[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two up­dates on the law­suit against Pur­due Phar­ma over its role in fu­el­ing the opi­oid epi­dem­ic, as the Sack­ler fam­i­ly threat­ens to walk away from their pledge to pay out $3 bil­lion if a bank­rupt­cy judge does not stop out­stand­ing state law­suits against them. At the same time, the com­pa­ny has asked per­mis­sion to pay mil­lions in bonus­es to se­lect em­ploy­ees.

Pur­due filed for chap­ter 11 bank­rupt­cy this week as part of its signed res­o­lu­tion to over 2,000 law­suits. The deal would see the Sack­ler fam­i­ly that owns Pur­due give $3 bil­lion from their per­son­al wealth and the com­pa­ny turned in­to a trust com­mit­ted to curb­ing and re­vers­ing over­dos­es.

But the back­lash to the pro­posed set­tle­ment was al­most im­me­di­ate, with Penn­syl­va­nia At­tor­ney Gen­er­al Josh Shapiro call­ing it a “slap in the face” to fam­i­lies of over­dose vic­tims. AGs from Mass­a­chu­setts, New York, New Jer­sey and Con­necti­cut al­so did not sign the set­tle­ment.

“It al­lows the Sack­ler fam­i­ly to walk away bil­lion­aires and ad­mit no wrong­do­ing,” Shapiro said in a state­ment.

The at­tor­ney gen­er­als asked the fam­i­ly to sell its British com­pa­ny Mundiphar­ma im­me­di­ate­ly, stop cre­at­ing drugs for in­ter­na­tion­al mar­kets and com­mit an­oth­er $1.5 bil­lion.

Now the fam­i­ly is say­ing that if a judge does not halt law­suits from those states for 270 days, they will pull their com­mit­ment.  Lawyers said the com­pa­ny is spend­ing $5 mil­lion per week in le­gal fees that could in­stead go to claimants and the pub­lic if lit­i­ga­tion is stopped.

On Tues­day, Pur­due re­quest­ed per­mis­sion to pay $34 mil­lion in bonus­es to se­lect em­ploy­ees, the Wash­ing­ton Post re­port­ed, say­ing they were vi­tal to keep­ing the com­pa­ny strong as it con­verts in­to a pub­lic trust.

But Con­necti­cut At­tor­ney Gen­er­al William Tong ob­ject­ed in court to the pro­pos­al, say­ing the mon­ey should go to vic­tims. And the re­quest drew larg­er con­dem­na­tion, in­clud­ing from Sen­a­tor Joe Manchin, whose home state of West Vir­ginia has by some mea­sures been the hit the hard­est by the opi­oid epi­dem­ic.

Al­though J&J has al­ready been found guilty and fined by an Ok­la­homa judge for its role in the cri­sis and oth­er com­pa­nies face law­suits, Pur­due is of­ten blamed for start­ing the epi­dem­ic in the 90s through its re­vival of oxy­codone in the form of Oxy­Con­tin and the ag­gres­sive and al­leged­ly mis­lead­ing sales tac­tics it used to mar­ket the drug to doc­tors, which in­clud­ed the claim that con­cerns about opi­oid ad­dic­tion were overblown.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Boston skyline (Shutterstock)

Boston, the Bay Area and San Diego dom­i­nate the life sci­ences re­al es­tate mar­ket. Where to next?

With strong competition for life sciences real estate in key clusters — greater Boston, San Francisco and San Diego — where will the industry look to expand next? That’s the question that real estate company JLL sought to answer in its latest report, released on Wednesday.

JLL scored US biotech hubs on a variety of criteria to come up with this year’s ranking, including talent, industry depth, innovation and lab real estate dynamics. Unsurprisingly, they found that last year’s top three clusters remain unchanged. JLL predicts that these core clusters will be “immovable” for the foreseeable future, comparing them to the Silicon Valley of biotech.

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Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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