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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus -- chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy reveal tomorrow with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.