The E100: Biotech ex­ecs are bull­ish about 2017, but fret about drug pric­ing and the FDA un­der Trump

About the End­points 100: This is our sec­ond biotech in­dus­try sur­vey, which we sent out to our in­vite-on­ly group of ex­ec­u­tives on Feb­ru­ary 6. 98 ex­ecs, pri­mar­i­ly in the US and Eu­rope, com­plet­ed the sur­vey, You can see a list of the en­tire group at the end of this ar­ti­cle.

The biotech in­dus­try is feel­ing bull­ish about its own prospects at the be­gin­ning of 2017, large­ly sat­is­fied with the fi­nan­cial sup­port that’s been flow­ing in to the field with most ex­ecs ready to hire through the year as the tem­po on deal-mak­ing re­mains up­beat.

But it’s not all com­ing up ros­es.

The in­dus­try is in a funk about the Trump ad­min­is­tra­tion af­ter a few weeks of head­lines over a trav­el ban con­tro­ver­sy and a rolling se­ries of out­spo­ken tweets, with a large seg­ment of these ex­ecs wor­ried that a new head of the FDA could come in ready to re­duce if not ac­tu­al­ly dis­card stan­dards on drug de­vel­op­ment.

And vir­tu­al­ly no mat­ter what Trump says or does, a clear ma­jor­i­ty add, we’ve en­tered a new era on drug pric­ing that will de­mand a new math on what ther­a­pies cost. As for the high-pro­file in­stances where com­pa­nies and CEOs have been fin­gered for price goug­ing, many be­lieve we’re see­ing an end game where the re­tal­i­a­tion is like­ly to be se­vere enough to stop such prac­tices for­ev­er.

That’s the bot­tom line from our lat­est End­points 100 sur­vey, which cap­tured the thoughts of a broad swathe of CEOs and top-lev­el ex­ecs in the in­dus­try.

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Down on Trump

Ful­ly two-thirds of these ex­ecs — out of 98 who re­spond­ed to our sur­vey — are deeply dis­en­chant­ed with Pres­i­dent Trump.

Thoughts ranged from “a smol­der­ing dump­ster fire with re­gards to health and hu­man safe­ty” to “his ac­tion on the im­mi­grant ban was mis­guid­ed. His in­abil­i­ty to re­frain from tweet­ing is ar­ro­gant. His ad­mi­ra­tion of Putin is fool­ish.”

A huge ma­jor­i­ty — 82% — dis­ap­proved of the pres­i­dent’s ac­tions. On­ly 4% found some­thing to ap­prove.

One of the pres­i­dent’s sig­na­ture ef­forts ear­ly on has been to blast what he calls out­ra­geous pric­ing for drugs. A big group — 63% — feel that the bio­phar­ma in­dus­try has en­tered a new era on drug pric­ing. But a strong ma­jor­i­ty of 56% be­lieve that al­low­ing Medicare to ne­go­ti­ate drug pric­ing, as Trump has said now re­peat­ed­ly, is the wrong move.

“I be­lieve that Phar­ma re­al­ly doesn’t get it,” said one ex­ec. “Ever since the fi­nan­cial cri­sis there has been a con­stant drum­beat by pa­tients, physi­cians, etc on the price of drugs. We need to be more fo­cused on bring­ing ‘val­ue for the mon­ey.’ There isn’t enough mon­ey in the world to ad­dress the world’s health­care. We need to raise the bar much high­er for our­selves and price re­spon­si­bly. We are killing the gold­en goose.”

“Trump told Phar­ma CEOs to get prices down, in­no­va­tion up and bring busi­ness­es back to the US. He means it and I be­lieve Phar­ma will self reg­u­late on bla­tant price in­creas­es (of which many are guilty).”

On­ly 24% felt that the sta­tus quo on pric­ing could be main­tained.

“Pay­ers are al­ready in­creas­ing pres­sure and there is ex­treme pres­sure in the EU. Ex­ces­sive price in­creas­es on gener­ic drugs must stop. Need to mod­er­ate price in­creas­es on drugs gen­er­al­ly to be more in line with in­fla­tion.”


