Te­va and about a dozen states have agreed in prin­ci­ple to pay a max­i­mum of $4.25 bil­lion over 13 years (in­clud­ing the al­ready set­tled cas­es for about $550 mil­lion) to set­tle opi­oid-re­lat­ed lit­i­ga­tion that will al­so see the Is­raeli-based gener­ic man­u­fac­tur­er pay an­oth­er $100 mil­lion to Na­tive Amer­i­can tribes.

Spe­cif­ic de­tails of the set­tle­ment are still be­ing fi­nal­ized, sev­er­al state at­tor­neys gen­er­al said, al­though the agree­ment would fol­low the same struc­ture as pre­vi­ous opi­oid set­tle­ments, in­clud­ing the $26 bil­lion agree­ment with opi­oid dis­trib­u­tors and John­son & John­son.

Te­va CEO Kåre Schultz told an­a­lysts in Wednes­day’s earn­ings call that the deal is very sim­i­lar­ly struc­tured to the one agreed up­on by J&J and Amerisource­Ber­gen, Car­di­nal Health, and McKesson.

“That means that the ac­tu­al im­ple­men­ta­tion will start some­time next year,” Schultz added.

Cal­i­for­nia At­tor­ney Gen­er­al Rob Bon­ta said last night that states al­leged Te­va pro­mot­ed po­tent, rapid-on­set fen­tanyl for use by non-can­cer pa­tients, de­cep­tive­ly mar­ket­ed opi­oids by down­play­ing the risk of ad­dic­tion and over­stat­ing their ben­e­fits and failed to com­ply with sus­pi­cious or­der mon­i­tor­ing re­quire­ments along with its dis­trib­u­tor, An­da.

“One prob­lem we en­coun­tered with Te­va (as we have with oth­er man­u­fac­tur­ers) is the ad­vice it gave when opi­oids were los­ing their ef­fec­tive­ness for clear­ly ad­dict­ed pa­tients – just up the dosage. I don’t have enough ad­jec­tives to de­scribe how poor that ad­vice was,” Ten­nessee At­tor­ney Gen­er­al Her­bert Slatery III said in a state­ment.

As part of this lat­est deal, Te­va will al­so pro­vide up to $1.2 bil­lion in gener­ic nalox­one (val­ued at whole­sale ac­qui­si­tion cost), which can re­verse an opi­oid over­dose, over a 10-year pe­ri­od, or $240 mil­lion of cash in lieu of prod­uct, ac­cord­ing to each state’s wish­es.

The ne­go­ti­a­tions are be­ing led by Cal­i­for­nia, Illi­nois, Iowa, Mass­a­chu­setts, New York, North Car­oli­na, Penn­syl­va­nia, Ten­nessee, Texas, Ver­mont, Vir­ginia and Wis­con­sin. Te­va and New York are al­so still en­gaged in fur­ther ne­go­ti­a­tions, the states and Te­va con­firmed.

Con­necti­cut At­tor­ney Gen­er­al William Tong added that this set­tle­ment al­so has no im­pact on the on­go­ing mul­ti­state price-fix­ing case Con­necti­cut is lead­ing against Te­va.

Te­va said in an SEC fil­ing yes­ter­day that it:

ex­pects that it will have the doc­u­men­ta­tion for the na­tion­wide set­tle­ment agree­ment fi­nal­ized with­in the com­ing weeks, with the na­tion­wide set­tle­ment sign-on process for states, sub­di­vi­sions, and tribes to fol­low. While the agree­ment will in­clude no ad­mis­sion of wrong­do­ing, it re­mains in our best in­ter­est to put these cas­es be­hind us and con­tin­ue to fo­cus on the pa­tients we serve every day.

“And the un­der­stand­ing be­tween the par­ties is, of course, that by far the ma­jor­i­ty of states and sub­di­vi­sions will opt-in. That’s the whole point of all the ne­go­ti­a­tions and ob­sta­cles, that you have a na­tion­wide set­tle­ment in prin­ci­ple. So we are very op­ti­mistic that we will see a very high par­tic­i­pa­tion rate, prob­a­bly sim­i­lar to what you saw with J&J,” Schultz told an­a­lysts.

While the new opi­oid set­tle­ment was the head­lin­er for the earn­ings call, rev­enue came in for the drug­mak­er at $3.8 bil­lion for Q2.

Part of that is due to the com­pa­ny’s launch back in March of a gener­ic form of lenalido­mide, aka Bris­tol Mey­ers’ on­col­o­gy block­buster Revlim­id. Com­pa­ny rev­enue guid­ance for 2022 had al­so dropped ap­prox­i­mate­ly $400 mil­lion, from a range be­tween $15.4 – $16.0 bil­lion to $15.0 – $15.6 bil­lion. Te­va not­ed in an SEC fil­ing and on the an­a­lyst call that the guid­ance change was main­ly due to “con­tin­ued for­eign ex­change head­winds.”

“There are no re­main­ing tri­als cur­rent­ly sched­uled against us in 2022, with the pos­si­ble ex­cep­tion of the re­lease phase of the tri­als in New York opi­oid lit­i­ga­tion. Ad­di­tion­al­ly, New York State and sub­di­vi­sions are en­gaged in on­go­ing set­tle­ment ne­go­ti­a­tions,” Schultz added on the con­fer­ence call.

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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The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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A federal appeals court on Tuesday denied prosecutors’ attempt to lengthen the sentences of two former GSK scientists who pleaded guilty to stealing trade secrets.

Yu Xue and Tao Li pleaded guilty back in 2018 to conspiracy to steal trade secrets, after they, along with others, formed a pharmaceutical company in China called Renopharma using hundreds of stolen documents from GSK, according to court documents. Xue, a former top chemist at GSK’s Upper Merion, PA, facility, was accused of stealing more than 200 documents, some of which contained trade secrets about pharmaceutical products under development, research data, and development and manufacturing processes.

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Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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