David Loew, Ipsen CEO (via Twitter)

Ipsen be­comes the lat­est phar­ma to ex­pand in Ire­land, with a $50M in­vest­ment in its fa­cil­i­ty in Dublin sub­urbs

It is no se­cret that Ire­land has be­come a hot spot for phar­ma man­u­fac­tur­ing projects over the past year, and it seems that Ipsen will be the lat­est play­er to get in on the ac­tion.

On Mon­day Ipsen un­veiled the €52 mil­lion ($49.9 mil­lion) ex­pan­sion it made in­to its ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­ing fa­cil­i­ty in Blan­chard­stown, a small sub­urb of Dublin. The in­vest­ment is aimed at boost­ing med­i­cine and in­gre­di­ent pro­duc­tion in can­cer and rare dis­ease space.

Ac­cord­ing to the In­dus­tri­al De­vel­op­ment Agency of Ire­land, the Ipsen site has al­ready scaled API pro­duc­tion by 10% and is look­ing to pump even more im­prove­ments in­to the fa­cil­i­ty. The com­pa­ny is look­ing at in­vest­ing an­oth­er €15 mil­lion ($14.1 mil­lion) in Blan­chard­stown over the next three years, up­grad­ing tech­nol­o­gy and in­stalling more sus­tain­abil­i­ty ef­forts.

While no de­tails were giv­en on the ex­act size or what the growth in head­count is, an Ipsen Ire­land ex­ec­u­tive stat­ed that the site cur­rent­ly em­ploys 175 em­ploy­ees and has grown its work­force by 20% in the past three years, par­tic­u­lar­ly in man­u­fac­tur­ing and R&D.

End­points News did reach out to Ipsen for more de­tails on the ex­pan­sion, but did not re­ceive a re­sponse by press time.

“The Irish mar­ket plays an im­por­tant role as part of Ipsen’s in­ter­na­tion­al net­work and Ipsen is com­mit­ted to con­tin­ued in­vest­ment and in­no­va­tion in Ire­land to sup­port im­proved care for pa­tients across the ther­a­peu­tic ar­eas we serve – on­col­o­gy, rare dis­ease, and neu­ro­science. This new in­vest­ment in Dublin is a mile­stone in our on­go­ing jour­ney of in­no­va­tion and our grow­ing foot­print in Ire­land,” Ipsen CEO David Loew said in a state­ment.

The site it­self has been in use by Ipsen since 1989 as a man­u­fac­tur­ing site and an R&D hub — main­ly in the de­vel­op­ment of APIs.

How­ev­er, Ipsen is just the lat­est com­pa­ny to ex­pand its pres­ence on Irish soil. On Thurs­day, Ab­b­Vie kicked off a €60 mil­lion ($58.9 mil­lion) in­to its tablet and cap­sule man­u­fac­tur­ing site in the town of Car­rigt­wohill, Ire­land, a sub­urb of Cork City in the south of Ire­land.

The Dublin area is al­so see­ing sev­er­al ex­pan­sions from phar­ma com­pa­nies in­clud­ing Alex­ion, who is in­ject­ing €65 mil­lion ($62.4 mil­lion), across two sites, one al­so in Blan­chard­stown and an­oth­er site at the Monksland In­dus­tri­al Park in the Irish town of Athlone. South Ko­re­an con­glom­er­ate SK’s CD­MO arm is al­so mak­ing an in­vest­ment in Dublin in the form of $35 mil­lion to ex­pand its phar­ma­ceu­ti­cal man­u­fac­tur­ing plant in the Dublin sub­urb of Swords.

Ab­bott, J&J, Eli Lil­ly, Hori­zon and Cam­brex are al­so just some of the oth­er com­pa­nies that are com­mit­ting to mul­ti­mil­lion-dol­lar projects in Ire­land this year.

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.