As Trump fin­gers phar­ma on drug prices, ex­ecs step up with the lat­est vows of self dis­ci­pline

Ab­b­Vie’s Richard Gon­za­lez

Just as Don­ald Trump was rip­ping the lid off a can of whup-ass and pour­ing it all over the bio­phar­ma in­dus­try, Ab­b­Vie’s chief was step­ping up to fol­low Al­ler­gan CEO Brent Saun­ders’ lead on cap­ping an­nu­al drug price in­creas­es.

In a talk at the J.P. Mor­gan con­fer­ence, Ab­b­Vie CEO Richard Gon­za­lez pledged to keep the com­pa­ny’s an­nu­al price hikes on its drug port­fo­lio to sin­gle dig­its, in line with Saun­ders promise to keep Al­ler­gan’s in­creas­es to sin­gle dig­its. And No­vo Nordisk has al­ready fol­lowed up with its com­mit­ment to do the same, mark­ing a ma­jor shift in the way the in­dus­try han­dles drug prices af­ter years of swift spikes.

“There’s a strong de­bate go­ing on right now about pric­ing,” Gon­za­lez told in­vestors, ac­cord­ing to a re­port in Reuters. “We need to make sure we are op­er­at­ing in an ap­pro­pri­ate way … and demon­strat­ing the val­ue of the prod­ucts that we have.”

What Gon­za­lez ev­i­dent­ly wasn’t aware of was that Trump veered in­to the drug pric­ing is­sue dur­ing his press con­fer­ence on Wednes­day, vow­ing to ham­mer drug prices down through a fed­er­al bid­ding process af­ter the in­dus­try had been  “get­ting away with mur­der.”

Joaquin Du­a­to (Pho­to: End­points News)

Drug prices, and what the in­dus­try is go­ing to do about the grow­ing pres­sure to con­trol costs, was at the cen­ter of a dis­cus­sion End­points News host­ed Tues­day morn­ing at J.P. Mor­gan in San Fran­cis­co. We start­ed with J&J’s Joaquin Du­a­to, who promised to re­veal an­nu­al price in­creas­es to help demon­strate the com­pa­ny’s dis­ci­pline.

But the glob­al phar­ma gi­ant is not go­ing to break down the price hikes on a drug-by-drug ba­sis, he added in re­sponse to a ques­tion, so they can main­tain a com­pet­i­tive edge.

“It’s go­ing to be done on an ag­gre­gate lev­el,” Du­a­to told the crowd. Spe­cif­ic prices are “some­thing that we do not want to dis­close be­cause of the com­pet­i­tive im­pli­ca­tions. The same way that we are talk­ing about dis­counts and re­bates, we are go­ing to dis­close them at an ag­gre­gate lev­el, be­cause dis­clos­ing dis­counts and re­bates by chan­nel does have a com­pet­i­tive im­pli­ca­tion too.”

Richard Pops, Brent Saun­ders (Pho­to: End­points News)

Whether or not that will be enough to dis­pel a grow­ing na­tion­al con­tro­ver­sy won’t be known for some time. But Trump’s re­marks un­der­scored that it’s a new day in bio­phar­ma when it comes to drug prices. And Richard Pops, the CEO of Alk­er­mes, not­ed that change is com­ing af­ter Big Phar­ma got hooked on the crack co­caine of ex­ten­sive price hikes for years.

For me it’s so in­ter­est­ing be­cause un­bur­dened with any ex­pe­ri­ence of hav­ing run a phar­ma­ceu­ti­cal com­pa­ny I come to it al­most like a Mar­t­ian from Mars com­ing to say, “How does this whole thing work?” It’s so bizarre be­cause, I must ad­mit, I don’t think any of us re­al­ized how fre­quent­ly phar­ma­ceu­ti­cal com­pa­nies were in­deed rais­ing prices over the last decade or so. How ex­ten­sive the price in­creas­es were, and in the set­ting of an in­vestor con­fer­ence, you re­al­ize just what crack co­caine that is when you cou­ple unit growth of a launch­ing med­i­cine with se­mi-an­nu­al price in­creas­es. You just get ex­plo­sive earn­ings growth, which is ex­act­ly what the mar­ket wants.

For Saun­ders, the in­dus­try is head­ed in the right di­rec­tion, but peo­ple should pay more at­ten­tion to net rather than gross price hikes.

Ten days in­to the year, you’re right, a lot of com­pa­nies are fig­ur­ing out that they need to be more thought­ful and cau­tious about price in­creas­es, which is a good thing….The re­al num­ber is the net. I mean, we could talk about the gross all day, and we’re hap­py to de­bate that, but the net…is prob­a­bly some­where be­tween one and 4%, de­pend­ing on what their re­bate and dis­count lev­els are. You know, I think com­pa­nies are act­ing more re­spon­si­bly than ever, and I think that’s a good thing.

We’ll have the full pan­el dis­cus­sion for you next week here at End­points.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Publicis Groupe CEO Arthur Sadoun (L) is joined by actor Michael Douglas in a holiday message encouraging HPV vaccination (Publicis Groupe/YouTube)

Pub­li­cis for­goes light­heart­ed hol­i­day mes­sage for more se­ri­ous HPV warn­ing with celebri­ty guest

When is an annual holiday greeting more like a disease awareness ad? That’s the case in this year’s video from French-based advertising holding company Publicis Groupe featuring chairman and CEO Arthur Sadoun and his predecessor Maurice Lévy.

The typically jovial interaction between the two quickly takes a serious turn to HPV cancers and vaccines — along with a guest star appearance by actor Michael Douglas.

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