Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drug­mak­er En­do In­ter­na­tion­al is en­ter­ing in­to bank­rupt­cy as it faces the weight of se­ri­ous lit­i­ga­tion re­lat­ed to its in­volve­ment in the opi­oid epi­dem­ic in the US.

The com­pa­ny has filed Chap­ter 11 pro­ceed­ings in the US Bank­rupt­cy Court for the South­ern Dis­trict of New York, with the com­pa­ny ex­pect­ed to file recog­ni­tion pro­ceed­ings in Cana­da, the UK and Aus­tralia. The com­pa­ny’s bank­rupt­cy fil­ing showed the com­pa­ny had as­sets and li­a­bil­i­ties in the range of $1 bil­lion to $10 bil­lion.

This comes as at­tor­neys gen­er­al from sev­er­al US states have reached a $450 mil­lion na­tion­wide set­tle­ment. Ac­cord­ing to the Mass­a­chu­setts at­tor­ney gen­er­al’s of­fice, an agree­ment in prin­ci­ple has been reached with En­do where, pend­ing the court’s ap­proval, En­do will pro­vide up to $450 mil­lion to par­tic­i­pat­ing states and lo­cal gov­ern­ments as well as ban the pro­mo­tion of En­do’s opi­oids and re­quire En­do to turn over mil­lions of doc­u­ments re­lat­ed to its role in the opi­oid cri­sis and for the docs to be pub­lished in a pub­lic on­line archive.

The agree­ment seeks to re­solve al­le­ga­tions that En­do had boost­ed opi­oid sales us­ing de­cep­tive mar­ket­ing that down­played the risk of ad­dic­tion while over­stat­ing the ben­e­fits.

En­do makes gener­ic and brand­ed opi­oids in­clud­ing Per­co­cet and En­do­cet, as well as Opana ER, ap­proved in 2006 but with­drawn in 2017. The states al­lege that En­do had false­ly pro­mot­ed the ben­e­fits of Opana ER’s abuse-de­ter­rent for­mu­la­tion, which did lit­tle to de­ter abuse.

An FDA ad­comm vot­ed 18-8 in 2017 stat­ing that the drug’s ben­e­fits no longer out­weighed the risks, as post-mar­ket­ing da­ta showed a “sig­nif­i­cant shift in the route of abuse.”

The bank­rupt­cy move was an­tic­i­pat­ed as far back as Ju­ly, as the com­pa­ny felt the heat from var­i­ous law­suits sur­round­ing the opi­oid cri­sis on top of the com­pa­ny be­ing $8 bil­lion in the hole.

“By de­fin­i­tive­ly ad­dress­ing the more than $8 bil­lion of debt that has bur­dened our bal­ance sheet and es­tab­lish­ing a path­way to clo­sure with re­spect to the thou­sands of opi­oid-re­lat­ed and oth­er law­suits that the Com­pa­ny has been de­fend­ing at an un­sus­tain­able cost, we will be able to move for­ward as a new En­do and reach our full po­ten­tial,” said En­do CEO Blaise Cole­man in a state­ment.

While En­do might be bull­ish about the move, the com­pa­ny is still fac­ing a de­clin­ing stock price $ENDP as it is well-en­trenched in the pen­ny stock zone at $.33 per share. The news to­day sent its price down 11% adding to an over 91% drop since Jan­u­ary.

The com­pa­ny has al­so shelled out sig­nif­i­cant amounts in set­tle­ments this year as it has paid $65 mil­lion to es­cape claims in Flori­da, $26 mil­lion to West Vir­ginia, $7.5 mil­lion to Louisiana and $25 mil­lion to Al­aba­ma.

En­do is the lat­est of sev­er­al opi­oid man­u­fac­tur­ers, in­clud­ing Pur­due Phar­ma and Mallinck­rodt, that have filed Chap­ter 11 fil­ings in re­cent years as well as faced steep fi­nan­cial penal­ties over the opi­oid cri­sis.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.