Catal­ent drops $350M to ex­pand In­di­ana site that in­cludes Mod­er­na-ded­i­cat­ed line

Bloom­ing­ton, IN, is the home of In­di­ana Hoosiers bas­ket­ball – and the cen­ter of Catal­ent’s bi­o­log­ics drug sub­stance man­u­fac­tur­ing op­er­a­tions. And while the uni­ver­si­ty’s for­ward Trayce Jack­son-Davis might be leav­ing town ear­ly to de­clare for the NBA Draft, the CD­MO has made it clear that it isn’t go­ing any­where.

On Thurs­day, Catal­ent an­nounced a mul­ti-year, $350 mil­lion in­vest­ment at the Bloom­ing­ton site to ex­pand drug sub­stance and prod­uct man­u­fac­tur­ing. The ad­di­tions will in­clude new biore­ac­tors, sy­ringe fill­ing lines and lyophiliza­tion ca­pac­i­ty, as well as au­to­mat­ed pack­ag­ing up­grades and qual­i­ty con­trol labs.

It gives the site the ca­pa­bil­i­ty to meet client needs for batch­es of drug sub­stance up to 4,000-liters us­ing sin­gle-use tech­nol­o­gy, or 5,000 liters us­ing the al­ready-ex­ist­ing stain­less steel biore­ac­tors.

There’s been an in­dus­try shift back to­ward sin­gle-use tech­nol­o­gy. The Amer­i­can Phar­ma­ceu­ti­cal Re­view pro­ject­ed a mar­ket that could see $10 bil­lion a year in growth for the next five years, back in 2018. Sin­gle-use sys­tems are sealed and ster­ile un­til the man­u­fac­tur­ing process is set to be­gin, al­low­ing a plug-and-play process and fur­ther en­sur­ing a ster­ile project. Multi­use or stain­less steel man­u­fac­tur­ing re­quires an ex­ten­sive ster­il­iza­tion process that can be cost­ly and less time­ly.

Catal­ent is adding to the site’s fill-fin­ish ca­pac­i­ty as well. A year ago, it pledged to ramp up the fill-fin­ish op­er­a­tions at the Bloom­ing­ton site to pump out 400 vials a minute and gave a ded­i­cat­ed fill­ing line to Mod­er­na through 2023 for its Covid-19 vac­cine.

It’s not the first makeover for the Bloom­ing­ton site over the last two years. In Sep­tem­ber 2020, Catal­ent said that it would spend $50 mil­lion to ex­pand the project, and did so in just 10 months, rough­ly hav­ing the nor­mal al­lot­ted time. The re­cent­ly an­nounced up­grade should be done in 2024. Once it’s com­plete, it will add an­oth­er 1,000 new jobs to the work­force in the fol­low­ing years.

Catal­ent al­ready had pledged to add an­oth­er 600 back in Oc­to­ber 2021. The com­pa­ny held two job fairs at the coun­ty con­ven­tion cen­ter, look­ing to hire for every po­si­tion from en­try-lev­el ware­house and man­u­fac­tur­ing jobs to di­rec­tors and tech­ni­cians. Much of the de­mand for em­ploy­ees came from the pres­sure from the pro­duc­tion of Covid-19 vac­cines, hu­man re­sources se­nior di­rec­tor Ar­turo Lopez told the lo­cal me­dia.

Mike Ri­ley

“These in­vest­ments will en­able us to ex­pand our flag­ship Bloom­ing­ton fa­cil­i­ty and ex­tend our lead­er­ship as one of the largest and most com­pre­hen­sive glob­al cen­ters for in­te­grat­ed man­u­fac­tur­ing ca­pa­bil­i­ties,” Catal­ent pres­i­dent of bio­ther­a­peu­tics Mike Ri­ley said in a state­ment. “The site of­fers high­ly flex­i­ble and scal­able so­lu­tions to com­pa­nies de­vel­op­ing new bi­o­log­i­cal drugs, vac­cines, RNA ther­a­pies, and oth­er in­no­v­a­tive treat­ments for pa­tients around the world.”

With the in­flux of mon­ey that came with Covid-19 vac­cine man­u­fac­tur­ing deals, Catal­ent has been ex­pand­ing and grow­ing.

A week ago, the com­pa­ny an­nounced that it would add new suites to a Kansas City site, giv­ing it the ca­pa­bil­i­ty to pro­duce 156,000 cap­sules per hour. In the first week of April, the com­pa­ny re­vealed that it won the high­ly com­pet­i­tive bid­ding war for the UK’s Vac­cine Man­u­fac­tur­ing and In­no­va­tion Cen­tre, and on top of that, plans to put an­oth­er $160 mil­lion in­to the site to com­plete the build and add mR­NA and pro­tein ca­pa­bil­i­ties. Fel­low gi­ants Lon­za and Fu­ji­film Diosynth were in the bid­ding mix as well, the Fi­nan­cial Times said.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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