Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New re­search pub­lished in Health Af­fairs to­day high­lights the way in which the FDA’s in­haler reg­u­la­tions have re­ward­ed in­cre­men­tal ad­just­ments to old­er prod­ucts, there­by en­abling com­pa­nies to skirt around cheap­er com­pe­ti­tion.

A DC ap­peals court clerk and re­searchers from Har­vard and the Uni­ver­si­ty of Cal­gary dug through all the patents and reg­u­la­to­ry ex­clu­siv­i­ties grant­ed to in­halers ap­proved by the FDA be­tween 1986 and 2020, find­ing that of the 62 in­halers ap­proved, 53 (or 85%) were brand-name prod­ucts, with a me­di­an of 16 years of pro­tec­tion from gener­ic com­pe­ti­tion.

“The on­ly in­haler to en­ter the US mar­ket dur­ing the study pe­ri­od with a new mech­a­nism of ac­tion was the mus­carinic an­tag­o­nist Atro­vent (ipra­t­ropi­um) in 1986,” they wrote.

First au­thor William Feld­man, as­so­ciate physi­cian in the di­vi­sion of pul­monary and crit­i­cal care med­i­cine at the Boston-based Brigham and Women’s Hos­pi­tal, ex­plained to End­points News that there are sev­er­al rea­sons why gener­ic com­pe­ti­tion for in­halers is so sparse.

“Brand-name man­u­fac­tur­ers have se­cured long pe­ri­ods of mar­ket ex­clu­siv­i­ty by patent­ing the de­liv­ery de­vices of their prod­ucts – even when the ac­tive in­gre­di­ents are off-patent – and by mov­ing ac­tive in­gre­di­ents from one de­vice to the next (which we re­fer to as ‘de­vice hop­ping’),” he said.

For in­stance, the re­searchers point­ed out GSK re­ceived 35 years of pro­tec­tion from com­pe­ti­tion af­ter FDA ap­proval on its flu­ti­ca­s­one in­halers through the suc­ces­sive re­lease of new in­haler de­vices con­tain­ing flu­ti­ca­s­one: Flovent (ap­proved in 1996), Flovent Ro­tadisk (1997), Flovent Diskus (2000), Flovent HFA (2004), and most re­cent­ly Ar­nu­ity El­lip­ta (2014).

The re­lease of these new in­haler ver­sions means that any gener­ic ver­sions linked to old­er prod­ucts are no longer in­ter­change­able and can­not au­to­mat­i­cal­ly be sub­sti­tut­ed at the phar­ma­cy for that new prod­uct, they ex­plained.

While patents are gen­er­al­ly the cul­prit to lim­it­ing com­pe­ti­tion, Feld­man al­so not­ed the high­er cost of de­vel­op­ing com­plex gener­ics like in­halers and the fact that the FDA “sets a high stan­dard for ap­prov­ing in­ter­change­able gener­ic in­halers.”

So what can be done to help bring down the cost of in­halers?

“We of­fer a num­ber of so­lu­tions aimed at tar­get­ing these life­cy­cle man­age­ment prac­tices, in­clud­ing Or­ange Book re­form (e.g., pre­vent­ing brand-name man­u­fac­tur­ers from list­ing de­vice patents in the Or­ange Book and/or pre­vent­ing man­u­fac­tur­ers from adding patents to the Or­ange Book af­ter ap­proval un­less as­so­ci­at­ed with mean­ing­ful clin­i­cal ben­e­fit) and re­form at the USP­TO (e.g., hav­ing a spe­cial art unit at the USP­TO fo­cused on phar­ma­ceu­ti­cals to en­sure the qual­i­ty of is­sued patents),” Feld­man said.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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