Mer­ck wins break­through ther­a­py des­ig­na­tion for po­ten­tial pneu­mo­coc­cal vac­cine suc­ces­sor

Less than a year af­ter win­ning FDA ap­proval for its next-gen­er­a­tion pneu­mo­coc­cal vac­cine last Ju­ly, Mer­ck is al­ready im­press­ing the agency with a po­ten­tial fol­low-up pro­gram.

Reg­u­la­tors be­stowed break­through ther­a­py des­ig­na­tion up­on Mer­ck’s V116 can­di­date, a 21-va­lent vac­cine de­signed to pre­vent in­va­sive pneu­mo­coc­cal dis­ease and pneu­mo­coc­cal pneu­mo­nia in adults. Mer­ck had turned in da­ta from a ran­dom­ized Phase I/II tri­al in pa­tients 18 and up for the agency’s re­view, and Phase III clin­i­cal tri­als for V116 are to be ini­ti­at­ed lat­er this year, the phar­ma said.

Eli­av Barr

This drug has been years in the mak­ing and is the lat­est chal­lenger in the pneu­mo­coc­cal vac­cine race. Mer­ck CMO Eli­av Barr said in a state­ment that the vac­cine can­di­date tar­gets serotypes present in 85% of pneu­mo­coc­cal dis­ease in peo­ple at least 65 years old, and in­cludes eight serotypes not in any cur­rent­ly li­censed vac­cine.

He added that “We look for­ward to dis­cussing the on­go­ing de­vel­op­ment of this in­ves­ti­ga­tion­al vac­cine, in­clud­ing the ap­proach for Phase III stud­ies, with the FDA and oth­er reg­u­la­to­ry agen­cies.”

V116 comes af­ter Vaxneu­vance, Mer­ck’s 15-strain pneu­mo­coc­cal vac­cine, was grant­ed FDA ap­proval last Ju­ly. When Mer­ck orig­i­nal­ly crossed the fin­ish line with Vaxneu­vance, the com­pa­ny hoped it would be able to com­pete with Pfiz­er’s 20-strain Pre­vnar 20 — ap­proved the month be­fore.

The two phar­ma gi­ants were em­bat­tled in a patent feud un­til Mer­ck agreed to pay Pfiz­er 7.25% of net sales of all of its PCV prod­ucts through 2026. Af­ter that, the phar­ma is still ex­pect­ed to pay up 2.5% of net sales un­til 2035.

With V116 hav­ing 21 strains, it could po­ten­tial­ly chal­lenge Pfiz­er’s Pre­vnar 20, which has one strain less (Pre­vnar 20 and V116 share 11 strains). And al­though V116 would have the most strains in re­cent vac­cines, it’s not the broad­est that Mer­ck has put out. That dis­tinc­tion goes to Pneu­movax 23, Mer­ck’s 23-strain pneu­mo­coc­cal vac­cine ap­proved back in the 1980s. How­ev­er, that vac­cine need­ed to get re­vamped be­cause of poor per­for­mance in chil­dren.

Thurs­day’s de­vel­op­ment al­so comes two weeks af­ter the FDA re­quest­ed more da­ta analy­ses from clin­i­cal tri­als on Vaxneu­vance be­ing used in mi­nors. That end­ed up with the PDU­FA date be­ing pushed out three months to Ju­ly 1.

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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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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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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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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