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.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Kelly Martin, Radius Health CEO

Ra­dius rock­ets high­er as Kel­ly Mar­tin boasts of a big PhI­II suc­cess — but the spoils be­long to Menar­i­ni

Radius Health stuck with some fuzzy top-line Phase III results for its oral SERD therapy elacestrant, but investors saw enough to push a rally that sparked a big surge in its share price.

According to researchers, the drug hit both primary endpoints among ER+/HER2- breast cancer patients: beating standard of care on progression-free survival in the overall population and PFS with tumors harboring estrogen receptor 1 mutations — a key factor in developing resistance. And while some analysts were left wondering about specific data, most of the crowd seemed happy to hear that the drug is now being steered to the FDA.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales.

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