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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Seat­tle Ge­net­ic­s' Astel­las-part­nered ADC nails con­fir­ma­to­ry PhI­II in urothe­lial can­cer

Nine months after Seattle Genetics nabbed an accelerated approval for its Astellas-partnered antibody-drug conjugate Padcev, the partners said the therapy has nailed a confirmatory Phase III, proving its worth in locally advanced or metastatic urothelial cancer.

Padcev, which has widely been tapped as a potential blockbuster, scored improvements in both overall survival and progression-free survival compared to chemotherapy, causing a 30% reduction in risk of death (p = 0.001) and 39% reduction in risk of disease progression or death (p<0.00001).

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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