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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

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Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

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Tom Hochuli, Vibalogics CEO

Vi­ral man­u­fac­tur­er Viba­log­ics plots out ex­pan­sion at Ger­man site as US growth plans are un­der­way

A German CDMO specializing in viral manufacturing is expanding its operations in Europe by building out an existing plant — and soon, it will be its own landlord, too.

Vibalogics has begun the first stage of a $50 million expansion of its Cuxhaven, Germany facility, the company announced. It will also buy the site outright from the current owner.

The CDMO specializes in the production of oncolytic viruses and viral vector-based vaccines and gene therapy products. The expansion will add another 100,000 square feet at the site for quality batch release and stability studies, drug product fill-finish and process development.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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