Man­u­fac­tur­ing roundup: Ace­to re­brands to Actylis; WuXi STA opens an­oth­er fa­cil­i­ty

A New York-based man­u­fac­tur­er has re­brand­ed af­ter net­ting sev­er­al ac­qui­si­tions in the past few years.

Ace­to, a man­u­fac­tur­er of in­gre­di­ents and raw ma­te­ri­als, has re­brand­ed to Actylis. The move will bring all 10 ac­qui­si­tions the com­pa­ny has made in the past sev­er­al years un­der one ban­ner.

“Actylis unites mul­ti­ple in­dus­try spe­cial­ists with a wide range of ca­pa­bil­i­ties in­to a new, glob­al en­ter­prise with a unique hy­brid ap­proach that is greater than the sum of its parts. This con­sol­i­da­tion en­ables us to of­fer cus­tomers across di­verse lo­ca­tions and in­dus­tries high­ly flex­i­ble, cus­tomized so­lu­tions ad­dress­ing their spe­cif­ic needs while as­sur­ing re­li­able on-time de­liv­ery of the high-qual­i­ty in­gre­di­ents es­sen­tial to their suc­cess,” said CEO Gilles Cot­ti­er in a state­ment.

With all the com­pa­nies now un­der one name, the com­pa­ny now boasts a head­count of over 850 staff with a pres­ence in 10 coun­tries.

The com­pa­ny ac­quired Irish com­pa­ny A&C Bio Buffer last year to help bol­ster its Covid-19 re­lief ef­forts and ex­pand its man­u­fac­tur­ing ca­pa­bil­i­ties.

WuXi STA con­tin­ues its ex­pan­sion dri­ve with the open­ing of an oral drug man­u­fac­tur­ing site

WuXi STA is keep­ing up its mo­men­tum by open­ing an­oth­er site in its man­u­fac­tur­ing chain.

The com­pa­ny an­nounced it has opened its high po­ten­cy oral drug prod­uct man­u­fac­tur­ing site at its cam­pus in Wuxi, Chi­na. Ac­cord­ing to the com­pa­ny, this move al­lows it to man­u­fac­ture high-po­ten­cy drug can­di­dates as well as build out its ca­pac­i­ty for more drug pro­duc­tion.

The fa­cil­i­ty can cov­er a wide range of ser­vices in­clud­ing wet and dry gran­u­la­tion, tablet com­pres­sion and coat­ing and cap­sule fill­ing. WuXi STA ex­pects the fa­cil­i­ty to man­u­fac­ture 400 mil­lion ta­bles and 200 mil­lion cap­sules an­nu­al­ly.

The fa­cil­i­ty will al­so al­low it to pro­vide a net­work for R&D ser­vices and man­u­fac­tur­ing of high po­ten­cy ac­tive phar­ma­ceu­ti­cal in­gre­di­ents in­to com­mer­cial prod­ucts. The com­pa­ny is al­so plan­ning to open an­oth­er high po­ten­cy parental pro­duc­tion plant at the WuXi cam­pus in Q3 of next year.

“As our glob­al part­ners and cus­tomers seek ac­cel­er­at­ed path­ways for new drug de­vel­op­ment, WuXi STA is com­mit­ted to fur­ther en­hanc­ing our in­te­grat­ed plat­form to en­able more health­care break­throughs that ben­e­fit pa­tients world­wide,” said WuXi STA CEO Mingzhang Chen, in a state­ment.

WuXi STA’s re­cent ex­pan­sion projects in­clude the build­ing of a 190-acre man­u­fac­tur­ing cam­pus in Mid­dle­town, DE, along with the open­ing of sev­er­al oth­er pro­duc­tion fa­cil­i­ties in Chi­na.

Chi­nese CD­MO plans for a build­ing project in Jiang­su Province

Asym­chem, a CD­MO that has a pres­ence on three con­ti­nents, is look­ing much clos­er to home for its next project.

Ac­cord­ing to a doc­u­ment sub­mit­ted to the Hong Kong Stock Ex­change, Asym­chem it is plan­ning to con­struct a site at the Jiang­su Taix­ing Eco­nom­ic De­vel­op­ment Zone, a de­vel­op­ment area along the banks of the Yangtze Riv­er out­side of Shang­hai.

The site will even­tu­al­ly house R&D op­er­a­tions as well as the man­u­fac­tur­ing of chem­i­cals and small mol­e­cule drug prod­ucts. The to­tal in­vest­ment that is planned for the site is planned to be with­in the range of RMB4,000,000,000 to RMB5,000,000,000 ($559.8 mil­lion to $669.77 mil­lion).

Asym­chem plans to fund the project with its cash or by “self-rais­ing funds”, but no de­tails have been re­leased. De­tails on size, em­ploy­ee count, or when con­struc­tion will start have al­so not been re­leased.

Nu­cle­us Bi­o­log­ics pulls back the cur­tain on new San Diego cell cul­ture man­u­fac­tur­ing site

A San Diego cell cul­ture pro­duc­er has opened a new fa­cil­i­ty.

Nu­cle­us Bi­o­log­ics, a provider of cell cul­ture me­dia prod­ucts, has cut the rib­bon on its newest fa­cil­i­ty. The com­pa­ny’s new 19,884-square-foot fa­cil­i­ty has two pow­der and four liq­uid clean­rooms to boost cell cul­ture man­u­fac­tur­ing.

Nu­cle­us said that it can in­crease its pro­duc­tion to 2.5 mil­lion liters of prod­uct per year.

“We have seen rapid growth in both the cell and gene ther­a­py in­dus­try and our busi­ness and are ex­pand­ing man­u­fac­tur­ing and clean­room ca­pac­i­ty to sup­port our ther­a­py cus­tomers to speed the time from dis­cov­ery to cure,” said David Shee­han CEO of Nu­cle­us Bi­o­log­ics, in a state­ment.

The move is one of the lat­est for the com­pa­ny as it has ex­pand­ed to 70 staff mem­bers and has net­ted deals with Cy­ti­va and with one of its spin­offs Sto­ic Bio.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.