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.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
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What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

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The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

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PureTech bags $200M from sale of Karuna shares — still siz­zling from promis­ing schiz­o­phre­nia da­ta

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

Boston-based PureTech had helped Eli Lilly vet Steve Paul launch Karuna and invent its lead program, which combines two old drugs that both act on the muscarinic receptor and balances each other out. Xanomeline, a discard from Lilly, stimulates the M1 and M4 receptors; trospium is an muscarinic receptor antagonist approved to treat overactive bladders.

UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.