Glax­o­SmithK­line's Benlysta earns first FDA ap­proval for lu­pus nephri­tis as com­peti­tors wait in the wings

When Glax­o­SmithK­line earned its first ap­provals back in 2011 for Benlysta, it promised reg­u­la­tors it would keep the ball rolling in its pur­suit of lu­pus nephri­tis, a se­vere form of the au­toim­mune dis­ease that can cause re­nal fail­ure. Now, near­ly a decade af­ter the bi­o­log­ic first hit the mar­ket, GSK has made good on that promise.

The FDA on Thurs­day ap­proved in­tra­venous and sub­cu­ta­neous Benlysta to treat LN, mak­ing it the first ther­a­py ever ap­proved for that in­di­ca­tion.

The agency based its re­view on re­sults from the Phase III Bliss-LN study, which showed 43% of lu­pus nephri­tis pa­tients in the Benlysta plus stan­dard-of-care arm achieved pri­ma­ry ef­fi­ca­cy re­nal re­sponse — a mea­sure of kid­ney func­tion — com­pared with 32% of pa­tients in the place­bo group. Pa­tients on Benlysta al­so post­ed sig­nif­i­cant­ly high­er re­sponse in sec­ondary end­points, in­clud­ing time to death or a kid­ney-re­lat­ed com­pli­ca­tion.

Lu­pus nephri­tis is a se­vere form of sys­temic lu­pus ery­the­mato­sus that can cause late-stage re­nal fail­ure and re­quire dial­y­sis or kid­ney re­place­ment in the worst cas­es. Hav­ing a ther­a­py on the mar­ket that can cut in­to the de­mand for those sur­gi­cal pro­ce­dures is a big win for the 60% of 328,000 se­vere US lu­pus pa­tients suf­fer­ing from lu­pus nephri­tis each year, GSK said.

“In the four decades I have been car­ing for peo­ple with lu­pus, we have not been able to achieve re­mis­sion in more than just one-third of pa­tients with lu­pus nephri­tis and, de­spite all of our ef­forts, 10% to 30% of pa­tients with lu­pus kid­ney dis­ease still progress to end-stage kid­ney dis­ease,” said Richard Fu­rie, chief of the di­vi­sion of rheuma­tol­ogy and pro­fes­sor at the Fe­in­stein In­sti­tutes for Med­ical Re­search at North­well Health and lead in­ves­ti­ga­tor of the Bliss study, in a re­lease. “There­fore, it is grat­i­fy­ing to see the re­wards of decades of re­search.”

Ex­pect­ing an uptick in de­mand for Benlysta and look­ing to fi­nal­ly crack in­to block­buster ter­ri­to­ry, GSK has been quick­ly ex­pand­ing its man­u­fac­tur­ing ca­pac­i­ty to dri­ve sup­ply world­wide.

In Oc­to­ber 2019, GSK un­veiled plans to in­fuse $139 mil­lion plant at its Rockville, MD site to add ca­pac­i­ty for Benlysta. The drug­mak­er chose to retro­fit an ex­ist­ing build­ing at the Mary­land site, where it al­ready had ex­per­tise in pro­duc­ing the in­ject­ed or in­fused drug. The in­vest­ment was used to pay for the de­mo­li­tion of ex­ist­ing suites and the en­gi­neer­ing, in­stal­la­tion and val­i­da­tion of new equip­ment.

Then, in May of this year, the British phar­ma worked out a $231 mil­lion deal with CD­MO Sam­sung Bi­o­log­ics to out­source pro­duc­tion of its bi­o­log­ic prod­ucts, in­clud­ing Benlysta, over the next eight years. The deal will ini­tial­ly cov­er Benlysta, with the first com­mer­cial sup­ply ex­pect­ed in 2022. Benlysta gen­er­at­ed sales of $747 mil­lion in 2019, prop­ping up an oth­er­wise mea­ger bi­o­log­ics port­fo­lio for the Big Phar­ma. The drug pulled in $252 mil­lion in sales in the third quar­ter, putting it on pace to hit the block­buster mark.

Mean­while, chal­lengers from Roche and Au­rinia are rac­ing to­ward the mar­ket in lu­pus, pos­ing an ex­is­ten­tial chal­lenge to Benlysta’s hold on the hard-to-win mar­ket.

In June 2019, Roche post­ed Phase II da­ta show­ing blood can­cer med Gazy­va on top of stan­dard-of-care ther­a­py best­ed stan­dard of care alone in achiev­ing com­plete re­nal re­sponse for lu­pus nephri­tis pa­tients. The drug earned the FDA’s break­through tag back in Sep­tem­ber 2019. An­oth­er chal­lenger, Au­rinia’s late-stage lu­pus nephri­tis can­di­date vo­closporin, faces an FDA re­view date of Jan. 22, mak­ing it the ear­li­est po­ten­tial chal­lenger to GSK’s newest in­di­ca­tion.

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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