En­do con­sid­ers bank­rupt­cy fil­ing as it feels the heat from thou­sands of opi­oid law­suits — re­port

En­do In­ter­na­tion­al is re­port­ed­ly con­sid­er­ing fil­ing for bank­rupt­cy in an at­tempt to dig it­self out from bil­lions of dol­lars in debt and a moun­tain of opi­oid law­suits.

Un­named sources told the Wall Street Jour­nal that En­do is weigh­ing a Chap­ter 11 fil­ing as it con­tends with $8 bil­lion in debt. The com­pa­ny has al­so yet to set­tle thou­sands of law­suits over its opi­oid pain med Opana ER, which was tak­en off the mar­ket in 2017 at the FDA’s re­quest. En­do did not re­spond to an in­ter­view re­quest as of press time.

Opana ER was first ap­proved in 2006, and six years lat­er, En­do in­tro­duced a re­for­mu­lat­ed ver­sion in­tend­ed to pre­vent phys­i­cal or chem­i­cal ma­nip­u­la­tion for abuse. How­ev­er, an FDA ad­vi­so­ry com­mit­tee vot­ed 18-8 in 2017 that the drug’s ben­e­fits no longer out­weighed the risks, as post-mar­ket­ing da­ta showed a “sig­nif­i­cant shift in the route of abuse.”

“The abuse and ma­nip­u­la­tion of re­for­mu­lat­ed Opana ER by in­jec­tion has re­sult­ed in a se­ri­ous dis­ease out­break,” for­mer CDER di­rec­tor Janet Wood­cock said in a state­ment at the time.

En­do set­tled some of the law­suits against it, agree­ing ear­li­er this year to pay $65 mil­lion to es­cape claims in Flori­da, $26 mil­lion to West Vir­ginia, $7.5 mil­lion to Louisiana and $25 to Al­aba­ma. Back in De­cem­ber, the com­pa­ny inked a $63 mil­lion set­tle­ment with Texas. How­ev­er, thou­sands of un­re­solved claims re­main.

In its lat­est quar­ter­ly re­port, En­do not­ed that it hasn’t been able to set­tle most of the opi­oid claims against it, and as a re­sult, ex­ecs are “ex­plor­ing a wide ar­ray of po­ten­tial ac­tions as part of our con­tin­gency plan­ning,” which may in­clude a bank­rupt­cy fil­ing. The com­pa­ny spent more than $32 mil­lion on le­gal costs in the first quar­ter, in­clud­ing opi­oid-re­lat­ed costs, ac­cord­ing to SEC pa­pers. 

Un­named sources told the WSJ that En­do is un­like­ly to reach a set­tle­ment with opi­oid plain­tiffs be­fore fil­ing for a Chap­ter 11, though they not­ed that the sit­u­a­tion may change.

Last month, the com­pa­ny an­nounced in an SEC fil­ing that it missed in­ter­est pay­ments of $38 mil­lion and has en­tered a 30-day grace pe­ri­od be­fore de­fault­ing on the loan.

En­do said the missed pay­ment was “not dri­ven by liq­uid­i­ty con­straints,” and added that it’s in dis­cus­sion with cred­i­tors about “strate­gic al­ter­na­tives.” As of March 31, the com­pa­ny re­port­ed $1.4 bil­lion in cash on hand.

If it choos­es to file for bank­rupt­cy, En­do would fol­low in the foot­steps of Oxy­con­tin man­u­fac­tur­er Pur­due Phar­ma and Mallinck­rodt, which al­so filed for a Chap­ter 11 amid mount­ing opi­oid claims.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.