Ac­cused of milk­ing the CMS with co-pay kick­backs, J&J's Acte­lion set­tles case for $310M

As the Trump ad­min­is­tra­tion con­tin­ues to pump out new pro­pos­als to guard the Cen­ters of Medicare and Med­ic­aid Ser­vices against high drug prices, its law en­force­ment arm has al­so been busy round­ing up bio­phar­ma com­pa­nies that it says have es­sen­tial­ly bought their ways in­to re­im­burse­ment for their ever-more-ex­pen­sive ther­a­pies.

Acte­lion has been made the lat­est ex­am­ple, hav­ing agreed to pay $360 mil­lion to re­solve kick­back al­le­ga­tions.

Jean-Paul Clozel

The scheme — which vi­o­lat­ed the False Claims Act, ac­cord­ing to the US At­tor­ney’s Of­fice — al­leged­ly took place be­tween 2014 and 2015, when Jean-Paul Clozel was still in charge and be­fore J&J be­gan en­gag­ing in a bid that cul­mi­nat­ed in a $30 bil­lion buy­out in 2017.

Per the al­le­ga­tions, Acte­lion used an as­sis­tance foun­da­tion to cov­er co-pays for thou­sands of Medicare pa­tients tak­ing its drugs for pul­monary ar­te­r­i­al hy­per­ten­sion, in­clud­ing Tr­a­cleer, Ven­tavis, Veletri and Op­sum­it. By foot­ing these re­quired pay­ments, the gov­ern­ment says, the com­pa­ny was in­duc­ing pa­tients to pur­chas­es drugs with oth­er­wise pro­hib­i­tive high prices — and pil­ing up bills for Medicare.

Acte­lion al­so al­leged­ly di­rect­ed Medicare pa­tients who qual­i­fied for its own free drug pro­gram to the foun­da­tion in­stead, fur­ther milk­ing gov­ern­ment re­im­burse­ment.

Im­por­tant­ly, the gov­ern­ment added, Acte­lion bud­get­ed its do­na­tions to the foun­da­tion care­ful­ly to make sure that its con­tri­bu­tion would not cov­er pa­tients tak­ing ri­val PAH drugs. It did so by keep­ing close track of the num­ber of pa­tients the foun­da­tion helped and the amount spent on them.

Joseph Hunt

“Phar­ma­ceu­ti­cal com­pa­nies can­not have it both ways — they can­not con­tin­ue to in­crease drug prices while en­gag­ing in con­duct de­signed to de­feat the mech­a­nisms that Con­gress de­signed to check such prices and then ex­pect Medicare to pay for the bal­loon­ing costs,” said As­sis­tant At­tor­ney Gen­er­al Joseph Hunt of the De­part­ment Jus­tice’s Civ­il Di­vi­sion in a state­ment.

Dur­ing the pe­ri­od cov­ered in the set­tle­ment, US At­tor­ney An­drew Lelling not­ed, “Acte­lion raised the price of its main PAH drug, Tr­a­cleer, by near­ly 30 times the rate of over­all in­fla­tion in the Unit­ed States.”

Car­ing Voice Coali­tion, the med­ical char­i­ty in­volved in the scheme, got in­to trou­bles of its own late last year when the gov­ern­ment re­voked its rights to pro­vide such co-pay as­sis­tance to pa­tients, due to con­cerns about im­prop­er in­flu­ence from drug­mak­ers.

Unit­ed Ther­a­peu­tics, an­oth­er PAH drug­mak­er, set­tled a sim­i­lar probe a month lat­er for $210 mil­lion, one of the first to emerge from an in­dus­try-wide in­ves­ti­ga­tion.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Ted Love. HAVERFORD COLLEGE

Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Ab­b­Vie touts new da­ta for Hu­mi­ra suc­ces­sor; Gilead inks dis­cov­ery deal

→ Ab­b­Vie is tout­ing new pos­i­tive da­ta com­par­ing their ag­ing block­buster Hu­mi­ra with their hoped-for block­buster upadac­i­tinib. Over 48 weeks a larg­er pro­por­tion of pa­tients tak­ing the ex­per­i­men­tal drug ex­pe­ri­enced clin­i­cal re­mis­sion than in the con­trol arm with Hu­mi­ra. Their drug brought in $20 bil­lion last year, top­ping the scales in the num­ber 1 slot.

→ Gilead has turned to Van­cou­ver-based Ab­Cellera for its lat­est dis­cov­ery deal. Ab­Cellera will use its know-how in “sin­gle-cell screen­ing of nat­ur­al im­mune sources” to find an­ti­body can­di­dates for Gilead to pur­sue in the in­fec­tious dis­ease field. The deal in­cludes an up­front and mile­stones.

Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

The Wash­ing­ton Post man­aged to whip up the quick­est in­dus­try con­sen­sus I’ve ever seen that one of its re­porters was pur­vey­ing overblown non­sense with a sto­ry that Pfiz­er was sit­ting on da­ta sug­gest­ing that En­brel could be an ef­fec­tive treat­ment for Alzheimer’s. 

In cov­er­ing that bit of an­ti-Big Phar­ma fan­ta­sy — there are lots of rea­sons to go af­ter phar­ma, but this piece was lu­di­crous — I not­ed com­ments in the sto­ry from some promi­nent peo­ple in the field crit­i­ciz­ing Pfiz­er for not pub­lish­ing the da­ta. I sin­gled out Rudy Tanzi at Har­vard and then ap­plied some added crit­i­cism for the things he’s done to hype — in my opin­ion — high­ly ques­tion­able as­sump­tions. You can see it in the link. 

Adding mar­quee in­vestors, Black­Thorn bags $76M to back an AI-dri­ven strat­e­gy for pre­ci­sion neu­ro med­i­cine

As ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing loom ever larg­er in drug dis­cov­ery and de­vel­op­ment, a biotech op­er­at­ing at the “nexus” of tech­nol­o­gy and neu­ro­sciences has cashed in with $76 mil­lion in fresh fi­nanc­ing.

The big idea at Black­Thorn Ther­a­peu­tics is to do for neu­robe­hav­ioral dis­or­ders what ge­net­i­cal­ly tar­get­ed ther­a­py has done for on­col­o­gy: Re­de­fine pa­tient pop­u­la­tions by the un­der­ly­ing bi­ol­o­gy — dys­reg­u­lat­ed brain cir­cuits, or neu­rotypes — in­stead of symp­toms, there­by find­ing the pa­tients who are most like­ly to ben­e­fit at en­roll­ment phase.