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-

Japan pharma to complete Avigan clinical trials in September

TOKYO - Fujifilm Holdings Corp. said Thursday it expects to complete in September clinical tests in Japan of the antiviral drug Avigan, a potential candidate treatment drug for COVID-19 - already behind schedule after a delay caused by difficulty in securing enough patient data.

The last patient will participate in the clinical study on Sunday and all necessary data will have been collected a month later, Fujifilm director Junji Okada said.

Fujifilm began clinical tests in March to see if Avigan is effective in treating patients with COVID-19, a respiratory disease caused by the novel coronavirus, with an eye to completing them by June. But the number of confirmed coronavirus cases in Japan was on a downtrend, making it difficult to meet the enrollment target of 96.

In recent weeks, Japan has seen infections resurging in various parts of the nation as economic and social activities resume.

"Although we've taken more time than planned, we will complete clinical tests as soon as possible and seek approval," president and chief operating officer Kenji Sukeno said during an online press briefing on the firm's earnings.

Prime Minister Shinzo Abe had expressed hope to have the drug approved in May but a Japanese university's interim report, released in mid-May, did not indicate clear efficacy of Avigan in treating COVID-19. 

The drug, also known as favipiravir, was developed by Fujifilm Toyama Chemical Co., a subsidiary of Fujifilm Holdings.

Kyodo News

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

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-

Fujifilm to resume sales of black-and-white film

TOKYO - Fujifilm Corp. said Monday it will resume sales of black-and-white film this fall after a one-year hiatus, following calls from fans of monochrome photography.

The company began selling monochrome photographic film in 1936 but ceased sales around October last year, citing declining demand as well as difficulties in obtaining materials for production.

Fujifilm received numerous requests for black-and-white film to be sold again, including from young social media users attracted by the aesthetic qualities of monochrome photography.

The price of the black-and-white Neopan 100 Acros II film, employing alternative raw materials and a new manufacturing process, has yet to be determined, company officials said.

source: news.abs-cbn.com