Kåre Schultz, Teva CEO (Getty)

Te­va ex­ecs claim mixed win­ning streak in pricey opi­oids court bat­tle — as per­ma­nent peace re­mains elu­sive

Te­va ex­ecs turned up for the Q4 call with an­a­lysts to go deep in­to the num­bers, but it wasn’t long be­fore the lit­i­ga­tion around opi­oids took cen­ter stage in the Q&A.

CEO Kåre Schultz ad­dressed the re­cent court de­ci­sions in the US re­lat­ed to the phar­ma’s role in the US opi­oid epi­dem­ic — and how there have been mixed re­sults in dif­fer­ent courts, specif­i­cal­ly Cal­i­for­nia, Ok­la­homa and in New York.

“We had a court de­ci­sion, which was a bench tri­al, in Or­ange Coun­ty, Cal­i­for­nia, where it ba­si­cal­ly was stat­ed that, you know, if you do every­thing cor­rect, and the pre­scrip­tions are cor­rect, the prod­ucts are in com­pli­ance with FDA reg­u­la­tions and DEA reg­u­la­tions, then there’s no ba­sis for claim­ing pub­lic nui­sance li­a­bil­i­ty,” Schultz told in­vestors and an­a­lysts — call­ing it a “clear win” for the phar­ma.

He then talked about the J&J ver­dict from the Ok­la­homa Supreme Court, which Schulz claimed was a sim­i­lar rul­ing to the one from Cal­i­for­nia  — along the lines of pub­lic nui­sance li­a­bil­i­ty. And then, they got a loss in New York, where the phar­ma was found to be li­able. How­ev­er, Schultz said the phar­ma has a mis­tri­al mo­tion still pend­ing.

And while that mo­tion is play­ing out, the phar­ma still has 3500 cas­es pend­ing, Schultz said on the call.

In oth­er set­tle­ments, Te­va is pay­ing the state of Texas $150 mil­lion over the next 15 years, and the state of Louisiana $15 mil­lion over the next 18 years. These in­clude an ad­di­tion­al $75 mil­lion to Texas and $3 mil­lion to Louisiana in gener­ic Nar­can and gener­ic Sub­ox­one.

Be­yond those set­tle­ments, Schultz said that he was “still op­ti­mistic that we can reach a na­tion­wide set­tle­ment with­in the next 12 months.”

When an­a­lysts asked about the po­ten­tial set­tle­ment, the phar­ma re­spond­ed that the ini­tial frame­work — $250 mil­lion in cash and $23 bil­lion in prod­uct — that was of­fered back in 2019 to set­tle thou­sands of law­suits wasn’t at­trac­tive to plain­tiffs’ lawyers. As Schultz said, “I think it’s fair to say the rea­son why it [the deal] didn’t re­al­ly fly was main­ly be­cause the plain­tiff lawyers, they ba­si­cal­ly did not see any fees com­ing in from the prod­uct part. And that means that it was not at­trac­tive for them.”

Even fur­ther, the com­pa­ny said that it could ab­sorb the set­tle­ments it made so far on its bal­ance sheets — pre­cise­ly be­cause the pay­out is over a long pe­ri­od of time. Pay­ing out the en­tire sum in the set­tle­ments now is not in the cards, ac­cord­ing to Schultz — giv­en Te­va’s cur­rent debt.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.