[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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.