Fujifilm partners with Shanghai firm to seek China COVID-19 approval for Avigan

TOKYO— Japan's Fujifilm Holdings Corp said on Thursday it has partnered with Shanghai-based Carelink Pharmaceutical Co to seek approval in China for Avigan to treat COVID-19 and influenza.

Carelink will use Fujifilm's data on Avigan's treatment of novel coronavirus infections and influenza to seek imported drug approval in China, Fujifilm said in a statement. The two companies also plan to develop an injectable form of the drug.

Fujifilm said last week it was seeking approval for Avigan as a treatment for COVID-19 in Japan. That followed results from a late-stage study in Japan that showed the antiviral drug reduced recovery time for patients with non-severe symptoms.

Avigan, originally developed as an emergency flu drug and known generically worldwide as favipiravir, has been approved in India and Russia to treat COVID-19.

Fujifilm sold global rights in July on Avigan to India's Dr Reddy's Laboratories and Dubai-based Global Response Aid. That deal excluded China, Japan and Russia.

Last month, Fujifilm said the late-stage study of 156 COVID-19 patients in Japan showed that symptoms of those treated with Avigan improved after 11.9 days, versus 14.7 days for a placebo group.

Results of the study, conducted by subsidiary Fujifilm Toyama Chemical, were found to be statistically significant. 

-reuters-

Fujifilm ties up with Indian firm on potential COVID-19 drug Avigan

TOKYO - Fujifilm Corp. said Wednesday it had signed an agreement with an Indian pharmaceutical company and a company that provides global medical supplies, granting them exclusive rights to develop, produce and sell its potential COVID-19 treatment drug Avigan overseas.

Under the tripartite agreement with India's Dr. Reddy's Laboratories Ltd. and Dubai-based Global Response Aid signed Tuesday, Fujifilm will receive a lump-sum license fee and royalties on sales of Avigan, also known as favipiravir, currently undergoing clinical testing as a possible coronavirus treatment drug in Japan.

Fujifilm Toyama Chemical Co., the Fujifilm subsidiary that developed Avigan, will provide the 2 companies with data accumulated so far on preclinical and clinical studies of the drug.

They "will make use of this data to swiftly implement clinical studies, targeting COVID-19 patients in India, the Middle East and other regions where infections have been spreading," Fujifilm said in a statement.

The license agreement excludes rights to sell Avigan in China and Russia, it said.

Fujifilm also said it would grant Dr. Reddy's the right to use Avigan production patents so that the Indian drugmaker can supply GRA's global sales network swiftly and stably.

Avigan has yet to be approved by the Japanese government for COVID-19 treatment, with clinical testing delayed due to insufficient enrollment.

The Japanese government gave up on its target for approval of the drug in May after an interim analysis of an Avigan clinical study, being conducted by a team led by Fujita Health University, did not show clear efficacy in treating the disease.

As Avigan can inhibit the replication of the novel coronavirus in cells, experts say it may bring about improvements in infected patients.

Avigan, which has been stockpiled by the government as an anti-flu drug, cannot be administered to expectant mothers or women who are likely to become pregnant as it may cause birth defects.

Kyodo News

Philippines, Japan plan Avigan trials vs coronavirus before end of April

The Philippines and Japan are planning to begin clinical trials of Avigan before the end of the month, in the hope of using the anti-influenza drug as a treatment for the new coronavirus.

Philippine Health Undersecretary Maria Rosario Vergeire told Kyodo News on late Thursday that arrangements are being finalized to begin testing on people afflicted with the disease as soon as possible.

"We are expediting the process, so we hope we could start before the end of the month," she said, noting that discussions for the testing size and duration have yet to be concluded.

The Philippines expressed willingness to participate in the clinical trials for Avigan during a virtual summit held last Tuesday with leaders of Southeast Asian countries, Japan, China and South Korea.

During the teleconference, Japanese Prime Minister Shinzo Abe said there are 50 countries interested in studying the drug further as a potential treatment for COVID-19, the illness caused by the virus.

Avigan is manufactured by a group firm of Japan's Fujifilm Holdings Corp., which has recently started boosting its production of the drug, aiming to have enough supply to treat 300,000 patients a month by September.

Aside from the clinical trials for Avigan, the Philippines, along with 69 other countries, will also participate in the tests organized by the World Health Organization for five other drugs.

Marissa Alejandria, president of the Philippine Society for Microbiology and Infectious Diseases, said the WHO clinical trials will study and evaluate the effectiveness of hydroxychloroquine, chloroquine, lopinavir, ritonavir plus interferon and remdesivir, for their effectiveness against COVID-19.

