HHS Secretary Xavier Becerra (AP Images)

'March-in' bat­tles heat up as non­prof­its pe­ti­tion HHS on 6 drugs as ear­li­er pe­ti­tion awaits de­ci­sion

Eight non­prof­its in­clud­ing Pub­lic Cit­i­zen and PrEP4All are pe­ti­tion­ing HHS Sec­re­tary Xavier Be­cer­ra to use con­tro­ver­sial “march-in” rights to low­er the prices of 6 drugs.

The idea be­hind the let­ter is cen­tered on the Bayh-Dole Act, which al­lows fed­er­al agen­cies to march-in on a fed­er­al­ly-fund­ed in­ven­tion when a rights hold­er fails to achieve “prac­ti­cal ap­pli­ca­tion” of the in­ven­tion, mean­ing that the rights hold­er fails to make the ben­e­fits of the in­ven­tion “avail­able to the pub­lic on rea­son­able terms.”

Such a move in the realm of drug prices has nev­er oc­curred be­fore, but sev­er­al high-pro­file De­moc­rats in re­cent months have sig­naled that it’s well with­in HHS’ le­gal bounds to get cre­ative in find­ing new ways to bring down drug prices. Re­pub­li­cans and phar­ma have de­rid­ed the idea as more of a cheap trick (NIH has nev­er agreed to use march-in) that would dis­cour­age R&D, and par­tic­u­lar­ly R&D on gov­ern­ment-fund­ed prod­ucts.

This lat­est pe­ti­tion re­leased Thurs­day tar­gets price re­duc­tions for Pfiz­er’s prostate can­cer drug Xtan­di ($129,000 per year) and its Covid-19 drug Paxlovid ($530 per 5-day course) which has been in short sup­ply, Gilead’s HIV drug De­scovy ($24,000 per year) and its he­pati­tis C drug Ep­clusa ($24,000 list price even with an au­tho­rized gener­ic), as well as in­halers and in­sulin, which are no­to­ri­ous­ly ex­pen­sive and dif­fi­cult to make gener­i­cal­ly.

Pe­ter De­Fazio

The pe­ti­tion builds on an ear­li­er pe­ti­tion from sev­er­al di­ag­nosed with prostate can­cer that is seek­ing to march-in to low­er Xtan­di’s price specif­i­cal­ly. NIH said yes­ter­day that it’s still re­view­ing that pe­ti­tion, al­though it pre­vi­ous­ly said it would com­plete its re­view by last month.

“We are cur­rent­ly re­view­ing the in­for­ma­tion sub­mit­ted in the 2021 pe­ti­tion to de­ter­mine whether the ini­ti­a­tion of the march-in pro­ce­dures out­lined in 37 CFR 401.6 may be war­rant­ed,” act­ing NIH di­rec­tor Lawrence Tabak said in a let­ter dat­ed March 24 to Rep. Pe­ter De­Fazio (D-OR).

Lloyd Doggett

Ear­ly last month, De­Fazio and Rep. Lloyd Doggett (D-TX) sent a let­ter to Be­cer­ra urg­ing him to use march-in to low­er these pre­scrip­tion drug costs. And this week’s pe­ti­tion­ers not­ed that the fed­er­al gov­ern­ment’s use of the law al­low­ing march-in oc­curred re­peat­ed­ly in the 1960s to buy low-cost gener­ic drugs.

But in­dus­try and oth­ers con­tin­ue to beat the drum over the wider ram­i­fi­ca­tions of such a move.

A lit­tle more than a week ago, near­ly 100 aca­d­e­mics, life sci­ence or­ga­ni­za­tions, lawyers and oth­ers sent a let­ter to Be­cer­ra call­ing on him to re­ject the pe­ti­tion, ex­plain­ing that march-in

was nev­er in­tend­ed as a means for the gov­ern­ment to im­pose ar­bi­trary price con­trols on re­sult­ing prod­ucts, as the NIH has con­clud­ed time and again. As then NIH Di­rec­tor Elias Zer­houni not­ed in 2004 while re­ject­ing the first march in pe­ti­tion seek­ing to im­pose price con­trols on a suc­cess­ful­ly com­mer­cial­ized prod­uct: ‘… the ex­tra­or­di­nary rem­e­dy of march-in rights is not anap­pro­pri­ate means of con­trol­ling prices.’ That was cor­rect then and re­mains so to­day.

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.