Kathrin Jansen, Pfizer via Twitter

Pfiz­er rolls out next-gen pneu­mo­coc­cal vac­cine with FDA win, beat­ing Mer­ck­'s 15-va­lent can­di­date to the punch

Mer­ck and Pfiz­er have been locked in a years­long bat­tle for a next-gen pneu­mo­coc­cal vac­cine win­ner, with the lat­ter look­ing to one-up — or should we say sev­en-up — its stan­dard 13-va­lent shot. Now, Pfiz­er has nosed out a win with the FDA’s back­ing, leav­ing Mer­ck and its 15-va­lent shot wait­ing in the wings.

Pfiz­er said on Tues­day that the FDA has ap­proved its Pre­vnar 20 for adults 18 years and old­er — just over a month be­fore Mer­ck’s PDU­FA date for its V114. The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is sched­uled to meet in Oc­to­ber to dis­cuss and up­date rec­om­men­da­tions on the use of pneu­mo­coc­cal vac­cines, ac­cord­ing to Pfiz­er.

“With a sin­gle in­jec­tion, PRE­VNAR 20 pro­vides adults with strong and mean­ing­ful pro­tec­tion against serotypes re­spon­si­ble for the ma­jor­i­ty of cir­cu­lat­ing pneu­mo­coc­cal dis­ease around the world,” Kathrin Jansen, SVP and head of vac­cine R&D at Pfiz­er, said in a state­ment.

There are cur­rent­ly two main types of pneu­mo­coc­cal vac­cine: pneu­mo­coc­cal con­ju­gate vac­cines (PCV) and pneu­mo­coc­cal poly­sac­cha­ride vac­cines (PPSV). Both con­tain poly­sac­cha­rides tak­en from serotypes of S. pneu­mo­ni­ae bac­te­ria, which cause pa­tients’ im­mune sys­tems to de­vel­op an­ti­bod­ies that will lat­er rec­og­nize that poly­sac­cha­ride.

Mer­ck came out with its 23-va­lent PPSV, Pneu­movax 23, back in 1983. How­ev­er, PPSVs have been shown to have poor per­for­mance in younger chil­dren. As a so­lu­tion, drug­mak­ers have de­vel­oped “con­ju­gat­ed” vac­cines, in which the poly­sac­cha­rides are at­tached to a car­ri­er pro­tein.

Pfiz­er got a 7-va­lent con­ju­gate vac­cine ap­proved in 2000, fol­lowed by its 13-va­lent megablock­buster Pre­vnar 13 in 2010. Pre­vnar 20 cov­ers all 13 strains that Pre­vnar 13 does, plus 8, 10A, 11A, 12F, 15B, 22F and 33F. The ad­di­tion­al sev­en strains ac­count for about 40% of all pneu­mo­coc­cal dis­ease cas­es and deaths in the US, ac­cord­ing to Pfiz­er.

Pre­vnar 13 raked in $5.8 bil­lion in 2020 and was once the world’s best-sell­ing vac­cine in pre-Covid times. The fol­low-on won’t bring in the $26 bil­lion that Pfiz­er’s Covid-19 vac­cine is ex­pect­ed to in 2021, but Prophe­cy Mar­ket In­sights ex­pects the glob­al pneu­mo­coc­cal vac­cine mar­ket to grow from $8.1 bil­lion in 2020 to $13.5 bil­lion by 2030.

The vac­cine was fast tracked by the FDA back in 2017, then giv­en pri­or­i­ty re­view in 2018. The FDA’s de­ci­sion was based on Phase I and II da­ta, as well as three Phase III tri­als that en­rolled a to­tal of 6,000 adults.

Pfiz­er un­veiled da­ta from one of those stud­ies — a piv­otal Phase III that en­rolled 902 adults with no his­to­ry of pneu­mo­coc­cal vac­ci­na­tion — back in Oc­to­ber at ID­Week. The study com­pared Pre­vnar 20’s per­for­mance to Pre­vnar 13 and Pneu­movax 23. All 20 serotypes in­duced “ro­bust re­spons­es” across three age co­horts (18 to 49, 50 to 59, and 60 or old­er), ac­cord­ing to Pfiz­er.

In the fo­cus group of adults 60 and old­er, Pre­vnar 20’s re­sponse was non-in­fe­ri­or to all serotypes in com­mon with Pre­vnar 13, and six of the sev­en new serotypes in com­mon with Pneu­movax 23 one month af­ter vac­ci­na­tion. Serotype 8 just bare­ly missed the non-in­fe­ri­or­i­ty low­er bound cri­te­ria, but showed im­mune re­spons­es in oth­er pa­ra­me­ters, the com­pa­ny said. Im­mune re­spons­es to Pre­vnar 20 in the two younger age co­horts were non-in­fe­ri­or to the same vac­cine’s re­spons­es in adults 60 to 64 years old.

Pfiz­er al­so read out da­ta from in­fant tri­als (en­rolling ba­bies 42 to 98 days old), which showed a con­sis­tent safe­ty pro­file com­pared to Pre­vnar 13 and im­mune re­sponse to all 20 serotypes one month af­ter the third dose. Boost­er re­spons­es were record­ed for all serotypes a month af­ter the fourth dose.

Mer­ck isn’t throw­ing in the tow­el just yet. Last month — even as it looked like Pre­vnar 20 might beat it to mar­ket — the Ke­nil­worth, NJ-based phar­ma read out topline re­sults from two Phase III pe­di­atric stud­ies, and said it’s on track to sub­mit a sup­ple­men­tary BLA by the end of the year.

V114 cov­ers the 13 serotypes cov­ered by Pre­vnar 13, plus an ad­di­tion­al two: 22F and 33F.

Roy Baynes

“Re­sults from these stud­ies sup­port the po­ten­tial of V114 to con­fer im­muno­genic­i­ty for PCV13 serotypes in in­fants who have pre­vi­ous­ly re­ceived one or mul­ti­ple dos­es of PCV13, and for the 15 serotypes in V114 in chil­dren in a catch-up set­ting,” Mer­ck Re­search Labs CMO Roy Baynes said.

As Mer­ck and Pfiz­er duke it out, a 24-va­lent can­di­date is in the mak­ing that hopes to top­ple them both. Vax­cyte, for­mer­ly known as SutroVax, is in ear­ly de­vel­op­ment with VAX-24 and ex­pects to file an IND in the first half of 2022. The com­pa­ny pulled in $249 mil­lion in an IPO last June, and says a Phase I/II read­out would fol­low be­tween late 2022 and ear­ly 2023.

On Jan. 11 — the same day the FDA ac­cept­ed a BLA for V114 — Mer­ck filed a law­suit chal­leng­ing three of Pfiz­er’s patents re­lat­ing to its pneu­mo­coc­cal con­ju­gate com­po­si­tions. The com­pa­ny has asked a judge to rule that V114 “does not and will not in­fringe any valid claim of these three patents.”

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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Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.