Kansas court pre­lim­i­nar­i­ly ap­proves Vi­a­tris' $264M EpiPen set­tle­ment

A fed­er­al court has 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 life-sav­ing EpiPens.

Kansas Judge Daniel Crab­tree pre­lim­i­nar­i­ly agreed to the set­tle­ment on Fri­day, paving the way for a fi­nal ap­proval that won’t come un­til at least the sec­ond half of the year. A fair­ness hear­ing will take place on Ju­ly 6, ac­cord­ing to court doc­u­ments.

The case dates back to 2017, when plain­tiffs filed a com­plaint al­leg­ing Vi­a­tris — cre­at­ed out of the merg­er of Up­john and My­lan — “de­vised an il­le­gal scheme” to pre­vent EpiPen com­peti­tors from com­ing to mar­ket. The com­pa­ny has been un­der heavy fire since 2016, when the price of two EpiPens surged to $608, up from $100 in 2007.

“As a re­sult, mil­lions of Amer­i­cans re­ly­ing on this life-sav­ing de­vice have paid ex­or­bi­tant prices for EpiPens that are in no way teth­ered to or con­strained by a com­pet­i­tive mar­ket,” an amend­ed com­plaint states.

The com­plaint ac­cus­es both My­lan and Pfiz­er, which man­u­fac­tured the EpiPen, of en­gag­ing in an­ti-com­pet­i­tive con­duct that cre­at­ed a mo­nop­oly.

The “scheme” con­sist­ed of mul­ti­ple parts, plain­tiffs said, al­leg­ing that the de­fen­dants: mis­clas­si­fied EpiPen un­der Med­ic­aid’s Med­ical Drug Re­bate Pro­gram; of­fered ag­gres­sive re­bates and in­cen­tives to phar­ma­cy ben­e­fit man­agers con­di­tioned on ex­clud­ing com­peti­tors from the mar­ket; of­fered free EpiPens to schools through its Ac­cess to Schools pro­gram, on the ex­clu­sion of com­peti­tor prod­ucts; cre­at­ed a patent thick­et; and as­sert­ed that EpiPens should be sold sole­ly in two-packs, dri­ving up cost.

These ac­tions “en­dan­gered the lives of mil­lions of Amer­i­cans,” the amend­ed com­plaint al­leges.

“It is al­so time to send a mes­sage that the law will not tol­er­ate the fraud­u­lent and an­ti­com­pet­i­tive ac­tions of Amer­i­ca’s phar­ma­ceu­ti­cal gi­ants,” the doc­u­ment states.

Heather Bresch

Then-My­lan CEO Heather Bresch, daugh­ter of De­mo­c­ra­t­ic Sen­a­tor Joe Manchin, left the com­pa­ny af­ter the merg­er in 2020. But she vig­or­ous­ly de­fend­ed the price in­crease be­fore the House Over­sight and Gov­ern­ment Re­form Com­mit­tee, say­ing, “Price and ac­cess ex­ist in a bal­ance, and we be­lieve we have struck that bal­ance.”

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.

“The Board of Di­rec­tors be­lieves that this set­tle­ment is in the best in­ter­ests of the Com­pa­ny and its stake­hold­ers. The res­o­lu­tion of these in­di­rect pur­chas­er cas­es will al­low the Com­pa­ny to move for­ward and con­tin­ue fo­cus­ing on its strate­gic pri­or­i­ties,” it said last month.

Crab­tree dis­missed much of the case against My­lan last June, leav­ing on­ly a claim con­cern­ing a 2012 patent lit­i­ga­tion set­tle­ment with gener­ic drug­mak­er Te­va. Pfiz­er al­so struck a $345 mil­lion set­tle­ment last year.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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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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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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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.