Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remde­sivir can work in fight­ing Covid-19, par­tic­u­lar­ly for pa­tients with less se­vere cas­es, but this is just a first step in the jour­ney to find­ing com­bos that can do the job much bet­ter.

Bioreg­num Opin­ion Col­umn by John Car­roll

That’s the bot­tom line from Gilead’s ran­dom­ized study pub­lished in the New Eng­land Jour­nal of Med­i­cine. An­a­lysts were quick to draw con­clu­sions about how the big biotech could turn this in­to a prof­itable ad­van­tage — with wide­spread ex­pec­ta­tion of con­sid­er­able pric­ing re­straint on Gilead’s part. Any­one look­ing for a new moun­tain of cash to count as the world grap­ples with the pan­dem­ic is like­ly to come away dis­ap­point­ed.

We al­ready know the salient con­clu­sions from the news in late April. The fi­nal score on mor­tal­i­ty for hos­pi­tal­ized pa­tients was 7.1% in the drug arm com­pared to 11.9% for the place­bo, a slight im­prove­ment over the first num­bers of­fered and a dis­tinct ad­van­tage that didn’t quite make it over the hur­dle re­quired to qual­i­fy as sta­tis­ti­cal­ly sig­nif­i­cant.

That short­fall on the da­ta may earn a thumbs down in any­thing out­side of Covid-19, but for a pan­dem­ic with noth­ing but emer­gency use au­tho­riza­tion drugs avail­able so far, close counts. Giv­en remde­sivir ver­sus noth­ing or the in­creas­ing­ly risky look­ing hy­drox­y­chloro­quine/chloro­quine matchup, physi­cians will cer­tain­ly use it un­til some­thing bet­ter comes along.

The sol­id ad­van­tage un­veiled in the study is for re­cov­ery — an av­er­age of 11 days in the drug arm com­pared to 15 days for place­bo. And pa­tients re­quir­ing sup­ple­men­tal oxy­gen did bet­ter. Here’s the con­clu­sion from the re­searchers:

These pre­lim­i­nary find­ings sup­port the use of remde­sivir for pa­tients who are hos­pi­tal­ized with Covid-19 and re­quire sup­ple­men­tal oxy­gen ther­a­py. How­ev­er, giv­en high mor­tal­i­ty de­spite the use of remde­sivir, it is clear that treat­ment with an an­tivi­ral drug alone is not like­ly to be suf­fi­cient. Fu­ture strate­gies should eval­u­ate an­tivi­ral agents in com­bi­na­tion with oth­er ther­a­peu­tic ap­proach­es or com­bi­na­tions of an­tivi­ral agents to con­tin­ue to im­prove pa­tient out­comes in Covid-19.

That in turn will con­tin­ue to spur on a fren­zy of R&D ac­tiv­i­ty around find­ing new drugs that tar­get the new virus.

Michael Yee at Jef­feries took a close look at the sub-group analy­sis avail­able and con­clud­ed that less-se­vere pa­tients did bet­ter, leav­ing the door open to treat­ing more mod­er­ate pa­tients, which would dri­ve wider use af­ter we see loom­ing ad­di­tion­al Phase III da­ta.

So what about the mon­ey?

Gilead CEO Dan O’Day has been gin­ger­ly tip­toe­ing around this is­sue, with the sure knowl­edge that any move to make quick bil­lions on a drug in a pan­dem­ic would be con­demned as prof­i­teer­ing. The com­pa­ny is pro­vid­ing the first big batch of drug for free. Af­ter that, Yee did some quick back-of-the-en­ve­lope pro­jec­tions and con­clud­ed that even on the low­er end of a $3,000 to $4,000 price tag sug­gest­ed by ICER — and an up­front in­vest­ment of a bil­lion dol­lars — there’s prof­it to be had.

Hence, even 500k pts x $3k = $1.5B…. In­deed, from an in­vestor per­spec­tive, the key ques­tion has most­ly been around whether GILD can mon­e­tize the as­set and to what ex­tent, and then ac­tu­al­ly whether the mar­ket will give any cred­it due to a per­cep­tion of one-time non-re­cur­ring stream of rev­enues, low lev­el of prof­itabil­i­ty, and/or whether vac­cines will make treat­ments less rel­e­vant.

Gilead’s stock has waxed and waned through­out the last 3 months on the back of some wild­ly spec­u­la­tive re­port­ing, jump­ing or falling on da­ta from stud­ies that had to be scrapped (use­less) as well as anec­do­tal re­ports of amaz­ing suc­cess­es. Remde­sivir is nei­ther a mir­a­cle nor a dud. It can work, and it’s des­per­ate­ly need­ed. There’s al­so lot more ahead defin­ing the right pop­u­la­tion. And we’ll see what hap­pens next on pric­ing.

This sto­ry isn’t over yet, by a long shot.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.