Couvet, Switzerland (via businesswire)

WuXi STA snaps up Bris­tol My­ers Squibb fa­cil­i­ty, plants feet in Eu­ro­pean CD­MO mar­ket­place

A WuXi AppTech spin­off will fi­nal­ly have a Eu­ro­pean fa­cil­i­ty un­der its belt af­ter buy­ing up a Bris­tol My­ers Squibb site, the com­pa­ny an­nounced Tues­day.

Minzhang Chen

WuXi STA, which launched as a CD­MO in 2003, will ac­quire Bris­tol My­ers Squibb’s site in Cou­vet, Switzer­land that spe­cial­izes in com­mer­cial-scale pro­duc­tion of var­i­ous cap­sules and tablet dosage forms. The com­pa­ny said in a press re­lease it will both en­hance and grow its man­u­fac­tur­ing ca­pac­i­ties through a “world-class” fa­cil­i­ty.

“We are pleased to add the Cou­vet man­u­fac­tur­ing fa­cil­i­ty to our grow­ing glob­al man­u­fac­tur­ing site net­work and look for­ward to work­ing with the tal­ent­ed team who share our fo­cus on ex­cel­lence and a pa­tient-cen­tered ap­proach,” WuXi STA CEO Minzhang Chen said in a state­ment. “The ac­qui­si­tion will al­low WuXi STA to bet­ter serve Eu­ro­pean mar­kets and sup­port our glob­al cus­tomers to de­liv­er in­no­v­a­tive med­i­cines and treat­ments to pa­tients around the world.”

Bris­tol My­ers Squibb EVP Lou Schmuk­ler said in a state­ment that he be­lieved WuXi STA would be suc­cess­ful in tak­ing over the Cou­vet fa­cil­i­ty, but that the trans­fer was al­so im­por­tant for his com­pa­ny’s fu­ture in the Eu­ro­pean mar­ket­place.

“This is an im­por­tant step in the on­go­ing evo­lu­tion of our man­u­fac­tur­ing net­work to sup­port our prod­uct port­fo­lio,” he said. “Switzer­land re­mains an im­por­tant strate­gic lo­ca­tion for Bris­tol My­ers Squibb, and we look for­ward to main­tain­ing a strong pres­ence in the Neuchâ­tel area.”

The Cou­vet site isn’t the on­ly one Bris­tol My­ers Squibb has un­loaded in re­cent years. In the sum­mer of 2019, the com­pa­ny sold its Anag­ni, Italy fa­cil­i­ty, and the 700+ em­ploy­ees who worked there at the time, to Catal­ent for an undis­closed amount.

Lou Schmuk­ler

The com­pa­nies an­tic­i­pate com­plet­ing the trans­ac­tion by Q2 2021, sub­ject to reg­u­la­to­ry ap­provals and the sat­is­fac­tion of oth­er clos­ing con­di­tions—one of which is that the Cou­vet fa­cil­i­ty will con­tin­ue op­er­at­ing un­der the Bris­tol My­ers Squibb name un­til the i’s are crossed and the t’s are dot­ted. WuXi STA will ac­quire the site’s op­er­a­tions and as­sets, in­clud­ing the plant, equip­ment, and an un­spec­i­fied num­ber of em­ploy­ees.

Fi­nan­cial terms of the ac­qui­si­tion weren’t dis­closed Tues­day.

The for­ay in­to Eu­rope is one of the big­ger moves WuXi STA has made of late. Its last one came ex­act­ly 13 months ago when the com­pa­ny an­nounced the open­ing of a large-scale oligonu­cleotide ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­ing fa­cil­i­ty in Changzhou, Chi­na. That mile­stone, the com­pa­ny said at the time, es­tab­lished the abil­i­ty to man­u­fac­ture those APIs from pre­clin­i­cal to com­mer­cial through a sin­gle com­pre­hen­sive plat­form.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

Man­u­fac­tur­ing roundup: AGC Bi­o­log­ics to man­u­fac­ture di­a­betes ther­a­py; Cam­brex caps ac­qui­si­tion of Snap­drag­on Chem­istry

The Washington-based CDMO AGC Biologics has been tapped to manufacture the type 1 diabetes treatment Tzield from Provention Bio.

AGC Biologics will produce Tzield at its Seattle protein biologics site. It was chosen after AGC helped to guide the product through process performance qualification (PPQ) manufacturing and validation batches, and, ultimately, FDA approval. Tzield is the only immunomodulatory treatment approved to delay the onset of Stage 3, type 1 diabetes in children and adults aged eight and older.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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Matthew Stober, newly-appointed Abzena CEO (Abzena)

Abzena lays off more than 60 em­ploy­ees in Cal­i­for­nia

Contract manufacturer Abzena has permanently laid off 66 employees at one of its San Diego sites, marking the latest in a string of layoffs spanning the biotech industry.

The layoffs took effect on Jan. 11 at the company’s 8810 Rehco Road site, according to a WARN notice filed with the Employment Development Department of California.

Abzena does have another location in the San Diego area, where the manufacturer invested $60 million and added 50,000 square feet in 2020. Endpoints News reached out to Abzena but has not received a response as of press time.

#JPM23: What's re­al­ly dri­ving the cost of health­care and drugs in 2023?

Executive Editor Drew Armstrong spoke with PhRMA CEO Steve Ubl, EmsanaRx CEO Greg Baker and ICER President Steve Pearson about how the debate over drug costs has changed (or not) in the last decade, the shifting payer landscape and why there seems to be so little movement on drug rebates. This transcript has been edited for brevity and clarity.

Drew Armstrong:

So first of all, thank you to everybody for being here and for our panel for being here. Incredibly excited to have this discussion on the cost of healthcare and drugs and what’s driving that. We’re here with Steve Ubl, the head of PhRMA. Thank you so much. Steve Pearson from ICER, and Greg Baker from EmsanaRx. I want to start this conversation with a little bit of a personal reminiscence. So about almost 10 years exactly. I was a reporter back in my previous job and I was covering drug pricing and Gilead had just launched their hepatitis C drug and I was having a conversation with another Steve over at Express Scripts and he made some comments essentially about how they intended to launch a price war over hepatitis C therapies.

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