GSK banks on promis­ing da­ta from its PhI­II Gem­i­ni pro­gram to stare down Gilead on HIV — but there are plen­ty of skep­tics

Af­ter more than a decade’s worth of work, Glax­o­SmithK­line $GSK re­searchers to­day are un­veil­ing pooled da­ta from their two late-stage tri­als of a two-drug reg­i­men for keep­ing HIV in check. Fac­ing off against some deep-seat­ed skep­ti­cism and a pow­er­house ri­val at Gilead $GILD, the phar­ma gi­ant’s ma­jor­i­ty owned sub­sidiary Vi­iV says the com­bo per­formed just as well as a triplet in their big face­off in­volv­ing treat­ment-naive pa­tients, mak­ing it a like­ly new en­try in the glob­al fight against the virus that spurs AIDS.

“Ther­a­py has got­ten bet­ter, peo­ple are liv­ing longer,” says Vi­iV CSO John Pot­tage. “Then you have to think about treat­ing peo­ple for their life­time, decades of ther­a­py.”

The sim­pler, the bet­ter.

John Pot­tage

Click on the im­age to see the full-sized ver­sion

The two drugs Vi­iV put to­geth­er in its big Gem­i­ni Phase III pro­gram are do­lute­gravir and lamivu­dine (3TC). The pooled da­ta demon­strat­ed a 91% con­trol rate, with the bulk of the pa­tients un­der the rate of HIV-1 RNA<50 copies/mL com­pared with 93% in a three-drug arm fea­tur­ing do­lute­gravir and two nu­cle­o­side re­verse tran­scrip­tase in­hibitors: teno­fovir diso­prox­il fu­marate/emtric­itabine.

Pot­tage al­so says that the da­ta hold up when you pull out the pa­tients with high vi­ral loads. 

This is one-year da­ta, mean­ing that re­searchers will con­tin­ue to watch on dura­bil­i­ty, a key fea­ture for any new treat­ment in this field, where pa­tients are mon­i­tored to see if their treat­ment reg­i­men is los­ing ef­fect and re­quires a shift to keep the virus at bay.

“It used to be month-to-month,” Pot­tage says to me about the drug changeover rate. “Here they last for years.”

In that sce­nario, the few­er drugs you use, the less like­ly you’ll run in­to prob­lems, in­clud­ing few­er drug-drug in­ter­ac­tions as these pa­tients get old­er and face mul­ti­ple co-mor­bidi­ties. It’s an edge, and an edge can amount to a ma­jor mar­ket niche in HIV.

If the da­ta hold up un­der reg­u­la­to­ry scruti­ny at the FDA, the EMA and in­deed around the world, GSK will quite like­ly have a new prod­uct in this block­buster are­na. Reg­u­la­tors and physi­cians love al­ter­na­tive drug op­tions to put on their list of go-to ther­a­pies for chron­ic dis­eases. But just get­ting an OK like­ly won’t damp­en the skep­ti­cism some an­a­lysts have of­fered about GSK as the UK phar­ma gi­ant bat­tles a dom­i­nant Gilead on what amounts to be their home turf.

Ge­of­frey Porges, Leerink

One of the most skep­ti­cal watch­ing the bat­tle of the HIV gi­ants is Leerink’s Ge­of­frey Porges, who re­cent­ly ticked off a line­up of hur­dles GSK will like­ly find dif­fi­cul­ty clear­ing. GSK al­ready fell be­hind Gilead’s lat­est 3-drug com­bi­na­tion Bik­tarvy with their oth­er two-drug com­bo Ju­lu­ca, us­ing do­lute­gravir and rilpivirine. That, he said, was clear­ly in­fe­ri­or.

Gilead looks to re­main the dom­i­nant play­er, he adds, not­ing:

Though we be­lieve physi­cians will be more will­ing to pre­scribe a two-drug HIV reg­i­men that in­cludes 3TC in­stead of rilpivirine, all of the HIV pre­scrip­tion trends and our pro­pri­etary sur­vey work sug­gest that GSK’s two-drug reg­i­mens will not un­der­mine Gilead’s in­creas­ing HIV mar­ket share trend over the next 3 years, and we do not an­tic­i­pate any val­ue ero­sion in Gilead’s stock from these dis­clo­sures or even the ap­proval of this sec­ond 2 drug com­bi­na­tion from Vi­iV.

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.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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