Covid-19 roundup: As­traZeneca gets EMA thumbs up for vac­cine amid bit­ter feud with EU; No­var­tis jumps in to man­u­fac­ture Pfiz­er/BioN­Tech vac­cine

The EMA has rec­om­mend­ed that the EU au­tho­rizes As­traZeneca and Ox­ford’s Covid-19 vac­cine, even as they’re in deep dis­pute over its de­liv­ery.

The agency said reg­u­la­tors based their as­sess­ment on com­bined re­sults from four clin­i­cal tri­als in the UK, Brazil and South Africa, in­volv­ing 24,000 peo­ple in to­tal, that sug­gest the vac­cine had a 60% ef­fi­ca­cy.

Ear­li­er in the day the EU made pub­lic their (heav­i­ly redact­ed) sup­ply con­tract, which of­fi­cials de­scribe as a bid to fos­ter trans­paren­cy and ac­count­abil­i­ty in the vac­cine roll­out. It comes af­ter Eu­ro­pean Com­mis­sion pres­i­dent Ur­su­la von der Leyen di­aled up the pres­sure on As­traZeneca, as­sert­ing that its de­ci­sion to re­duce sup­plies to the EU a breach of “bind­ing or­ders” in the con­tract.

As­traZeneca no­ti­fied the bloc last week that it will be de­liv­er­ing far few­er dos­es to mem­ber coun­tries than it had promised to, blam­ing pro­duc­tion prob­lems at a Bel­gian fac­to­ry.

The cuts, which amount­ed to a 60% re­duc­tion from 80 mil­lion to 31 mil­lion de­liv­ered dos­es by March, trig­gered fiery back­lash from the EU, which was al­ready deal­ing with de­lays of the Pfiz­er/BioN­Tech vac­cine and lags in vac­ci­na­tion. Skep­ti­cal of As­traZeneca’s ex­pla­na­tion, of­fi­cials had sus­pect­ed that As­traZeneca sold vac­cines in­tend­ed for Eu­rope to oth­er coun­tries at a high­er price.

The EU has al­so de­mand­ed that the phar­ma gi­ant send dos­es pro­duced in the UK to make up for the short­age — some­thing the British gov­ern­ment has pub­licly op­posed.

“We want to pub­lish it to­day,” von der Leyen told Eu­ronews af­ter the EU post­ed the con­tract. “This is busi­ness sen­si­tive da­ta, that’s clear. But ba­si­cal­ly: we want to cre­ate trans­paren­cy on these is­sues that I have just touched on. We know ex­act­ly what is in the con­tract, which is why it is im­por­tant to us that it is now made pub­lic.”

Un­der a con­tract signed in Au­gust, the EU has agreed to pur­chase 300 mil­lion dos­es of the ade­n­ovirus-based vac­cine, which was co-de­vel­oped by As­traZeneca and Ox­ford. They al­so se­cured rights to or­der 100 mil­lion more dos­es.

No­var­tis jumps in to man­u­fac­ture Pfiz­er/BioN­Tech vac­cine

Af­ter its own shots at de­vel­op­ing a Covid-19 treat­ment came up short, No­var­tis is ready to lend a hand to the more suc­cess­ful pro­grams.

Its first move is to fill vac­cine vials with bulk mR­NA ac­tive in­gre­di­ent made by BioN­Tech un­der a con­tract man­u­fac­tur­ing agree­ment, be­fore ship­ping it back for dis­tri­b­u­tion.

While not No­var­tis’ first in­volve­ment in the vac­cine hunt, it would be the lat­est ex­am­ple in a glob­al health cri­sis that’s cat­alyzed a string of un­usu­al pacts be­tween bio­phar­ma ri­vals, all pledg­ing to do what they can to help end the pan­dem­ic.

CEO Vas Narasimhan told Bloomberg on Thurs­day that No­var­tis is “in con­ver­sa­tions with a range of dif­fer­ent play­ers” to see about help­ing man­u­fac­ture their prod­ucts — every­thing from mon­o­clon­al an­ti­bod­ies to vac­cines. He didn’t name any of the po­ten­tial part­ners.

