Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Sin­ga­pore has long es­tab­lished it­self as a ma­jor hub for phar­ma man­u­fac­tur­ing, and now sev­er­al big play­ers are look­ing to fur­ther ce­ment their pres­ence in the Li­on City.

Take­da, Sanofi and GSK are form­ing a part­ner­ship with the Sin­ga­pore-based Agency for Sci­ence, Tech­nol­o­gy and Re­search (A*STAR) and sev­er­al lo­cal aca­d­e­m­ic in­sti­tu­tions, in­clud­ing the Na­tion­al Uni­ver­si­ty of Sin­ga­pore, Nanyang Tech­no­log­i­cal Uni­ver­si­ty, Sin­ga­pore, its en­ter­prise com­pa­ny called NTU­itive and Sin­ga­pore In­sti­tute of Tech­nol­o­gy to pro­vide a greater boost to the man­u­fac­tur­ing of bi­o­log­ics.

The part­ner­ship be­tween the phar­mas, A*STAR and the uni­ver­si­ties will be for­mal­ized through the Bi­o­log­ics Phar­ma In­no­va­tion Pro­gramme Sin­ga­pore (BioPIPS), a con­sor­tium that was ini­ti­at­ed by A*STAR and has sup­port from the Sin­ga­pore Eco­nom­ic De­vel­op­ment Board (EDB).

“The (BioPIPS) pro­gramme will de­vel­op high­ly pro­duc­tive, sus­tain­able and ad­vanced pro­duc­tion tech­nolo­gies and so­lu­tions. We look for­ward to deep­en­ing part­ner­ships with like-mind­ed com­pa­nies to strength­en Sin­ga­pore’s po­si­tion as a glob­al bio­phar­ma man­u­fac­tur­ing hub,” said Tan Kong Hwee, ex­ec­u­tive vice pres­i­dent of the EDB, in a state­ment.

Ac­cord­ing to a Sanofi spokesper­son via email to End­points News, the com­pa­ny is al­ready build­ing a man­u­fac­tur­ing site, dubbed the EVo­lu­tive Fa­cil­i­ties (EVF), which plans to bring dig­i­tal and mod­u­lar vac­cine pro­duc­tion to Asia. As for its es­tab­lished in­fra­struc­ture, Sanofi al­ready has around 500 em­ploy­ees in Sin­ga­pore along with an es­tab­lished man­u­fac­tur­ing site and a lo­cal of­fice and re­gion­al head­quar­ters.

“The BioPIPS pro­gramme’s fo­cus on trans­form­ing bi­o­log­ics and vac­cines man­u­fac­tur­ing through pre-com­pet­i­tive part­ner­ships is aligned with Sanofi’s vi­sion for the Evo­lu­tive Fa­cil­i­ty, to con­tin­u­ous­ly push the en­ve­lope of in­no­va­tion for bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing,” the Sanofi spokesper­son said. “The con­sor­tium will bring to­geth­er lead­ing in­dus­try ex­perts and Sin­ga­pore’s re­search ecosys­tem to en­hance man­u­fac­tur­ing pro­duc­tiv­i­ty, im­prove op­er­a­tional ef­fi­cien­cy and achieve sus­tain­abil­i­ty goals. The con­sor­tium ul­ti­mate­ly aims to make Sin­ga­pore’s bi­o­log­ics man­u­fac­tur­ing ca­pa­bil­i­ties best-in-class and well-po­si­tioned for the in­tro­duc­tion of new prod­ucts and nov­el man­u­fac­tur­ing tech­nolo­gies.”

A Take­da spokesper­son, in an email to End­points, said the agree­ment will help to fur­ther strength­en Take­da’s man­u­fac­tur­ing ca­pa­bil­i­ties and es­tab­lish more sus­tain­able ways to pro­duce med­i­cines, as one of the ob­jec­tives of the con­sor­tium is to achieve net ze­ro gas emis­sions be­fore 2035.

“Sin­ga­pore is an im­por­tant hub for Take­da as it serves as our Growth & Emerg­ing Mar­kets Busi­ness Unit re­gion­al hub. The Sin­ga­pore plant has been man­u­fac­tur­ing bi­o­log­ics since its of­fi­cial open­ing in Au­gust 2014. The plant has al­so been sup­port­ing the pro­duc­tion of one of our new mol­e­c­u­lar en­ti­ties in Take­da’s glob­al R&D pipeline,” the Take­da spokesper­son said.

Sin­ga­pore has been a ma­jor fo­cal point for phar­ma and bi­o­log­ics man­u­fac­tur­ing, and that com­mit­ment doesn’t seem to be go­ing away any­time soon.

In Oc­to­ber, Mer­ck opened a new sec­ondary pack­ag­ing fa­cil­i­ty and broke ground on a sep­a­rate fa­cil­i­ty that will man­u­fac­ture next-gen­er­a­tion in­halers. The two man­u­fac­tur­ing sites are part of a wider $500 mil­lion in­vest­ment by the com­pa­ny to ex­pand pro­duc­tion of med­i­cines and vac­cines in Sin­ga­pore over five years.

WuXi Bi­o­log­ics, in the sum­mer, an­nounced that it will ex­pand its re­search, de­vel­op­ment and large-scale drug sub­stance and drug prod­uct man­u­fac­tur­ing ca­pac­i­ty and ca­pa­bil­i­ties in Sin­ga­pore, mark­ing a 10-year, $1.4 bil­lion in­vest­ment plan from the com­pa­ny. And BioN­Tech an­nounced last month that its Sin­ga­pore-based af­fil­i­ate, BioN­Tech Phar­ma­ceu­ti­cals Asia Pa­cif­ic Pte. Ltd., had agreed with No­var­tis to ac­quire a GMP man­u­fac­tur­ing fa­cil­i­ty in the coun­try, with the move de­signed to grow its foot­print in Asia.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

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.