New law­suit ac­cus­es GSK of 'de­vice hop­ping' to block gener­ic in­haler com­pe­ti­tion

De­spite in­halers be­ing on the mar­ket for decades, many pa­tients still can’t af­ford them. A new law­suit filed in Mis­souri fed­er­al court puts the blame on GSK.

Last week, plain­tiff El­liot Con­rad Dale — who’s paid for GSK’s Ven­tolin and Ar­nu­ity El­lip­ta in­halers — filed a class-ac­tion law­suit against the phar­ma gi­ant, ac­cus­ing it of schem­ing to block gener­ic ver­sions of its brand-name in­halers.

Dale al­leged that GSK en­gaged in “de­vice hop­ping,” or in oth­er words, re­tir­ing a brand­ed in­haler while plac­ing the same ac­tive in­gre­di­ents in a fol­low-on in­haler with new patent pro­tec­tions. Gener­ics that were pre­vi­ous­ly ap­proved for an ear­li­er ver­sion of a brand­ed in­haler are not ap­proved for these fol­low-on ver­sions.

“Thus, de­vice hop­ping pre­vents gener­ics from ever hav­ing an un­pro­tect­ed brand name in­haler to ref­er­ence for a gener­ic,” the com­plaint states.

Plain­tiffs al­lege that through this scheme, GSK en­joyed 60 years of un­in­ter­rupt­ed patent and reg­u­la­to­ry pro­tec­tion for its Ven­tolin in­haler line, and 35 years for its Flovent and Ar­nu­ity El­lip­ta in­haler line.

Cur­rent­ly, in­halers ac­count for about 5% of to­tal net re­tail spend­ing on pre­scrip­tion drugs in the US, ac­cord­ing to the com­plaint.

The class-ac­tion suit seeks an in­junc­tion that would bar GSK from “en­gag­ing in the de­cep­tive, un­fair, un­con­scionable, and un­law­ful busi­ness prac­tices al­leged in this Com­plaint,” as well as com­pen­sato­ry dam­ages to the plain­tiff and pro­posed class.

A GSK spokesper­son de­clined to com­ment, but said the com­pa­ny would “thor­ough­ly re­view the com­plaint.”

Just last week, new re­search pub­lished in Health Af­fairs ac­cused fol­low-on in­haler prod­ucts (in­clud­ing ones from GSK) of block­ing com­pe­ti­tion from cheap­er gener­ics.

Re­searchers point­ed out that GSK re­ceived 35 years of pro­tec­tion from com­pe­ti­tion af­ter the FDA ap­proval of 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).

“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’),” au­thor William Feld­man told End­points News at the time.

The news comes as GSK looks to stand out from the pack in se­vere asth­ma, win­ning ap­proval for a 40 mg pre­filled sy­ringe of Nu­cala for cer­tain kids be­tween 6 and 11 years old back in Jan­u­ary. That means they can take the drug at home, rather than go­ing to the doc­tor’s of­fice every four weeks.

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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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.

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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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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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.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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