Delphi Genetics

Catal­ent un­corks play in plas­mid DNA with buy­out of Bel­gian neigh­bor Del­phi, Mary­land ex­pan­sion launch

Dri­ven by boom­ing de­mand for cell and gene ther­a­py con­tract work, Catal­ent has signed some big checks in the past few years to se­cure its place as CD­MO No. 1 in that space. Now, the man­u­fac­tur­er is tar­get­ing plas­mid DNA pro­duc­tion to dive even deep­er — and it didn’t have to search long for a good place to start.

Catal­ent un­veiled plans to dive head­first in­to plas­mid DNA pro­duc­tion with the pur­chase of Bel­gian CD­MO Del­phi Ge­net­ics as well as the launch of man­u­fac­tur­ing ser­vices in that space at its Rockville, Mary­land fa­cil­i­ty, the com­pa­ny said Tues­day.

Del­phi Ge­net­ics, found­ed in 2001 and head­quar­tered near Catal­ent’s fa­cil­i­ty in Gos­selies, Bel­gium, will add a 17,000-square-foot fa­cil­i­ty to the Catal­ent fold spe­cial­iz­ing in all stages of clin­i­cal plas­mid sup­ply. Non-chro­mo­so­mal DNA plas­mids are key com­po­nents in some cell and gene ther­a­pies, a space where Catal­ent has plugged some ma­jor cash in re­cent years.

Man­ja Boer­man

Fi­nan­cial terms of the deal were not dis­closed and a Catal­ent spokesman didn’t re­spond to a re­quest for com­ment. Catal­ent ex­pects to ab­sorb all of Del­phi’s em­ploy­ees as part of the tran­si­tion, ac­cord­ing to a re­lease.

Mean­while, Catal­ent is al­so of­fi­cial­ly launch­ing its own in-house plas­mid man­u­fac­tur­ing ser­vices at its Rockville site, an ex­pan­sion that was an­nounced back in 2019. The plant will craft clin­i­cal and com­mer­cial plas­mid sup­ply.

“Hav­ing in­te­grat­ed pDNA sup­ply is a crit­i­cal com­po­nent for the fast and ef­fi­cient pro­duc­tion of vi­ral vec­tors,” said Man­ja Boer­man, pres­i­dent of Catal­ent’s cell and gene ther­a­py unit. “By pro­vid­ing these ca­pa­bil­i­ties in both Eu­rope and the US, where the vast ma­jor­i­ty of ge­net­ic ther­a­py com­pa­nies are based, we will help our part­ners im­prove process­es and re­duce time­lines as they bring their life-chang­ing ther­a­pies to pa­tients.”

It’s not the first time Catal­ent has bought out one of its Bel­gian neigh­bors amid a broad-scale ex­pan­sion on both sides of the At­lantic. Back in Feb­ru­ary 2020, Catal­ent shelled out $315 mil­lion for MaS­Ther­Cell Glob­al and its 32,000 square-foot fa­cil­i­ty in Hous­ton along with a 25,000 square-foot fa­cil­i­ty in Gos­selies. MaS­Ther­Cell al­so plot­ted a 60,000-square-foot ad­di­tion in Bel­gium that’s set to open in Fall 2021.

In Oc­to­ber of last year, Catal­ent ac­quired an­oth­er Gos­selies cell and gene ther­a­py play­er, Bone Ther­a­peu­tics, and its 31,000-square-foot for a mea­ger $14 mil­lion. A month ear­li­er, Catal­ent out­lined its plans to in­fuse $130 mil­lion in­to its cell and gene ther­a­py man­u­fac­tur­ing fa­cil­i­ty in Har­mans, Mary­land, specif­i­cal­ly tar­get­ing late clin­i­cal-stage sup­ply.

That in­vest­ment will add five late-stage clin­i­cal and com­mer­cial man­u­fac­tur­ing suites to the Har­mans site, bring­ing the site’s to­tal num­ber of man­u­fac­tur­ing suites to 15 at the planned 350,000-square-foot com­plex near the Bal­ti­more/Wash­ing­ton In­ter­na­tion­al air­port.

The Har­mans fa­cil­i­ty re­cent­ly re­ceived FDA ap­proval for com­mer­cial pro­duc­tion, and its ini­tial 10 man­u­fac­tur­ing suites are set to be ful­ly op­er­a­tional by the first quar­ter of 2021.

The five new suites will be lo­cat­ed in a sec­ond build­ing at the site that will al­so house cold-stor­age ware­hous­ing and added of­fice space, Catal­ent said. The Har­mans com­plex is one of five Mary­land sites for Catal­ent’s cell and gene ther­a­py man­u­fac­tur­ing port­fo­lio.

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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Ab­b­Vie of­floads UK site for $119M in sale to Chi­nese cell and gene ther­a­py play­er Phar­maron

With its Allergan buyout now long in the books, AbbVie has been taking a hard look at its suddenly expansive global ops to find space for a deal. Now, working with a Chinese cell and gene therapy player hungry for more elbow room abroad, AbbVie has taken one UK facility off its books.

AbbVie has offloaded its Liverpool manufacturing site as part of a $118.7 million sale to Chinese cell and gene therapy player Pharmaron, which is pitching the purchase as the next step in its global expansion plans, the companies said last week.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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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.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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