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BloombergBusinessweek May 18, 2020ThankstoitsworkonEbola,Gileadalreadyhada small
supply of remdesivir on hand. Sitting in cold storage in
SwitzerlandandCaliforniawereenough30-millilitervialsof
thedrugtotreat5,000people,whichmadeit possibletobegin
humantrials in the U.S., China, and elsewhere. In a factory
in Edmonton, Alb., Gilead also had 100 kilograms of the bulk
powder, perhaps enough to treat 90,000 patients.
To fill enough remdesivir vials to treat millions in a pan-
demic, however, would require a metric ton or more of the
bulk drug. Gilead didn’t have close to that—and still doesn’t.
So back in January it ordered more than a dozen of the most
crucial starting materials and reagents from suppliers in
China, Europe, and elsewhere. Gilead also helped its contrac-
tors locate sufficient supplies of compounds needed to make
those starting materials.
There haven’t been a lot of stories of foresight and prepared-
ness in this pandemic. This is one. After a big trial sponsored
by the National Institute of Allergy and Infectious Diseases,
remdesivir was authorized on May 1 for emergency use on
Covid-19, the disease caused by the new coronavirus. Anthony
Fauci,thedirectoroftheNIAID,haslikenedthetrialofrem-
desivirtothefirstbigtrialofAZT,thefirstdrugforHIV.As
AZTwas,remdesiviris beingauthorizedforwideusebefore
it’sfullyclearhoweffectiveit willbe.Preliminarydatafrom
the1,060-persontrialshowthemedicinespedrecoveryin
themostseriouscasesofCovid-19byaboutfourdays.Full
detailshaven’tbeenpublished,anda smallertrialinChina
didn’tfinda benefit.TheFoodandDrugAdministration,in
grantingtheemergencyauthorization,didn’tallowGileadto
claimthedrugissafeandeffectiveforCovid-19;theagency
saidonlythatit’sreasonabletobelievethemedicinemayhelp.
“Itis nota cure,”O’Daysays.“Itis a firststep,butit is an
importantfirststep.”Manyadditionaldrugsandvaccineswill
probablybeneededtostopthepandemic,hesays.Gilead
itselfisworkingonaneasier-to-administerinhaledformof
remdesivir that might be useful for less severe cases.
But with few other medicines available and the number of
Covid-19 cases continuing to grow steadily—about 4.3 million
cases and 294,000 deaths at press time—the drug is likely to be
in high demand until a better treatment or a vaccine is avail-
able. Gilead plans to donate the first 1.5 million vials, enough for
roughly 200,000 patients. (The number depends on the dosage:
The emergency use authorization allows both a 10-day course
of treatment for patients on ventilators and a 5-day course for
those not on ventilators.) Those will be delivered this spring.
By the fall a much larger supply should start to become avail-
able, and Gilead is also working with other companies to bring
new factories online overseas. The question is, can Gilead make
enough of it for the whole world?GILEAD, BASED IN FOSTER CITY, CALIF., IS THE MOST
successful maker of antiviral drugs in history. The company
was founded in 1987, and early on its chemists invented the
influenza drug Tamiflu. In the 2000s it started packaging mul-
tiple powerful anti-HIV medicines into simple once-a-day pills,replacing complicatedmulti-pillregimens.In2013 it came out
with Sovaldi, a breakthrough drug for hepatitis C. The news
was overshadowed, initially, by a furor over the price: $1,000
a pill. As cheaper competing drugs hit the market, Gilead’s
hepC revenuedeclined.WallStreethasn’tcaredforthat
andhaspressuredGileadtoexpandbeyondantiviralsinto
faster-growing arenas such as cancer treatments.
Until January, there wasn’t much reason for a drug company
to work on coronaviruses. For years they were considered mere
nuisances, responsible mostly for many common colds. The first
deadly human disease caused by a coronavirus, severe acute
respiratory syndrome, or SARS, was stopped in 2003, before
it gained a significant foothold in the human population. The
next deadly coronavirus, MERS, doesn’t spread efficiently in
humans. The virus that causes Covid-19 is more closely related
to SARS, so much so that its official designation is SARS-CoV-2.
A precursor to remdesivir was developed in 2009 by Gilead
chemists hunting for hepatitis C drugs. It was difficult to admin-
ister, however, and Gilead had more promising drugs for hep C,
in pill form, so it mostly sat on the shelf for several years. But in
studying the compound, Gilead scientists showed in the test tube
that it could slow the replication of a broad number of viruses.
During the Ebola outbreak in West Africa in 2014, Gilead
put together a team of scientists to look at whether any of its
existing drugs could help treat it or other emerging viruses.
Remdesivir quickly moved to the top of the list. By mid-2015,
working with government scientists, Gilead had shown the
drug worked against Ebola in laboratory animals and begun
human safety trials. But by the time remdesivir was ready for
human efficacy trials, the Ebola outbreak was fading.
During the same period, Gilead was invited to participate in
a government-sponsored consortium of academic researchers
working on possible drugs for emerging viruses. Two virologists↑Barrels of remdesivir in
powder form→Filled vials are inspected
before they’re labeled
and packaged