Center for Breakthrough Medicines‘ headquarters at the Discovery Labs, King of Prussia, Pennsylvania

Ko­re­an con­glom­er­ate SK takes out stake in cell and gene ther­a­py CD­MO with plans for a ma­jor hir­ing spree out­side Philly

A Penn­syl­va­nia CD­MO spe­cial­iz­ing in cell and gene ther­a­py man­u­fac­tur­ing is re­ceiv­ing a big in­flux of cash from a South Ko­re­an drug­mak­er — and it has plans for a ma­jor hir­ing spree.

SK, the hold­ing com­pa­ny of SK bio­science, will in­vest $350 mil­lion of eq­ui­ty fi­nanc­ing in­to the Cen­ter for Break­through Med­i­cines, with plans to add an ad­di­tion­al 2,000 em­ploy­ees as part of a re­dux at the CD­MO’s King of Prus­sia, PA fa­cil­i­ty.

CBM will use the funds to add au­toma­tion to its man­u­fac­tur­ing op­er­a­tions from pre-clin­i­cal all the way through com­mer­cial scale. That in­cludes process de­vel­op­ment, vi­ral vec­tor man­u­fac­tur­ing, cell pro­cess­ing, plas­mid DNA and cell bank­ing, it said. The com­pa­ny will bring 700,000 ad­di­tion­al square feet of ca­pac­i­ty on­line and hire staff mem­bers for its site out­side Philadel­phia. The space will be run by The Dis­cov­ery Labs.

Bri­an O’Neill

The deal has been in the works since last Jan­u­ary. It comes eight months af­ter SK’s takeover of the French gene and cell ther­a­py com­pa­ny Yposke­si.

CBM was es­tab­lished in 2019. It an­nounced over the sum­mer that it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024. That ex­pan­sion will add more than 1 mil­lion square feet of pro­duc­tion space in An­dong, South Ko­rea, and was the first site in the coun­try to get the OK for Covid-19 vac­cine man­u­fac­tur­ing on the con­ti­nent.

“We chose to part­ner with SK based on our shared deep de­sire to cure can­cer and erad­i­cate ge­net­ic dis­ease,” CBM chair­man Bri­an O’Neill said in a state­ment. “Thou­sands of peo­ple are dy­ing every day, and we have the abil­i­ty to cure pa­tients by man­u­fac­tur­ing these new tech­nolo­gies.

Dong Hoon Lee

The move is a step in the right di­rec­tion for SK Pharmte­co to be­come a top-tier CD­MO by 2025, Dong Hoon Lee, the EVP of SK, said in a state­ment.

In Au­gust, South Ko­re­an Pres­i­dent Moon Jae-in said that he hopes the coun­try can be­come one of the five largest man­u­fac­tur­ing bases in the world by 2025. Moon added biotech man­u­fac­tur­ing to the list of na­tion­al strate­gic tech­nolo­gies along with semi­con­duc­tors and bat­ter­ies and of­fers tax breaks for those com­pa­nies to help pay for ma­te­ri­als, parts and equip­ment.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

FDA slams door to piv­otal tri­al for bub­ble boy dis­ease gene ther­a­py as Mus­tang Bio runs in­to an­oth­er hold

Mustang Bio is in familiar territory, but that isn’t a place it necessarily wants to be.

The FDA has placed a hold on Mustang Bio’s pivitol trial for its gene therapy to treat patients with bubble boy disease, citing issues surrounding chemistry, manufacturing and controls clearance. It’s the second hold due to CMC issues the company has received in roughly 18 months.

An investigational new drug application was submitted in December 2021. If granted an IND, a Phase II study will then assess safety, tolerability and efficacy of MB-207. If approved by the FDA, the therapy would one day be eligible for a rare pediatric disease voucher.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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