David Sackler (House Television via AP Images)

Fed­er­al bank­rupt­cy judge ap­proves Pur­due Phar­ma and Sack­ler­s' $6 bil­lion opi­oid set­tle­ment

A US bank­rupt­cy judge on Wednes­day ap­proved Pur­due Phar­ma’s set­tle­ment plan that will see the Sack­lers pay up to $6 bil­lion to states and vic­tims of ad­dic­tion for their role in the opi­oid epi­dem­ic — which is a bil­lion more than a pre­vi­ous set­tle­ment that was tossed out in De­cem­ber.

The Sack­ler fam­i­ly, who owns Pur­due Phar­ma, will pay be­tween $5.5 bil­lion and $6 bil­lion over 18 years, ac­cord­ing to a re­cent state­ment from Con­necti­cut At­tor­ney Gen­er­al William Tong. And while the plan would put an end to civ­il claims against the fam­i­ly over Pur­due’s in­volve­ment in the opi­oid epi­dem­ic, it does not re­lease them from fu­ture crim­i­nal li­a­bil­i­ty.

“No set­tle­ment will ever come close to ad­dress­ing the mag­ni­tude of suf­fer­ing and harm caused by Pur­due and the Sack­ler fam­i­ly,” Tong said Wednes­day. “But in reach­ing this $6 bil­lion set­tle­ment we rec­og­nized that we could not stall this process for­ev­er for vic­tims and our sis­ter states.”

As with the orig­i­nal set­tle­ment, the com­pa­ny will be dis­solved or sold, and the Sack­lers will be banned from the opi­oid in­dus­try in the US and around the world. But the lat­est re­vi­sions would al­so re­quire the Sack­lers to al­low in­sti­tu­tions to re­move the fam­i­ly name from build­ings, schol­ar­ships, and fel­low­ships, ac­cord­ing to Tong.

“Mu­se­ums and uni­ver­si­ties may now scrub the tar­nished Sack­ler name from their walls—en­sur­ing this fam­i­ly is re­mem­bered through­out his­to­ry for their cal­lous dis­dain for hu­man suf­fer­ing and noth­ing else,” the AG said last week.

The set­tle­ment is still wait­ing on fi­nal ap­proval.

The Sack­lers said last week that they are “pleased to have reached a set­tle­ment,” and con­tin­ue to main­tain their in­no­cence.

“While the fam­i­lies have act­ed law­ful­ly in all re­spects, they sin­cere­ly re­gret that Oxy­Con­tin, a pre­scrip­tion med­i­cine that con­tin­ues to help peo­ple suf­fer­ing from chron­ic pain, un­ex­pect­ed­ly be­came part of an opi­oid cri­sis that has brought grief and loss to far too many fam­i­lies and com­mu­ni­ties,” they said in a state­ment last week.

On Thurs­day, the fam­i­ly heard court pre­sen­ta­tions from vic­tims and their fam­i­lies.

Pur­due filed for bank­rupt­cy back in 2019 amid mount­ing law­suits al­leg­ing de­cep­tive mar­ket­ing of the com­pa­ny’s high­ly ad­dic­tive pain re­liev­er Oxy­con­tin. While the Sack­lers de­ny any wrong­do­ing, Pur­due plead­ed guilty to three felonies in 2020: one count of con­spir­a­cy to de­fraud the US and vi­o­late the FDA Cos­met­ic Act, and two counts of con­spir­a­cy to vi­o­late the fed­er­al an­ti-kick­back statute.

“As to­day’s plea to felony charges shows, Pur­due put opi­oid prof­its ahead of peo­ple and cor­rupt­ed the sa­cred doc­tor-pa­tient re­la­tion­ship,” Christi­na Nolan, US At­tor­ney for Ver­mont, said in a press re­lease at the time.

Back in De­cem­ber, a fed­er­al judge over­turned a $4.5 bil­lion set­tle­ment that would have shield­ed mem­bers of the fam­i­ly from fu­ture lit­i­ga­tion. US Bank­rupt­cy Judge Robert Drain in White Plains, NY, had ini­tial­ly ap­proved that plan in Sep­tem­ber. But amid op­po­si­tion from mul­ti­ple states, in­clud­ing Con­necti­cut, Judge Colleen McMa­hon said it should not go for­ward.

“Five months ago, Con­necti­cut said no to a Pur­due bank­rupt­cy plan that al­lowed the Sack­ler fam­i­ly to pur­chase life­time le­gal im­mu­ni­ty with­out so much as an apol­o­gy,” Tong said.

Twen­ty states have ob­ject­ed to the new set­tle­ment, ac­cord­ing to a Reuters re­port, be­cause it in­cludes a $277 mil­lion pay­ment ex­clu­sive­ly to states that ne­go­ti­at­ed the $6 bil­lion deal.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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