Look­ing to build in red-hot vi­ral vec­tor space, Ther­mo Fish­er inks $878M deal for Bel­gian man­u­fac­tur­er's 2 plants

Be­tween Covid-19 vac­cines and gene ther­a­pies, the con­tract man­u­fac­tur­ing mar­ket for vi­ral vec­tor tech has grown at a rapid clip. Ther­mo Fish­er Sci­en­tif­ic, al­ready one of the biggest CD­MOs on the block, has now made a move to buoy its EU foot­print in that field.

Ther­mo Fish­er will pay $878 mil­lion to ac­quire Henogen SA, No­vasep’s vi­ral vec­tor man­u­fac­tur­ing busi­ness, which com­pris­es two Bel­gian lo­ca­tions in Sen­effe and Gos­selies that of­fer over 75,000 square feet of clin­i­cal and com­mer­cial man­u­fac­tur­ing ca­pac­i­ty, the Mass­a­chu­setts com­pa­ny said Fri­day.

Over two decades, No­vasep has grown to some 400 em­ploy­ees and boast­ed a 2020 rev­enue of around $95 mil­lion through its CD­MO ser­vices that fo­cus on vac­cines and oth­er ther­a­pies to large biotech com­pa­nies and oth­er in­dus­try cus­tomers. Michel La­garde, Ther­mo Fish­er’s ex­ec­u­tive vice pres­i­dent, said in a state­ment that the ad­di­tion of Eu­ro­pean man­u­fac­tur­ing ca­pac­i­ty will com­ple­ment the com­pa­ny’s four CD­MO sites in the US.

“(No­vasep) bring(s) an in­cred­i­bly tal­ent­ed team with more than two decades of ex­pe­ri­ence across a broad range of vi­ral vec­tors,” La­garde said. ” The com­bi­na­tion will ben­e­fit our glob­al cus­tomers seek­ing sup­port and ca­pac­i­ty in the re­gion as well as Eu­ro­pean cus­tomers bring­ing new med­i­cines to pa­tients in­side and out­side of Eu­rope.”

In the last month, Ther­mo Fish­er has un­veiled plans for sev­en oth­er man­u­fac­tur­ing fa­cil­i­ties across the US and Eu­rope, vary­ing in de­grees of fo­cus and pub­licly-avail­able fi­nanc­ing de­tails.

The first four sites were an­nounced Dec. 11, fo­cused on pro­vid­ing ser­vices for a range of clients, “whether it’s an emerg­ing biotech work­ing on a vac­cine for a nov­el virus or a high-vol­ume phar­ma­ceu­ti­cal man­u­fac­tur­er de­liv­er­ing nec­es­sary med­i­cines at scale,” a spokesper­son told End­points News at the time. Those sites are lo­cat­ed in Greenville, NC, Fer­enti­no and Mon­za, Italy, and Swin­don, Eng­land — fo­cus­ing on com­mer­cial-scale fill­ing lines and cold-chain stor­age for vac­cines that must be stored at ex­treme­ly low tem­per­a­tures.

Four days lat­er, the com­pa­ny ramped up its clin­i­cal sup­ply chain of­fer­ings — no­tably to aid the on­go­ing Covid-19 re­sponse ef­fort —in Ger­many with two new fa­cil­i­ties in Rhe­in­felden and Weil am Rhein. The Rhe­in­felden site went on­line in De­cem­ber, and the Weil am Rhein site is set to go on­line some­time this month.

Then, on Dec. 17, Ther­mo Fish­er an­nounced its third ma­jor ex­pan­sion, this time a 67,000 square-foot cGMP fa­cil­i­ty spe­cial­iz­ing in the pro­duc­tion of plas­mid DNA ther­a­peu­tics in­volv­ing in­de­pen­dent­ly-repli­cat­ing mol­e­cules at its ex­ist­ing Carls­bad, CA site.

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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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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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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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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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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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.

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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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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