Min­neso­ta judge nar­rows charges in class ac­tion suit against My­lan, phar­ma­cy ben­e­fit man­agers over EpiPen price hikes

Sec­ond time’s the charm for Vi­a­tris and a suite of phar­ma­cy ben­e­fit man­agers in a pro­posed class-ac­tion law­suit al­leg­ing col­lu­sion over price hikes for the com­pa­ny’s EpiPen.

Af­ter try­ing — and suc­ceed­ing, in part — to get claims against them dis­missed back in 2021, the de­fen­dants cel­e­brat­ed a win on Tues­day when a Min­neso­ta fed­er­al judge dis­missed a large chunk of the claims due to a lack of ev­i­dence.

The case stems back to a com­plaint filed in 2020 al­leg­ing that My­lan — be­fore it com­bined with Pfiz­er’s Up­john unit to form Vi­a­tris — col­lud­ed with a range of PBMs in­clud­ing CVS Care­mark, Ex­press Scripts, Unit­ed Health and Op­tum­Rx to spike the price of EpiPen list prices. Plain­tiffs ac­cused My­lan of pay­ing bribes and kick­backs to PBMs, in re­turn for fa­vor­able place­ment on for­mu­la­ries, and the elim­i­na­tion of price con­straints.

EpiPen list prices surged be­tween 2012 and 2016, in­creas­ing from $240 to $609, ac­cord­ing to court doc­u­ments.

PBMs are “the gate­keep­ers of which drugs will be cov­ered by their health plan/in­sur­er clients,” the com­plaint states, and thus have in­flu­ence over which drugs are pre­scribed and pur­chased. Plain­tiffs ar­gued that PBMs ben­e­fit­ed from EpiPen’s ris­ing cost be­cause the al­leged kick­backs were gen­er­al­ly cal­cu­lat­ed as a per­cent­age of the whole­sale price.

The com­plaint was filed by Rochester Drug Co-Op­er­a­tive, on be­half of it­self and oth­er di­rect pur­chasers of EpiPen.

“Plain­tiffs, who paid the list price for EpiPens, were left to bear the bur­den of these steep price in­creas­es,” they said in the com­plaint.

My­lan ar­gued that plain­tiffs didn’t plau­si­bly al­lege that the be­hav­ior ex­clud­ed com­peti­tors from the mar­ket, or was “out­side in­dus­try norms such that oth­er com­peti­tors [could not] com­pete in the same way.”

Judge Er­ic Tostrud dis­missed some claims against the PBMs back in 2021 with prej­u­dice, mean­ing plain­tiffs can’t re­file the claim in the same court. How­ev­er, he de­nied the My­lan de­fen­dants’ mo­tion to dis­miss.

On Tues­day, how­ev­er, he nar­rowed the case even more, while post­pon­ing a de­ci­sion on the time­li­ness of the an­titrust claims.

“Be­cause Plain­tiffs could save some as­pects of their Sher­man Act claims with ev­i­dence of con­tin­u­ing vi­o­la­tions, a fi­nal de­ci­sion on the time­li­ness of the an­titrust claims will be post­poned un­til such dis­cov­ery can be tak­en,” he wrote.

A Vi­a­tris spokesper­son said in an emailed state­ment to End­points News that the com­pa­ny will con­tin­ue to fight the re­main­ing claims:

The Com­pa­ny is pleased with the Court’s de­ci­sion to sig­nif­i­cant­ly nar­row the case and will con­tin­ue to de­fend it­self vig­or­ous­ly against the re­main­ing claims.

Just last month, a Kansas fed­er­al court signed off on a set­tle­ment that will see Vi­a­tris pay $264 mil­lion to re­solve claims that it con­spired with Pfiz­er to “mo­nop­o­lize the mar­ket” for its EpiPens. That case dates back to 2017 when plain­tiffs filed a com­plaint al­leg­ing Vi­a­tris “de­vised an il­le­gal scheme” to pre­vent EpiPen com­peti­tors from com­ing to mar­ket.

Vi­a­tris has de­nied any wrong­do­ing but agreed to pay $264 mil­lion to re­solve the cas­es pend­ing in the US Dis­trict Court for the Dis­trict of Kansas.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Fed­er­al claims court rules in fa­vor of Gilead in CDC Tru­va­da patent case

Gilead pulled a win last week in its ongoing patent battle with the CDC over the HIV drug Truvada for pre-exposure prophylaxis (PrEP).

The US Court of Federal Claims ruled on Nov. 21 that the government breached certain agreements with Gilead by failing to promptly notify the company of its patent applications for Truvada for PrEP, according to documents unsealed on Wednesday.

The issue traces back to around 2004 when Truvada won an accelerated approval to treat HIV. Because HIV is known to develop resistance to therapy, patients at the time were often required to take more than one drug at a time. Truvada combines Gilead’s prior HIV drugs, Emtriva and Viread, making life easier for patients who were taking separate pills daily. Shortly after, the CDC and Gilead struck up a partnership to research Truvada’s use as a preventative measure prior to exposure.