Pur­due Phar­ma pro­pos­es $12B set­tle­ment to clean up opi­oid mess — re­port

Af­ter months of ne­go­ti­a­tions with states and fed­er­al plain­tiffs ac­cus­ing it of in­sti­gat­ing the opi­oid cri­sis through ag­gres­sive and de­cep­tive mar­ket­ing tac­tics, Pur­due Phar­ma is ready to pay $10 to $12 bil­lion to set­tle it all.

Dan Pol­ster Fed­er­al Bar As­so­ci­a­tion

The po­ten­tial deal would cov­er hun­dreds of law­suits be­ing waged against the com­pa­ny by states, cities, towns and tribes, which is be­ing over­seen by Unit­ed States dis­trict judge Dan Pol­ster in Cleve­land, along­side cas­es in­volv­ing oth­er pre­scrip­tion opi­oid mak­ers. As part of the deal, the Sack­ler fam­i­ly — who had been charged with build­ing a “multi­bil­lion-dol­lar drug em­pire based on ad­dic­tion” — will give up own­er­ship in Pur­due.

The ma­jor­i­ty of the set­tle­ment will come in the form of in-kind drug do­na­tions and prof­its, with the ex­cep­tion of a $3 bil­lion cash pay­ment from the Sack­ler fam­i­ly ($4.5 bil­lion if they man­age to sell Mundiphar­ma, an­oth­er drug com­pa­ny they own, for more). Pur­due has re­port­ed­ly pledged to pro­vide more than $4 bil­lion in drugs, in­clud­ing mar­ket­ed and ex­per­i­men­tal treat­ments for opi­oid ad­dic­tion and over­dose re­ver­sals, to the pub­lic for free. Un­der a new pub­lic ben­e­fit trust struc­ture, all sales of its oth­er drugs — in­clud­ing Oxy­Con­tin, the opi­oid at the cen­ter of its mis­deeds — would al­so go to the plain­tiffs.

If the set­tle­ment is reached, Pur­due will set a re­struc­tur­ing plan in­to mo­tion by first de­clar­ing Chap­ter 11 bank­rupt­cy, then tran­si­tion in­to a trust made of court-ap­point­ed trustees, who will then se­lect a board of di­rec­tors to run the day-to-day op­er­a­tions.

“While Pur­due Phar­ma is pre­pared to de­fend it­self vig­or­ous­ly in the opi­oid lit­i­ga­tion, the com­pa­ny has made clear that it sees lit­tle good com­ing from years of waste­ful lit­i­ga­tion and ap­peals,” the com­pa­ny said in a state­ment to NBC News, which first re­port­ed the deal.

Pur­due Phar­ma — which has re­port­ed­ly made more than $35 bil­lion in Oxy­Con­tin sales — and the Sack­ler fam­i­ly have pre­vi­ous­ly de­nied the le­gal al­le­ga­tions against them.

It’s un­clear whether, or how many, plain­tiffs are on board with the pro­posed terms of the deal. Pur­due is fram­ing it as a take it or leave it deal, since they plan to file for bank­rupt­cy no mat­ter the out­come and the re­sult­ing amount that could go in­to a set­tle­ment would be low­er than cur­rent­ly of­fered, ac­cord­ing to NBC.

An­drew Pol­lis Case West­ern Re­serve

“(The deal is) very sig­nif­i­cant. Nev­er be­fore have we ever seen a mem­ber of a pri­vate in­dus­try of­fer so much mon­ey to try to deal with a pub­lic health cri­sis of this mag­ni­tude,” An­drew Pol­lis, a law pro­fes­sor at Case West­ern Re­serve Uni­ver­si­ty, told NBC.

Opi­oid-re­lat­ed over­dos­es have claimed al­most 400,000 lives from 1999 to 2017, ac­cord­ing to the CDC. Gov­ern­ment at­tor­neys have brought over 2,000 law­suits against opi­oid man­u­fac­tur­ers and dis­trib­u­tors, both seek­ing dam­ages and at­tempt­ing to hold ex­ec­u­tives be­hind the de­ci­sions to boost opi­oid sales at all costs ac­count­able.

In May, ex­ec­u­tives at In­sys — which mar­kets a po­tent fen­tanyl spray — were found guilty of en­gag­ing in a bribery scheme to get doc­tors to pre­scribe their drug, Sub­sys. The com­pa­ny had pre­vi­ous­ly agreed to pay $225 mil­lion to set­tle fed­er­al lit­i­ga­tions, but are still in set­tle­ment talks with states af­ter de­clar­ing bank­rupt­cy. And on Mon­day glob­al phar­ma con­glom­er­ate J&J was found guilty and fined $572 mil­lion in an Ok­la­homa court for its role in the opi­oid epi­dem­ic there.

The par­ties have un­til Fri­day to re­port back to Pol­ster on the deal, the dis­trict judge who had en­cour­aged the set­tle­ment talks, the Wash­ing­ton Post not­ed.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

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While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

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The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

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The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

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Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.