Catal­ent keeps adding on at key Ital­ian plant, this time with a pair of new biore­ac­tors and 100 jobs

For the sec­ond time in less than six months, Catal­ent will up­grade its sleek new fa­cil­i­ty in Anag­ni, Italy, this time to add bi­o­log­ics drug sub­stance man­u­fac­tur­ing ca­pa­bil­i­ties to sup­port an in­crease in de­mand.

Two new 2,000 liter sin­gle-use biore­ac­tors with new man­u­fac­tur­ing suites will sup­port ear­ly-phase clin­i­cal de­vel­op­ment and late-stage com­mer­cial trans­fers, the com­pa­ny said in a press re­lease, as well as space for an­oth­er six biore­ac­tors to be added in the fu­ture. The project is ex­pect­ed to add 100 new em­ploy­ees, and it should be op­er­a­tional in April 2023.

Up­on com­ple­tion, the ex­pan­sion will have 16,000 liters of man­u­fac­tur­ing ca­pa­bil­i­ty. Batch­es will be able to range from 2,000 to 8,000 liters. The pro­gram will cost about $100 mil­lion, and Catal­ent’s EVP of Mar­ket­ing and Strat­e­gy Bernie Clark said that though the com­pa­ny hasn’t signed off on adding the sub­se­quent biore­ac­tors, it can hap­pen in “very short or­der,” and Catal­ent’s plan is to max out the fa­cil­i­ty.

“Catal­ent is com­mit­ted to sup­port­ing cus­tomers from small and vir­tu­al biotechs to large bio­phar­ma com­pa­nies that re­quire the right ca­pa­bil­i­ties, scale of ca­pac­i­ty, and in­te­grat­ed so­lu­tions to meet their needs for new bi­o­log­ic ther­a­pies and vac­cines,” Re­gion­al Bi­o­log­ics Pres­i­dent for Eu­rope Mario Gargiu­lo said in a press re­lease. “Catal­ent was an ear­ly adopter of sin­gle-use tech­nol­o­gy be­cause of its flex­i­bil­i­ty, and we con­tin­ue to in­vest in tech­nol­o­gy that en­ables adapt­able, scal­able so­lu­tions for the fast-grow­ing seg­ment of bi­o­log­ics ad­dress­ing mid-sized and or­phan pa­tient pop­u­la­tions.”

The plant was ac­quired from BMS in 2019, and the CD­MO was drawn to it, large­ly be­cause of site’s ex­pe­ri­enc­ing launch­ing prod­ucts in­to  sev­en or eight new mar­kets a year, and its state-of-the-art, near­ly un­touched vial fill­ing lines. The orig­i­nal plan wasn’t for a glob­al pan­dem­ic to break out, but once it did, Catal­ent upped its vial fill­ing, in­spec­tion, la­bel­ing, and pack­ag­ing ser­vices there.

“It usu­al­ly takes some time to start fill­ing ca­pac­i­ty and hav­ing high­er lev­els of uti­liza­tion on any new line, it’s a process that could take months or years, but what was re­al­ly in­ter­est­ing in the time frame was that Catal­ent, who has a lot of ex­pe­ri­ence do­ing tech trans­fer and scale up had these new as­sets,” Clark said in a phone call to End­points News. “That’s why in short or­der…we had part­nered with…As­traZeneca and John­son & John­son to be able to hit the ground run­ning in a sense. It was a very unique time, and I think we’ve re­spond­ed pret­ty well to be able to meet those man­u­fac­tur­ing time­lines.”

In March, the com­pa­ny an­nounced that it would amp up sup­plies of the J&J Covid-19 vac­cine  That deal scaled up a vial fill­ing line to line up with J&J’s FDA ap­proval. Right now, the plant in Italy is sole­ly fo­cused on churn­ing out J&J and As­traZeneca Covid-19 vac­cines, un­til a need for an­oth­er bi­o­log­ic aris­es. With­in Catal­ent, the com­pa­ny has kept its eyes peeled for what the next big de­mand will be. But with news chang­ing every day, and the prob­lems the Delta vari­ant has caused, it’s not rul­ing any­thing out.

“We just need to be pre­pared for any­one of those sce­nar­ios,” Clark said.

The plant made head­lines in March, when Ital­ian po­lice of­fi­cers raid­ed it amidst com­plaints that As­traZeneca had been stock­pil­ing dos­es of its vac­cine, which As­traZeneca lat­er de­nied, say­ing that the process was “com­plex and time con­sum­ing.”

The ex­pan­sion adds on to its Eu­ro­pean op­er­a­tions in Limo­ges, France, and Brus­sels, Bel­gium, and state­side in Madi­son, WI, and Bloom­ing­ton, IN. The New Jer­sey CD­MO just wrapped up an ex­pan­sion at the Wis­con­sin plant to add its fourth and fifth man­u­fac­tur­ing suites with new sin­gle-use biore­ac­tors

Since the pan­dem­ic, there’s been a flur­ry of ac­tiv­i­ty with­in CD­MO in­dus­try, and Catal­ent’s been at the fore­front of that. Last week, it an­nounced a part­ner­ship with Austin, TX-based Cur­tana Phar­ma­ceu­ti­cals to make CT-179, its drug ther­a­py for brain can­cers. It al­so joined the cannabid­i­ol world with a part­ner­ship with JOS Phar­ma­ceu­ti­cals to study an awake anesth­sia us­ing CBD to use in cataract surg­eries.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.