Medicare price ne­go­ti­a­tions

There’s no doubt­ing the con­sid­er­able op­po­si­tion in the in­dus­try to push­ing Medicare in­to price ne­go­ti­a­tions. But a large mi­nor­i­ty, 44%, felt that there was good rea­son for Medicare price ne­go­ti­a­tions.

“Wrong move or right move, it’s an ob­vi­ous move. It’s the biggest pay­er and some­how, some way, this will hap­pen.”

None of the sol­id ma­jor­i­ty who op­posed see­ing Medicare lever­age low­er prices di­rect­ly ex­pressed their opin­ion on it.

Scott Got­tlieb

It’s ear­ly days in this ad­min­is­tra­tion, but sev­er­al of the ex­ecs who took this sur­vey ex­pect to see some fast changes out of Con­gress, some of which will like­ly spur the M&A side of the busi­ness.

“Ex­pect repa­tri­a­tion (of over­seas prof­its) which will dri­ve more col­lab­o­ra­tion/ac­qui­si­tion. Ex­pect volatil­i­ty in com­mu­ni­ca­tion from ad­min­is­tra­tion re­lat­ing to pric­ing, dri­ving con­tin­ued un­cer­tain­ty un­til ad­min­is­tra­tion clar­i­fies po­si­tion one way or an­oth­er on pric­ing.”

“The biggest im­pact they will have will be in the ap­point­ment of the HHS sec­re­tary and the head of the FDA (hope­ful­ly Scott Got­tlieb).”

“Wild­ly un­pre­dictable. Of the var­i­ous un­knowns now the no­tion that the FDA might con­vert ap­provals to “safe­ty on­ly” is the most alarm­ing.”


The FDA

There is a sig­nif­i­cant di­vi­sion of opin­ion about what the FDA should do un­der a new com­mis­sion­er. 43% said no sig­nif­i­cant changes are need­ed in terms of reg­u­la­tions, sat­is­fied that changes made over the last few years has sub­stan­tial­ly ben­e­fit­ed bio­phar­ma and stream­lined de­vel­op­ment with­out erod­ing stan­dards.

37%, though, are look­ing for sig­nif­i­cant changes.The theme, though, sug­gests the in­dus­try is look­ing for a con­tin­ued evo­lu­tion of the reg­u­la­to­ry land­scape, fa­vor­ing de­vel­op­ers but not gut­ting the gold stan­dard on ef­fi­ca­cy and safe­ty.
“Con­tin­ue to build on ac­cel­er­at­ed ap­proval frame­work.” 

“Do not low­er sci­en­tif­ic stan­dards; re­tain safe­ty and ef­fi­ca­cy hur­dle; in­crease use of sur­ro­gate and re­al world end­points, in­clud­ing da­ta from wear­able and dig­i­tal sources to help stream­line ap­proval with more dis­ease- and pa­tient-rel­e­vant end­points of ef­fi­ca­cy.”

“FDA has been do­ing a good job. We need to keep the high ef­fi­ca­cy stan­dard.”

“I ac­tu­al­ly think over­all the FDA is do­ing a great job, I don’t think rad­i­cal re­form is need­ed. But I do think that many of the ini­tia­tives and re­forms of re­cent years have been em­braced by Sr. man­age­ment, but not by the rest of the bu­reau­cra­cy yet.”

“Ter­ri­fy­ing to think of low­er­ing ef­fi­ca­cy stan­dards sig­nif­i­cant­ly. Not good for the pub­lic or the in­dus­try!”

