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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well-man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.