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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.