43Kentestimatedthatwithoutimprovementsintheprocessit
wouldtake9 to 12 monthstomakea batchofremdesivirfrom
scratch.Thatincludeda fewmonthsforsuppliersscattered
aroundtheworldtomaketherawingredients,sixmonthsfor
Gileadtoassemblethoseingredientsintothepreciouspow-
der,anda finalmonthtofinishandpackagethedrugatthe
fillingplantinLaVerne,Calif.
ThiscalculationledKentandOliyaitobriefO’Dayonthe
needtoordermorerawingredientsandothersuppliesright
awaytopreventbottlenecks.O’Daysignedoffimmediately,
Kentsays.Atthesametime,Kentassembleda teamof 20
chemistswhostartedworkingonwaystospeeduptheman-
ufacturingprocessonboththeremdesivirpowdermadein
EdmontonandthestarterchemicalsmadebyGilead’scon-
tractors.Eventuallytheyinstitutedtweaksthatreducedthe
timetomanufacturethedrugtosixmonths.
OnFeb.2,GileadflewthepowderleftoverfromitsEbola
effort—100kilogramspackedinhigh-densitypolyurethane
drumswithtamper-evidentseals—fromEdmontontoLaVerne.
Atthefillingplant,thepowderwasmixedwithsterilewater
andexcipients(substancesthatenhancethepowder’ssolu-
bility)inreactionvessels,thenpassedthroughanotherfiltra-
tionsteptoensuresterility.Anautomatedfillingmachineput
it invials.Aftertwoweeksofsterilitytesting,labelswerepre-
paredandchecked.
TheEdmontonplantalsohadenoughrawmaterialsto
startonanotherbatchofpowderinitsglass-linedsteelreac-
tors.Thisbatch,enoughforatleast30,000patients,wascom-
pletedbyearlyApril.Soonafter,themassiveorderofsupplies
GileadhadplacedinJanuarystartedtoarrivebyplane,allow-
ingworkerstostartproducingfarlargerbatchesofthedrug.
ThosewillbeginshippingtotheCaliforniafillingplantinJune,
Gileadsays.A contractmanufacturerinIowawillalsostart
releasingbatchesofremdesivirinAugust,andthecompany
hasbeguntoassemblea consortiumofchemicalandphar-
maceuticalmanufacturersinIndia,Pakistan,andelsewhere
tohelpsupplytherestoftheworld.
THEU.S.DEPARTMENTOFHEALTHANDHUMAN
servicesrecentlyannouncedthat607,000oftheinitial1.5mil-
lionvialsofremdesivirwillbedistributeddomestically—
enough for about 78,000 patients. That leaves enough of the
drug for about 115,000 non-U.S. patients. If the pandemic is
still raging when the supply of donated drugs runs out, and
if vaccines or better treatments still aren’t available, there
will be a furious debate about the price. Gilead says it spent
$50 million on the drug in the first quarter of the year and
could spend as much as $1 billion by yearend, mostly on
manufacturingbutalsopotentiallyonadditionalclinicaltrials.
O’Day says that Gilead is committed to making sure the
medicine is accessible and affordable to patients around the
world and that it’s simply too soon to talk about price. Wall
Street doesn’t think so. Analysts are already pressing him on
how his company will make money from remdesivir.
“What is special about Covid?” Geoffrey Porges, an ana-
lyst at the investment bank SVB Leerink LLC, asked O’Day on
an April 30 earnings call. “Should we assume the returns are
going to be similar to the returns you have generated in other
parts of the business?” Porges later explains that he views a
pandemic as exactly the time a drug breakthrough should pay
offbig.“The50thmedicineforbloodpressureweareallow-
ingthemtomakea profiton,butprotectingtheworldfrom
apandemic—you can’t make a profit on that?” he asks. “It is
crazy. It should be the opposite.”
Otheranalystshaveestimatedthepricecouldbe$3,000
to$5,000pertreatment,inlinewithothernewdrugstotreat
infectionsinhospitalizedpatients.Atthatpriceremdesivir
could generate $1 billion or more in annual sales, if it ends up
being used by hundreds of thousands of people.
While the drug is complicated to make, it won’t necessarily
be expensive to produce on a per-person basis once production
is scaled up and manufacturing efficiencies are maximized.
In April scientists at the University of Liverpool and Howard
University estimated that generics manufacturers could pro-
duce remdesivir for just $9 per dose, according to a study pub-
lished in the Journal of Virus Eradication.
Gilead’ssharesareup22%thisyear,andinvestorsexpect
thecompanywilleventuallyearna returnonitsmosthigh-
profile drug, assuming the drug is still needed. At the same
time,activistspushingfora lowcostarepointingoutthegov-
ernment’skeyroleinidentifyingremdesivir’spotentialfor
treatingcoronaviruses. Public Citizen says the U.S. govern-
ment has spent at least $70.5 million funding research on the
possible uses of the drug.
In the best case scenario that everyone is hoping for, vac-
cines now in early trials will work well, halt the virus’s spread,
and render drugs like remdesivir largely obsolete. Even if that
happens, Gilead’s pricing decision on remdesivir may have a
lasting impact. As the first drug in a new category, it may set a
precedent for other Covid-19 treatments. The coronavirus has
already caused untold economic damage, leading to the high-
est U.S. unemployment rate since the Great Depression. And
the virus looks like it isn’t going away. Vaccines and drugs for
Covid-19 may be needed for years to come. We could spend
years asking how much society is willing to pay for a cure. <BW>
�With Susan Berfieldilead says it’s simply too
soon to talk about price.
Wall Street doesn’t think so