Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stake­hold­ers sent com­ments to the FTC on whether the com­mis­sion should look fur­ther in­to phar­ma mid­dle­men, known as PBMs, with many of the com­menters call­ing for more fed­er­al over­sight.

Sim­i­lar to the crit­i­cal open com­ment pe­ri­od in a dead­locked FTC ses­sion last Feb­ru­ary, phar­ma­cies and phar­ma­cy groups are con­tin­u­ing to call out the lack of trans­paren­cy among the top 3 PBMs, which con­trol about 80% of the mar­ket.

“What has be­come ap­par­ent dur­ing the in­crease of con­trol and au­thor­i­ty of PBMs in the pre­scrip­tion drug mar­ket, is that when PBM ac­tiv­i­ty neg­a­tive­ly im­pacts in­de­pen­dent phar­ma­cies, it al­so neg­a­tive­ly im­pacts con­sumers,” the Na­tion­al Com­mu­ni­ty Phar­ma­cists As­so­ci­a­tion said in its com­ment.

What’s dif­fer­ent be­tween Feb­ru­ary and now is that there is one more Biden-ap­point­ed com­mis­sion­er on the FTC, so the bal­ance has shift­ed to a 3-2 ad­van­tage for Lina Khan, open­ing the door for a clos­er look in­to PBMs.

A coali­tion of the largest em­ploy­ers in the US al­so sent a let­ter to Khan yes­ter­day out­lin­ing their “dis­tress with the con­tin­ued preda­to­ry be­hav­ior of the PBM in­dus­try, an in­ex­cus­able lack of over­sight, and the co­hort’s rec­om­men­da­tions for the Com­mis­sion to in­crease trans­paren­cy and ad­dress the un­ten­ably high costs in health care.”

And the Amer­i­can Col­lege of Rheuma­tol­ogy said it’s “par­tic­u­lar­ly con­cerned” with sev­er­al PBM prac­tices that neg­a­tive­ly im­pact pa­tients, in­clud­ing “PBM-im­posed ac­cess bar­ri­ers, such as step ther­a­py and pri­or au­tho­riza­tion, [that] de­lay and de­ny nec­es­sary care for pa­tients,” and the way PBMs “cre­ate ad­min­is­tra­tive bur­dens for clin­i­cians and take valu­able time away from pa­tient care.”

Con­gress is sim­i­lar­ly push­ing for such sun­shine, and it’s been a bi­par­ti­san ef­fort too.

Re­pub­li­can Sens. Chuck Grass­ley (IA) and Mike Braun (IN), along­side De­mo­c­rat Sen. Ron Wyden (OR), sub­mit­ted a let­ter to Khan last week, call­ing for some­thing to be done af­ter the com­mis­sion­ers re­mained dead­locked in that 2-2 vote in Feb­ru­ary on whether to for­mal­ly look in­to an­ti-com­pet­i­tive prac­tices of PBMs.

At the time, Khan said, “We have a re­al moral im­per­a­tive to act, this in­quiry is long over­due.”

Ear­li­er this week, chairs of their re­spec­tive com­mit­tees, Sens. Maria Cantwell (D-WA) and Grass­ley in­tro­duced a new bill to shine a light on the PBM mar­ket and em­pow­er the FTC and state at­tor­neys gen­er­al to stop un­fair and de­cep­tive PBM busi­ness prac­tices.

The leg­is­la­tion would make it il­le­gal for PBMs to en­gage in what’s known as “spread pric­ing” in which they charge health plans and pay­ers more for a pre­scrip­tion drug than what they re­im­burse to the phar­ma­cy, and they pock­et the dif­fer­ence. The bill would al­so pro­hib­it PBMs from claw­ing back pay­ments made to phar­ma­cies, in­creas­ing fees or low­er­ing re­im­burse­ments to off­set re­im­burse­ment changes in fed­er­al­ly-fund­ed health plans.

Mean­while, in­dus­try group PhRMA praised a new re­port from Xcen­da that found PBMs are in­creas­ing­ly re­strict­ing pa­tient ac­cess to pre­scrip­tion med­i­cines.

In 2022, the re­port notes, 1,156 med­i­cines were ex­clud­ed from at least one of the three largest PBMs’ stan­dard com­mer­cial in­sur­ance for­mu­la­ries, which is a near­ly 1,000% in­crease in the num­ber of ex­clud­ed med­i­cines since 2014.

What’s worse is that brand-name drugs with­out a gener­ic or biosim­i­lar al­ter­na­tive ac­count­ed for near­ly half (47%) of to­tal for­mu­la­ry ex­clu­sions, leav­ing pa­tients with few­er and typ­i­cal­ly more ex­pen­sive treat­ment op­tions.

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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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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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.