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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spinout is garnering even more investment and space even after only being around for about a year.

AmplifyBio, a CRO and R&D biotech, has received a nine-figure investment to expand its facilities to a second location in New Albany, a suburb of the state capital of Columbus.

The company is receiving an investment of around $150 million to establish a new 350,000-square-foot facility. With this investment, the company is also expected to create over 200 new jobs both at its new location and at an existing location in West Jefferson, another Columbus suburb. That location, which has 220,000-square-feet of space for the young biotech, is the headquarters for nonprofit Battelle, which spun out AmplifyBio last year.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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