“In many ar­eas, reg­u­la­to­ry sci­ence is decades be­hind ad­vances in new tech­nolo­gies and med­ical sci­ence. In the rare dis­eases, for in­stance, we need a rig­or­ous yet flex­i­ble reg­u­la­to­ry frame­work that does not ex­ist to­day. The fact that there is not even a re­view di­vi­sion at FDA ded­i­cat­ed to rare ge­net­ic dis­eases is a tragedy in it­self. “

“In­creased use of bio­mark­ers, ac­cel­er­at­ed ap­proval path­ways and per­haps even the in­tro­duc­tion of ‘con­di­tion­al’ ap­proval path­ways will dri­ve med­i­cines that are proven safe and ef­fec­tive to pa­tients as quick­ly as pos­si­ble. In fact, the most sig­nif­i­cant change that could be made at the FDA is to in­clude the pa­tient per­spec­tive at every step of the drug de­vel­op­ment and reg­u­la­to­ry re­view process. Do­ing so will save count­less lives.”
John F. Crow­ley Chair­man & CEO Am­i­cus Ther­a­peu­tics

Brent Saun­ders’ pledge

One change that got a broad thumbs up from the E100: Brent Saun­ders’ call for an in­dus­try pledge to keep an­nu­al price in­creas­es on drugs in the sin­gle dig­its, un­der 10%. A to­tal of 67% en­dorsed the move, with quite a few call­ing it sen­si­ble and vi­able or “a breathe of fresh air.”

But there was al­so a de­tectable air of skep­ti­cism that this kind of ap­proach could work as a longterm so­lu­tion, with many see­ing it as a log­i­cal tem­po­rary step.

“This seems clos­er to fol­low­ing the laws of grav­i­ty than a plan. But it should cre­ate some much-need­ed day­light btwn in­dus­try and (con­tro­ver­sial Tur­ing founder Mar­tin) Shkre­li”

“I found Brent’s procla­ma­tion a bit disin­gen­u­ous… He pro­claims he wilre­spon­si­ble on pric­ing but then takes 9.9% across his en­tire port­fo­lio. Re­al­ly! What in­dus­try gets 9.9% price in­creas­es?”

“I would say that we should em­pha­size ty­ing price in­creas­es to in­fla­tion in some way. If in­fla­tion goes to 15% you would not raise prices by 9% and if in­fla­tion is 1% you would raise less than 9%. I wor­ry about dog­mat­ic state­ments like “sin­gle” dig­it which do not take in­to ac­count the macro eco­nom­ic is­sues.”


The pulse on biotech prospects in 2017: Run­ning strong

This is the sec­ond sur­vey that is keep­ing the thumbs on the pulse of in­dus­try con­fi­dence, which is em­phat­i­cal­ly strong. On­ly 2% of the crowd are less than some­what con­fi­dence, with three out of four run­ning the gamut of con­fi­dent to ex­treme­ly con­fi­dence.

We have 57% rat­ing the flow of in­vest­ments from VCs as ‘good.’

“The cap­i­tal is there from spe­cial­ists for the right com­pa­nies.”

“If you have a great team and a good sto­ry, you can get fund­ed.”

But not every­one is hap­py about their ac­cess to cap­i­tal these days.

“I am con­tin­u­al­ly per­plexed by the de­sire to fund “the dream” ver­sus val­i­dat­ed, re­al drugs. I wish there was more in­ter­est in re­al biotech com­pa­nies that have rev­enues and de­liv­er strong cash flows.”

IPOs are off to a so-so start af­ter a weak 2016, so it’s not too sur­pris­ing to see ex­pec­ta­tions are lim­it­ed for the rest of the year. Forty-two per­cent ranked the IPO sec­tor as fair, with 27% fair, 17% good and 14% poor. No one thought it was ex­cel­lent.

About half thought that the IPO mar­ket will stay this way for the rest of the year, with the “bet­ter” and “worse” group split 29% to 19%.


Hir­ing

Close to 4 out of 5 of these ex­ecs work in or with com­pa­nies that are hir­ing in the first quar­ter, al­so re­flect­ing a strong up­beat tem­po in terms of ex­pand­ing em­ploy­ment, which we al­so saw last fall in our first sur­vey. 86% are hir­ing this year. No one plans to re­duce staff. The biggest prob­lem cit­ed: Find­ing the right peo­ple can be dif­fi­cult.

“We’ll hire ag­gres­sive­ly again this year.”

“Job mar­ket re­mains very hot. Lots of com­pe­ti­tion to ac­cess the best tal­ent.”

