Pfiz­er gets an FDA fast-pass for an old vac­cine with po­ten­tial mil­i­tary ap­pli­ca­tions

Pfiz­er spent the last year in a heat­ed race to de­vel­op the world’s first coro­n­avirus vac­cine and the last few years jock­ey­ing with Mer­ck and oth­ers to de­vel­op a se­quel to their block­buster pneu­mo­coc­cal vac­cine, Pre­vnar. Now the FDA is giv­ing the New York drug­mak­er an ex­pe­dit­ed re­view for an in­oc­u­la­tion few were watch­ing — one, in fact, that has al­ready been in use for decades.

Pfiz­er has re­ceived pri­or­i­ty re­view for Tico­V­ac, their vac­cine for tick-borne en­cephali­tis, set­ting the com­pa­ny up for a de­ci­sion by Au­gust. If ap­proved, Pfiz­er said, the vac­cine could be giv­en to Amer­i­cans, in­clud­ing armed ser­vice mem­bers, trav­el­ing to re­gions where the virus is com­mon, such as Eu­rope and parts of Asia. It would po­ten­tial­ly pro­tect trav­el­ers against menin­gi­tis and long-term neu­ro­log­i­cal symp­toms the virus can trig­ger.

Un­like the mR­NA Covid-19 vac­cine or Pre­vnar 2.0 (tech­ni­cal­ly called 20vP­nC), Tico­V­ac doesn’t use any fan­cy new tech­nol­o­gy: It’s an old fash­ioned in­ac­ti­vat­ed virus vac­cine, the same plat­form Jonas Salk used for po­lio.

The vac­cine has been used wide­ly in Eu­rope for four decades, hav­ing been first rolled out by Bax­ter AG in the 70s in Aus­tria, al­though tweaks were made over the en­su­ing decades. Pfiz­er ac­quired the prod­uct when they bought out Bax­ter’s vac­cine unit for $635 mil­lion in 2014. It is high­ly ef­fec­tive — es­ti­mates are in the 96%  to 99% range — but like most old­er vac­cines, not a ma­jor mon­ey mak­er: Pfiz­er col­lect­ed just $27 mil­lion from the vac­cine last year, or a lit­tle less than what Ibrance earns them in a week.

A Pfiz­er spokesper­son said that the com­pa­ny has been work­ing with the U.S. Army Med­ical Ma­te­r­i­al De­vel­op­ment Ac­tiv­i­ty to gain ap­proval in the US. Al­though mil­i­tary mem­bers sta­tioned in Eu­rope can choose to get the vac­cine, the process is bur­den­some: They of­ten have to ob­tain a re­fer­ral and then trav­el to a dif­fer­ent coun­try for each of the three dos­es.

It is “lo­gis­ti­cal­ly dif­fi­cult for Ser­vice Mem­bers and their fam­i­lies to ob­tain pro­tec­tion,” he said. A US ap­proval would sim­pli­fy the process.

Pfiz­er is al­so now de­vel­op­ing a vac­cine for an­oth­er tick-borne ill­ness: Ly­me dis­ease. Last year, they signed a $308 mil­lion deal with Val­ne­va to co-de­vel­op their Phase II shot, mak­ing a bid to de­vel­op the first in­oc­u­lant against a grow­ing in­fec­tion since Glax­o­SmithK­line pulled theirs off the mar­ket in 2002.

So­cial: zz/STRF/STAR MAX/IPx via AP Im­ages

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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