Gilead proves it's one tough con­tender in HIV, but don't count GSK out of the fight

Look­ing to de­fend it­self against a new HIV drug from Gilead, Glax­o­SmithK­line’s $GSK Vi­iV post­ed a near mir­ror im­age of vi­ral sup­pres­sion for its two-drug com­bo of Tivicay (do­lute­gravir) tied to J&J’s rilpivirine com­pared with the re­sults from the three- and four-drug cock­tails it hopes to re­place. But Gilead $GILD struck first, re­leas­ing the first look at some im­pres­sive Phase II da­ta on their ri­val drug bicte­gravir.

Re­port­ing out da­ta from its two Phase III stud­ies, SWORD-1 and SWORD-2, GSK re­vealed this evening that the cur­rent cock­tails in use suc­cess­ful­ly sup­pressed the virus in 485 of 511 pa­tients; 95%. Do­lute­gravir + rilpivirine man­aged to do the same in 486 of 513 pa­tients, al­so 95% with an ad­just­ed dif­fer­ence of -0.2%. Study re­sults were pre­sent­ed at the an­nu­al Con­fer­ence on Retro­virus­es and Op­por­tunis­tic In­fec­tions in Seat­tle.

John Pot­tage

John C. Pot­tage, chief sci­en­tif­ic and med­ical of­fi­cer for Vi­iV com­ment­ed:

The re­sults from these stud­ies may change our un­der­stand­ing of how HIV can be man­aged. For more than 20 years we thought that three or more drugs were re­quired to main­tain vi­ro­log­ic sup­pres­sion, but the SWORD stud­ies pro­vide com­pelling da­ta that sup­pres­sion may be main­tained with a two drug reg­i­men of do­lute­gravir and rilpivirine. These da­ta mark an ex­cit­ing first step to­wards mak­ing two drug reg­i­mens a re­al­i­ty in HIV treat­ment. We are plan­ning reg­u­la­to­ry sub­mis­sions for this two-drug reg­i­men as a sin­gle tablet in 2017.

An­a­lysts who fol­low the field gave GSK’s com­bo a very close re­view, but it’s the Phase II da­ta on bicte­gravir they were wait­ing for. Gilead hus­tled quick­ly in­to Phase III stud­ies with­out wait­ing for their mid-stage da­ta re­view. And late-stage da­ta is ex­pect­ed to fall in Q2. But the Phase II pre­view Mon­day evening earned some rave re­views.

At 24 weeks, Gilead re­port­ed, HIV was un­de­tectable in 97% of the pa­tients tak­ing bicte­gravir, com­pared to 94% for do­lute­gravir. At 48 weeks Gilead’s drug main­tained that 97% rate, while GSK’s drug dropped to 91%.

This was a small mid-stage study, but an­a­lysts are hope­ful that this will all play out the same way in Phase III, set­ting up a big show­down be­tween two big play­ers.

Bri­an Abra­hams at Jef­feries had this to say:

Giv­en the small size of the study, this did not reach stat. sig., but we cal­cu­late that it would po­ten­tial­ly be suf­fi­cient to be stat. sig. in ph.III if com­pa­ra­ble vi­ro­log­i­cal sup­pres­sion ob­served. Even if not, we be­lieve hints at po­ten­tial ad­van­ta­geous pro­file of bic vs. dolu. No­tably, no pa­tients on ei­ther reg­i­men who had vi­ro­log­i­cal fail­ure de­vel­oped re­sis­tance. CD4 count in­creas­es al­so looked a bit bet­ter for bic (+258 vs. +192 for dolu).

For GSK, their Phase III suc­cess un­der­scores the im­por­tance of Vi­iV as the main drug pipeline con­tin­ues to leave an­a­lysts cold and gener­ic Ad­vair threat­ens to un­load an avalanche of trou­ble. GSK is the big play­er at Vi­iV, with small­er stakes in the hands of Pfiz­er and Sh­iono­gi. And a two-drug reg­i­men could of­fer a bet­ter way to soft­en side ef­fects for pa­tients and per­haps cut costs for pay­ers in a com­pet­i­tive field.

Quite a few an­a­lysts, though, ex­pect Gilead to come out on top of this lat­est dust-up.

The stakes for Gilead have grown con­sid­er­ably in the last 6 months, as its he­pati­tis C fran­chise has be­gun to melt away and a se­ries of set­backs in the clin­ic wiped out much of the en­thu­si­asm for the com­pa­ny’s pipeline. A win on bicte­gravir is es­sen­tial.

Leerink’s Ge­of­frey Porges re­cent­ly not­ed:

We be­lieve that in­vestor ex­pec­ta­tions are now that bicte­gravir is nu­mer­i­cal­ly bet­ter than do­lute­gravir in the head to head phase II tri­al be­ing pre­sent­ed and dis­closed pub­licly this week (Tues­day, Feb­ru­ary 14). Any­thing less than a nu­mer­i­cal su­pe­ri­or­i­ty and un­blem­ished safe­ty and tol­er­a­bil­i­ty would be a dis­ap­point­ment to in­vestors, who are in­creas­ing­ly fo­cused on HIV as Gilead’s foun­da­tion and val­ue dri­ver.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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