A Chinese Drugmaker Has Started Mass-Producing Remdesivir

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Chinese drugmaker said it has started mass-producing an experimental drug from Gilead Sciences that has the potential to fight the novel coronavirus, as China accelerates its effort to find a treatment for the widening outbreak.

 

Suzhou-based BrightGene Bio-Medical Technology said in a statement that it has developed the technology to synthesize the active pharmaceutical ingredients of remdesivir, Gilead’s drug that is a leading candidate to treat the highly-infectious virus. The drug isn’t licensed or approved anywhere in the world yet.

 

While BrightGene said that it intends to license the drug from Gilead, its move to start manufacturing at this early stage is highly unusual and a potential infringement of the American company’s intellectual property. It comes a week after Chinese researchers filed an application to patent the drug to treat the new coronavirus, a bid that would give China sway over the global use of the therapy to fight the outbreak.

 

Large areas of China have been paralyzed by the coronavirus epidemic, and Gilead’s drug is seen as a potential breakthrough after it showed signs of working on infected patients in the U.S. Chinese researchers are now testing the drug on 761 patients in clinical trials in Wuhan.

 

BrightGene said it will have to license the patent from Gilead, conduct clinical trials and procure regulatory approvals before it can sell the drug on the market. The technology it developed to make remdesivir may not be of much value if the epidemic comes under control soon, it said.

 

Gilead did not immediately respond to a request for comment on BrightGene’s announcement. Last week, the company said it invented remdesivir and has patented it in China, including filing patent applications for use on coronaviruses. The company also said that it is working with Chinese, U.S. and World Health Organization officials to rapidly determine whether the drug can be used to treat the virus.

 

BrightGene did not immediately respond to Bloomberg queries on its remdesivir production.

 

Source:  https://time.com/5782633/covid-19-drug-remdesivir-china/

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China Wants to Patent Gilead’s Experimental Coronavirus Drug

The Wuhan Institute of Virology -- based in the Chinese city at the center of the epidemic -- has applied for a patent in China for the use of the antiviral drug, known as remdesivir, in treating the ailment. The application was made on Jan. 21 together with a military academy, according to a Feb. 4 statement on the institute’s website.

 

The move may revive longstanding concerns about China’s respect for intellectual property rights. The country has made strides in the pharmaceutical space in recent years as it works to nurture a domestic industry based on innovative drugs.

It’s not clear if or when China’s intellectual property authorities will approve the institute’s application.

 

Chinese scientists have found Gilead’s remdesivir, and chloroquine, an 80-year-old malaria drug, “highly effective” in laboratory studies at thwarting the coronavirus, they said Tuesday in a paper in the journal Cell Research.

 

Gilead will retain the global rights to market the antiviral medication, once approved, in treating illnesses such as Ebola and SARS for which the drug was originally intended.

 

At its end, Gilead is shipping enough doses to treat 500 patients and is ramping up supply in case the clinical trials work.

 

While the drug is challenging to produce, Gilead is working as fast as possible to produce more, according to Parsey. “It has been very no-holds-barred on our side,” he said.

 

Source: https://www.bloomberg.com/news/articles/2020-04-29/gilead-remdesivir-trial-for-covid-19-has-met-primary-endpoint

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Who owns remdesivir, how much can they make, and how much does it cost?

The drug was originally developed for Ebola but has shown promise with COVID-19.

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Earlier on Wednesday, we reported on some clinical trial data that offered good, if ambiguous, news about treating COVID-19. In the study, participants treated with a drug called remdesivir recovered on average 30 percent quicker than those receiving a placebo. But who owns the drug, how much of it can be made, and what does it cost?

 

To answer the first question, remdesivir is owned by Gilead Sciences, a US biotechnology company. Gilead got its first patent for the drug in 2017 when the company was originally targeting it as a possible treatment for the Ebola virus. That didn't pan out, but as our earlier article explains, biochemical similarities in how the Ebola and SARS-CoV-2 viruses function led Gilead to see if remdesivir could be repurposed for treating COVID-19. Gilead's patents mean that it has a monopoly on the drug in the United States, so barring government intervention or Gilead licensing the patent to others, it's the only company that can manufacture it until 2037, at which point a generic version could be possible.

 

To answer the second question, Gilead announced in April that it had ramped up production of remdesivir at its factory in La Verne, California, in January, and by the beginning of April, it had already stockpiled enough to treat 140,000 patients, each over the course of 10 days. The company also said that it plans to produce enough remdesivir to treat 500,000 patients by October and a million patients by the end of 2020. (This explains why there was some outcry in March when it was revealed that Gilead had applied for something called "orphan drug status" for remdesivir, which is supposed to be reserved for rare diseases. Gilead withdrew that application.)

 

Finally, there's the question of how much that will cost. As of today, we don't know how much Gilead intends to charge for remdesivir in the US or elsewhere. In CEO Daniel O'Day's April letter that revealed the existing stockpile, he wrote that the company "is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access, and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations."

 

A recent study published in the Journal of Virus Eradication attempts to analyze the cost of manufacturing remdesivir. The authors looked at the chemical synthesis of the drug and concluded that a 10-day course for one person would cost $9, allowing for 20 percent losses during formulation, plus the cost of the vials, a profit margin, and tax. However, whether it costs Gilead that to actually produce the drug is unknown, and one needn't be a scholar of the US healthcare system to be skeptical that a novel treatment would end up being quite so cheap.

 

 

Source: Who owns remdesivir, how much can they make, and how much does it cost? (Ars Technica)