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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.