Te­va to pay $4.3B to set­tle opi­oid epi­dem­ic lit­i­ga­tion with states

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.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

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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FDA's vac­cine ad­comm to re­view first fe­cal trans­plant to treat C. dif­fi­cile in­fec­tions

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.