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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.