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.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.