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.

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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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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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.

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

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).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.

Plagued by de­lays, As­traZeneca HQ costs soar to £750M as it edges to­ward 2020 com­ple­tion

In the lat­est up­date on As­traZeneca’s de­lay-prone HQ project, the phar­ma gi­ant re­vealed that the cost of con­struc­tion has swelled to £750 mil­lion ($956 mil­lion) — more than dou­ble the orig­i­nal es­ti­mate in 2013.

The move-in date is still in 2020, a spokesper­son con­firmed, af­ter As­traZeneca pushed pro­ject­ed com­ple­tion from 2016 to 2017, and then to the spring of 2019. While the ini­tial plan called for a £330 mil­lion (then $500 mil­lion) in­vest­ment, the cost bal­looned to £500 mil­lion ($650 mil­lion), and more in the most re­cent up­date.