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.

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.