Alex Gorsky, J&J CEO (Evan Vucci/AP Images)

As suits mount, J&J spins out talc li­a­bil­i­ties in­to Chap­ter 11 us­ing 'Texas two-step' ma­neu­ver

With law­suits pil­ing up al­leg­ing its talc ba­by pow­der prod­ucts are un­safe, J&J has tak­en the con­tro­ver­sial step of spin­ning out its re­lat­ed li­a­bil­i­ties in­to a new com­pa­ny and fil­ing for Chap­ter 11 bank­rupt­cy, ac­cord­ing to court pa­pers filed late Thurs­day.

The pro­ce­dures will now head to bank­rupt­cy court in North Car­oli­na, halt­ing all law­suits and their re­spec­tive dis­cov­ery process­es. It’s a move that comes a few months af­ter the Wall Street Jour­nal and Reuters both re­port­ed J&J was ex­plor­ing this op­tion, and af­ter a fed­er­al judge said the process could move for­ward in Au­gust.

Had J&J not en­gaged in the new sub­sidiary’s Chap­ter 11, the pay­outs would not have been ten­able, it said in court doc­u­ments. As the law­suits have mount­ed, grow­ing to near­ly 40,000 claims, J&J said it’s spent al­most $1 bil­lion in de­fense costs in the last five years. Set­tle­ments and ju­ry-award­ed pay­ments, mean­while, reached as high as $3.5 bil­lion.

“[T]he costs as­so­ci­at­ed with the con­tin­ued lit­i­ga­tion of the claims for decades to come would have been sim­ply un­sus­tain­able,” the doc­u­ments read. “The sta­tus quo there­fore was un­ten­able, and this chap­ter 11 case is nec­es­sary to ap­pro­pri­ate­ly as­sess, re­solve, and ad­min­is­ter these claims in an ef­fi­cient and eq­ui­table man­ner.”

Al­though J&J it­self, the world’s biggest phar­ma com­pa­ny worth more than $420 bil­lion in mar­ket cap, did not de­clare bank­rupt­cy, it uti­lized a Texas law that al­lows li­a­bil­i­ties to be sep­a­rat­ed from as­sets in­to a new en­ti­ty. J&J’s sub­sidiary, called LTL Man­age­ment, was cre­at­ed sole­ly for the pur­pose of hold­ing the talc-re­lat­ed debts and pay­ing out cred­i­tors.

The process is known for­mal­ly as a di­vi­sion­al merg­er but col­lo­qui­al­ly — and de­ri­sive­ly by crit­ics — as a Texas two-step bank­rupt­cy. Sev­er­al com­pa­nies fac­ing as­bestos-re­lat­ed lit­i­ga­tion have used the ma­neu­ver to shield them­selves from Chap­ter 11 pro­ceed­ings.

The bar­rage of law­suits has stemmed from al­le­ga­tions that the com­pa­ny’s tal­cum-based ba­by pow­der prod­ucts con­tained harm­ful ma­te­ri­als, such as as­bestos, and J&J hid the in­for­ma­tion while con­tin­u­ing to mar­ket and sell. J&J has tak­en talc-re­lat­ed suits to court in the past, los­ing a Mis­souri case in 2018 when a ju­ry award­ed plain­tiffs more than $4.7 bil­lion in dam­ages.

J&J is al­so ap­peal­ing an­oth­er suit in which a Mis­sis­sip­pi court ruled against the com­pa­ny, pe­ti­tion­ing the Supreme Court in Au­gust to re­view the case. Ear­li­er this month, eight for­mer FDA of­fi­cials filed an am­i­cus brief sup­port­ing J&J, say­ing the low­er court’s de­ci­sion “threat­ens to up­end” the way the agency makes la­bel­ing de­ci­sions.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges


Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.