"We are just waiting for the approval of the (Food and Drug Administration) and our ethical review board to start the clinical trials," she said yesterday, adding that the tests will commence in the coming weeks.

As of Friday, the Philippine government had recorded 5,878 coronavirus cases nationwide and 387 deaths.

news.abs-cbn.com

Fujifilm expands production for COVID-19 treatment Avigan

TOKYO - Japan's Fujifilm Holdings Corp said it has expanded manufacturing capacity to "significantly increase" production of its anti-flu drug Avigan that is being tested as a treatment for COVID-19.

Fujifilm expects to increase the production of Avigan up to 100,000 treatment courses by July 2020, about 2.5 times more compared to the beginning of March when the company first began its current production run, and then to 300,000 by September, it said in a statement on Wednesday.

Fujifilm is allocating additional capacity at its Fujifilm Wako Pure Chemical Co. facility in Japan to produce the ingredients used to make Avigan. The company has also made partnerships with domestic and overseas companies for manufacturing processes and the production of raw ingredients.

Fujifilm is conducting clinical trials of Avigan on patients of COVID-19, the disease caused by the novel coronavirus, in Japan and the United States.

-reuters-

Japan to boost Avigan drug stockpile as part of coronavirus stimulus

TOKYO - Japan is considering increasing the stockpile of Fujifilm Holding Corp's Avigan anti-flu drug during this fiscal year so it can be used to treat 2 million people, according to a planning document seen by Reuters.

Local media reported on Sunday that Japan was hoping to triple the production of the drug from current levels, which is enough to treat 700,000 people if used by coronavirus patients.

Avigan, also known as Favipiravir, is manufactured by a subsidiary of Fujifilm, which has a healthcare arm although it is better known for its cameras. The drug was approved for use in Japan in 2014. Avigan is being tested in China as a treatment for COVID-19.

In the emergency stimulus package expected to be rolled out on Tuesday, the government also planned to prioritize the clinical trial process of the drug so it can be formally approved to be used in treating coronavirus patients.

According to the document, Japan also plans to boost subsidies to domestic companies that supply masks and disinfectants and will secure enough capacity to supply 700 million masks a month.

The Nikkei newspaper reported on Sunday that in efforts to reduce its dependence on China as its manufacturing hub, it will subsidize companies that will move some of their production facilities back to Japan.

Prime Minister Shinzo Abe said on Friday a stimulus package to combat the coronavirus pandemic will target small firms and households hardest hit by social distancing policies that are affecting consumption.

The package will include cash payouts to small firms and households facing sharp falls in income, Abe said.

The government will also urge private financial institutions to join government-affiliated lenders in offering zero-interest rate loans to cash-strapped small and midsized firms, he said.

Philippine Health Undersecretary Maria Rosario Vergeire said Sunday there has been an offer for a clinical trial coming from Japan, "whereby this drug will be used and we are going to identify hospitals and patients."

"We had communicated already through our (Department of Foreign Affairs) that we are interested in joining so that we can access this drug," Vergeire told ANC.

-- with ABS-CBN News

-Reuters-

Japan mulls offering anti-flu drug Avigan to nations fighting coronavirus

The Japanese government is considering offering the anti-influenza drug Avigan for free to countries looking to use it to treat new coronavirus patients, its top government spokesman said Friday.

"Some 30 countries have made requests through diplomatic channels to Japan for the procurement of Avigan," Chief Cabinet Secretary Yoshihide Suga said at a press conference. The drug developed by a group firm of Fujifilm Holdings Corp. is seen as effective in treating the COVID-19 disease caused by the virus.

"We intend to expand clinical research on Avigan with countries wishing to cooperate," Suga said.

Prime Minister Shinzo Abe told a press conference last Saturday that the government will push the development of drugs and vaccines, including Avigan, to fight the pneumonia-causing coronavirus.

Fujifilm Toyama Chemical Co. said Tuesday it has started clinical tests to evaluate the efficacy of the drug, also known as Favipiravir, to COVID-19 patients.

On Thursday, the German health ministry said it will seek to purchase Avigan tablets as a treatment drug for the new coronavirus. Local media said the ministry will buy several million tablets to treat patients with severe symptoms.

A study by researchers at Wuhan University and other institutions in China has shown cases in which Avigan was effective against the coronavirus, especially for the treatment of those with mild symptoms.

Avigan has been manufactured and stocked in Japan as an anti-influenza drug. There is hope it can also help treat other diseases, including Ebola, as well as a tick-borne illness.

Kyodo News