Gilead gets a block­buster boost from an FDA OK of HIV triplet Bik­tarvy — and ri­val GSK fires back

Un­der the gun as an­a­lysts watch the moun­tain of cash gar­nered from its hep C fran­chise melt away, Gilead $GILD got some good news to­day with the FDA’s ap­proval of its big triplet for HIV. And their ri­vals at Glax­o­SmithK­line swift­ly re­tal­i­at­ed, fil­ing a fed­er­al law­suit in the US ac­cus­ing Gilead of in­fring­ing on its HIV patents.

Known as BIC/F/TAF in the trade, com­bin­ing the nov­el bicte­gravir with the back­bone com­bi­na­tion of emtric­itabine/teno­fovir alafe­namide in­to a sin­gle dai­ly pill, the FDA not­ed its ap­proval in the record books. And it will re­place a reg­i­men that once re­quired a mul­ti­tude of pills to keep the virus un­der con­trol.

Gilead will call this new oral ther­a­py Bik­tarvy, and the con­sen­sus on peak sales is right at $6 bil­lion a year, mak­ing it one of the biggest drugs in the in­dus­try’s pipeline. And not every­one is sat­is­fied that Gilead will top out there. Leerink’s Ge­of­frey Porges is all in on a mega suc­cess sto­ry.

We cur­rent­ly fore­cast $1bn of sales for Bik­tarvy dur­ing 2018, which is most­ly in the US giv­en the tim­ing of EU ap­proval. Our long-term fore­cast is for Bik­tarvy to reach glob­al sales of $10bn by 2025 and this is con­sid­er­ably above re­cent con­sen­sus es­ti­mates of $6.1bn.

Some of that mon­ey, of course, will be can­ni­bal­ized out of ex­ist­ing sales at Gilead, but the HIV fran­chise re­mains a big and grow­ing part of the com­pa­ny as it tack­les its new work with Kite on CAR-T.

Gilead faces some ma­jor league com­pe­ti­tion from Glax­o­SmithK­line’s HIV unit Vi­iV, which wres­tled an ear­ly ap­proval for their sin­gle pill reg­i­men Ju­lu­ca last No­vem­ber. It sells for $2,579 a month, lead­ing some an­a­lysts to spec­u­late that they could put pres­sure on Gilead’s pric­ing, which has yet to be re­vealed. GSK is al­so ex­pect­ed to reap about $5 bil­lion in an­nu­al sales from its ri­val ther­a­py.

Al­most im­me­di­ate­ly, GSK — which is fac­ing painful gener­ic com­pe­ti­tion for Ad­vair — re­spond­ed to the news of the FDA OK Wednes­day af­ter­noon by fil­ing a patent in­fringe­ment suit against Gilead in fed­er­al court. From their state­ment:

Vi­iV Health­care will seek to prove that Gilead Sci­ences Inc’s triple com­bi­na­tion HIV drug con­tain­ing the HIV in­te­grase in­hibitor bicte­gravir in­fringes Vi­iV Health­care’s patent cov­er­ing Vi­iV Health­care’s do­lute­gravir and many oth­er com­pounds that in­clude do­lute­gravir’s unique chem­i­cal scaf­fold…. Vi­iV Health­care will … seek fi­nan­cial re­dress for patent in­fringe­ment.

R&D chief Nor­bert Bischof­berg­er not­ed dur­ing the com­pa­ny’s Q4 call yes­ter­day that the PDU­FA date for the triplet was set for Feb­ru­ary 12, and this com­pa­ny is primed and ready to roll on the com­mer­cial front. He said:

BIC/FTC/TAF met its pri­ma­ry ob­jec­tive of non-in­fe­ri­or­i­ty at 48 weeks across all four stud­ies and no par­tic­i­pants failed BIC/F/TAF for treat­ment-emer­gent vi­ro­log­i­cal re­sis­tance. Ad­di­tion­al clin­i­cal tri­als of BIC/F/TAF are on­go­ing, in­clud­ing a ded­i­cat­ed study in women as well as a study in ado­les­cents liv­ing with HIV. We plan to present da­ta from these stud­ies at sci­en­tif­ic con­fer­ences in 2018.


Im­age: Gilead CEO John Mil­li­gan Bloomberg via Get­ty Im­ages

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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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 help@endpointsnews.com 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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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.