Un­der the deal with Pfiz­er and BioN­Tech, No­var­tis plans to start pro­duc­tion at a fa­cil­i­ty in Stein, Switzer­land in Q2 and have the first ship­ment in Q3.

“We have pro­duc­tion ca­pac­i­ty across our net­work that we’re will­ing to make avail­able,” he said.

Lim­it­ed sup­ply has been a con­sis­tent is­sue for drug­mak­ers, who be­gan scal­ing up man­u­fac­tur­ing while their vac­cines or treat­ments were still in clin­i­cal tri­als. But with as­tro­nom­i­cal de­mand from all cor­ners of the world and plen­ty of pre-or­ders in place, com­pa­nies like As­traZeneca can find them­selves in the hot seat scram­bling to sat­is­fy every cus­tomer.

Ear­li­er this week, Sanofi an­nounced that it would make a plant in Frank­furt avail­able to as­sist Pfiz­er and BioN­Tech in their pro­duc­tion, while its own Glax­o­SmithK­line-part­nered pro­gram gets back on track. Mer­ck KGaA is re­port­ed­ly al­so con­sid­er­ing sev­er­al ways to help fel­low Ger­man play­er BioN­Tech in­crease out­put, in­clud­ing open­ing up its “fill and fin­ish” ca­pa­bil­i­ties.

For No­var­tis, Narasimhan sug­gest­ed every­thing is on the ta­ble. Ad­di­tion­al dis­cus­sions sur­round mR­NA pro­duc­tion, ther­a­peu­tic pro­tein pro­duc­tion as well as raw ma­te­r­i­al pro­duc­tion, the com­pa­ny not­ed in a re­lease.

“The ear­ly stages of scal­ing up from a few tens of thou­sands of dos­es to hun­dreds of mil­lions of dos­es in gen­er­al is a chal­leng­ing scale-up,” he said in an in­ter­view with Bloomberg. “It’s not sur­pris­ing that we have some bumps in the road. What’s im­por­tant right now is that we man­age pub­lic ex­pec­ta­tions ap­pro­pri­ate­ly, and then I think the sup­plies will start to come through.”

The Swiss phar­ma gi­ant has ex­tend­ed its ten­ta­cles in a few dif­fer­ent di­rec­tions to tack­le Covid-19, pitch­ing Jakafi for se­vere pa­tients, hav­ing its AveX­is gene ther­a­py sub­sidiary man­u­fac­ture a vac­cine de­vel­oped by two Mass­a­chu­setts hos­pi­tals, back­ing Mol­e­c­u­lar Part­ners’ pre­clin­i­cal pro­gram in a $231 mil­lion deal, and lat­er bet­ting on a stem cell ther­a­py from Mesoblast.

Jakafi and the Mesoblast pro­gram flopped in late-stage stud­ies, though the oth­er two are still on­go­ing.

Ger­many rec­om­mends against giv­ing As­traZeneca/Ox­ford vac­cine to el­der­ly

As­traZeneca’s vac­cine shouldn’t be giv­en to el­der­ly peo­ple over the age of 65, an ex­pert pan­el in Ger­many has rec­om­mend­ed.

While the head of the coun­try’s vac­cine reg­u­lar ex­pects the EU au­tho­riza­tion — ex­pect­ed im­mi­nent­ly — to come with­out any age re­stric­tions, Ger­many’s of­fi­cial rec­om­men­da­tion will be to on­ly of­fer it to peo­ple aged 18 to 64, un­like the mR­NA jabs from Pfiz­er/BioN­Tech and Mod­er­na.

“There are cur­rent­ly in­suf­fi­cient da­ta avail­able to as­sess the vac­cine ef­fi­ca­cy from 65 years of age,” the com­mit­tee’s draft res­o­lu­tion read. It was made avail­able by the Ger­man health min­istry on Thurs­day.

With­in the Phase III tri­als, 341 peo­ple old­er than 65 were vac­ci­nat­ed but on­ly one be­came in­fect­ed — of­fer­ing lit­tle ev­i­dence of its ef­fi­ca­cy in this high-risk pop­u­la­tion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.