Mod­er­na's Covid-19 vac­cine sales to trail Pfiz­er's to­tal sig­nif­i­cant­ly in 2021 and 2022

Pfiz­er’s and Mod­er­na’s mR­NA vac­cines to pre­vent Covid-19 are of­ten con­sid­ered equals in many re­spects. Both have shown strong pro­tec­tion from the virus, with lim­it­ed side ef­fects or safe­ty con­cerns among the hun­dreds of mil­lions who have now re­ceived them.

But in its sec­ond quar­ter earn­ings call Thurs­day, Mod­er­na re­vealed how the two are di­verg­ing when it comes to vac­cine sales, as Mod­er­na’s ex­pec­ta­tions for 2021 to­tal about $20 bil­lion, based on the ex­pect­ed man­u­fac­ture of be­tween 800 mil­lion and 1 bil­lion dos­es. Pfiz­er said last week it ex­pects about $33 bil­lion in 2021 Covid vac­cine sales on 2.1 bil­lion dos­es, al­though that amount may in­crease to about 3 bil­lion dos­es.

The quick start for Pfiz­er may even out a lit­tle more, but not by much: In 2022, Mod­er­na says it al­ready has signed con­tracts for about $12 bil­lion in vac­cine sales, with op­tions for $8 bil­lion more, and the man­u­fac­tur­ing ca­pac­i­ty to make be­tween 2 and 3 bil­lion dos­es next year. By con­trast, Pfiz­er CEO Al­bert Bourla said the com­pa­ny is ready to make about 4 bil­lion dos­es in 2022, al­though the Big Phar­ma has yet to project any 2022 sales fig­ures, a spokesper­son con­firmed.

In terms of vac­cine dose pric­ing, both com­pa­nies have seen in­creas­es in the US, and the EU, even as they both of­fer less ex­pen­sive ver­sions of their vac­cines for low- and mid­dle-in­come coun­tries.

Pfiz­er’s vac­cine price rose from $19.50 per dose to about $24 per dose in this lat­est US gov­ern­ment pur­chase of 200 mil­lion dos­es.

Mod­er­na said Thurs­day its US gov­ern­ment price has risen slight­ly from about $15 per dose (for the first 100 mil­lion dos­es) to $16.50 each (for the next 400 mil­lion dos­es), which takes in­to con­sid­er­a­tion the gov­ern­ment funds via BAR­DA to un­der­write the firm’s Phase III tri­al for the vac­cine. High­er in­come ex-US coun­tries start with a price range of $32 to $37 per dose, Mod­er­na added. But some­times there are dis­counts based on vol­ume, or for low­er- and mid­dle-in­come coun­tries, in­clud­ing sales to CO­V­AX, which Mod­er­na said are priced sig­nif­i­cant­ly cheap­er than dos­es for the US gov­ern­ment.

Both Pfiz­er and Mod­er­na are al­so de­vel­op­ing their Covid-19 vac­cine boost­er strate­gies, even as the CDC and FDA have said such boost­ers are not nec­es­sary yet, and as the WHO calls on de­vel­oped coun­tries to not pro­vide boost­ers un­til at least the end of Sep­tem­ber.

Mod­er­na pres­i­dent Stephen Hoge said on the earn­ings call the com­pa­ny be­lieves boost­ers will be need­ed be­fore win­ter, par­tic­u­lar­ly due to the Delta vari­ant. Clin­i­cal da­ta ap­pear to sup­port a 50 μg of the Mod­er­na vac­cine boost­er, the com­pa­ny said, al­though it will wait for 100 μg da­ta com­ing in the next sev­er­al weeks to con­firm the se­lec­tion of 50 μg as a boost­er dose be­fore fil­ing for EUA.

Pfiz­er said it ex­pects a boost­er shot EUA fil­ing as ear­ly as this month: “Pend­ing reg­u­la­to­ry ap­proval, we al­so plan to start an im­muno­genic­i­ty and safe­ty study in Au­gust to eval­u­ate an up­dat­ed ver­sion of our vac­cine specif­i­cal­ly de­signed to tar­get the Delta vari­ant,” Pfiz­er CSO Mikael Dol­sten said last week on its earn­ings call.

Mod­er­na al­so said in its Q&A at the end of its earn­ings call it may jump fur­ther in­to the space of gene edit­ing. As an in­no­va­tor in the worlds of lipid nanopar­ti­cles and mR­NA, Hoge said that “it’s the right time for us to ex­pand in that di­rec­tion,” point­ing to gene edit­ing.

“On the gene edit­ing ques­tion, we do have, as you know, pro­grams that tar­get the liv­er. But as we’ve pre­sent­ed at pre­vi­ous sci­ence days and even to­day, we have a plat­form tech­nol­o­gy that al­so we think al­lows us to get in broad­ly in­to the im­mune sys­tem and par­tic­u­lar­ly hematopoi­et­ic stem cells. And so what you’ll — where we imag­ine our strong suit to be is in de­liv­er­ing nu­cle­ic acid tech­nolo­gies to those ar­eas. Of course, as we look to ex­pand­ing in gene edit­ing, You’ll see us look to those tech­nolo­gies that we’ve got the most ex­pe­ri­ence with first and then bring­ing a range of dif­fer­ent pay­loads to — in­to our ca­pa­bil­i­ties,” Hoge said.

