Man­u­fac­tur­ing roundup: Cy­ti­va part­ners with Au­risco to build site for oligonu­cleotides; Eu­roAPI in­vest­ing €40M to boost pro­duc­tion

The Chi­nese CD­MO Au­risco is link­ing up with Cy­ti­va to build a plat­form to pro­duce oligonu­cleotides.

Dubbed the Oglio Flex­Fa­cotry plat­form, the com­pa­nies tout the line as a faster and more ef­fi­cient way to make oligonu­cleotides.  It will be the first of three new com­mer­cial man­u­fac­tur­ing lines that Au­risco is build­ing in Yangzhou, Chi­na. The site will be plan­ning to pro­duce 200 kilo­grams of oligonu­cleotides an­nu­al­ly.

In an email to End­points News, a Cy­ti­va spokesper­son said that Au­risco and Cy­ti­va have been col­lab­o­rat­ing since 2021.

“In this new col­lab­o­ra­tion, Cy­ti­va will of­fer a com­pre­hen­sive en­ter­prise so­lu­tion to Au­risco. It in­cludes an Oli­go Flex­Fac­to­ry plat­form and var­i­ous tech­ni­cal and ser­vice sup­port, such as process de­sign of the man­u­fac­tur­ing site, as well as life-cy­cle project man­age­ment,” the spokesper­son said.

They added that the size of the fa­cil­i­ty would be around 2,500 square me­ters, with the phase one in­vest­ment be­ing in the “dozens of mil­lions” of dol­lars. The fa­cil­i­ty is sched­uled to be com­plet­ed in the first quar­ter of 2024 and will hire around 100 peo­ple.

Eu­roAPI is plac­ing an in­vest­ment in its man­u­fac­tur­ing site in France

The API man­u­fac­tur­er that spun off from Sanofi, Eu­roAPI, is in­vest­ing in one of its fa­cil­i­ties in France.

Eu­roAPI’s board ap­proved a €40 mil­lion ($43.3 mil­lion) in­vest­ment for new tech­nol­o­gy ded­i­cat­ed to vi­t­a­min B12 pro­duc­tion at its man­u­fac­tur­ing site in Saint-Aubin-lès-El­beuf, France. The in­vest­ment is de­signed to boost its man­u­fac­tur­ing ca­pac­i­ty by 2025. The in­vest­ment al­so comes with fi­nan­cial sup­port from the French gov­ern­ment to the tune of €7.9 mil­lion ($8.5 mil­lion).

This ex­pan­sion, along with oth­er in­vest­ments at this site, plans to boost pro­duc­tion by 60% with the new tech­nol­o­gy cut­ting down on waste and wa­ter con­sump­tion.

“This key in­vest­ment in France will en­able us to in­crease our pro­duc­tiv­i­ty in a dy­nam­ic vi­t­a­min B12 mar­ket, grow­ing at 6-7% per an­num. It will al­so in­crease the lev­el of dif­fer­en­ti­a­tion of our port­fo­lio while im­ple­ment­ing tech­nol­o­gy for green­er pro­duc­tion,” said Karl Rot­thi­er, Eu­roAPI’s CEO, in a state­ment.

Vi­ral­gen gets the ok to start man­u­fac­tur­ing at a new site in Spain

Vi­ral­gen, a mem­ber of the Bay­er group, has got­ten the cGMP cer­ti­fi­ca­tion to man­u­fac­ture hu­man med­i­c­i­nal prod­ucts at its site in San Se­bas­t­ian, Spain.

The ap­proval came from the Span­ish Agency for Med­i­cines and Med­ical De­vices, a part of the EMA net­work. Vi­ral­gen now has two sites in San Se­bas­t­ian op­er­at­ing and has 300,000 square feet of space and can pro­duce 2,000 liters of prod­uct.

The CD­MO will be pro­duc­ing re­com­bi­nant ade­no-as­so­ci­at­ed (rAAV) gene ther­a­pies. Vi­ral­gen is al­so plan­ning to open more man­u­fac­tur­ing and de­vel­op­ment space at the end of Q1 2023. Vi­ral­gen is al­so look­ing to ex­pand its part­ner­ship ca­pa­bil­i­ties and works with com­pa­nies that are en­ter­ing Phase III stud­ies and seek­ing ap­provals for com­mer­cial­iza­tion.

“Be­ing a ful­ly in­te­grat­ed CD­MO, we of­fer a con­tin­u­um of prod­ucts and ser­vices, in­clud­ing process, an­a­lyt­i­cal de­vel­op­ment, sta­bil­i­ty stud­ies and fill and fin­ish for all types of rAAV serotypes. This can sig­nif­i­cant­ly short­en the time to mar­ket, help with the pre­dictable cost of goods and re­duce the wait­ing time ex­pe­ri­enced by pa­tients who have run out of op­tions and hope for break­through treat­ments,” said Jim­my Van­hove, CEO of Vi­ral­gen, in a state­ment.

Lifecore Bio­med­ical net $38M+ Se­ries A to start the year

The Chas­ka, MN-based CD­MO Lifecore Med­ical has grabbed it­self some cash to start the year.

The CD­MO net­ted $38.75 mil­lion in a pri­vate place­ment, it an­nounced on Mon­day, sell­ing 38,750 shares.

