Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

John­son & John­son unit Janssen on Wednes­day sued Am­gen over the com­pa­ny’s pro­posed biosim­i­lar to its megablock­buster Ste­lara (ustek­inum­ab), af­ter Am­gen said it was ready to launch next May or as soon as the FDA signs off on it.

If Am­gen car­ries through with that plan, Janssen told the Delaware dis­trict court that the Thou­sand Oaks, CA-based com­pa­ny will in­fringe on at least two Janssen patents.

The suit fol­lows Am­gen’s an­nounce­ment in April that pre­lim­i­nary re­sults from a Phase III study eval­u­at­ing the ef­fi­ca­cy and safe­ty of its ustek­inum­ab biosim­i­lar, known as ABP 654, met its pri­ma­ry ef­fi­ca­cy end­point in adult pa­tients with mod­er­ate-to-se­vere plaque pso­ri­a­sis, demon­strat­ing no clin­i­cal­ly mean­ing­ful dif­fer­ences be­tween ABP 654 and Ste­lara.

Ear­li­er this month, Am­gen al­so said that the Phase III da­ta were sub­mit­ted to the FDA to sup­port its biosim­i­lar ap­pli­ca­tion, and Janssen says Am­gen is al­so seek­ing an in­ter­change­abil­i­ty tag, which could po­ten­tial­ly make it more com­pet­i­tive if oth­er biosim­i­lars to Ste­lara en­ter the mar­ket.

Janssen says that the FDA sub­mis­sion con­sti­tutes an in­fringe­ment on its Ste­lara patents, even as the J&J sub­sidiary con­tends that Am­gen re­fused to dis­close when it filed its ap­pli­ca­tion, whether the FDA has ac­cept­ed it, whether Am­gen will par­tic­i­pate in the so-called “patent dance,” or whether the law’s dead­line by which Am­gen must pro­vide Janssen with a copy of its ap­pli­ca­tion has passed.

“Am­gen’s stat­ed in­ten­tion to launch its ABP 654 biosim­i­lar prod­uct as soon as pos­si­ble presents a con­tro­ver­sy of suf­fi­cient im­me­di­a­cy to sup­port de­clara­to­ry judg­ment of patent in­fringe­ment,” the suit says.

First ap­proved in 2009, Ste­lara hauled in more than $11 bil­lion in sales in 2020 and 2021, and is now pre­scribed as a treat­ment for plaque pso­ri­a­sis, pso­ri­at­ic arthri­tis, Crohn’s dis­ease and ul­cer­a­tive col­i­tis.

Oth­er po­ten­tial Ste­lara biosim­i­lar com­peti­tors may come from Ice­land-based Alvotech, Ger­many’s Formy­con, Chi­na-based Bio-Thera So­lu­tions, as well as the Ko­rea-based com­pa­nies Sam­sung Bioepis, Cell­tri­on, and Dong-A ST. The com­po­si­tion of mat­ter patent for Ste­lara ex­pires next year.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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