Start­ing Strong with As­sured Sup­ply of Qual­i­ty Ma­te­ri­als for Im­mune Cell Ther­a­pies

This blog post is the second in a series about accelerating the development and manufacturing of cell-based cancer therapies. In the last post, we outlined the promise and potential of immune cell therapies to treat cancer along with an overview of the central challenges that impede their broad accessibility. In this article, we take a closer look at key considerations for establishing a reliable supply chain of quality materials to ensure a robust and reproducible workflow.

Alex Gorsky, J&J CEO (Andrew Harnik/AP Images)

UP­DAT­ED: J&J sets out to split the world's largest health­care con­glom­er­ate, hiv­ing off the con­sumer di­vi­sion

J&J is joining the movement in pharma to double down on risky but high-growth drugs and devices while hiving off huge consumer divisions. CEO Alex Gorsky says that sometime in the next 18 to 24 months they’ll be splitting the company into 2 different operations, dividing the largest conglomerate in healthcare.

Just as Merck and Pfizer and GlaxoSmithKline before, which followed similar strategies, the move will put a beacon on the R&D side of the business, where new drug development — and the high margins they can deliver — will be critical to the new company’s success.

J&J's im­pend­ing split; And the next FDA com­mish is...; Aduhelm back in spot­light; #AHA21; 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 we mark the 40th edition of this Saturday recap, I’d like to spend a moment marveling at just how much Endpoints News has grown in the past year. We used to just have two daily reports. But we now send out weekly email newsletters dedicated to pharma marketing (Endpoints MarketingRx), regulatory news (Endpoints FDA+) and manufacturing (Endpoints Manufacturing). Want to get them in your inbox? You can customize your list of subscriptions in the reader profile.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

UP­DAT­ED: It’s Califf: Biden picks the for­mer FDA com­mish to head back to the helm

Confirming one of the worst kept secrets in Washington, Robert Califf has been nominated on Friday to lead the FDA for a second time.

It’s an announcement biopharma has anxiously been waiting for, although not a surprising one. After vetting multiple names churned out by the rumor mills, President Joe Biden’s final choice is one both the industry and agency insiders have hailed as the perfect one.

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Lew Cantley (Cornell)

Scoop: Famed can­cer re­searcher — and biotech founder — Lew Cant­ley is head­ed to Dana-Far­ber

Lew Cantley, the famed cancer researcher best known for his discovery of the PI3K pathway and his groundbreaking work on cancer metabolism, is headed to Dana-Farber.

We got tipped off by someone at the institute that Cantley will make his move from Weill Cornell Medicine next February after Dana-Farber chief Laurie Glimcher sent out a note heralding his impending arrival as a faculty member in the Department of Cancer Biology. That puts the ex-Harvard professor right back in the center of things during an unprecedented biotech boom that has put Cambridge/Boston right at the epicenter of drug R&D.

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Kevin Ali, Organon CEO

Months af­ter a Mer­ck spin­out, Organon con­tin­ues its string of deals with a $954M buy­out pack­age

Five months after ejecting out of the mother ship at Merck, the women’s health experts at Organon have racked up another deal, this time buying up a small biotech advancing an experimental therapy for endometriosis.

Organon put out word Thursday morning that it bagged Forendo Pharma out of Finland to beef up the pipeline. They’re paying $75 million upfront and shouldering $9 million in debt to land the asset with a hefty $870 million in milestone money on the table. Altogether the M&A package weighs in at close to a billion dollars — provided the drug is successful.

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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca ex­pects 'mod­est prof­itabil­i­ty' for next round of Covid-19 vac­cine sup­ply deals — and prunes pipeline in Q3 up­date

Having sent 1.5 billion Covid-19 vaccines around the world on a not-for-profit basis, AstraZeneca says it’s time to move into “modest profitability.”

While the priority is to deliver all the “pandemic doses” — a total of 3 billion are set to be delivered by the end of the year — AstraZeneca expects to be taking new orders in Q4, leading to a blend in sales.

“Don’t expect massive profitability, which is sometimes the case for other vaccine makers,” Ruud Dobber, head of the biopharmaceuticals business unit, told Endpoints News.

Cor­texyme low­ers dose amid safe­ty con­cerns, rais­ing ques­tions about fu­ture of off­beat Alzheimer’s ap­proach

Late last month, Cortexyme announced a subset of patients saw their cognitive decline slow while taking the high dose of the company’s experimental Alzheimer’s drug, offering some support for an outside-the-box approach to treating the disease.

But on Thursday the biotech revealed it would push forward with a lower dose of the molecule because of liver toxicity concerns in the recent trial. Although the reduced quantity — 40 mg as opposed to 80 mg — appeared safer, it also appeared less effective, potentially setting up a rocky path toward any possible approval.

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A cou­ple months ahead of its PDU­FA da­ta, Bris­tol My­ers rolls out long-term da­ta for mava­camten

It’s almost time for the FDA to make a decision on mavacamten, the myosin inhibitor at the center of Bristol Myers Squibb’s $13 billion MyoKardia buyout. With a Jan. 28 PDUFA date looming, the pharma giant is now taking the wraps off some long-term data it hopes will bolster the drug’s case for approval.

Heart patients who received mavacamten in a cohort of the long-term MAVA-LTE study saw significant reductions in median levels of a hormone called NT-proBNP (58% at week 24 and 67% at week 48), Bristol Myers reported at this year’s American Heart Association conference. Higher than normal NT-proBNP levels are indicative of heart failure.