Kathrin Jansen, Pfizer vaccine chief

Beat­ing Mer­ck, Pfiz­er gets pri­or­i­ty re­view as the first Pre­vnar fol­low-up heads to the FDA

It won’t get quite the work-on-Thanks­giv­ing wel­come that the Covid-19 jab re­ceived, but an­oth­er Pfiz­er vac­cine is head­ed to the FDA, where it will re­ceive a speedy re­view.

Pfiz­er an­nounced Wednes­day that an ap­pli­ca­tion for its new pneu­mo­coc­cal vac­cine, 20vP­nC, has been ac­cept­ed and grant­ed pri­or­i­ty re­view at the agency, set­ting up a de­ci­sion by June of next year.

With the ac­cep­tance, Pfiz­er re­mains a step ahead of Mer­ck in the race to de­vel­op a fol­low-on to one of the Big Phar­ma’s most im­por­tant prof­it gen­er­a­tors. While most vac­cines are slim mar­gin prod­uct, Pre­vnar col­lect­ed $6 bil­lion in rev­enue last year, more than any oth­er ful­ly owned Pfiz­er prod­uct.

With Pre­vnar near­ing patent ex­pi­ra­tion and ri­val vac­cines ad­vanc­ing in late-stage tri­als, though, Pfiz­er has pushed to get a next gen­er­a­tion pneu­mo­coc­cal shot ap­proved.

Un­like Pre­vnar, which pro­tects against 13 dif­fer­ent strains of path­o­gen­ic pneu­mo­coc­cal bac­te­ria, the new shot is de­signed to pro­tect against 20. Pfiz­er is tout­ing it as su­pe­ri­or to any pneu­mo­coc­cal shot on the mar­ket and any of the oth­er ones near­ing the mar­ket.

“If ap­proved, 20vP­nC will cov­er more serotypes re­spon­si­ble for the ma­jor­i­ty of pneu­mo­coc­cal dis­ease than any oth­er pneu­mo­coc­cal con­ju­gate vac­cine cur­rent­ly li­censed or cur­rent­ly in late-stage clin­i­cal de­vel­op­ment,” Kathrin Jansen, Pfiz­er’s vac­cine chief, said in a state­ment. “Im­por­tant­ly, 20vP­nC has shown to in­duce im­mune mem­o­ry, which pro­vides pro­tec­tion and ef­fi­ca­cy against non-bac­teremic pneu­mo­nia, par­tic­u­lar­ly in old­er adults.”

In a Phase III tri­al un­veiled in March, Pfiz­er an­nounced that the vac­cine suc­cess­ful­ly stim­u­lat­ed an­ti­bod­ies against 19 of the 20 strains in vol­un­teers over the age of 50, in­clud­ing all 13 of the strains in Pre­vnar 13. The 20th strain nar­row­ly missed, the com­pa­ny said.

Mer­ck, mean­while, an­nounced in Sep­tem­ber pos­i­tive Phase III da­ta for its vac­cine de­signed to de­fend against 15 dif­fer­ent strains. That in­clud­ed one strain where, the com­pa­ny claimed, they out­per­formed Pre­vnar.

Both Mer­ck and Pfiz­er’s can­di­dates have re­ceived break­through des­ig­na­tions from the FDA.

The two be­he­moths may soon al­so have to con­tend with an ad­di­tion­al play­er. The Cal­i­for­nia biotech Vax­cyte raised near­ly $300 mil­lion on pri­vate mar­kets and, this year, launched a $287.5 mil­lion IPO to de­vel­op its own pneu­mo­coc­cal vac­cine. The com­pa­ny ex­pects to file an IND un­til the sec­ond half of next year, with the first clin­i­cal da­ta com­ing in 2022.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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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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