With eye on rev­enue sta­bi­liza­tion, Gilead takes 4.9% hike on a bas­ket of drugs

Once the hep C ti­tan, Gilead is now for­ti­fy­ing its still dom­i­nant HIV busi­ness with a round of list price hikes it took over the week­end un­der new chief Daniel O’Day, as the drug­mak­er looks to stem more than two years of shrink­ing sales rev­enue.

Phil Nadeau

The biotech has hiked prices on its big tick­et prod­ucts — in­clud­ing its ar­se­nal of HIV drugs, but ex­clud­ing its HCV fran­chise and CAR-T ther­a­py Yescar­ta — by 4.9%, which is in line his­tor­i­cal­ly with its prac­tice of rais­ing prices an­nu­al­ly in the first quar­ter, ac­cord­ing to Cowen’s Phil Nadeau.

The hikes come at a time when pres­sure to rein in drug prices is mount­ing, with Con­gress con­duct­ing hear­ings to un­pack the role drug­mak­ers and phar­ma­cy ben­e­fit man­agers play in sky­rock­et­ing out-of-pock­et costs. Mean­while, the Trump ad­min­is­tra­tion has is­sued a string of pro­pos­als to curb prices, in­clud­ing im­port­ing prices from over­seas, and HHS sec­re­tary Azar has im­plied “nam­ing and sham­ing” tac­tics will be em­ployed against drug­mak­ers who raise prices.

The price in­creas­es are no­table as var­i­ous big drug­mak­ers — in­clud­ing Roche, Pfiz­er $PFE, No­var­tis $NVS and Mer­ck $MRK — had pledged not to raise prices un­til the end of 2018, af­ter Trump’s drug pric­ing blue­print was un­veiled in the sec­ond quar­ter of 2018.

“Gilead’s price in­creas­es would seem to sig­nal a re­turn to its his­tor­i­cal prac­tices with the cal­en­dar’s turn to 2019,” Nadeau said. “Gilead will not rec­og­nize the full mag­ni­tude of the price in­creas­es be­cause of dis­counts, re­bates, and reg­u­la­tions. The price to Med­ic­aid, for ex­am­ple, can on­ly in­crease by an amount re­lat­ed to in­fla­tion. Nonethe­less, these price in­creas­es give us ad­di­tion­al con­fi­dence in our 2019 U.S. HIV fran­chise es­ti­mates, which project 16% Y/Y growth in rev­enue.”

Gilead’s 2019 fore­cast — is­sued last month — im­plied “prod­uct sales growth of -2% to +0.5%, sug­gest­ing that over­all Gilead‘s busi­ness has fi­nal­ly plateaued,” Nadeau added.

So new­ly crowned O’Day has his work cut out for him: Gilead’s hep C fran­chise is melt­ing away, its $12 bil­lion buy­out of Kite (and its CAR-T ther­a­py Yescar­ta) re­mains an open ques­tion mark and its big bet on late-stage NASH drug selon­sert­ib has hit a ma­jor road­block. What re­mains is its sta­ble, foun­da­tion­al HIV busi­ness — which may have post­poned its best-be­fore date with new, eas­i­er-to-use ther­a­pies — and piles of cash in its cof­fers ly­ing around for the next meaty buy­out deal.

“We be­lieve the HIV busi­ness’ fun­da­men­tals are sound. The rapid con­ver­sion of pa­tients from TDF to TAF-based reg­i­mens plus Bik­tarvy’s strength in the treat­ment naïve set­ting should keep Gilead the mar­ket leader de­spite emerg­ing com­pe­ti­tion and patent ex­pi­ra­tions start­ing in 2021,” BMO’s Matthew Lu­chi­ni wrote in an ini­ti­a­tion note last week.

The 2019 price in­creas­es in­clude “Atripla (to $2,857.55/month), Bik­tarvy (to $3,089.99/month), Com­plera (to $2,812.13/month), De­scovy (to $1,757.90/month), Gen­voya (to $3,089.99/month), Odef­sey (to $2,812.13/month), Stri­bild (to $3,241.40/month), Tru­va­da (to $1,757.90/ month), Letairis (to $9,708.09/month), Ranexa (to $614.60/month), Vem­lidy (to $1,118.88/ month), Viread (to $1,196.09/month), Zy­delig (to $1,0717.14/month) and Hep­sera (to $1,484.35/month),” ac­cord­ing to Nadeau.

These 14 drugs — in­clud­ing 6 block­buster treat­ments — ac­count­ed for a bulk of Gilead’s 2018 rev­enue.

“Gilead has in­creased list prices of these med­i­cines…to re­flect the ris­ing costs of goods and ser­vices nec­es­sary to pro­duce ground­break­ing med­i­cines. This in­crease is low­er than the stan­dard mea­sure of health care in­fla­tion, based on an in­de­pen­dent es­ti­mate of growth in health ex­pen­di­tures, and is low­er than price in­creas­es in pre­vi­ous years,” a Gilead spokesper­son told End­points News.

“These prices al­so do not im­pact the price freeze that Gilead es­tab­lished for state AIDS Drug As­sis­tance Pro­grams (ADAPs) in 2008, which is ef­fec­tive through 2019.”

The hikes come at a time when Gilead’s ex­ec­u­tive team is in a state of in­flux. O’Day’s first week as new CEO was marked by the de­par­ture of one of the com­pa­ny’s top re­search sci­en­tists, ex­ec­u­tive VP of on­col­o­gy Alessan­dro Ri­va. The ex­ec­u­tive team has suf­fered some­what of an ex­o­dus re­cent­ly, with the ex­its of CEO John Mil­li­gan, Chair­man John Mar­tin and R&D chief Nor­bert Bischof­berg­er. Bischof­berg­er’s re­place­ment, An­drew Cheng, stepped up as chief med­ical of­fi­cer be­fore he left as well to run his own biotech.

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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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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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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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.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.