Covid-19 roundup: Flood, dead­ly fire threat­en As­traZeneca vac­cine plants; Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls

As re­ports crop up that de­liv­er­ies of Pfiz­er and BioN­Tech’s Covid-19 vac­cine are be­ing un­ex­pect­ed­ly cut, Italy won­ders if it can take the vac­cine de­vel­op­ers to court, ac­cord­ing to the Wall Street Jour­nal. 

Af­ter its ship­ment for this week was cut by 29%, the Ital­ian gov­ern­ment con­sult­ed its at­tor­ney gen­er­al about tak­ing le­gal ac­tion, the WSJ re­port­ed. Pfiz­er and BioN­Tech had warned the EU and Cana­da last week that their al­lo­ca­tions would be re­duced as Pfiz­er up­grades its Bel­gium fac­to­ry. What Italy says it doesn’t ap­pre­ci­ate, though, is the short no­tice.

Italy isn’t the first coun­try to com­plain of vac­cine short­ages as au­thor­i­ties scram­ble to get dos­es in arms. Ger­many’s Ham­burg said they al­so re­ceived a small­er ship­ment — and they’re strug­gling to ex­tract a full six dos­es from vials.

While the vials were ini­tial­ly la­beled for five dos­es, the EU found ear­li­er this month that it was pos­si­ble to squeeze out a sixth dose. Pfiz­er and BioN­Tech said they are com­mit­ted to de­liv­er­ing a cer­tain amount of dos­es — not vials, ac­cord­ing to the WSJ. But with­out a spe­cial sy­ringe, those ad­min­is­ter­ing the vac­cine can’t quite get that sixth dose out, the pa­per re­port­ed.

Last month, sev­er­al US states al­so com­plained of sharply re­duced vac­cine al­lo­ca­tions. Wash­ing­ton Gov. Jay In­slee said the CDC told him to ex­pect 40% few­er dos­es one week, NPR re­port­ed. Iowa was ex­pect­ing a 30% short­fall. Pfiz­er said it had mil­lions of dos­es sit­ting in a ware­house, and was await­ing in­struc­tions from the gov­ern­ment. HHS Sec­re­tary Alex Azar, on the oth­er hand, blamed Pfiz­er’s pro­duc­tion ca­pac­i­ty.

The news comes as the US lags be­hind its dis­tri­b­u­tion plans. While fed­er­al pro­jec­tions had aimed to dis­trib­ute 20 mil­lion dos­es by the end of 2020, on­ly 16.5 mil­lion dos­es have been ad­min­is­tered so far, ac­cord­ing to the CDC.

Dead­ly fire strikes fa­cil­i­ties mak­ing As­traZeneca vac­cine in In­dia

A dead­ly fire broke out Thurs­day at the Serum In­sti­tute of In­dia, where hun­dreds of mil­lions of dos­es of the As­traZeneca Covid-19 are be­ing man­u­fac­tured.

Five peo­ple died in the blaze, the cause of which re­mains un­known. Serum In­sti­tute CEO Adar Poon­awal­la ex­pressed con­do­lences for the fam­i­lies and sought to as­sure that the tragedy would not im­pact vac­cine pro­duc­tion, as the in­sti­tute had 50 mil­lion dos­es in re­serve and oth­er build­ings ded­i­cat­ed to pro­duc­tion.

The fire broke out in a new build­ing the man­u­fac­tur­er was build­ing to scale pro­duc­tion of the As­traZeneca vac­cine. Murlid­har Mo­hol, may­or of Pune city, where the Serum In­sti­tute is lo­cat­ed, said the vic­tims were like­ly con­struc­tion work­ers, AP re­port­ed.

The fire was one of two dis­as­ters to threat­en fa­cil­i­ties mak­ing As­traZeneca’s Covid-19 vac­cine in the last 24 hours. A vac­cine plant in Wrex­ham, Wales sought aid from lo­cal au­thor­i­ties Wednes­day as a storm tore in­to the town, caus­ing flood­ing and evac­u­a­tions.

