John Rim, Samsung Biologics CEO

Amidst large in­vest­ment from par­ent com­pa­ny, Sam­sung Bi­o­log­ics seeks to ramp up biotech fund­ing

Dur­ing End­points News’ time in San Diego for #BIO22, it was hard to miss all the Sam­sung Bi­o­log­ics signs plas­tered along­side the high­way to the air­port, adorn­ing near­ly every lamp post. How­ev­er, ad­ver­tis­ing is not the on­ly place where Sam­sung is look­ing to spend.

Last month, it was re­port­ed that South Ko­rea’s Sam­sung Group raised spend­ing by more than 30% to KRW 450 tril­lion, or around $360 bil­lion, to in­vest in sev­er­al lines of busi­ness in­clud­ing elec­tron­ics and biotech, among oth­ers. Sam­sung Bi­o­log­ics CEO John Rim spoke to End­points at #BIO22 to dis­cuss how this in­vest­ment will af­fect the biotech arms of one of South Ko­rea’s largest con­glom­er­ates.

Rim said that a sig­nif­i­cant por­tion of that mon­ey will be in­vest­ed in­to biotech, but a hard fig­ure was not giv­en to End­points. Rim did in­di­cate that the com­pa­ny is build­ing out a plat­form that will be com­plet­ed around Oc­to­ber, with it com­ing ful­ly on­line next year on the back of the in­vest­ment.

Al­so, the com­pa­ny is in the process of pur­chas­ing ad­di­tion­al land, dubbed Bio Cam­pus Two, which will be ad­ja­cent to their cur­rent 60-acre cam­pus in Song­do, South Ko­rea. Rim said their cur­rent cam­pus is now ful­ly oc­cu­pied and is now in need of ex­pan­sion. This new cam­pus will be planned to be ful­ly staffed with­in the next 10 years and be 30% larg­er, Rim said. Ac­cord­ing to a reg­u­la­to­ry fil­ing, the com­pa­ny will spend around KRW 426 Bil­lion, or $347 mil­lion, to ac­quire the land for the new 80-acre cam­pus.

While Sam­sung Bi­o­log­ics is al­so build­ing out an­oth­er plant in Song­do, la­beled as a ‘su­per plant’ with a $2 bil­lion price tag, Rim said that the in­vest­ment will al­so build out two more man­u­fac­tur­ing plants to bring their to­tal to six.

Rim did not share any specifics on the size or cost of the pro­posed plants, but said the idea is to have sim­i­lar-sized fa­cil­i­ties to what they have now. Rim said they are fac­ing a very ro­bust client de­mand, and the com­pa­ny will look for the right time for an of­fi­cial an­nounce­ment on their de­vel­op­ment. The com­pa­ny will al­so look to in­vest in ad­di­tion­al fa­cil­i­ties re­lat­ed to CDO, gene ther­a­py and mR­NA pro­duc­tion.

Rim said that the com­pa­ny will not on­ly be look­ing at large-scale pro­duc­tion but open in­no­va­tion and mul­ti-modal prod­ucts as well.

“The Sam­sung Group has said biotech­nol­o­gy will be the sec­ond arm of growth be­yond Sam­sung Elec­tron­ics. So, there’s a huge amount of fo­cus and at­ten­tion around that area. And Ko­rea is fo­cused on biotech­nol­o­gy be­cause they see that as an on­go­ing growth in­dus­try,” Rim said.

As to why the Sam­sung Group sees this as a greater in­vest­ment op­por­tu­ni­ty, Rim pre­sent­ed sev­er­al fac­tors, such as im­prov­ing tech­nol­o­gy, an ag­ing pop­u­la­tion and a con­tin­ued in­crease in GDP over time.

How­ev­er, this in­vest­ment comes at a time when oth­er South Ko­re­an con­glom­er­ates are al­so throw­ing their weight around in biotech man­u­fac­tur­ing. In May, the Lotte Group ac­quired a drug man­u­fac­tur­ing fa­cil­i­ty from Bris­tol My­ers Squibb in Syra­cuse, NY.

Rim said bud­ding com­pe­ti­tion from oth­er con­glom­er­ates is a good thing as it speaks to the rapid­ly grow­ing in­ter­est in biotech in Ko­rea. As for fu­ture ac­qui­si­tions in the US, Rim said that while noth­ing is con­firmed, the com­pa­ny will be keep­ing its eye out for fu­ture tar­gets to ac­quire.

This in­jec­tion is ul­ti­mate­ly set­ting Sam­sung Bi­o­log­ics on a ma­jor build­ing spree, with deep in­vest­ments in­to man­u­fac­tur­ing and oth­er biotech op­er­a­tions.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Man­u­fac­tur­ing roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.