treatments,
aiming for domestic approval in May and offering to give it away to
other countries. He mentioned the drug in at least 10 official
speeches from February.
But Abe has lately gone mum on the drug and regulatory deadlines
have lapsed, while researchers at Fujita Health University said
earlier this month that their Avigan study was inconclusive.
"I think that does not look good for any early approval," said one
clinical trial expert, referring to the Fujita study, and asking not
to be identified due to professional connections in Japan.
Interest in Avigan, developed more than 20 years ago, soared in
March after a Chinese official said it appeared to help patients
recover from COVID-19. It is now the subject of at least 28 clinical
trials around the world.
Fujifilm has not yet submitted the drug for approval to Japanese
authorities as a treatment for COVID-19, and has said it will take
that step as soon as possible. Health ministry official Yasuyuki
Sahara said the government stands ready to review Avigan once
Fujifilm submits it for approval.
The former chief of Japan's main drug regulator, however, warned
against a hasty approval of Avigan before its efficacy can be
proven.
"When it comes to regulatory bodies, trust is critically important,"
said Tatsuya Kondo who ran the Pharmaceuticals and Medical Devices
Agency for 11 years until 2019. "If they make an incomplete
judgment, it could raise doubts about the whole process."
As the coronavirus pandemic rages on worldwide, though, some are
still hopeful of positive outcomes of the Avigan trials.
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Tetsuya Nakamura, the lead researcher at Gunma University, which is running one
of the two remaining trials on Avigan in Japan, told Reuters the university is
"calmly advancing our research without pressure on the results," as their study
doesn't rely on public funds.
Fujifilm Toyama Chemical, the Avigan-manufacturing unit of Fujifilm whose own
trial is still listed as recruiting patients, is working to complete phase III
clinical trials as soon as possible, Fujifilm spokesman Shunsuke Saito said.
The company is continuing with plans to boost Avigan production to 300,000 doses
a month in line with a request from the government, he said.
Stanford University is soon to start a phase II trial of 120 patients with mild
symptoms and could move to a phase III around September, said Stanford professor
Yvonne Maldonado.
"We're moving as fast as we can," she said. If the drug can be shown to reduce
symptoms and the viral load among patients, "that would be a big deal".
Although Avigan, generically known as favipiravir, has gone off patent in many
markets, the brand and Fujifilm's know-how in making it still have value.
Earlier this month, Fujifilm sold off most overseas rights on Avigan to India's
Dr Reddy's Laboratories.
That deal involves a research partnership, and Japanese media reported that Dr
Reddy's will carry out a clinical trial of Avigan in Kuwait on behalf of
Fujifilm.
That data could possibly help Fujifilm build its regulatory case in Japan, said
Credit Suisse analyst Fumiyoshi Sakai.
"Probably it is too early to count out Avigan," Sakai said.
(Reporting by Rocky Swift; Editing by Miyoung Kim and Muralikumar Anantharaman)
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