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Gilead’s Drug Leads Global Race for Coronavirus Treatment (1)

Feb. 25, 2020, 10:40 AM

China will release results at the end of April from clinical trials of a Gilead Sciences Inc. drug that is emerging as a frontrunner in the race to find an effective treatment for the novel coronavirus.

The outcome of trials of the experimental medication remdesivir on 761 patients in Wuhan, the city where the virus originated, will be made public on April 27, China’s National Intellectual Property Administration said Tuesday.

The update on the trials’ progress came a day after the World Health Organization said that remdesivir may be the only effective treatment so far for the disease, which has infected almost 80,000 people and killed over 2,600, most of them in China, and has no approved therapy or vaccine so far.

As new infections surge in South Korea, Italy and the Middle East, presaging a second spike in an outbreak that was previously concentrated in China, the push to develop treatments and vaccines has taken on new urgency globally.

On Tuesday, Fujifilm Holdings Corp. surged after its flu drug was mentioned by Japan as a treatment, while pharmaceutical giants GlaxoSmithKline Plc and Sanofi are developing vaccines for the pathogen whose spread has shut down travel and economic activity across the world.

China Stages Clinical Trial Blitz in Search of Coronavirus Cure

Foster City, California-based Gilead, whose remdesivir is not licensed or approved for use anywhere in the world, seems poised to benefit as confidence grows in its drug’s efficacy in treating the coronavirus. If the trials prove remdesivir works, China could roll out the treatment more quickly than the usual deployment of new drugs due to the critical need among patients.

But it faces a potential hurdle over intellectual property control of the therapy, which was originally developed to treat other coronaviruses like SARS and has also been tested on Ebola.

At the Tuesday briefing, He Zhimin, vice head of National Intellectual Property Administration, said that China has not yet granted the full patent protection Gilead wants over the drug.

Gilead has filed eight patent applications for remdesivir in China, seeking protection over the compound’s structure, manufacturing method and usage. Only three of them have been licensed, while the other five are still under review, He said, without elaborating.

China Wants to Patent Gilead’s Experimental Coronavirus Drug

It is unclear if or when the five remaining patent applications will be approved in China. Earlier this month, researchers from the virology institute in Wuhan filed an application to patent the drug’s use for treating the virus. Some Chinese drugmakers are already mass-producing the drug and its ingredients, potentially infringing on Gilead’s control of the therapy.

Gilead did not immediately respond to a request for comment made outside of office hours.

Japan’s Fujifilm Drug

In Japan, which is seeing an uptick of cases of infection, the health minister mentioned favipiravir, an anti-viral drug developed and sold by Fujifilm under the brand name Avigan, as one of several drugs the country is testing as a treatment. The perceived endorsement sent the company’s shares up as much as 8.8% on Tuesday.

Avigan is approved in Japan as a treatment for novel or re-emergent influenza and has previously also been used to treat Ebola patients in Guinea.

The company is considering boosting output of Avigan after a request from the Japanese government, Fujifilm spokesman Takahiro Taguchi said. Fujifilm has previously supplied the government with an Avigan stockpile for two million people. It’s not clear whether the dosage used for influenza would be appropriate for new coronavirus, Taguchi said.

A generic version of Avigan is also being tested in China on coronavirus patients.

More than 100 clinical trials have been launched in China to study everything from anti-flu drugs and antibody-containing plasma from recovered patients, to traditional Chinese herbal medicine. China’s National Health Commission has also recommended the use of AbbVie Inc.’s anti-HIV infection therapy Kaletra, anti-malaria drug chloroquine phosphate and anti-flu drug arbidol in its antiviral regimen.

Gilead’s remdesivir is now being tested in double-blinded, randomized and controlled clinical trials across several hospitals in Wuhan. That means neither the patients nor the investigators of the trial now know who is taking the drug and who is not. About 66% of 761 patients in the trial will be given the drug, while the rest will take a placebo.

(Updates with information on drug deployment in sixth paragraph)

--With assistance from Grace Huang.

To contact Bloomberg News staff for this story:
Dong Lyu in Beijing at dlyu3@bloomberg.net;
Lisa Du in Tokyo at ldu31@bloomberg.net

To contact the editor responsible for this story:
Rachel Chang at wchang98@bloomberg.net

© 2020 Bloomberg L.P. All rights reserved. Used with permission.

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