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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.