Albert Bourla (AP Images)

Pfiz­er emerges from pan­dem­ic cru­cible with con­fi­dence to go so­lo in tak­ing mR­NA vac­cines be­yond Covid-19

The pan­dem­ic has changed Pfiz­er.

It’s not just the $15 bil­lion in cash they ex­pect their BioN­Tech-part­nered Covid-19 vac­cine to bring in 2021. Rather, the phar­ma gi­ant is poised for a trans­for­ma­tion from a ma­jor part­ner in mR­NA tech­nol­o­gy to a ma­jor leader with its own de­vel­op­ment and man­u­fac­tur­ing ex­per­tise, with plans to grow the R&D team in Pearl Riv­er, NY by at least 50.

“We are the best po­si­tioned com­pa­ny right now to take it to the next step be­cause of our size and our ex­per­tise,” CEO Al­bert Bourla told the Wall Street Jour­nal in a sit-down in­ter­view.

With­in the past year, he not­ed, Pfiz­er’s sci­en­tists and en­gi­neers have gained a decade’s worth of ex­pe­ri­ence from work­ing with BioN­Tech, with whom they’ve been col­lab­o­rat­ing since 2018.

“We like work­ing with BioN­Tech, but we don’t need to work with BioN­Tech,” he added. “We have our own ex­per­tise de­vel­oped.”

Bourla, af­ter all, sees the suc­cess of Pfiz­er and BioN­Tech’s vac­cine — which he had de­cid­ed to fund 100%, shun­ning any gov­ern­ment sup­port — as enor­mous val­i­da­tion for the shift he’s been spear­head­ing at Pfiz­er, shed­ding the weight of lega­cy busi­ness­es to make room for a care­ful­ly pipeline-fo­cused com­pa­ny. Just as he’s con­fi­dent that Pfiz­er has edged out a lead for it­self in the sud­den­ly ac­cel­er­at­ed mR­NA race along­side Mod­er­na, he is in­tent on keep­ing it.

While the CEO didn’t go in­to de­tails about his plans, the more ad­vanced mR­NA vac­cine can­di­dates lin­ing up in Pfiz­er’s pipeline ap­pear to still come from BioN­Tech. In par­tic­u­lar, the com­pa­ny is set to take over the R&D, man­u­fac­tur­ing and com­mer­cial­iza­tion for an in­fluen­za jab this Ju­ly as part of the 2018 deal with BioN­Tech, hav­ing al­ready done part of the tech trans­fer.

Un­der that pact, Pfiz­er could al­so score two oth­er ex­per­i­men­tal vac­cines against cy­tomegalovirus and res­pi­ra­to­ry syn­cy­tial virus.

With a be­spoke pro­duc­tion net­work that now boasts of spe­cial equip­ment and raw ma­te­ri­als re­quired to make mR­NA vac­cines, Pfiz­er would be re­ly­ing less on sup­pli­ers — both to make boost­er Covid-19 shots, which they are now test­ing in the clin­ic, and the new shots to come.

They would com­ple­ment a slate of vac­cines in the port­fo­lio over­seen by Kathrin Jansen that are made from more tra­di­tion­al tech­nolo­gies such as Pre­vnar 13, the top-sell­ing pneu­mo­coc­cal shot that yield­ed $6 bil­lion in sales last year; and 20vP­nC, the fol­low-on vac­cine that’s now un­der pri­or­i­ty re­view at the FDA. Oth­er mid- and late-stage vac­cines are aimed at fight­ing RSV, meningo­coc­cal in­fec­tions, in­va­sive Group B strep­to­coc­cus, C. dif­fi­cile and Ly­me dis­ease.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech read­ies for plunge in Covid sales, will boost mR­NA and on­col­o­gy pipelines

BioNTech is estimating €5 billion (nearly $5.4 billion) in Covid-19 vaccine sales this year, a marked drop from €17.1 billion ($18.5 billion) in 2022 — and way off analysts’ expectations of around €8 billion ($8.6 billion).

In BioNTech’s year-end earnings call on Monday, it reported a total of €17.3 billion ($18.7 billion) in 2022 revenue, almost all from vaccine sales, which include those via its Pfizer deal and direct sales.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.