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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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