Stephen Ubl, president and chief executive officer of PhRMA (Photographer: Andrew Harrer/Bloomberg via Getty Images)

Two sides of 'his­toric' drug pric­ing bill: Phar­ma in­dus­try blasts 'mis­take' while ad­vo­cates plan for 'first ever' gains

Both Con­gres­sion­al De­moc­rats and the phar­ma in­dus­try agree that pend­ing drug pric­ing leg­is­la­tion is “his­toric” — they just di­a­met­ri­cal­ly dis­agree on the mod­i­fi­er.

Trade in­dus­try group PhRMA’s CEO Stephen Ubl called it an “his­toric mis­take” on Wednes­day, joined by Eli Lil­ly CEO David Ricks, At­las Ven­ture part­ner Jean-Fran­cois Formela along with a hema­tol­ogy on­col­o­gy-lead­ing physi­cian and a metasta­t­ic breast can­cer sur­vivor in a press con­fer­ence.

Mean­while, Sen­ate De­moc­rats lined up their own press con­fer­ence for lat­er in the day, tap­ping pa­tient ad­vo­ca­cy lead­ers and AARP CEO Jo Ann Jenk­ins to of­fer its his­to­ry-mak­ing take.

“This leg­is­la­tion would be his­toric, and that’s not an ex­ag­ger­a­tion,” said David Mitchell, founder of Pa­tients for Af­ford­able Drugs and speak­er at the Hill event. “Why his­toric? For the first time ever, af­ter al­most 20 years of fight­ing, Medicare will be able to use its pur­chas­ing pow­er to ne­go­ti­ate low­er drug prices for Amer­i­can. For the first time ever, there are go­ing to be curbs on an­nu­al drug price in­creas­es to lim­it to no more than the rate of in­fla­tion. And for the first time ever, there’s go­ing to be an an­nu­al cope on what Medicare Part D ben­e­fi­cia­ries pay for our drugs an­nu­al­ly.”

While nei­ther side can claim vic­to­ry for now, the bill spon­sors have hint­ed that pas­sage should be ex­pect­ed as they can use rec­on­cil­i­a­tion and on­ly need a sim­ple ma­jor­i­ty to pass the bill. The House has al­so sig­nalled a will­ing­ness to re­turn from their sum­mer re­cess to pass the bill next month.

Sen­ate Dems and Re­pub­li­cans met last week with the Sen­ate par­lia­men­tar­i­an to iron out what pro­vi­sions could be in­clud­ed if they use this short-cut, but sen­a­tors who are usu­al­ly on the fence, like Sen. Joe Manchin (D-WV), are now on board.

PhRMA, not sur­pris­ing­ly, sees those pro­vi­sions dif­fer­ent­ly — with Ubl call­ing Medicare ne­go­ti­a­tions “non­sense.”

“An in­no­v­a­tive drug­mak­er has two choic­es un­der this bill — ac­cept the gov­ern­ment’s price or pay a 95% tax on the sale of that med­i­cine,” he said, adding, “That’s not ne­go­ti­a­tion, that’s gov­ern­ment price set­ting. Let’s be hon­est and call it what it is.”

PhRMA is al­so unit­ed in the view that the bill’s pro­vi­sions, in­clud­ing a cap on the num­ber of years phar­mas can in­de­pen­dent­ly set drug prices, will stymie in­no­va­tion, and keyed in on can­cer treat­ments as an ex­am­ple.

Ricks said the bill will af­fect “de­ci­sions we make about how to in­vest in in­no­v­a­tive med­i­cines and those in par­tic­u­lar for can­cer.”

He out­lined two spe­cif­ic ef­fects on a like­ly de­crease in drug de­vel­op­ment for rare can­cers with small­er pop­u­la­tions (which cost just as much to de­vel­op as those for larg­er tar­get au­di­ences) and slow­ing ear­ly stage can­cer drug de­vel­op­ment. Can­cer drugs are of­ten ap­proved for lat­er-stage use, then move ear­li­er over time and ad­di­tion­al re­search to get to ad­ju­vant us­es, he said.

“Man­u­fac­tur­ers and in­vestors won’t sup­port that type of se­quen­tial de­vel­op­ment (any­more),” he said.

An­oth­er point of con­tention is the im­pact on new drug de­vel­op­ment. The Con­gres­sion­al Bud­get Of­fice (CBO) es­ti­mat­ed the bill would re­duce drug­mak­ers’ 1,300 to­tal ap­provals by about 10 drugs over the next three decades.

Ubl said the CBO “just got it wrong.”

He point­ed in­stead to Uni­ver­si­ty of Chica­go re­search ear­li­er this year that es­ti­mat­ed 135 few­er drug ap­provals through 2039 amid its pro­ject­ed drop of $663 bil­lion in R&D spend­ing.

Ricks said, “I would be shocked if the im­pact of this bill doesn’t re­sult in 15 few­er med­i­cines from Eli Lil­ly and Co. alone. I think that would im­ply one every oth­er year that we can­celled be­cause of this. But right now, 40% of our port­fo­lio are small mol­e­cules. We’ll need to reeval­u­ate every sin­gle one of those projects for vi­a­bil­i­ty.”

He al­so pre­dict­ed the po­ten­tial for R&D in­no­va­tion to leave the US, point­ing to the fact that R&D moved from Eu­rope to the US be­cause “Eu­rope has the same harm­ful poli­cies as em­bed­ded in this bill” caus­ing in­vest­ments to shift.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.