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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Jeff Albers, Blueprint CEO

Blue­print Med­i­cines nabs 4th ap­proval in bid to­ward prof­itabil­i­ty

Blueprint Medicines’ push to profitability continues.

On Wednesday, the Cambridge biotech announced the FDA approved its longtime lead drug, Ayvakit, for advanced systemic mastocytosis, a group of debilitating rare diseases where one type of immune cell — mast cells — builds up uncontrollably in a particular organ. The decision came on the heels of Phase III trials showing that more than half of late-stage patients who received the drug responded to it and did so for just over three years.

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Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

UP­DAT­ED: Cure­Vac blames vari­ants as a close­ly-watched Covid vac­cine goes down in flames, fail­ing piv­otal study with woe­ful da­ta

CureVac was widely expected to come in with a late but likely late-stage winner in the race to develop new vaccines for the Covid-19 pandemic. Instead, late Wednesday, the German biotech said their mRNA candidate CVnCoV flat failed a pivotal trial — quashing any hopes for a quick entry in the blockbuster field and gutting their share price.

CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Days af­ter con­tro­ver­sy greet­ed Bio­gen's block­buster Alzheimer's OK, the big biotech con­cedes a set­back on the tau front

Just days after triggering a maelstrom of controversy with their decision to launch an unproven Alzheimer’s drug with a $56,000 price, Biogen $BIIB is back with the latest data on its mid-stage tau drug.

And it’s not good.

The big biotech says that gosuranemab — targeted at tau, the second leading drug target in Alzheimer’s — flat failed its Phase II and will now be taken out and dumped in the mass grave for all but one other Alzheimer’s drug in the past generation.

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