David Sackler testifies via video to a House Oversight Committee hearing (House Television via AP)

Sack­lers threat­en to walk away from Pur­due opi­oid set­tle­ment as anger builds over im­mu­ni­ty pro­vi­sions — re­port

Pur­due Phar­ma has been ne­go­ti­at­ing with the gov­ern­ment for months over how much it should owe for its role in the opi­oid cri­sis, in a plan that’s seen the com­pa­ny de­clare bank­rupt­cy and plead guilty to three crim­i­nal charges.

But the wealthy Sack­lers who own Pur­due are now re­port­ed­ly threat­en­ing to walk away from the deal should a broad le­gal shield pro­tect­ing the fam­i­ly be dropped.

In what’s be­lieved to be the first-ever court­room ap­pear­ance from a mem­ber of the Sack­lers in an opi­oid case, for­mer board mem­ber David Sack­ler told the bank­rupt­cy court Tues­day the fam­i­ly would not sup­port any deal that doesn’t in­clude an ex­pan­sive im­mu­ni­ty pro­vi­sion pro­tect­ing in­di­vid­ual Sack­lers from li­a­bil­i­ty as­so­ci­at­ed with opi­oid law­suits, the New York Times re­port­ed. The im­mu­ni­ty pro­vi­sion has emerged as a con­tentious is­sue in the tri­al, with crit­ics as­sail­ing the pro­posed deal as not go­ing far enough to get jus­tice for those af­fect­ed by the opi­oid epi­dem­ic.

“We need a re­lease that is suf­fi­cient to get our goals ac­com­plished, and if the re­lease fails to do that, then we will not sup­port it,” Sack­ler re­port­ed­ly said dur­ing the fourth day of tes­ti­mo­ny. Sack­ler said should the fam­i­ly fol­low through on its threat, all cas­es would be fought “to their fi­nal out­comes.”

The Sack­lers had pledged to com­mit $4.5 bil­lion to be paid out over nine to 10 years, in a set­tle­ment deal that would see Pur­due Phar­ma turn in­to a pub­lic ben­e­fits com­pa­ny ded­i­cat­ed to fight­ing the opi­oid cri­sis. Sack­ler fam­i­ly mem­bers would al­so give up all own­er­ship of Pur­due but be al­lowed to re­tain in­volve­ment in their oth­er phar­ma en­ter­pris­es for up to sev­en years, when they’d be sold to help fund lit­i­ga­tion pay­ments.

With­out that sum, the set­tle­ment would like­ly fall apart af­ter near­ly two years of ne­go­ti­a­tions fol­low­ing the com­pa­ny’s bank­rupt­cy fil­ing.

A fed­er­al judge had been ex­pect­ed to ap­prove the plan, the NYT re­port­ed, af­ter sev­er­al states that had pre­vi­ous­ly ob­ject­ed to the set­tle­ment with­drew their op­po­si­tion last month. But through­out the bank­rupt­cy tri­al’s tes­ti­mo­ny, the Sack­lers’ le­gal shield has drawn sig­nif­i­cant crit­i­cism, and the judge even not­ed he had “some con­cerns about the breadth” of the li­a­bil­i­ty pro­tec­tions.

In par­tic­u­lar, David Sack­ler said he ex­pects the im­mu­ni­ty will cov­er not on­ly his fam­i­ly, but about 1,000 oth­er in­di­vid­u­als such as con­trac­tors and con­sul­tants. Sack­ler added the fam­i­ly is an­tic­i­pat­ing the pro­tec­tion will ex­tend to law­suits un­re­lat­ed to opi­oids, in­clud­ing fu­ture suits over oth­er drugs pro­duced by Pur­due and Sack­ler-owned en­ti­ties.

Pur­due first sub­mit­ted its Chap­ter 11 plans in Sep­tem­ber 2019, fol­low­ing a pletho­ra of law­suits over at least a decade and a half seek­ing to hold the drug­mak­er ac­count­able for its role in the opi­oid epi­dem­ic. Many of these suits ob­ject­ed to Pur­due’s mar­ket­ing strate­gies of the painkiller Oxy­con­tin, in which the com­pa­ny down­played its ad­dic­tive­ness.

At first, the plan called for about $10 bil­lion in pay­ments to set­tle the suits, but that num­ber was re­vised down­ward in No­vem­ber 2020 to $8.3 bil­lion when Pur­due plead­ed guilty to ob­struct­ing the DEA’s ef­forts to com­bat the cri­sis, fail­ing to pre­vent the painkillers from end­ing up on the black mar­ket and en­cour­ag­ing doc­tors to write more painkiller pre­scrip­tions. Pur­due plead­ed guilty to more charges last month over mis­lead­ing the fed­er­al gov­ern­ment about its mar­ket­ing prac­tices.

In­di­vid­ual mem­bers of the Sack­ler fam­i­ly have not plead­ed guilty to any charges.

Pur­due is not the on­ly com­pa­ny im­pli­cat­ed in the opi­oid epi­dem­ic that has rav­aged the US for decades. In­sys and Mallinck­rodt al­so filed for bank­rupt­cy, with crit­ics slam­ming the moves say­ing they can freeze lit­i­ga­tion and leave those lit­i­gants com­pet­ing for pay­outs with a com­pa­ny’s cred­i­tors.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Nurses star in J&J's campaign centered on the importance of nurses who are increasingly stressed, burnt out and quitting the profession (via Johnson & Johnson)

Thank­ful for nurs­es: J&J's new cam­paign aims to re­set pan­dem­ic clock back to grat­i­tude

In the early days of the pandemic, people cheered for nurses – delivering food, writing thank you notes and ringing bells nightly to show their appreciation. But something shifted this summer, and now Johnson & Johnson wants to remind people of the gratitude that nurses still deserve.

Call it politics or pandemic weariness or the result of almost two years of a deadly pandemic, but nurses today face threats and mistreatment from patients and their angry family members. And nurses are leaving the profession in record numbers.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Drug­mak­ers cut prices on av­er­age by more than 60% to get on Chi­na's 2022 NDRL list — re­port

China’s National Reimbursement Drug List (NRDL) is a crystal clear example of the country’s bargaining power in the biotech and pharma market, as more firms have reportedly agreed to cut their prices for 67 new medicines to be included in its national medical insurance coverage starting in January.

Being on the list is lucrative. Essentially, if a biotech or pharma company gets on this list, they’re covered by the biggest insurance network in the country. Given China’s vast population, the Chinese government has significant leverage to decide which medicines can make a profit. While domestic drugmakers are quite willing to play that game, cutting prices significantly in exchange for getting on the list, international companies don’t do it as often.