“We ex­pect to use the pro­ceeds of the in­vest­ment to sup­port both our work­ing cap­i­tal and cap­i­tal ex­pen­di­ture re­quire­ments to de­liv­er on our in­creased near- and longer-term cus­tomer de­mands while we fo­cus on ad­di­tion­al cost sav­ings, dri­ving free cash flow and di­vest­ing our non-CD­MO as­sets,” said Lifecore CEO James Hall in a state­ment.

The pri­vate place­ment was led by Le­gion Part­ners and 22NW Fund with par­tic­i­pa­tion from Wyn­nefield Cap­i­tal, Cove Street Part­ners and 325 Cap­i­tal.

Sov­er­eign Phar­ma­ceu­ti­cals ac­quires Texas man­u­fac­tur­ing fa­cil­i­ty from Monarch

Sov­er­eign Phar­ma­ceu­ti­cals, a sub­sidiary of Alo­ra Phar­ma­ceu­ti­cals, has pur­chased a man­u­fac­tur­ing fa­cil­i­ty in Fort Worth, TX, from Monarch PCM.

The ac­qui­si­tion, which closed on Jan. 4, in­cludes all of Monarch’s equip­ment at the site along with a leased space, which is in the same com­plex as Sov­er­eign’s main fa­cil­i­ty. This move will al­low Sov­er­eign to ex­pand its cur­rent op­er­a­tions once the site is ren­o­vat­ed, and add 48 em­ploy­ees to Sov­er­eign’s ranks.

Sov­er­eign now has around 60,000 square feet of man­u­fac­tur­ing space, bring­ing its to­tal foot­print to over 300,000 square feet.

“The ac­qui­si­tion of the Monarch as­sets will sig­nif­i­cant­ly im­prove our abil­i­ty to man­u­fac­ture sol­id, se­mi-sol­id and liq­uid man­u­fac­tur­ing in large vol­umes,” ac­cord­ing to Art Deas, CEO of Alo­ra, in a state­ment.

Sai Life Sci­ences part­ners with Schrödinger to set up a re­search lab in In­dia

The In­di­an con­tract re­search and man­u­fac­tur­ing com­pa­ny Sai Life Sci­ences has inked a 5-year agree­ment with Schrödinger to es­tab­lish a re­search lab­o­ra­to­ry in the city of Hy­der­abad, In­dia.

The lab, which is be­ing built on Sai’s R&D cam­pus in Hy­der­abad, will be ded­i­cat­ed to re­search­ing med­i­c­i­nal and syn­thet­ic chem­istry, in vit­ro bi­ol­o­gy and oth­er chem­i­cal process­es to de­vel­op can­di­dates. Schrödinger will pro­vide tech­no­log­i­cal plat­forms for the lab.

The lab is sched­uled to open in April of this year and staff around 75 peo­ple, with Sai ac­tive­ly re­cruit­ing po­si­tions.

Cana­di­an CD­MO re­lo­cat­ing and ex­pand­ing its de­vel­op­ment lab­o­ra­to­ries

The Cana­da-based Eu­rofins CD­MO Alpho­ra is re­lo­cat­ing its ac­tive phar­ma­ceu­ti­cal in­gre­di­ent de­vel­op­ment lab­o­ra­to­ries with­in the city lim­its of Mis­sis­sauga, On­tario, Cana­da.

The 56,000-square-foot build­ing will house Eu­rofins’ API R&D lab, along with its an­a­lyt­i­cal ser­vices team. The new site has the ca­pac­i­ty for sev­er­al re­search and de­vel­op­ment process­es and new of­fice space while ex­pand­ing its over­all lab space.

The site is al­so part of the CD­MO’s vi­sion for a 14-acre cam­pus at a near­by re­search park where the com­pa­ny plans to es­tab­lish more man­u­fac­tur­ing ser­vices, in­clud­ing a new plant to pro­duce APIs, which plans to come on­line in the mid­dle of this year.

As­trea Biosep­a­ra­tions ac­quires chro­matog­ra­phy columns man­u­fac­tur­er

As­tra Biosep­a­ra­tions, a pro­duc­er of pu­rifi­ca­tion and biosep­a­ra­tion tech, has ac­quired Delta Pre­ci­sion for an undis­closed amount.

Delta is a man­u­fac­tur­er of chro­matog­ra­phy columns that are used by phar­ma­ceu­ti­cal and biotech com­pa­nies.

The move will al­so al­low As­trea to ex­pand its prod­uct of­fer­ings to in­clude a “full range” of chro­matog­ra­phy columns for bio­man­u­fac­tur­ing and add to its port­fo­lio of resins, reusable columns and oth­er prod­ucts.

“This is a high­ly strate­gic move for us, al­low­ing us to of­fer a full range of in­dus­try-lead­ing pu­rifi­ca­tion and sep­a­ra­tion tools,” said As­trea Biosep­a­ra­tions CEO Ter­ry Pizzie, in a state­ment.

WuXi STA starts up an oral sol­id man­u­fac­tur­ing line close to home

WuXi AppTec sub­sidiary WuXi STA has start­ed op­er­a­tions on a new con­tin­u­ous man­u­fac­tur­ing line for oral solids at its fa­cil­i­ty in WuXi city, Chi­na.

Ac­cord­ing to the com­pa­ny, this new man­u­fac­tur­ing line will pro­vide a high­er yield of oral solids as well as short­ened time­lines for get­ting to mar­ket.

Minzhang Chen, the CEO of WuXi STA, said in a state­ment that this line is the first con­tin­u­ous man­u­fac­tur­ing line for oral solids at its site in WuXi city.

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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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.

Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

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.

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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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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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.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.