Supreme Court re­jects Pfiz­er's bid to re­view an­ti-kick­back case

The Supreme Court shot down Pfiz­er’s pe­ti­tion on Mon­day to re­view a case that pre­vents it from pro­vid­ing fi­nan­cial as­sis­tance to help Medicare ben­e­fi­cia­ries ac­cess its rare heart con­di­tion drug.

The case re­volves around tafamidis, Pfiz­er’s drug for transthyretin amy­loid car­diomy­opa­thy (AT­TR-CM), a rare con­di­tion that oc­curs when clumps of ab­nor­mal pro­teins build up in the heart, mak­ing it hard­er to pump. Symp­toms may start with fa­tigue and short­ness of breath but can be­come fa­tal, ac­cord­ing to court doc­u­ments.

While Pfiz­er’s drug, mar­ket­ed as Vyn­daqel and Vyn­damax, costs rough­ly $225,000 per year, the phar­ma gi­ant pro­posed an as­sis­tance pro­gram that would cov­er a ma­jor­i­ty of the $13,000 an­nu­al co­pay for cer­tain Medicare ben­e­fi­cia­ries who can’t af­ford the drug, lim­it­ing their costs to $35 a month. HHS, how­ev­er, re­fused to al­low it, cit­ing the fed­er­al An­ti-Kick­back Statute. Low­er courts sided with the gov­ern­ment, lead­ing Pfiz­er to bring the case to the Supreme Court back in Oc­to­ber.

“This case is about how re­spon­dents’ over­broad in­ter­pre­ta­tion of a crim­i­nal statute out­laws a wide swath of rou­tine, ben­e­fi­cial con­duct in con­nec­tion with fed­er­al­ly fund­ed health­care,” Pfiz­er wrote in its pe­ti­tion.

Fur­ther, the com­pa­ny ar­gued that the “stag­ger­ing­ly over­broad con­struc­tion of the AKS” would “cur­tail a range of rou­tine com­mer­cial in­ter­ac­tions and chill, or even fore­close, char­i­ta­ble ef­forts to en­able ac­cess to es­sen­tial med­ical care.”

The Supreme Court not­ed on Mon­day that the pe­ti­tion was de­nied. Pfiz­er was not im­me­di­ate­ly avail­able for com­ment.

The news comes as the com­pe­ti­tion clos­es in on Pfiz­er in the AT­TR-CM space. Al­ny­lam sub­mit­ted a sup­ple­men­tal new drug ap­pli­ca­tion just last month for its patisir­an, cur­rent­ly sold as On­pat­tro for the treat­ment of polyneu­ropa­thy of hered­i­tary AT­TR amy­loi­do­sis in adults.

This marks the lat­est in a string of an­ti-kick­back cas­es in­volv­ing phar­ma com­pa­nies, in­clud­ing Bio­gen, which paid $22 mil­lion in 2021 to set­tle claims that it schemed to con­vince pa­tients in­to tak­ing its mul­ti­ple scle­ro­sis drugs by spon­sor­ing their Medicare co­pays.

Back in Sep­tem­ber, the com­pa­ny shelled out an­oth­er $900 mil­lion to set­tle years-old al­le­ga­tions that it sub­mit­ted false claims to Medicare and Med­ic­aid by pay­ing kick­backs to physi­cians for train­ing or con­sult­ing, as part of ef­forts to en­cour­age them to pre­scribe Bio­gen drugs.

Ear­li­er that month, Bay­er paid $40 mil­lion to set­tle two cas­es, one of which ac­cused the com­pa­ny of pay­ing kick­backs to doc­tors and hos­pi­tals to con­vince them to use Bay­er drugs Tra­sy­lol and Avelox. At the time, Bay­er said the set­tle­ment re­flect­ed a “busi­ness de­ci­sion” and did not ad­mit wrong­do­ing.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.

Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.

Bill Anderson, incoming Bayer CEO (David Paul Morris/Bloomberg via Getty Images)

Bay­er taps Roche's Bill An­der­son to lead phar­ma gi­ant as CEO

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

Iya Khalil, Merck VP and head of data, AI and genome sciences (Novartis)

Mer­ck-No­var­tis re­volv­ing door spins again as AI leader Iya Khalil switch­es phar­mas

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.