Kåre Schultz, Teva CEO (Christopher Goodney/Bloomberg via Getty Images)

Te­va reach­es $523M agree­ment with New York in lat­est opi­oid-re­lat­ed set­tle­ment

Te­va has been work­ing on mak­ing head­way with its planned na­tion­al set­tle­ment over its role in the US opi­oid epi­dem­ic. And it has one less state to be fo­cused on.

Te­va ex­ecs con­firmed that a set­tle­ment was reached in New York, echo­ing an an­nounce­ment from New York At­tor­ney Gen­er­al Leti­tia James ear­li­er this week. The AG con­firmed that the state gets more than half a bil­lion dol­lars from the gener­ics gi­ant, end­ing the state’s lit­i­ga­tion against opi­oid man­u­fac­tur­ers and dis­trib­u­tors.

“And it’s done in the way that New York ba­si­cal­ly signs on to the na­tion­al agree­ment, which has a cer­tain val­ue. And then they al­so get what you call a tri­al bump be­cause they have a ver­dict against us,” CEO Kåre Schultz told in­vestors and an­a­lysts.

The chief ex­ec­u­tive con­tin­ued:

They get some ex­tra mon­ey. And what’s im­por­tant for us is, of course, that the na­tion­al agree­ment is what we al­ready had ac­crued for. We had al­so ac­crued for the pre­mi­um for New York, most of it, and we now have an arrange­ment where the ex­tra mon­ey they get, they get it over 18 years, which is good for us be­cause it means that it’s very man­age­able in re­la­tion to our cash flow and our debt sit­u­a­tion. So we are quite sat­is­fied with that out­come.

That tri­al bump that Schultz re­ferred to was elab­o­rat­ed by James, who said that as part of Te­va’s na­tion­al set­tle­ment pre­vi­ous­ly an­nounced ear­li­er this year, New York’s share of that multi­bil­lion-dol­lar pay­out would be around $210.5 mil­lion. The tri­al win adds an ad­di­tion­al $313.3 mil­lion to New York’s pay­ments, adding up to $523.8 mil­lion.

The drug­mak­er had agreed in prin­ci­ple with over a dozen states to pay out $4.25 bil­lion over 13 years (in­clud­ing al­ready set­tled cas­es for about $550 mil­lion). Spe­cif­ic de­tails of the set­tle­ment were still be­ing fi­nal­ized, sev­er­al state at­tor­neys gen­er­al said at the time. And not even a week af­ter Te­va reached a deal, Ab­b­Vie’s Al­ler­gan unit al­so agreed to pay $2.37 bil­lion to state and lo­cal gov­ern­ments.

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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