Catal­ent pledges to in­crease pro­duc­tion of Mod­er­na vac­cine at its In­di­ana fill-fin­ish plant

One of the big con­tract part­ners in the Covid-19 ef­fort, Catal­ent has signed deals with most of the ma­jor vac­cine play­ers to help ramp up sup­ply. Now, the New Jer­sey firm will ex­pand its deal with Mod­er­na in hopes of churn­ing out dou­ble the amount of fin­ished vials in time for sum­mer.

The CD­MO will in­crease its pro­duc­tion ca­pac­i­ty of the vac­cine in its Bloom­ing­ton, IN bi­o­log­ics fa­cil­i­ty through its new high-speed vial fill­ing line, Catal­ent an­nounced Tues­day. Sources close to the mat­ter told The Wall Street Jour­nal that agree­ment will in­crease the vac­cine out­put in April to 400 vials a minute.

New dos­es will be ready for ship­ment in May, and the plant’s up­grades will al­low for an ad­di­tion­al 80 mil­lion vials a year, the WSJ re­port­ed. This will help with Pres­i­dent Joe Biden’s push to pro­vide enough shots to vac­ci­nate every Amer­i­can adult by late May, and comes at a cru­cial time as talks of ex­pand­ing vac­cine avail­abil­i­ty to chil­dren have tak­en shape in re­cent weeks.

The ex­pand­ed deal fol­lows a March 17 an­nounce­ment that Catal­ent would sig­nif­i­cant­ly in­crease its man­u­fac­tur­ing ca­pac­i­ty for com­mer­cial sup­ply of the J&J vac­cine in Anag­ni, Italy, through late 2022.

Mod­er­na will now have a ded­i­cat­ed fill­ing line at Catal­ent’s In­di­ana fa­cil­i­ty through 2023, where, for now, it will man­u­fac­ture the Covid-19 vac­cine. On March 29, Mod­er­na an­nounced that it had pro­duced its 100 mil­lionth dose of that vac­cine.

Juan An­dres

Catal­ent an­nounced in Sep­tem­ber that it would spend $50 mil­lion to ex­pand the Bloom­ing­ton fa­cil­i­ty. The project, which the com­pa­ny said nor­mal­ly takes around 18 months to com­plete, was fin­ished in 10.

“We ap­pre­ci­ate this ex­pand­ed col­lab­o­ra­tion with Catal­ent and the ded­i­ca­tion of their team,” Mod­er­na CTO Juan An­dres said in a state­ment. “This ad­di­tion­al fill-fin­ish ca­pac­i­ty will be im­por­tant for not on­ly our COVID-19 vac­cine, but al­so po­ten­tial­ly for oth­er pro­grams in our clin­i­cal de­vel­op­ment pipeline.”

Catal­ent’s fa­cil­i­ty in Italy made head­lines at the end of March, when Ital­ian po­lice of­fi­cers raid­ed its Anag­ni plant amidst com­plaints that As­traZeneca was stock­pil­ing dos­es of its vac­cine. That vac­cine was made out­side of the EU and brought to An­gani to be filled in­to vials, a state­ment from As­traZeneca said, and it was “in­cor­rect to de­scribe this as a stock­pile.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.