Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

GSK and Vi­iV score break­through ther­a­py des­ig­na­tion in HIV pre­ven­tion, as Tru­va­da show­down draws near­er

A lit­tle less than a week af­ter beef­ing up the da­ta pack­age it plans to take to the FDA for the ex­per­i­men­tal HIV drug cabote­gravir, GSK-owned Vi­iV Health­care has re­ceived good news on the med­i­cine’s prospects.

Reg­u­la­tors des­ig­nat­ed cabote­gravir as a break­through ther­a­py for pre­ven­ta­tive HIV treat­ment, the com­pa­ny an­nounced Tues­day af­ter­noon, set­ting up a show­down with Gilead’s Tru­va­da. Vi­iV R&D chief Kim­ber­ly Smith said it like­ly sets up an NDA sub­mis­sion in the first half of next year, with the hope of launch­ing the drug in ear­ly 2022.

“It just fur­ther val­i­dates how im­por­tant this prod­uct is,” Smith told End­points News. “Even in the Unit­ed States, even with the pres­ence of dai­ly oral ther­a­py, there’s still 38,000 to 40,000 cas­es of HIV di­ag­nosed every year. If we con­tin­ue to have cas­es at that rate, we won’t get to the end of the epi­dem­ic in the US.”

The BTD comes off the re­sults of two tri­als, both of which re­port­ed re­sults ear­li­er this year.

In the for­mer, ex­am­in­ing men and trans­gen­der women who have sex with men, re­searchers com­pared the ef­fects of cabote­gravir against the dai­ly oral pills. There, with a 0.41% in­ci­dence rate in the in­jec­tion group and 1.22% in the pill group, cabote­gravir proved 66% more ef­fec­tive in a fi­nal analy­sis in Ju­ly.

The lat­ter study, in sub-Sa­ha­ran African cis­gen­der women, was stopped by the DSMB ear­li­er this month af­ter an in­ter­im analy­sis that showed it had al­ready met its pri­ma­ry end­point. Vi­iV’s re­sults here showed cabote­gravir to be 89% more ef­fec­tive than Tru­va­da in both the 200 mg and 300 mg dos­es. Among the 38 women who con­tract­ed HIV, 34 came from the Tru­va­da arm, trans­lat­ing to in­ci­dence rates of 1.79% and 0.21% in the Tru­va­da and cabote­gravir arms, re­spec­tive­ly.

Where­as Tru­va­da is a once-dai­ly pill, cabote­gravir is a long-last­ing in­jectable tak­en every eight weeks for pre­ven­tion. Vi­iV and GSK are hop­ing to cap­i­tal­ize on the idea that pa­tients are less like­ly to for­get to take their med­i­cine, as op­posed to the risk of miss­ing a Tru­va­da dose.

“Many peo­ple have a tough time tak­ing it con­sis­tent­ly every day,” Smith said. “As long as you get your shot, in the in­ter­im you don’t have to wor­ry about tak­ing a pill every day.”

Tru­va­da has long been the cham­pi­on in pre­ven­ta­tive HIV treat­ment, re­duc­ing the risk of con­tract­ing the virus by more than 99%. But gener­ics for the drug launched this year, with Is­raeli drug­mak­er Te­va launch­ing its own ver­sions of Tru­va­da and an­oth­er Gilead HIV drug Atripla.

Vi­iV is hop­ing to take a bite out of that pie as well, in both the pre­ven­tion and treat­ment ar­eas. Smith said that on the treat­ment side, cabote­gravir in com­bi­na­tion with J&J’s rilpivirine is cur­rent­ly be­ing eval­u­at­ed as a month­ly reg­i­men by the FDA, with an ex­pect­ed PDU­FA date of next Jan. 28. The orig­i­nal NDA there was sub­mit­ted back in ear­ly 2019, but the FDA shot it down with a CRL last De­cem­ber, cit­ing CMC is­sues.

The com­bo has al­so been ap­proved in oth­er coun­tries, such as Cana­da, and is mar­ket­ed as Cabe­nu­va.

Gilead has es­sen­tial­ly owned the HIV mar­ket since Tru­va­da’s ap­proval in 2012, with the drug net­ting $2.8 bil­lion in sales for both pre­ven­tion and treat­ment in 2019. The com­pa­ny al­so scored an ap­proval for De­scovy in HIV pre-ex­po­sure pro­phy­lax­is late last year.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.