Michael Goettler, Viatris CEO

Vi­a­tris agrees to pay $264M to set­tle EpiPen class ac­tion case

Just as Bio­con signs off on a $3.3 bil­lion buy­out of their shared biosim­i­lars busi­ness, Vi­a­tris’s pend­ing law­suit for its con­tro­ver­sial EpiPen might be no more — if the court signs off on it.

Keep­ing de­tails short, the phar­ma snuck in an an­nounce­ment about its EpiPen prod­uct in its Q4 re­port:

The Com­pa­ny has agreed, sub­ject to ap­proval by the Court, to a $264 mil­lion set­tle­ment, while deny­ing any al­le­ga­tion of wrong­do­ing, to re­solve the EpiPen Au­to-In­jec­tor in­di­rect pur­chas­er class ac­tion cas­es pend­ing in the U.S. Dis­trict Court for the Dis­trict of Kansas.

The phar­ma added that “the Board of Di­rec­tors be­lieves that this set­tle­ment is in the best in­ter­ests of the Com­pa­ny and its stake­hold­ers. The res­o­lu­tion of these in­di­rect pur­chas­er cas­es will al­low the Com­pa­ny to move for­ward and con­tin­ue fo­cus­ing on its strate­gic pri­or­i­ties.”

Heather Bresch

The phar­ma play­er, cre­at­ed out of the merg­er of Up­john and My­lan, came un­der heavy fire amid ac­cu­sa­tions of greed and price goug­ing af­ter news sur­faced in 2016 that the price of My­lan’s EpiPen, an au­to-in­jec­tor to treat se­vere al­ler­gic re­ac­tions, in­creased from about $100 in 2007 to $608 for a two-pack. At the time, the com­pa­ny had rev­enues of $11 bil­lion a year — fu­el­ing scathing cri­tiques about ris­ing US drug prices.

Then-My­lan CEO Heather Bresch, daugh­ter of De­mo­c­ra­t­ic sen­a­tor Joe Manchin, left the com­pa­ny af­ter the merg­er in 2020. But she vig­or­ous­ly de­fend­ed the price in­crease at the time be­fore the Con­gress Over­sight and Gov­ern­ment Re­form Com­mit­tee, say­ing that “Price and ac­cess ex­ist in a bal­ance, and we be­lieve we have struck that bal­ance.”

Fast for­ward one year, and My­lan fi­nal­ized a $465 mil­lion set­tle­ment with the US De­part­ment of Jus­tice to re­solve claims that it over­charged the gov­ern­ment for the EpiPen.

Daniel Crab­tree

The class-ac­tion case, brought be­fore Kansas City, KS judge Daniel Crab­tree, was on be­half of con­sumers and third-par­ty pay­ers such as in­sur­ers — with the plain­tiffs seek­ing $1 bil­lion in dam­ages, a sum that un­der some state an­titrust laws could have been mul­ti­plied.

The law­suit ac­cused both My­lan and Pfiz­er, which man­u­fac­tured the EpiPen, of en­gag­ing in an­ti­com­pet­i­tive con­duct — po­ten­tial­ly al­low­ing the com­pa­nies to main­tain a mo­nop­oly over the mar­ket for the de­vices. While the case was slat­ed to go on tri­al this month, Crab­tree dis­missed much of the case against My­lan last June, leav­ing on­ly a claim con­cern­ing a 2012 patent lit­i­ga­tion set­tle­ment with gener­ic drug­mak­er Te­va.

Pfiz­er had al­so set­tled last year for $345 mil­lion.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

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.