Pfiz­er hits the gas ped­al in the mR­NA flu vac­cine de­vel­op­ment race, ink­ing a $425M in­vest­ment pact with BioN­Tech

The mR­NA spe­cial­ists at BioN­Tech have added an­oth­er deep-pock­et phar­ma gi­ant to the fold.

Pfiz­er has stepped up with a $120 mil­lion cash com­mit­ment — cov­er­ing an an un­cer­tain mix of up­front cash, eq­ui­ty and near-term re­search sup­port — to get the Ger­man biotech to fo­cus its drug plat­form on sea­son­al and pan­dem­ic flu. And there’s an­oth­er $305 mil­lion on the line in po­ten­tial mile­stone pay­outs if they can score mar­ketable prod­ucts.

Con­cep­tu­al­ly, mR­NA is sim­ple. De­vel­op­ers are adapt­ing a nat­ur­al sys­tem that dis­patch­es in­struc­tions en­cod­ed in RNA that trig­gers the pro­duc­tion of ther­a­peu­tic pro­teins. Cre­at­ing a game-chang­ing plat­form tech that can or­ches­trate this process, and the man­u­fac­tur­ing op­er­a­tions need­ed to pro­duce it, is enor­mous­ly com­plex, in­spir­ing bil­lions of dol­lars worth of in­vest­ments in BioN­Tech, Cure­Vac and Mod­er­na from big play­ers like Sanofi, Genen­tech and As­traZeneca.

And now Pfiz­er is jump­ing in, which is push­ing the to­tal in­vest­ed in BioN­tech so far well past the bil­lion-dol­lar mark.


BioN­Tech’s pipeline is con­cen­trat­ed on on­col­o­gy, with can­cer vac­cines part­nered with Genen­tech as a cen­tral fo­cus. And that’s where they see a key ad­van­tage as re­searchers work with Pfiz­er on the flu.

“Some of the un­der­ly­ing mech­a­nisms are the same,” BioN­Tech COO Sean Marett tells me in his lat­est up­date. “We’ve been us­ing some of that syn­er­gy in in­fec­tious dis­eases for awhile….You can tar­get mR­NA so that you get it to the im­mune cells of choice. We re­al­ly do see that with our on­col­o­gy process.”

One of the key ad­van­tages of mR­NA for flu vac­cines is that it can elim­i­nate the oner­ous and rel­a­tive­ly ex­pen­sive egg-based sys­tem used to or­der up huge batch­es of sea­son­al flu vac­cines as the WHO makes its best guess about which vi­ral strains are like­ly to cause the most trou­ble in the midst of flu sea­son. And the same ba­sic mR­NA ap­proach can be adapt­ed from sea­son­al flu for use against sud­den pan­demics.

“Once the back­bone is op­ti­mized for ex­pres­sion in the rel­e­vant set­ting, it’s just a ques­tion of ex­chang­ing anti­gens,” adds Marett. “In our ex­pe­ri­ence with on­col­o­gy vac­cines, it’s re­al­ly quick. You need the se­quence, the trick is that your back­bone is op­ti­mized.”

For any big play­er in vac­cines, it’s the kind of tech­nol­o­gy that could dis­rupt the en­tire vac­cines field — if it works — and this is one area of mR­NA where re­searchers feel they’re on sol­id ground in search­ing for suc­cess. Not en­gag­ing with one of the lead­ers would leave them vul­ner­a­ble to be­ing cut out of the mar­ket.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.