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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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