Ok­la­homa judge finds J&J guilty for its role in the opi­oid epi­dem­ic — but shares spike on $572M fine

An Ok­la­homa judge on Mon­day found phar­ma gi­ant J&J guilty of help­ing lay the ground­work on a na­tion­wide epi­dem­ic of opi­oid ad­dic­tion, but on­ly fined the com­pa­ny $572 mil­lion — at the very bot­tom of the range an­a­lysts had set, which stretched up in­to the bil­lions.

The close­ly watched out­come will help cal­i­brate es­ti­mates of just what kind of li­a­bil­i­ty the multi­na­tion­al com­pa­ny faces for an epi­dem­ic the CDC says has cost the lives of hun­dreds of thou­sands of peo­ple through­out the coun­try.

For in­vestors, it was good news, as J&J shares spiked close to 4% on the guilty rul­ing.

Michael Ull­mann

The Ok­la­homa At­tor­ney Gen­er­al had ar­gued that J&J’s ag­gres­sive sales prac­tices cre­at­ed an over­sup­ply of opi­oids that drove the epi­dem­ic, while un­der­play­ing the dan­gers and hyp­ing the re­wards of opi­oids. J&J was the on­ly re­main­ing de­fen­dant, af­ter Te­va and Pur­due Phar­ma reached their own set­tle­ments with­out ad­mit­ting guilt.

Not sur­pris­ing­ly, J&J saw it dif­fer­ent­ly, say­ing the state’s case nev­er proved their con­tention that the com­pa­ny’s ac­tions had cre­at­ed a pub­lic nui­sance. Now they’re go­ing to ap­peal.

“Janssen did not cause the opi­oid cri­sis in Ok­la­homa, and nei­ther the facts nor the law sup­port this out­come,” said Michael Ull­mann, J&J’s gen­er­al coun­sel. “We rec­og­nize the opi­oid cri­sis is a tremen­dous­ly com­plex pub­lic health is­sue and we have deep sym­pa­thy for every­one af­fect­ed. We are work­ing with part­ners to find ways to help those in need.”

This case was con­sid­ered a bell­wether suit which could have a big im­pact on the hun­dreds of state and lo­cal cas­es that are be­ing jug­gled now, pre­sent­ing the pos­si­bil­i­ty of a mas­ter agree­ment that could reach past $100 bil­lion.

For its part, J&J ar­gued that it played — at most — a mi­nus­cule role in the epi­dem­ic in Ok­la­homa. The phar­ma gi­ant tried, with­out suc­cess, to get the case thrown out, ar­gu­ing it was pro­tect­ed by the First Amend­ment. 

Ok­la­homa AG Mike Hunter coun­tered by say­ing that J&J ex­ecs co­or­di­nat­ed their mar­ket­ing work on opi­oids with Pur­due for years. 

Pur­due’s own­ers, the Sack­ler fam­i­ly, came to a $270 mil­lion set­tle­ment deal with the state, which will be used to pay for a new drug re­search cen­ter.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,400+ biopharma pros reading Endpoints daily — and it's free.

FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

Endpoints Premium

Premium subscription required

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

Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

Less than a year after pulling in an impressive $62 million Series C round, PMV Pharma is back at it again.

The Cranbury, NJ-based biotech announced Monday an additional $70 million in Series D financing as it seeks to develop cancer therapies targeting p53 mutations. Additionally, PMV also introduced longtime biotech entrepreneur Rich Heyman as chairman of the board of directors.

“This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic,” said PMV president and CEO David Mack in a statement.

Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Therapeutics closed $102 million in Series C funding led by Biotechnology Value Fund and Redmile Group, CEO Nello Mainolfi noted the protein degradation player was “at the cusp of transitioning” into a fully integrated R&D company. Five months and a major Sanofi pact later, he’s back asking for another little push to get there.

Kymera has penciled in $100 million in its first IPO pitch — although given the public market’s seemingly insatiable appetite for biotechs these days the final figure is anyone’s guess.

CymaBay flash­es pos­i­tive re­sults from the tri­al they have to re­launch

Two weeks after the FDA lifted its clinical hold on their lead drug, CymaBay said it showed positive results in an aborted Phase III trial.

The drug, a small molecule known as seladelpar, had been in development for three different liver conditions before an independent review of a NASH study last year showed that it might actually be damaging patient’s liver cells. The FDA slapped a clinical hold across all three trials, only lifting it last month when an FDA review determined that the drug hadn’t caused liver damage.