Will sup­ply chain de­mands freeze Pfiz­er and BioN­Tech out of a big chunk of the Covid-19 mar­ket?

Since the start of the pan­dem­ic, far more at­ten­tion has been paid to de­vel­op­ing a vac­cine than to the sticky process of ac­tu­al­ly get­ting that vac­cine, once de­vel­oped, to peo­ple.

As the first vac­cines near pos­si­ble ap­proval, though, that ques­tion is gain­ing ur­gency, and it’s pos­ing a par­tic­u­lar prob­lem for the new tech­nol­o­gy that has al­lowed some of these can­di­dates to move so quick­ly: mR­NA. To re­main sta­ble, mR­NA vac­cines have to be stored at in­cred­i­bly low tem­per­a­tures — as low as -80 de­grees Cel­sius (-112 Fahren­heit). Dis­trib­ut­ing them, ex­perts have warned, pose a ma­jor lo­gis­ti­cal chal­lenge for the US and an even greater chal­lenge to the world.

On Wednes­day, Mod­er­na al­le­vi­at­ed some of those con­cerns. At a meet­ing for Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, the now house­hold-name com­pa­ny said that its vac­cines would have to be stored long-term at -20 de­grees Cel­sius and kept in nor­mal vac­cine re­frig­er­a­tors for around 7 days. That’s still a chal­lenge, but it im­pos­es few­er de­mands than some had feared. It was al­so no­tice­ably less strict than what BioN­Tech and Pfiz­er, pre­sent­ing on the same day, said they would need for their joint­ly-de­vel­oped mR­NA vac­cine: Long-term stor­age at -70 de­grees, and on­ly 24 hours of stan­dard re­frig­er­a­tion.

The dif­fer­ences have im­pli­ca­tions both for who gets a vac­cine and when and for the in­vestor-watched race for Covid-19 mar­ket share. To­wards the end of the meet­ing, CDC med­ical of­fi­cer Kath­leen Dool­ing sketched dif­fer­ent dis­tri­b­u­tion plans de­pend­ing on if Mod­er­na’s vac­cine is ap­proved, if BioN­Tech’s is ap­proved, or if both are ap­proved. If Mod­er­na came first, it would “re­quire dili­gent vac­cine man­age­ment to min­i­mize waste,” she said. A BioN­Tech ap­proval, on the oth­er hand, would all but elim­i­nate com­mu­ni­ty clin­ics and lo­cal phar­ma­cies from the ini­tial roll­out. Health­care work­ers at “cen­tral­ized sites with ad­e­quate equip­ment and high through­put” — e.g. large, ur­ban hos­pi­tals — would take pri­or­i­ty.

Nan­cy Mes­son­nier

Pfiz­er says it has “ther­mal ship­pers” that can be stored at room tem­per­a­ture and keep the vac­cine cold for 10 days if they’re re­plen­ished with dry ice. But Nan­cy Mes­son­nier, di­rec­tor of the CDC’s Na­tion­al Cen­ter for Im­mu­niza­tion and Res­pi­ra­to­ry Dis­eases, said their ap­proach still posed sig­nif­i­cant bar­ri­ers.

“The com­plex­i­ties of this plan for vac­cine stor­age and han­dling will have ma­jor im­pact in our abil­i­ty to ef­fi­cient­ly de­liv­er the vac­cine,” Mes­son­nier said af­ter their pre­sen­ta­tion, as Reuters re­port­ed.

An­a­lysts agreed that less strin­gent re­quire­ments could give Mod­er­na an “ad­van­tage,” as SVB Leerink’s Mani Foroohar put it, but they ac­knowl­edged that ad­van­tage may be tem­po­rary or lim­it­ed. The oth­er vac­cine ap­proach­es, such as vi­ral vec­tor or re­com­bi­nant pro­tein, don’t tend to re­quire such glacial stor­age con­di­tions and will like­ly be eas­i­er to dis­trib­ute when they ar­rive.

No­vavax has said their re­com­bi­nant pro­tein can be kept in a stan­dard vac­cine re­frig­er­a­tor. End­points News has reached out to the rest of the lead­ing US-backed vac­cine com­pa­nies about their re­quire­ments, as well as to Cure­Vac, the third ma­jor com­pa­ny de­vel­op­ing an mR­NA Covid-19 vac­cine. Mer­ck, which has said it chose its Covid-19 can­di­dates to be as broad­ly dis­trib­utable as pos­si­ble, said in an email they ini­tial­ly plan to store their vi­ral vec­tor vac­cines at -70 de­grees Cel­sius but are work­ing to­ward stor­ing “at more typ­i­cal re­frig­er­a­tor con­di­tions.”

The dark­horse mR­NA vac­cine ef­fort, Sanofi-part­nered Trans­late Bio, said in May they were at­tempt­ing to come up with a for­mu­la­tion that can be stored at warmer tem­per­a­tures. But they have said lit­tle of the ef­fort since.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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