Covid-19 Man­u­fac­tur­ing Roundup: Ther­mo Fish­er plant ramps up As­traZeneca vac­cine pro­duc­tion; No­vavax ex­pands Ko­re­an man­u­fac­tur­ing pact

Short­ly af­ter Ther­mo Fish­er’s $878.2 mil­lion buy­out of No­vasep’s vi­ral vec­tor man­u­fac­tur­ing busi­ness, it took over a plant in Bel­gium tasked with pro­duc­ing ade­n­ovirus vec­tors for As­traZeneca’s ver­sion of the Covid-19 shot.

That pro­duc­tion agree­ment was in­sti­gat­ed when No­vasep was still in charge, and the plant shoul­dered much of the blame for the oft-pub­li­cized slow­down of vac­cine out­put in re­cent weeks. Now that Ther­mo Fish­er has tak­en over, though, the plant has “dras­ti­cal­ly” ramped up its pro­duc­tion of late, Reuters re­port­ed Wednes­day. 

Eu­ro­pean Union in­dus­try com­mis­sion­er Thier­ry Bre­ton said the pro­duc­tion ca­pac­i­ty at the fac­to­ry that pro­duced shots for As­traZeneca had “dras­ti­cal­ly” in­creased, Reuters said.

A re­port in the Wall Street Jour­nal had sin­gled out the Bel­gian plant as the source of the de­lay in pro­duc­tion that had pit­ted As­traZeneca against the EU at times re­cent­ly, re­port­ing that the plant had on­ly been pro­duc­ing a third of the yield the vac­cine mak­er was ex­pect­ing. —Con­ner Mitchell

Ko­rea’s SK vac­cine sub snags deal to ramp up a sup­ply of 40M dos­es of No­vavax’s Covid-19 jab

The vac­cine sub­sidiary of Ko­rea’s SK Group has ex­pand­ed on its orig­i­nal man­u­fac­tur­ing pact with No­vavax, which has been de­vel­op­ing a new vac­cine for Covid-19.

Un­der the new agree­ment, SK Bio­science now has a li­cense to man­u­fac­ture and com­mer­cial­ize NVX-CoV2373. That is be­ing added to a tech­nol­o­gy trans­fer pact re­lat­ed to the man­u­fac­tur­ing of No­vavax’s pro­tein anti­gen, sup­ply of Ma­trix M ad­ju­vant, with added sup­port for SK Bio­science as need­ed to se­cure reg­u­la­to­ry ap­proval.

SK con­cur­rent­ly struck an agree­ment to sup­ply the Ko­re­an gov­ern­ment with 40 mil­lion dos­es of the vac­cine, which has cleared an in­ter­im re­view in the UK, with Phase III da­ta com­ing up in the US.

“We are hon­ored to con­tin­ue to man­u­fac­ture No­vavax’s in­no­v­a­tive COVID-19 vac­cine and pro­vide a sup­ply to the Ko­re­an Gov­ern­ment through this agree­ment,” said Jaey­ong Ahn, the CEO of SK Bio­science. —John Car­roll

Japan’s Kane­ka Eu­ro­gen­tec gains GMP ac­cred­i­ta­tion to pro­duce mR­NA vac­cines

Japan’s Kane­ka Eu­ro­gen­tec, bol­stered by a re­cent deal to man­u­fac­ture dos­es of In­ovio’s Covid-19 vac­cine, now has a new ac­co­lade in its port­fo­lio.

Eu­ro­gen­tec’s new fa­cil­i­ty in Seraing, Bel­gium has re­ceived GMP ac­cred­i­ta­tion for man­u­fac­tur­ing mR­NA, the key com­po­nent of many Covid-19 vac­cines cur­rent­ly on the mar­ket and a close coun­ter­part to In­ovio’s plas­mid DNA-based vac­cine for the res­pi­ra­to­ry virus.

The Bel­gian fa­cil­i­ty will ini­tial­ly al­low Kane­ka Eu­ro­gen­tec to pro­duce and pu­ri­fy up to a 10g scale — or 1 mil­lion vac­cine dos­es — of RNA that can be used in both clin­i­cal tri­als and the com­mer­cial sup­ply chain, and can po­ten­tial­ly be ex­pand­ed fur­ther. —Con­ner Mitchell

Mod­er­na, Pfiz­er-BioN­Tech ink deals for mil­lions of more vac­cine dos­es in EU

The Eu­ro­pean Com­mis­sion this week inked deals with Mod­er­na and Pfiz­er for a to­tal of 350 mil­lion more vac­cine dos­es, to be de­liv­ered through­out 2021. Mod­er­na’s to­tal com­mit­ment now sits at 310 mil­lion dos­es in 2021, and as part of the new agree­ment, the EU al­so holds the op­tion to buy an­oth­er 150 mil­lion dos­es for de­liv­ery in 2022.

The deal al­so will sup­ply 200 mil­lion more dos­es of the Pfiz­er-BioN­Tech vac­cine, and the new ad­di­tion­al dos­es will bring the EU’s to­tal sup­ply up to 500 mil­lion. More biotechs are jump­ing in to as­sist Pfiz­er-BioN­Tech with de­vel­op­ment, in­clud­ing Mer­ck KGaA, which says it can ac­cel­er­ate its sup­ply of cus­tom lipids.

No­var­tis has al­so agreed to lend a hand with de­vel­op­ment, and Sanofi has of­fered the use of its Frank­furt plant to pro­duce more than 100 mil­lion dos­es. —Con­ner Mitchell

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

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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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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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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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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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant viral vector Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

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.

Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.