“We’re hir­ing ag­gres­sive­ly but good can­di­dates are hard to find,” says Yu­val Co­hen, CEO of Cor­bus Phar­ma­ceu­ti­cals.”


Biotech val­u­a­tions: Fair to good

The pace on deals and buy­outs has start­ed off with some siz­able num­bers in biotech, but our E100 ex­ecs weren’t feel­ing gid­dy about any of it.

57% of these ex­ecs found li­cens­ing deals were be­ing done for av­er­age amounts, 37% said they were high and on­ly 5% thought of them as low. There was a split on M&A, though, with 47% rank­ing val­u­a­tions at av­er­age and 43% call­ing them out as high. That cold be a sell­ers per­spec­tive, though, as Big Phar­ma buy­ers have been say­ing for sev­er­al years now that val­u­a­tions have been run­ning ex­treme­ly high, in their view.


So where do we go from here?

“Let’s keep our eye on the prize: mak­ing im­por­tant new ther­a­peu­tics that ad­dress hu­man needs. Let us em­brace val­ue-based pric­ing. Let us shun var­i­ous his­tor­i­cal in­dus­try prac­tice to un­rea­son­ably ex­tend patent mo­nop­oly. Let us aban­don un­jus­ti­fied year-over-year cost in­creas­es in the ab­sence of proven ad­di­tion­al pa­tient ben­e­fit or con­ve­nience.”

“A good year for biotech in 2017. Too many ex­cel­lent tech­nolo­gies and in­no­va­tion . They all will find homes!”

We end with an anony­mous com­pli­ment:

“Well done, John and col­leagues. End­points is a re­fresh­ing new source for biotech- and phar­ma-re­lat­ed news and views.”

It was just 1 out of 98, but we see a trend de­vel­op­ing.

Do you have an idea for our next sur­vey? Drop me a line at john@end­pointsnews.com

