Lonza breaks ground on its first large-scale commercial drug product manufacturing facility in Stein, Switzerland.

Lon­za breaks ground on $500M+ Swiss man­u­fac­tur­ing fa­cil­i­ty

Lon­za’s ma­jor con­struc­tion project in Switzer­land is tak­ing a big step for­ward.

The Swiss CD­MO has bro­ken ground on a fill-fin­ish man­u­fac­tur­ing site in the town of Stein, Switzer­land, about 20 miles from its head­quar­ters in Basel. The CHF 500 mil­lion ($544 mil­lion) fa­cil­i­ty was an­nounced last sum­mer and will be con­struct­ed on the same cam­pus as Lon­za’s cur­rent clin­i­cal drug prod­uct fa­cil­i­ty.

Pe­ter Droc

In an email to End­points News, Pe­ter Droc, the head of prod­uct ser­vices at Lon­za, said the fa­cil­i­ty is still on track for com­ple­tion, with op­er­a­tions slat­ed to start in 2026. The fa­cil­i­ty still in­tends to man­u­fac­ture large-scale com­mer­cial prod­ucts. Ad­di­tion­al­ly, Lon­za ex­pects to add around 400 full-time po­si­tions at the fa­cil­i­ty by 2026.

Droc al­so added that the cap­i­tal be­ing in­vest­ed in the fa­cil­i­ty is en­tire­ly from Lon­za and that no gov­ern­ment as­sis­tance has been con­tributed.

“The new fa­cil­i­ty will en­able us to pro­vide cus­tomers with an in­te­grat­ed end-to-end of­fer­ing across their en­tire prod­uct life cy­cle, thus in­creas­ing speed to mar­ket, flex­i­bil­i­ty and sim­plic­i­ty. In ad­di­tion, the fa­cil­i­ty’s lo­ca­tion is ide­al due to its prox­im­i­ty to our ex­ist­ing DPS sites, our glob­al head­quar­ters and Basel’s life sci­ences clus­ter, which en­ables us to ac­cess ex­ist­ing in­fra­struc­ture, ca­pa­bil­i­ties and tal­ent,” Droc said.

Lon­za’s ground­break­ing in Stein comes as the com­pa­ny saw a rise in cus­tomers and a growth in sales for 2022, but the man­u­fac­tur­er does ex­pect a re­duc­tion in Covid sales for 2023.

Lon­za will al­so be fac­ing more com­pe­ti­tion in Switzer­land as oth­er man­u­fac­tur­ers, such as Ther­mo Fish­er, Cy­ti­va, and lo­cal com­pa­ny ten23, have been turn­ing to the com­pa­ny’s back­yard to ex­pand their own sites over the past year.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; 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 you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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