GSK sets the stage for a toe-to-toe mar­ket show­down with Gilead­'s HIV cham­pi­on Tru­va­da

Vi­iV Health­care and ma­jor­i­ty own­er Glax­o­SmithK­line have cleared an­oth­er im­por­tant hur­dle on a long-run­ning quest to chal­lenge Gilead’s dom­i­nance in pre­ven­ta­tive HIV treat­ments.

The fi­nal analy­sis of a new study shows the GSK sub­sidiary’s long-last­ing in­jec­tion, cabote­gravir, proved 66% more ef­fec­tive in HIV pre­ven­tion than Gilead’s break­through Tru­va­da pill. And they now in­tend to carve away some of the block­buster rev­enue that Gilead has en­joyed for years.

The study, re­leased Tues­day, com­pared the ef­fects of pa­tients tak­ing cabote­gravir ver­sus those tak­ing dai­ly oral pills. With­in the in­jec­tion arm of the test, re­searchers doc­u­ment­ed on­ly 13 cas­es of HIV, or an in­ci­dence rate of 0.41%. In the pill arm, 39 cas­es were found, amount­ing to a rate of 1.22%. The study al­so not­ed high lev­els of ad­her­ence to dai­ly oral ther­a­py.

Due to the Covid-19 pan­dem­ic, the blind­ed phase of the study was halt­ed in May. Af­ter a fi­nal analy­sis and re­view, Vi­iV was able to con­firm the in­jec­tions proved more ef­fec­tive than dai­ly pills at the high­light­ed 66 per­cent rate.

Kim­ber­ly Smith

“This ad­vance­ment has the po­ten­tial to be a game-chang­er for HIV pre­ven­tion, of­fer­ing … the con­ve­nience of re­duced dos­ing from dai­ly to just six times per year,” Kim­ber­ly Smith, R&D chief at Vi­iV, told Reuters.

The re­sults of the study come as gener­ic ver­sions of Tru­va­da, a once-dai­ly pill that re­duces the risk of con­tract­ing HIV through sex by about 99 per­cent, are about to hit the mar­ket. Tru­va­da and De­scovy, an­oth­er Gilead HIV treat­ment, have al­lowed the com­pa­ny to es­sen­tial­ly own the en­tire drug sec­tor ever since Tru­va­da was green-lit by the FDA in 2012 as the first pre­ven­ta­tive mea­sure for HIV.

How­ev­er, Gilead is fac­ing a law­suit from ac­tivists claim­ing the com­pa­ny ex­tend­ed its mo­nop­oly by il­le­gal­ly al­ter­ing de­vel­op­ment times, and a law­suit from the US gov­ern­ment al­leg­ing im­prop­er patent prac­tices. Gilead has al­so faced heavy crit­i­cism of price goug­ing, as Tru­va­da treat­ment can cost around $20,000 per year.

Tru­va­da net­ted Gilead $2.8 bil­lion in sales last year in both HIV pre­ven­tion and treat­ment.

Though Tru­va­da and De­scovy are al­ready high­ly ef­fec­tive treat­ments, GSK hopes it can sell the idea of in­creased com­pli­ance with its new drug. Be­cause cabote­gravir on­ly re­quires one in­jec­tion every two months, pa­tients are less like­ly to for­get to take it, as op­posed to the risk of miss­ing a dai­ly Tru­va­da pill.

Cabote­gravir has had its own share of road bumps as well. Back in De­cem­ber, the FDA is­sued a com­plete re­sponse let­ter to Vi­iV and re­ject­ed its ap­pli­ca­tion for month­ly cabote­gravir in­jec­tions, cit­ing man­u­fac­tur­ing and con­trol con­cerns. As a re­sult, the NDA for the bi­month­ly reg­i­men was pushed back from the first quar­ter of 2020.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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