The fac­to­ry, though, ap­pears to have weath­ered the tu­mult. A spokesper­son told Bloomberg Thurs­day that they ex­pe­ri­enced mild flood­ing, but suf­fered no dis­rup­tions to work and pro­duc­tion is on­go­ing.

As­traZeneca, de­spite fac­ing sub­stan­tial set­backs in its vac­cine pro­gram, has pur­sued the most am­bi­tious pro­duc­tion goals of any Covid-19 de­vel­op­er, aim­ing to pro­duce 3 bil­lion dos­es world­wide by the end of 2021. The Serum In­sti­tute ac­counts for around 1 bil­lion dos­es of that to­tal.  — Ja­son Mast

US recom­mits to WHO un­der new Biden ad­min­is­tra­tion

On his first day in of­fice, Pres­i­dent Joe Biden inked a di­rec­tive recom­mit­ting the US to the World Health Or­ga­ni­za­tion, re­vers­ing the Trump’s ad­min­is­tra­tion’s calls to aban­don the agency amid the pan­dem­ic.

Ac­cord­ing to Sec­re­tary of State-des­ig­nate Tony Blinken, that means join­ing CO­V­AX, a pro­gram set up by CEPI, the WHO and Gavi to eq­ui­tably dis­trib­ute vac­cines around the world, the Wash­ing­ton Post re­port­ed.

More than 180 coun­tries had signed agree­ments to the CO­V­AX Fa­cil­i­ty as of Oct. 14, in­clud­ing France, the UK and Chi­na. The co­op­er­a­tive aims to de­liv­er 2 bil­lion dos­es by the end of 2021. The Trump ad­min­is­tra­tion, how­ev­er, re­fused to join. One White House spokesman said the coun­try won’t be “con­strained by mul­ti­lat­er­al or­ga­ni­za­tions in­flu­enced by the cor­rupt World Health Or­ga­ni­za­tion and Chi­na,” ac­cord­ing to a Bloomberg re­port.

The Trump ad­min­is­tra­tion gave no­tice of plans to with­draw from the WHO back in Ju­ly. But sev­er­ing ties with the agency isn’t that sim­ple. Ac­cord­ing to the terms of a joint res­o­lu­tion passed in 1948, the US must give a year’s no­tice and pay back debts be­fore it can leave. How­ev­er, whether Trump could do so with­out Con­gress was un­clear, and De­mo­c­ra­t­ic law­mak­ers pushed back.

Stephen Mor­ri­son, di­rec­tor of the Glob­al Health Pol­i­cy Cen­ter at the Cen­ter for Strate­gic and In­ter­na­tion­al Stud­ies, told WaPo that he thinks the WHO will wel­come the US. “But there’s go­ing to be an edge to it,” he said.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.

No­var­tis pairs up with Cure­Vac to help dri­ve Covid-19 shot pro­duc­tion but may miss the show in the US, EU

With the pandemic potentially entering its later stages, major drugmakers like Merck have jumped in to aid in the gargantuan task of manufacturing other companies’ vaccines. Now, after a relatively quiet year, Novartis is teaming up with one of the mRNA players to help the production crunch.

Novartis will help manufacture bulk drug substance for CureVac’s mRNA-based Covid-19 shot, dubbed CVnCoV, at its Kundl, Austria site with plans to produce up to 50 million doses by the end of 2021, the Swiss drugmaker said Thursday.

In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Covid-19 roundup: EMA starts rolling re­view of Rus­si­a's Sput­nik V; No­vavax says shot is 51% ef­fec­tive against vari­ant in South Africa 

The EMA has started a rolling review of Sputnik V, the Russian vaccine that holds the dubious title of the world’s first registered jab for Covid-19.

Seven months after the controversial clearance in Russia, Europe’s human medicines committee says it’s convinced to start looking at the application by data indicating that the adenovirus-based vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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