President Joe Biden listens as Pfizer CEO Albert Bourla speaks (Patrick Semansky/AP Images)

Covid-19 roundup: Pfiz­er lands mas­sive $5B+ deal with US for po­ten­tial pill; Boost­ers for all adults are in­com­ing

Pfiz­er’s pill to treat Covid-19 is out­pac­ing its top ri­val from Mer­ck not on­ly in terms of ef­fi­ca­cy da­ta but now in the size of its US gov­ern­ment con­tract, too.

The US on Thurs­day an­nounced it will pay $5.29 bil­lion for 10 mil­lion cours­es of Pfiz­er’s po­ten­tial treat­ment, which is the largest sin­gle pro­cure­ment of any ther­a­peu­tic or vac­cine since the pan­dem­ic be­gan. And at $529 per course for the Pfiz­er pill, that’s sig­nif­i­cant­ly cheap­er than the $2.2 bil­lion the US paid for just 3 mil­lion cours­es of Mer­ck’s treat­ment, which adds up to about $730 per course.

Both com­pa­nies are still seek­ing EUAs to mar­ket their prod­ucts, al­though based on the size of these deals, those de­ci­sions from FDA may seem like an af­ter­thought.

Da­ta from a sched­uled in­ter­im analy­sis for Pfiz­er’s po­ten­tial drug showed an 89% re­duc­tion in risk of Covid-re­lat­ed hos­pi­tal­iza­tion or death from any cause com­pared to place­bo in pa­tients treat­ed with­in three days of symp­tom on­set. Pfiz­er said it halt­ed en­roll­ment in the tri­al be­cause of the pos­i­tive re­sults, and in con­sul­ta­tion with the FDA.

Mean­while, Pfiz­er said it will con­tin­ue to in­vest up to about $1 bil­lion to sup­port the man­u­fac­tur­ing and dis­tri­b­u­tion of its pill, in­clud­ing ex­plor­ing po­ten­tial con­tract man­u­fac­tur­ing op­tions. And Pfiz­er an­nounced a de­ci­sion ear­li­er this week to sign a vol­un­tary li­cens­ing agree­ment with the Med­i­cines Patent Pool to help ex­pand ac­cess.

US gov­ern­ment to in­vest bil­lions in mR­NA man­u­fac­tur­ing, with Pfiz­er and Mod­er­na’s help

Yes­ter­day’s press brief­ing from the White House COVID-19 Re­sponse Team un­veiled an in­ter­est­ing new nugget of in­fo on how this ad­min­is­tra­tion is plan­ning to ramp up vac­cine man­u­fac­tur­ing, al­though a lot of those plans will de­pend on the kind­ness of Pfiz­er and Mod­er­na.

White House coro­n­avirus re­sponse co­or­di­na­tor Jeff Zients told re­porters that HHS is so­lic­it­ing in­ter­est from com­pa­nies that have ex­pe­ri­ence man­u­fac­tur­ing mR­NA vac­cines to iden­ti­fy op­por­tu­ni­ties to scale up their pro­duc­tion ca­pac­i­ty.

“Im­por­tant­ly, ini­tial pro­duc­tion could pro­vide more mR­NA COVID vac­cines for the world. The goal of this pro­gram is to ex­pand ex­ist­ing ca­pac­i­ty by an ad­di­tion­al bil­lion dos­es per year, with pro­duc­tion start­ing by the sec­ond half of 2022,” Zients said.

The pro­gram is geared to pro­duc­ing dos­es with­in six to nine months of iden­ti­fy­ing a fu­ture pathogen and en­sur­ing enough vac­cines for all Amer­i­cans. BioN­Tech’s CEO told End­points in an in­ter­view last week that his com­pa­ny is try­ing to have a plan that would have a vac­cine shipped with­in three months of iden­ti­fy­ing a new vari­ant.

The plan cur­rent­ly is to “com­bine the ex­per­tise of the U.S. gov­ern­ment in ba­sic sci­en­tif­ic re­search with the ro­bust abil­i­ty of phar­ma­ceu­ti­cal com­pa­nies to man­u­fac­ture mR­NA vac­cines. We hope com­pa­nies step up and act quick­ly to take us up on this op­por­tu­ni­ty to ex­pand pro­duc­tion of mR­NA vac­cines for the cur­rent pan­dem­ic and set us up to re­act quick­ly to any fu­ture pan­dem­ic threats,” Zients said.

Com­ing soon: Mod­er­na and Pfiz­er boost­er shots for all adults

Mod­er­na and Pfiz­er have now both asked the FDA to sign off on their boost­er shots for all adults, which the agency could OK as ear­ly as this week, ac­cord­ing to the New York Times.

The CDC’s ad­vi­so­ry com­mit­tee is meet­ing to­mor­row for three hours in the af­ter­noon to dis­cuss the boost­er ef­fi­ca­cy and safe­ty da­ta, which some crit­ics have said is flim­sy, and en­tire­ly based on Is­raeli da­ta. But so far, 31 mil­lion Amer­i­cans have now re­ceived boost­ers too, ac­cord­ing to Zients.

And CDC Di­rec­tor Rochelle Walen­sky of­fered sup­port­ing da­ta on Wednes­day, telling re­porters:

In re­cent weeks, we have al­so seen ad­di­tion­al da­ta that re­in­force the im­por­tance of COVID-19 boost­ers for these pop­u­la­tions at high­er risk of se­vere dis­ease, par­tic­u­lar­ly to en­sure pro­tec­tion against se­vere ill­ness and hos­pi­tal­iza­tions…When we com­pare rates of COVID-19 dis­ease be­tween those who are vac­ci­nat­ed with two dos­es and those who have re­ceived a boost­er dose, the rate of dis­ease is marked­ly low­er for those who re­ceived their boost­er shot, demon­strat­ing our boost­ers are work­ing. FDA is cur­rent­ly eval­u­at­ing da­ta on the au­tho­riza­tion of boost­er dos­es for all peo­ple over age 18.  As we’ve done be­fore, CDC will quick­ly re­view the safe­ty and ef­fec­tive­ness da­ta and make rec­om­men­da­tions as soon as we hear from FDA.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

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 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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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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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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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.

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.