By Joseph Walker
A team of a dozen executives at drugmaker Gilead Sciences Inc. meets daily to discuss the coronavirus epidemic in China and the company's cross-continental scramble to develop the first drug for the new disease.
If the company's drug succeeds in studies in China, it could become the first treatment proven to work against a respiratory virus that has killed more than 1,000 people and infected some 42,600 in fewer than three months.
There are some positive albeit preliminary signs, notably the recovery of a 35-year-old man in Washington state whose condition rapidly improved after receiving the drug and who was recently discharged from the hospital.
"We've done this long enough that we know it could be an anecdote," says Gilead's chief medical officer, Merdad Parsey, cautioning that the result could be a false positive and that the drug could fail in broader testing.
Gilead has been sprinting to ramp up manufacturing of the drug, called remdesivir, to meet a surge in demand if it proves effective, and provide the medicine to two clinical trials of 760 Chinese patients and a handful of patients requesting emergency use.
The Foster City, Calif., drug maker is among several companies developing treatments targeting the coronavirus. AbbVie Inc. and Johnson & Johnson have shipped HIV drugs to China to see if the agents work against the virus.
Gilead, a longtime maker of treatments for viruses like HIV and hepatitis C, had been monitoring the outbreak since late December when the first reports of an unexplained pneumonia outbreak emerged from China.
The company accelerated its push to study remdesivir after Chinese scientists said Jan. 9 that they had identified the source of the outbreak as a coronavirus, a family of diseases common in animals that can cause severe respiratory illness when transmitted to humans.
Gilead invented remdesivir several years ago and first developed it to treat Ebola, a virus that has ravaged parts of eastern and central Africa. The drug was less effective than rival drugs in a study of Ebola patients in Congo last year.
Yet Gilead had reason to think remdesivir might work in coronaviruses. Company researchers working with academic scientists found that remdesivir was effective in treating mice infected with another coronavirus known as Middle East respiratory syndrome, or MERS. The work was partially funded with $3.8 million in grants from the National Institutes of Health. The mice studies were far from definitive but suggested the drug had promise against the new coronavirus. The data were published in the journal Nature Communications on Jan. 10.
"The attention level went up dramatically when we found out it was a coronavirus, and that was the turning point," Dr. Parsey says. "That's when we got mobilized and formed a team across the company to see what we could do here."
Gilead was soon exchanging information about the virus with officials from the Chinese Center for Disease Control and Prevention, the World Health Organization and the U.S. Centers for Disease Control and Prevention. They discussed how to determine if remdesivir might be effective at treating the outbreak.
By Jan. 20, Gilead was in talks with Beijing pulmonologist Cao Bin, a prominent researcher deployed to Wuhan to help lead the medical care of patients. With input from the U.S. Food and Drug Administration and the WHO, Gilead worked with Dr. Cao's team to design the studies, says Gilead's Diana Brainard, senior vice president for HIV and emerging viral infections.
The trials are being conducted at several hospitals in Wuhan, according to Chinese news reports.
Last week, Gilead shipped the last batch of remdesivir needed to supply the two studies, the first in patients with mild-to-moderate disease and the second in patients with severe disease. The studies are expected to be completed in early April.
"We're all tracking the number of infections and deaths, and we really want to help," says Dr. Brainard.
The company's "coronavirus response team" now numbers about 100 employees across the company and includes executives from all major departments.
Gilead employees in the U.S., along with many of the 400 employees it has in Beijing and Shanghai, have worked hundreds of extra hours since the mobilization began, juggling 3 a.m. conference calls, late-night text messages and 7 a.m. office meetings to keep up with colleagues in different time zones, Dr. Brainard says.
In addition to supplying remdesivir to the China trials, Gilead has provided doses for individuals in countries including the U.S. and France. Typically companies supply experimental drugs only in clinical testing, though they can make exceptions in life-threatening situations if the FDA gives approval.
CDC officials told the medical team treating the infected man in Washington about remdesivir after his condition worsened. The company got a compassionate-use request for the drug on Jan. 25. Within 24 hours, the FDA approved the request, and Gilead shipped the drug to Washington.
Gilead's stock rose 9% last week following a report in the New England Journal of Medicine detailing the Washington patient's recovery.
Yet some analysts express doubts that remdesivir will become a money-maker anytime soon, even if it is shown to work against the novel coronavirus.
If approved in China, Gilead may be able to charge only as little as $260 per treatment course in the country, according to Morgan Stanley estimates, far less than what a similar drug would cost in the U.S. Some analysts say Gilead might not even make that much, if China decides to bypass the company and authorize manufacturing of generic versions.
China could grant a patent to a state-run Chinese research institute, which last week applied for a patent covering use of remdesivir against the coronavirus. China also could invoke a World Trade Organization "compulsory license" rule that allows countries to manufacture generic copies of patented drugs in order to protect public health, some analysts have said. Gilead would likely get paid royalties in either scenario.
Gilead says it applied for a patent on remdesivir use in coronaviruses in 2016, and the application is pending in China.
Despite the uncertainty, Gilead has been building manufacturing capacity. Over the past month, Gilead began coordinating with contract manufacturers to start producing the drug again in North America and halted production of an approved product at one of its own facilities in North America so it could start making remdesivir itself, Dr. Parsey says.
--Fanfan Wang contributed to this article.
Write to Joseph Walker at firstname.lastname@example.org