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 joseph.walker@wsj.com
(END) Dow Jones Newswires
February 12, 2020 13:30 ET (18:30 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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