Kåre Schultz, Teva CEO

Opi­oids, price-fix­ing and now kick­backs. Pros­e­cu­tors add an­oth­er ‘en­rich­ing’ scheme to the claims against Te­va

Te­va Phar­ma­ceu­ti­cals $TE­VA is in le­gal trou­ble again, this time for al­leged­ly de­fraud­ing Medicare.

On Tues­day, fed­er­al pros­e­cu­tors sued the Is­raeli drug­mak­er, ac­cus­ing them of pay­ing hun­dreds of mil­lions of dol­lars to two foun­da­tions as part of a scheme to boost sales for the block­buster mul­ti­ple scle­ro­sis drug Co­pax­one. The suit comes af­ter a se­ries of le­gal chal­lenges — large­ly over their role in the opi­oid cri­sis and in price-fix­ing schemes with oth­er gener­ic pro­duc­ers — that have helped knock Te­va from its for­mer po­si­tion as one of the world’s top drug­mak­ers.

The lat­est chal­lenge knocked Te­va’s shares down near­ly 15% Tues­day, from $11.62 to $9.92, al­though it has al­ready be­gun to re­bound.

Ac­cord­ing to the com­plaint, filed in the US Dis­trict Court of Mass­a­chu­setts, from 2006 through at least 2015, Te­va paid over $300 mil­lion in kick­backs to The As­sis­tance Fund and the Chron­ic Dis­ease Fund. These pay­ments were os­ten­si­bly to sup­port funds the foun­da­tions keep to help pa­tients with co-pays, but the Jus­tice De­part­ment al­leges that Te­va con­spired with the groups to as­sure that a max­i­mum amount of the do­na­tions went to Co­pax­one pa­tients.

Those sub­si­dies al­lowed Te­va to more than quin­tu­ple the cost of Co­pax­one with­out hav­ing pa­tients feel the brunt of those costs and turn to oth­er drugs, pros­e­cu­tors al­leged, un­der­min­ing the Medicare co-pays meant to act as a mar­ket-based check on drug prices. They said the ac­tions vi­o­lat­ed fed­er­al leg­is­la­tion against kick­backs and meant that tax­pay­ers shoul­dered the bur­den for Te­va’s ris­ing prices.

“Te­va in­tend­ed the pay­ments to en­sure that Co­pax­one pa­tients nev­er faced the steep prices that Te­va charged for its drug, thus in­duc­ing the pa­tients, in­clud­ing Medicare pa­tients, to pur­chase the drug,” the law­suit claims.

The scheme, they wrote, re­sult­ed in “in­creas­ing Co­pax­one sales and en­rich­ing Te­va in amounts that far ex­ceed­ed its pay­ments to the foun­da­tions.”

The gov­ern­ment is seek­ing dam­ages, plus “re­cov­ery of all monies by which Te­va has been un­just­ly en­riched, in­clud­ing prof­its Te­va earned be­cause of il­le­gal in­duce­ments.”

In state­ments to mul­ti­ple me­dia out­lets, in­clud­ing Reuters and The Wall Street Jour­nal, Te­va said it would de­fend it­self, adding that the law­suit “on­ly seeks to fur­ther re­strict pa­tients’ ac­cess to im­por­tant med­i­cines and health­care.”

For years, Co­pax­one was a cash cow for Te­va, fu­el­ing its rise from a gener­ics pro­duc­er to one of the world’s top drug­mak­ers. At its peak, the drug earned Te­va more than $3 bil­lion in a sin­gle year.

The drug then played an in­stru­men­tal role in Te­va’s fall as, be­gin­ning in 2015, gener­ics ate in­to the com­pa­ny’s mar­ket. At­tempts at suc­ces­sor drugs and new block­busters failed, and with the drug­mak­er quick­ly at the cen­ter of both price-fix­ing and opi­oid law­suits and with gener­ic drug prices falling, share prices fell from near­ly $70 in 2015 to around $10 to­day.

Still, the com­pa­ny had been eye­ing a turn­around of late. In 2017, they brought in a new CEO in long­time No­vo Nordisk ex­ec­u­tive Kåre Schultz, who steered Te­va to $4.5 bil­lion in rev­enue last year — $100 mil­lion above ex­pec­ta­tions.  In opi­oid ne­go­ti­a­tions, he has ar­gued with ap­par­ent suc­cess that “we don’t have that much mon­ey,” reach­ing a set­tle­ment frame­work cen­tered on do­nat­ed an­ti-ad­dic­tion drugs, with few cash pay­ments.

In the spring, Te­va walked away from ne­go­ti­a­tions over crim­i­nal price-fix­ing charges, threat­en­ing the case could put the com­pa­ny out of busi­ness and gam­bling that the US gov­ern­ment would be un­will­ing to come down hard on a drug­mak­er dur­ing a pan­dem­ic.

And ear­li­er this week, when states re­dou­bled de­mands on opi­oid pro­duc­ers and an­nounced plans to seek a $26.4 bil­lion set­tle­ment, Te­va was no­tice­ably ab­sent from the list.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

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AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Eli Lilly CSO Dan Skovronsky (file photo)

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The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Dan Skovronsky, Eli Lilly CSO

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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