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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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