Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ire­land has been on a roll in 2022, with sev­er­al large phar­ma com­pa­nies an­nounc­ing mul­ti­mil­lion-eu­ro projects. Now As­traZeneca’s rare dis­ease out­fit Alex­ion is look­ing to get in on the ac­tion.

Alex­ion on Fri­day an­nounced a €65 mil­lion ($68.8 mil­lion) in­vest­ment in new and en­hanced ca­pa­bil­i­ties across two sites in the coun­try, in­clud­ing at Col­lege Park in the Dublin sub­urb of Blan­chard­stown and the Monksland In­dus­tri­al Park in the cen­tral Irish town of Athlone, ac­cord­ing to the In­dus­tri­al De­vel­op­ment Agency of Ire­land.

The project can be bro­ken down in­to three in­vest­ments in­clud­ing the in­stal­la­tion of new drug sub­stance pro­duc­tion equip­ment and ware­hous­ing fa­cil­i­ties to sup­port am­bi­ent and cold stor­age at Col­lege Park and Athlone, and the con­struc­tion of a man­u­fac­tur­ing sci­ences and tech­nol­o­gy lab at Col­lege Park.

“The equip­ment and ware­house fa­cil­i­ty in each site will ex­pand Alex­ion’s drug sub­stance pro­duc­tion ca­pa­bil­i­ties in Ire­land,” IDA Ire­land stat­ed.

The scale-up of bi­o­log­ics man­u­fac­tur­ing ca­pa­bil­i­ty and R&D ex­pan­sion at these two sites will oc­cur over the next 18 months, ac­cord­ing to a state­ment Alex­ion emailed to End­points News. Ap­prox­i­mate­ly 1,000 peo­ple work across both sites and the ex­pan­sion will add a small num­ber of jobs, though no sol­id num­bers were giv­en.

For the Alex­ion Man­u­fac­tur­ing Sci­ences & Tech­nol­o­gy Lab at Col­lege Park, the in­vest­ment will seek to fa­cil­i­tate the scal­ing up of bi­o­log­ics drug sub­stance man­u­fac­tur­ing in Ire­land, al­though de­tails on the con­struc­tion were not im­me­di­ate­ly avail­able to End­points.

“This in­vest­ment will al­low for new ca­pa­bil­i­ties for As­traZeneca in Ire­land and sup­port our glob­al am­bi­tion to ac­cel­er­ate the de­vel­op­ment and de­liv­ery of life-chang­ing med­i­cines for more peo­ple af­fect­ed by rare dis­eases,” Alex­ion CEO Marc Dunoy­er said in a state­ment.

Col­lege Park has been a hot spot for both Alex­ion and As­traZeneca. In 2021, the Big Phar­ma shelled out $360 mil­lion to build an API plant for small mol­e­cules at its Alex­ion cam­pus in Col­lege Park, Dublin, fo­cus­ing on late-stage de­vel­op­ment and ear­ly com­mer­cial sup­ply for small mol­e­cule ther­a­pies.

As Alex­ion com­mits to Ire­land, the com­pa­ny finds it­self among an ever-grow­ing crowd of man­u­fac­tur­ers. In Feb­ru­ary, Eli Lil­ly an­nounced it would pump al­most $1.5 bil­lion in­to two new man­u­fac­tur­ing fa­cil­i­ties. Mer­ck KGaA an­nounced in May it was mak­ing a €440 mil­lion ($470 mil­lion) in­vest­ment to in­crease mem­brane man­u­fac­tur­ing ca­pac­i­ty in Car­rigt­wohill, Ire­land, and build a new man­u­fac­tur­ing fa­cil­i­ty at Blar­ney Busi­ness Park, in Coun­ty Cork, Ire­land.

Most re­cent­ly, New Jer­sey-based CD­MO Cam­brex ac­quired Q1 Sci­en­tif­ic, a provider of en­vi­ron­men­tal­ly con­trolled cGMP sta­bil­i­ty stor­age ser­vices, lo­cat­ed in the city of Wa­ter­ford, Ire­land.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

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

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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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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.

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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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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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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Lars Fruergaard Jørgensen, Novo Nordisk CEO (Christopher Goodney/Bloomberg via Getty Images)

No­vo Nordisk notch­es big GLP-1 sales amid re­bound­ing sup­plies, but cau­tions on fu­ture 'pe­ri­od­ic con­straints'

With Novo Nordisk’s obesity treatment Wegovy fully back in stock in December, sales are beginning to soar, the Danish pharma reported during its annual earnings call on Wednesday. Total scripts of the glucagon-like peptide 1 (GLP-1) Wegovy topped 37,000 weekly in mid-January, a hockey stick uptick from end-of-year levels below 15,000 per week.

The new prescriptions come on top of the overall momentum of Novo obesity drug sales in 2022, although the then supply-constrained Wegovy was only part of that. Sibling obesity med Saxenda accounted for DKK 10.7 billion ($1.58 billion) of the total DKK 16.9 billion ($2.49 billion), or about 63%, in Novo Nordisk’s reported obesity segment sales.