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.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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