Joyce Fitzharris, SK biotek Ireland president (via SK biotek)

South Ko­re­an gi­ant's biotech arm to make $35M in­vest­ment in Irish fa­cil­i­ty

Amidst a hail of in­vest­ments com­ing from South Ko­re­an con­glom­er­ates in­to biotech, in­clud­ing Lotte and Sam­sung, SK is look­ing to get in on the ac­tion.

SK Pharmte­co, a CD­MO and sub­sidiary of the sec­ond-largest con­glom­er­ate in South Ko­rea, is in­vest­ing $35 mil­lion to ex­pand SK’s phar­ma­ceu­ti­cal man­u­fac­tur­ing plant in the Dublin sub­urb of Swords, Ire­land, in­clud­ing a new build­ing.

Ac­cord­ing to SK, the ex­pan­sion project will pro­vide an in­crease in the site’s man­u­fac­tur­ing ca­pac­i­ty and ca­pa­bil­i­ties, com­ing on­line some­time in 2024.

The first phase of the project will in­clude a new man­u­fac­tur­ing build­ing, which will aim to in­crease re­ac­tor vol­ume ca­pac­i­ty. The new build­ing will al­so con­tain fil­tra­tion and dry­ing equip­ment, as­so­ci­at­ed util­i­ties and the ca­pa­bil­i­ty for ad­di­tion­al man­u­fac­tur­ing lines and tech­nolo­gies in fu­ture phas­es of the project.

The ex­pan­sion will hap­pen over two phas­es, with ad­di­tion­al fund­ing for sub­se­quent phas­es. On com­ple­tion, the ex­pan­sion will re­sult in an over­all 50% in­crease in ca­pac­i­ty at the Swords cam­pus.

“With sub­stan­tial growth in our busi­ness base, this ex­pan­sion sup­ports SK biotek Ire­land’s po­si­tion as a key con­trib­u­tor to SKPT’s EU and world­wide busi­ness,” said Joyce Fitzhar­ris, pres­i­dent of SK biotek Ire­land, in a state­ment.  The new plant will be lo­cat­ed on the foot­print of a de­com­mis­sioned pro­duc­tion build­ing on-site, with­in prox­im­i­ty to SK’s oth­er site fa­cil­i­ties.

This is the sec­ond ma­jor ex­pan­sion project SK has em­barked on. In 2020, the Swords Cam­pus com­plet­ed a $30 mil­lion re­ac­tor ca­pac­i­ty ex­pan­sion.

The cam­pus has been around for 60 years as a small mol­e­cule API man­u­fac­tur­er, pro­duc­ing on­col­o­gy and car­di­ol­o­gy treat­ments.

This comes at a time not on­ly when oth­er com­pa­nies are look­ing to build out or ex­pand on the Emer­ald Isle, but as SK is mak­ing more in­vest­ments in biotech.

Ear­li­er this year, SK said it will in­vest $350 mil­lion in­to the Cen­ter for Break­through Med­i­cines, with plans to add 2,000 em­ploy­ees as part of a re­dux at the CD­MO’s King of Prus­sia, PA, fa­cil­i­ty.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Rahul Singhvi, Resilience CEO

Q&A: Re­silience boss Rahul Singhvi talks $2B US bio­man­u­fac­tur­ing ini­tia­tive and post Se­ries D deals

When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Funding is going towards manufacturing infrastructure, training, R&D and security measures, among others, something that domestic manufacturers are bullish about.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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