  • Here’s a list of all par­tic­i­pat­ing End­points 100 ex­ec­u­tives
    Jef­frey Al­bers Blue­print Med­i­cines
    Alan Auer­bach Puma
    Stephane Ban­cel Mod­er­na
    Chuck Baum Mi­rati Ther­a­peu­tics
    John Bea­dle PsiOxus
    Kees Been Lyso­so­mal Ther­a­peu­tics
    Arie Bellde­grun Kite Phar­ma
    Nes­san Berming­ham In­tel­lia Ther­a­puet­ics
    Jean-Jacques Bi­en­aimé Bio­Marin Phar­ma­ceu­ti­cal
    Kate Bing­ham SV Life Sci­ences
    Detlev Bin­iszkiewicz Sur­face On­col­o­gy
    Kevin Bit­ter­man Po­laris Part­ners
    Robert Blum Cy­to­ki­net­ics, Inc.
    Bruce Booth At­las Ven­ture
    Ed­uar­do Bra­vo Tigenix, SAU
    Wern­er Cautreels Se­lec­ta
    Chip Clark Geno­cea Bio­sciences
    Robert Cof­fin Replimune
    Ron Co­hen Acor­da
    Yu­val Co­hen Cor­bus Phar­ma
    Robert Con­nel­ly Ax­cel­la (Pronu­tria)
    Bernard Coulie Pli­ant Ther­a­peu­tics
    John Crow­ley Am­i­cus
    David de Graaf Syn­tim­mune
    Kim Drap­kin Jounce Ther­a­peu­tics
    Cameron Dur­rant Kalo­Bios
    Glyn Ed­wards Sum­mit Ther­a­peu­tics plc
    Eliot Forster Im­muno­core
    Tas­sos Gi­anakakos MyoKar­dia
    David Giljo­hann Ex­i­cure
    Robert Gould Ful­crum Ther­a­peu­tics
    Max­ine Gowen Treve­na
    Mike Grey Am­plyx
    Geral­dine Hamil­ton Em­u­late
    John Hau­rum F-star
    Rachel Hau­r­witz Cari­bou
    Pe­ter Hecht Iron­wood
    Mary Lynne Hed­ley Tesaro
    Olav Helle­bø ReNeu­ron Group plc
    Rus­sell Hern­don Hy­dra Bio­sciences
    Rich Hey­man Hey­man Biotech
    Na­tal­ie Holles Au­dentes Ther­a­peu­tics, Inc.
    Steve Holtz­man Deci­bel Ther­a­peu­tics
    Hervé Hop­penot In­cyte
    An­nal­isa Jenk­ins Di­men­sion Ther­a­peu­tics
    Jeff Jonker NGM Bio
    Kevin Ju­dice DiCE Mol­e­cules
    Rachel King Gly­comimet­ics
    Gene Kin­ney Prothena
    Art Krieg Check­mate Phar­ma­ceu­ti­cals
    Je­re­my Levin Ovid Ther­a­peu­tics
    Howard Liang BeiGene
    Jay Lichter Aval­on Ven­tures
    John Maraganore Al­ny­lam
    Alex­ey Mar­golin Al­lena Phar­ma­ceu­ti­cals
    Tim Mayleben Es­pe­ri­on
    Sean Mc­Carthy Cy­tomX Ther­a­peu­tics
    David Mott NEA
    Lon­nie Moul­der Tesaro
    Glenn Ned­win Sec­ond Genome
    Don Nichol­son Nim­bus Ther­a­peu­tics
    Hugh O’Dowd Neon Ther­a­peu­tics
    Bernat Olle Vedan­ta
    Rick Orr Ad­ynxx
    Ju­lia Owens Mil­len­do
    An­toine Pa­piernik Sofinno­va
    Pier­lui­gi Parac­chi GENEN­TA Sci­ence
    Alexan­der Pas­teur F-Prime Cap­i­tal Part­ners
    Joe Payne Arc­turus Ther­a­peu­tics
    Michael Pelli­ni Foun­da­tion Med­i­cine
    An­drea Pfeifer AC Im­mune
    An­drew Phillips C4 Ther­a­peu­tics
    Richard Pops Alk­er­mes
    An­na Pro­topa­pas Mer­sana Ther­a­peu­tics
    Lau­rence Reid Warp Dri­ve Bio
    Nor­bert Riedel Aptinyx
    Adam Rosen­berg Rodin Ther­a­peu­tics
    Gregg San­do Cell Med­ica
    David Schenkein Agios
    Denise Scots-Knight Mereo Bio­phar­ma
    Paul Sekhri Lyc­era Corp.
    Tito Ser­afi­ni Atre­ca
    Ar­mon Sharei SQZ Ther­a­peu­tics
    Lau­ra Shawver Cleave Bio
    Clay Sie­gall Seat­tle Ge­net­ics
    Nan­cy Si­mon­ian Sy­ros Phar­ma­ceu­ti­cals
    Harpreet Singh Im­mat­ics US
    Sander Slootweg For­bion Cap­i­tal Part­ners
    Jeff Stein Cidara
    Carmine Sten­gone Ave­las Bio­sciences, Inc.
    Niclas Stiern­holm Tril­li­um Ther­a­peu­tics
    Clif­ford Stocks On­coRe­sponse
    Hamza Suria Anap­tys­Bio
    Mary Szela Aege­ri­on Phar­ma­ceu­ti­cals
    Nan­cy Thorn­ber­ry Kally­ope
    Praveen Tipir­neni Mor­phic Ther­a­peu­tic
    He­len Tor­ley Halozyme
    Dou­glas Tre­co Ra Phar­ma­ceu­ti­cals
    Steve Tre­gay For­ma Ther­a­peu­tics
    Tim Van Hauw­er­meiren Ar­genx
    Mark Vel­le­ca G1 Ther­a­peu­tics
    Greg Ver­dine Fog Phar­ma
    George Vla­suk Nav­i­tor Phar­ma­ceu­ti­cals, Inc.
    Robert Ward Ra­dius
    Ryan Watts De­nali
    Mal­colm Weir Hep­tares
    Mar­tin Welschof Op­sona Ther­a­peu­tics Ltd
    Doug Williams Co­di­ak
    Troy Wil­son Ku­ra On­col­o­gy
    Steve Yang WuXi AppTec

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

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Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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