Wal­mart is next in line on na­tion­al opi­oid set­tle­ment, pay­ing $3B+ for its role in epi­dem­ic

Fol­low­ing opi­oid-re­lat­ed set­tle­ments from CVS and Wal­greens with states and oth­er na­tion­al groups, Wal­mart is now do­ing the same: not ad­mit­ting any guilt but agree­ing to pay more than $3 bil­lion.

Wal­mart an­nounced the set­tle­ment Tues­day morn­ing, adding that it had agreed to “fi­nan­cial amounts and pay­ment terms to re­solve sub­stan­tial­ly all opi­oids-re­lat­ed law­suits filed against the Com­pa­ny, as well as all po­ten­tial claims that could be made against the Com­pa­ny, by states and po­lit­i­cal sub­di­vi­sions and tribes,” per an SEC fil­ing.

Wal­mart is set­tling amid ac­cu­sa­tions of how its phar­ma­cies han­dled opi­oids, with the New York At­tor­ney Gen­er­al’s of­fice say­ing in a state­ment Tues­day that the com­pa­ny con­tributed to the US opi­oid cri­sis by fail­ing to reg­u­late opi­oid pre­scrip­tions at its stores.

The of­fice added that Leti­tia James co-led a group of at­tor­neys gen­er­al, in­clud­ing those from Cal­i­for­nia, Col­orado, Illi­nois, Mass­a­chu­setts, Ohio and Texas, among the 15 states that ne­go­ti­at­ed the set­tle­ment.

James pinned blame on Wal­mart by say­ing in a state­ment, “Phar­ma­cies such as Wal­mart played an un­de­ni­able role in per­pet­u­at­ing opi­oids’ de­struc­tion.”

The set­tle­ment nets New York $116 mil­lion and will re­quire “sig­nif­i­cant im­prove­ments in how Wal­mart’s phar­ma­cies han­dle opi­oids.” The set­tle­ment is be­ing sent to oth­er states for re­view and ap­proval, and James’ of­fice added that the at­tor­ney gen­er­al is op­ti­mistic that the set­tle­ment will gain the sup­port of the re­quired 43 states by the end of 2022, which would al­low lo­cal gov­ern­ments to join on ear­ly next year.

The set­tle­ment al­so in­cludes cer­tain court-or­dered re­quire­ments that Wal­mart would have to com­ply with, in­clud­ing flag­ging sus­pi­cious pre­scrip­tions and im­ple­ment­ing over­sight to pre­vent fraud­u­lent pre­scrip­tions.

Wal­mart is uti­liz­ing two frame­works — apt­ly named the “State Set­tle­ment Frame­work” and the “Trib­al Set­tle­ment Frame­work” — to set­tle al­most all opi­oid claims that ei­ther have been made against Wal­mart or could be made against the gro­cery store gi­ant for up to $3.1 bil­lion. That amount al­so in­cludes mon­ey set aside for “re­me­di­a­tion of al­leged harms” as well as at­tor­neys’ fees.

Wal­mart al­so said that the $3.1 bil­lion in­cludes some amounts from pre­vi­ous­ly agreed re­cent set­tle­ments — but not all.

Wal­mart said that if enough states agree to the frame­work and all oth­er con­di­tions were met, then the com­pa­ny would start mak­ing pay­ments as soon as No­vem­ber 2023.

And as par for the course for set­tle­ments, the frame­works “in­clude no ad­mis­sion of wrong­do­ing or li­a­bil­i­ty by the Com­pa­ny.”

Hints of Wal­mart join­ing the set­tle­ment trick­led out weeks ago, when Bloomberg tipped off that the su­per­store would pay out $3 bil­lion to set­tle opi­oid claims — af­ter CVS agreed to shell out more than $5 bil­lion over the next decade and Wal­greens set­tled on $4.8 bil­lion over a 15-year pe­ri­od.

The set­tle­ment would be one of the largest in re­cent mem­o­ry as part of the US opi­oid scan­dal, af­ter drug dis­trib­u­tors agreed to a multi­bil­lion-dol­lar set­tle­ment ear­li­er this year. Un­der that set­tle­ment, Amerisource­Ber­gen agreed to pay up to $6.1 bil­lion, Car­di­nal will con­tribute up to $6 bil­lion, and McKesson is on the hook for up to $7.4 bil­lion over the next 18 years.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; and more

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.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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