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.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”