Ar­a­digm com­pletes dis­as­trous reg­u­la­to­ry run as FDA slaps down Lin­haliq ap­pli­ca­tion

Ar­a­digm has com­plet­ed the reg­u­la­to­ry tri­fec­ta for dis­as­ter, stum­bling from a bad FDA re­view to a neg­a­tive pan­el vote and now a for­mal re­jec­tion for its in­haled an­tibi­ot­ic Lin­haliq that will re­quire a whole new Phase III pro­gram to over­come.

Ig­or Gon­da

The writ­ing for this as­set has been on the wall since an out­side pan­el of agency ex­perts shook their heads over the mixed da­ta gath­ered in two late-stage tri­als for the an­tibi­ot­ic, an in­haled for­mu­la­tion of ciprofloxacin which is de­signed to fight lung in­fec­tions trig­gered by “ab­nor­mal di­lata­tion of the bronchi and bron­chi­oles.” Reg­u­la­tors had al­ready dissed the da­ta in their in­ter­nal re­view.

Its shares $ARDM took an­oth­er nose dive this morn­ing, tum­bling 39% to $1.36 — af­ter slid­ing steadi­ly from $6.70 at the be­gin­ning of last De­cem­ber.

Get­ting over this hur­dle will nei­ther be cheap or quick.

The Hay­ward, CA-based com­pa­ny says the FDA wants a new Phase III tri­al that can pro­vide ev­i­dence of two years or more of dura­bil­i­ty in pre­vent­ing “the co-pri­ma­ry end­points of fre­quen­cy and sever­i­ty of ex­ac­er­ba­tions.” Reg­u­la­tors are al­so look­ing for in­de­pen­dent ver­i­fi­ca­tion of its cur­rent Phase III da­ta, a hu­man fac­tors study to back up the la­bel and an in vit­ro re­port on the drug re­lease method de­vel­op­ment.

Ar­a­digm CEO Ig­or Gon­da says the com­pa­ny plans to meet with the FDA on re­sub­mis­sion, while pur­su­ing an ap­proval in the EU.

New FDA com­mis­sion­er Scott Got­tlieb had pledged to start open­ing up on CRLs when he was con­firmed for the top job at the FDA. But in the mean­time he’s de­cid­ed to re­nege on that promise, look­ing for a com­pro­mise on trans­paren­cy through a new tri­al pro­gram that rests on vol­un­tary sub­mis­sion of some in­fo. Com­pa­nies are still free to present CRLs any way they like, de­spite crit­i­cism from reg­u­la­tors that not all bio­phar­ma com­pa­nies are en­tire­ly up­front about why their drugs are re­ject­ed.

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

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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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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