J&J set­tles Ohio opi­oid case for $20.4M, avoids loom­ing tri­al

J&J has agreed to a $20.4 mil­lion set­tle­ment with two Ohio coun­ties that at the height of the opi­oid cri­sis saw around 1,000 com­bined an­nu­al over­dose deaths, pro­vid­ing a large cash in­fu­sion for a pair of lo­cal­i­ties that have act­ed with fierce and some­times con­tro­ver­sial in­de­pen­dence to com­bat se­vere lo­cal man­i­fes­ta­tions of a na­tion­al epi­dem­ic.

The pay­out pales in com­par­i­son to the half-bil­lion dol­lar fine the phar­ma­ceu­ti­cal gi­ant was or­dered to pay out in Ok­la­homa, al­though that deal cov­ered the en­tire state rather than two coun­ties.

This was the first fed­er­al tri­al brought in the opi­oid case, mak­ing it a flash­point for the states, towns and tribes as well as the opi­oid mak­ers and dis­trib­u­tors in­volved in sim­i­lar cas­es na­tion­wide. Ear­ly next year, a sim­i­lar case in West Vir­ginia — the state with the high­est rate of opi­oid deaths — is set to be tak­en up.

J&J will give the Cuya­hoga and Sum­mit coun­ties $10 mil­lion com­bined, plus $5 mil­lion in le­gal fees and $5.4 mil­lion to opi­oid-re­lat­ed char­i­ties in the area, the com­pa­ny an­nounced. They ad­mit­ted no wrong­do­ing, main­tain­ing they “re­spon­si­bly mar­ket­ed” their opi­oid drugs and “ac­count­ed for less than one per­cent of to­tal opi­oid pre­scrip­tions in the Unit­ed States.”

This won’t end opi­oid-re­lat­ed lit­i­ga­tion for ei­ther J&J or the Ohio coun­ties. Like oth­er drug­mak­ers, J&J faces over 2,000 oth­er suits na­tion­wide, while Cuya­hoga and Sum­mit both stand to earn pay­outs in the pend­ing $12 bil­lion Pur­due Phar­ma pay­out and are con­tin­u­ing law­suits against oth­er com­pa­nies. The two al­ready re­ceived a com­bined $24 mil­lion from Mallinck­rodt Phar­ma­ceu­ti­cals – a com­pa­ny DEA in­ves­ti­ga­tors once called “the king­pin of the drug car­tel.” En­do In­ter­na­tion­al $ENDP and Al­ler­gan Plc $AGN al­so set­tled in Au­gust.

These set­tle­ments have not come with­out con­tro­ver­sy or push­back from the oth­er states and lo­cal­i­ties in­volved in the na­tion­wide le­gal bat­tle to put phar­ma­ceu­ti­cal in­dus­try cash in the hands of gov­ern­ments and char­i­ties try­ing to curb a na­tion­wide cri­sis they say the in­dus­try start­ed. In Au­gust, Ohio At­tor­ney Gen­er­al Dave Yost tried to de­lay the Cuya­hoga and Sum­mit tri­als, ar­gu­ing they could set a prece­dent that would un­der­cut state ef­forts to help a broad­er pop­u­la­tion.

“I just want to be ab­solute­ly clear that my in­ter­est in the law, that it should be con­sol­i­dat­ed un­der Ohio’s ju­ris­dic­tion legal­ly, does not change the fact that the mon­ey needs to be spent on the lo­cal lev­el,” he said. “Be­cause the mis­ery and the ad­dic­tion isn’t hap­pen­ing [just] in Colum­bus, it’s hap­pen­ing in com­mu­ni­ties all the way across the state.”

Thir­teen oth­er states and the Dis­trict of Co­lum­bia agreed with Yost. Judge Dan Pol­ster has al­so pushed for a na­tion­al tri­al, even as he’s al­lowed the Cuya­hoga and Sum­mit case to go through. Fac­ing vol­leys from all sides, J&J and oth­er large phar­mas al­so pre­fer con­sol­i­da­tion and are pur­su­ing a plan to join on­to the mas­sive Pur­due Phar­ma deal in a bid to reach a glob­al set­tle­ment.

J&J for­mer­ly mar­ket­ed painkillers Dura­gesic and Nucyn­ta and owned two com­pa­nies that processed and im­port­ed the raw ma­te­r­i­al for oxy­codone, a drug of­ten seen as the linch­pin of the cri­sis.

Six phar­ma­ceu­ti­cal com­pa­nies are still set to face tri­al on Oc­to­ber 21. They are McKesson Corp, Amerisource­Ber­gen, Car­di­nal Health, Te­va Phar­ma­ceu­ti­cal In­dus­tries, Wal­greens Boots Al­liance and Hen­ry Schein.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

Endpoints News

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Alex Karnal (Deerfield)

Deer­field vaults to the top of cell and gene ther­a­py CD­MO game with $1.1B fa­cil­i­ty at Philadel­phi­a's newest bio­phar­ma hub

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.

Tri­fec­ta of sick­le cell dis­ease ther­a­pies ex­tend life ex­pectan­cy, but are not cost-ef­fec­tive — ICER

Different therapeutic traits brandished by the three approved therapies for sickle cell disease all extend life expectancy, but their impact on quality of life is uncertain and their long-term cost-effectiveness is not up to scratch according to the thresholds considered reasonable by ICER, the non-profit concluded in a draft guidance report on Thursday.

Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.