Vi­iV's Dova­to wins speedy US ap­proval with PRV, em­pow­er­ing GSK to mus­cle in­to Gilead­'s HIV em­pire

GSK’s Vi­iV is poised to take a bite out of Gilead’s HIV em­pire, af­ter its dual HIV reg­i­men — Dova­to — se­cured FDA ap­proval on Mon­day, af­ter the British drug­mak­er sub­mit­ted its mar­ket­ing ap­pli­ca­tion with a pri­or­i­ty re­view vouch­er (PRV) last Oc­to­ber, en­abling a speedy re­sponse from the US reg­u­la­tor.

Deb­o­rah Wa­ter­house

Dova­to is an im­prove­ment over GSK’s ex­ist­ing two-drug reg­i­men Ju­lu­ca, which does not in­clude a nu­cle­o­side ana­log re­verse tran­scrip­tase in­hibitor or a ‘nuke.’ This fam­i­ly of drugs are used to thwart an en­zyme called re­verse tran­scrip­tase, which is used by the HIV virus to make copies of it­self in­side a healthy cell.

Akin to Ju­lu­ca, GSK’s new two-drug reg­i­men Dova­to al­so in­cludes its in­te­grase in­hibitor, do­lute­gre­vir (DTC). In­te­grase in­hibitors, such as do­lute­gre­vir and Gilead’s bicte­gre­vir, work against HIV’s in­te­grase pro­tein, block­ing its abil­i­ty to in­te­grate its ge­net­ic code in­to hu­man cells.

How­ev­er, un­like Gilead, GSK has a chron­ic is­sue with its HIV com­bi­na­tion reg­i­mens: sub­op­ti­mal nukes, Ever­core ISI’s Umer Raf­fat high­light­ed in a note. For ex­am­ple, GSK’s Tri­umeq — which in­cludes DTC and two nukes — fea­tures aba­cavir, a nuke that has been linked to hy­per­sen­si­tiv­i­ty and CV is­sues, he said, un­der­scor­ing that due to patent is­sues GSK was not able to use a nuke bet­ter than aba­cavir in the past.

This has had an im­pact on GSK’s HIV sales. Pre­scrip­tion vol­umes in­di­cate that de­mand for its DTC monother­a­py, Tivicay, and DTC com­bo Tri­umeq are sim­i­lar, ac­cord­ing to Raf­fat. In ef­fect, it looks like half the pa­tients tak­ing DTC un­der­go the has­sle of tak­ing an­oth­er pill in ad­di­tion to Tivicay: Gilead’s clean two-nuke com­bo Tru­va­da, he said.

Due to these is­sues, Gilead’s sin­gle tablet with two good nukes in it — Bik­tarvy — has done ex­treme­ly well, Raf­fat not­ed.

Umer Raf­fat

With the Dova­to ap­proval, GSK now has a prod­uct that does not re­quire sep­a­rate Tru­va­da ad­min­is­tra­tion, does not in­clude an aba­cavir com­po­nent which has safe­ty con­cerns, and can com­pete di­rect­ly against Bik­tarvy. (Al­though the da­ta from pa­tients in Botswana sug­gest­ed a link be­tween DTC and birth de­fects, prompt­ing the WHO to rec­om­mend that women in the ear­ly stages of their preg­nan­cy not use the drug). In ad­di­tion, GSK’s Dova­to fea­tures an off-patent nuke called lamivu­dine, which al­lows for a com­par­a­tive­ly cheap­er list price ver­sus Bik­tarvy.

Ac­cord­ing to Raf­fat, Bik­tarvy car­ries an­nu­al price tag of $37,000, while Dova­to is 26% cheap­er at $27,500.

GSK’s ap­proach to grab­bing mar­ket share from Gilead $GILD  — which cur­rent­ly dom­i­nates the HIV mar­ket that is es­ti­mat­ed to hit $22.5 bil­lion by 2025 — is to con­vince reg­u­la­tors, doc­tors and pa­tients to adopt its two-drug reg­i­mens, ver­sus Gilead’s triple-drug cock­tails, that could po­ten­tial­ly re­sult in few­er tox­ic side-ef­fects, re­duce dos­ing fre­quen­cy, and be more cost-ef­fec­tive — al­though crit­ics sug­gest this may not be the most ef­fec­tive strat­e­gy be­cause the virus will on­ly have to fight against two drugs which could cul­mi­nate in drug re­sis­tance.

Re­sults of two phase III GEM­I­NI tri­als test­ing Dova­ta pre­sent­ed last year showed that GSK’s ther­a­py worked as well as stan­dard three-drug ther­a­py in treat­ment-naive pa­tients with both low and high lev­els of the virus, and sig­nif­i­cant­ly, no pa­tient in the 1,400 pa­tients en­rolled across the tri­als, de­vel­oped drug re­sis­tance. This was a cru­cial wor­ry as there was a re­port­ed case of drug re­sis­tance in a pre­vi­ous study.

The reg­i­men is cur­rent­ly un­der re­view in Eu­rope, Cana­da, Aus­tralia, Switzer­land, and South Africa.

Ac­cord­ing to WHO es­ti­mates, 36.9 mil­lion peo­ple were liv­ing with HIV glob­al­ly in 2017. The best way to thwart the spread of HIV is to use con­doms. But for those al­ready af­flict­ed with the virus, an­ti­retro­vi­ral ther­a­py must be tak­en every sin­gle day to sup­press the virus or un­bri­dled repli­ca­tion can over­whelm the im­mune sys­tem and even­tu­al­ly cause AIDS. Dai­ly pills al­so rack up ex­pen­sive bills in the Unit­ed States, with month­ly ex­pen­di­ture on treat­ment hit­ting thou­sands per month — de­pend­ing on the reg­i­men, in­sur­ance provider and re­bates/dis­counts.

“With Dova­to, the first com­plete, sin­gle-tablet, two-drug reg­i­men for treat­ment-naïve adults, Vi­iV Health­care is de­liv­er­ing what pa­tients are re­quest­ing—a chance to treat their HIV-1 in­fec­tion with as few drugs as pos­si­ble,” Vi­iV chief Deb­o­rah Wa­ter­house said in a state­ment.

Vi­iV was es­tab­lished in 2009 by GSK $GSK in part­ner­ship with Pfiz­er $PFE, with Sh­iono­gi join­ing as a share­hold­er in 2012.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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Russ­ian sci­en­tist plans to one-up Jiankui He in cre­at­ing his own CRISPR ba­bies — Na­ture

If De­nis Re­brikov has his way, the world could be ex­pect­ing more CRISPR ba­bies soon.

The Russ­ian sci­en­tist has told Na­ture he is con­sid­er­ing fol­low­ing Jiankui He’s ex­am­ple in knock­ing out the CCR5 gene in em­bryos and im­plant­i­ng them in­to women — ex­cept do­ing it in a bet­ter way. It marks the first de­c­la­ra­tion of in­ter­est in con­tin­u­ing the work when re­searchers around the world are call­ing for sus­pen­sion of hu­man germline edit­ing and stricter stan­dards, fol­low­ing a glob­al back­lash against He’s claims that he fa­cil­i­tat­ed the birth of twin girls who had been CRISPR-ed as em­bryos.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).