In­sys founder, for­mer ex­ecs face decades in jail af­ter be­ing found guilty in land­mark opi­oid case

In­sys should’ve paid heed to this ill-fat­ed line from its own sales rap song. “If you want to be great, lis­ten to my voice. You can be great — but its your choice.” In­stead, its (for­mer) bil­lion­aire founder John Kapoor and four of his high rank­ing col­leagues were found guilty of en­gag­ing in a bribery scheme to get doc­tors to pre­scribe its po­tent, ad­dic­tive painkiller and dupe in­sur­ers in­to pay­ing for the drug, by a fed­er­al ju­ry on Thurs­day.

Each de­fen­dant — for­mer Chair­man Kapoor; for­mer vice-pres­i­dent of man­aged mar­kets Michael Gur­ry; for­mer na­tion­al di­rec­tor of sales Richard Si­mon; and for­mer re­gion­al sales di­rec­tors Sun­rise Lee and Joseph Rowan — faces up to twen­ty years in jail, al­though they have de­nied any wrong­do­ing and sig­naled plans to ap­peal. The crim­i­nal con­vic­tion is his­toric as it takes aim at the pow­er­ful mas­ter­minds be­hind a mar­ket­ing ploy de­signed to put prof­it ahead of pa­tients — in­stead of mere fines, or let­ting pow­er­ful ex­ec­u­tives make sac­ri­fi­cial lambs of their lieu­tenants.

Kapoor cre­at­ed In­sys $IN­SY in 1990. In 2012, the com­pa­ny’s fen­tanyl spray Sub­sys was ap­proved by the FDA for break­through can­cer pain. Fen­tanyl is a man-made opi­oid 50 times more po­tent than hero­in and 100 times more po­tent than mor­phine, ac­cord­ing to the CDC. Three years lat­er, Rod­dy Boyd of the South­ern In­ves­tiga­tive Re­port­ing Foun­da­tion first brought to light the dead­ly im­pact of in­dis­crim­i­nate Sub­sys pre­scrib­ing, trig­gered by In­sys’ ques­tion­able mar­ket­ing prac­tices in this damn­ing re­port. In 2017, the In­di­an-born Kapoor was charged with the crim­i­nal con­spir­a­cy — on the very day Pres­i­dent Trump de­clared the US opi­oid cri­sis a pub­lic health emer­gency.

Pros­e­cu­tors charged In­sys with in­flat­ing Sub­sys sales by brib­ing doc­tors to pre­scribe the drug to pa­tients with­out can­cer — in an elab­o­rate scheme that in­clud­ed win­ing and din­ing them, pay­ing them to speak at “ed­u­ca­tion­al events” and in one case even a lap dance — fu­el­ing the rag­ing opi­oid cri­sis that kills 130 Amer­i­cans every day.

Tri­al ju­rors were giv­en a front-row seat to the ob­scene video de­signed to train sales reps, in which two im­pec­ca­bly suit­ed men — os­ten­si­bly In­sys em­ploy­ees — ‘rap’ the Ari­zona-based drug­mak­er’s sin­is­ter strat­e­gy re­plete with rapid hand ges­tures: “I love titra­tions. Yeah, that’s not a prob­lem. I got new pa­tients, and I got a lot of ‘em…If you want to be great, lis­ten to my voice. You can be great — but it’s your choice.”

Al­though Kapoor’s lawyers as­sert­ed that the 75-year-old was kept in the dark about these ac­tiv­i­ties, the tes­ti­mo­ny of for­mer In­sys sales head Alec Burlakoff — who emerges as the man adorn­ing the Sub­sys cos­tume in the video that lit­er­al­ly blue­prints In­sys’ reck­less mar­ket­ing strat­e­gy — sul­lied that ar­gu­ment as the gov­ern­ment’s key wit­ness. Burlakoff, along with for­mer chief ex­ec­u­tive Michael Babich, tes­ti­fied against Kapoor af­ter plead­ing guilty to par­tic­i­pat­ing in the scheme.

Alec Burlakoff

The tri­al’s ver­dict is in­dica­tive of the “ac­tions of a se­lect few for­mer em­ploy­ees of the com­pa­ny,” In­sys spokesper­son Jack­ie Mar­cus told End­points News in an emailed state­ment, adding that “Kapoor’s (In­sys) shares have been and will re­main man­aged by an in­de­pen­dent trust, with which Kapoor is not in­volved.”

Last Au­gust, In­sys had agreed to fork over at least $150 mil­lion in a re­lat­ed set­tle­ment with the U.S. Jus­tice De­part­ment. Un­der fire for the role in played in the cri­sis of opi­oid abuse, mis­use and ad­dic­tion in the Unit­ed States, the com­pa­ny in No­vem­ber said it was look­ing to di­vest its ar­se­nal of opi­oid as­sets — in­clud­ing Sub­sys — to sharp­en its fo­cus on its pipeline of cannabis-de­rived ther­a­peu­tics.

Michael Babich

But as the com­pa­ny’s le­gal fees be­gan to add up, In­sys’ au­di­tor last month raised doubts on the drug­mak­er’s abil­i­ty to con­tin­ue as a go­ing con­cern. In­sys is hard­ly the on­ly opi­oid drug mak­er in fi­nan­cial trou­ble. Pur­due Phar­ma — the mak­er of one of most wide­ly abused pre­scrip­tion opi­oid painkiller Oxy­con­tin — is re­port­ed­ly con­sid­er­ing bank­rupt­cy.

Mean­while, oth­er drug man­u­fac­tur­ers, dis­trib­u­tors and phar­ma­cies are al­so fac­ing hun­dreds of civ­il law­suits for their role in the prop­a­gat­ing opi­oid cri­sis.


Im­age Source: John Kapoor. AP

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Covid-19 roundup: EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund; Bei­jing ar­rests ex-Bio­gen staffer who flew while in­fect­ed

For months now, the US government has doled out unprecedented grants to vaccine developers in hopes of speeding the completion of a Covid-19 candidate, even if that meant putting hundreds of millions or billions behind efforts that ultimately failed. Now, the European Union may do the same.

The EU is planning to use a $2.7 billion rainy day fund to make advance purchases of vaccine candidates, Reuters reports. The news comes a day after the Trump Administration reportedly settled on the five finalists for its Operation Warp Speed, all of whom will get significant funding and other US assistance to finish testing and scale up their vaccine candidates.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

Doug Throckmorton speaks via video conference to the Senate Finance Committee, June 2, 2020 (Andrew Caballero-Reynolds, AP Images)

FDA de­fends its over­sight of for­eign drugs amid Sen­ate, GAO crit­i­cism

During a Senate Committee on Finance hearing Tuesday, officials from the FDA responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.

The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic.

Much of the criticism centered on the agency’s practice of giving foreign facilities advanced notice of inspections while most domestic surveillance inspections are unannounced, as well as US reliance on foreign drug manufacturing.