Am­gen adds new NC plant to the list as part of $1B man­u­fac­tur­ing ex­pan­sion plans state­side

What can $1 bil­lion buy? If you’re Am­gen, it’s good for two man­u­fac­tur­ing fa­cil­i­ties in the US.

The Cal­i­for­nia-based drug gi­ant will in­vest close to $550 mil­lion in a drug sub­stance plant in Hol­ly Springs, NC, adding it­self to an ever-grow­ing list of biotech com­pa­nies that have de­cid­ed to call North Car­oli­na home, and mark­ing its sec­ond drug man­u­fac­tur­ing an­nounce­ment in a lit­tle more than a month.

Am­gen pre­vi­ous­ly an­nounced an ex­pan­sion in Ohio, along with an agree­ment with Ohio State Uni­ver­si­ty to cre­ate an ex­pe­ri­en­tial learn­ing pro­gram, to­ward the end of June. But the news of its Hol­ly Springs, NC in­vest­ment snuck in­to its Q2 earn­ings re­port Tues­day.

“In an­tic­i­pa­tion of fu­ture de­mand for our med­i­cines, we will in­vest ap­prox­i­mate­ly $1 bil­lion to build two new man­u­fac­tur­ing fa­cil­i­ties – a pack­ag­ing plant in Ohio and a drug sub­stance plant in North Car­oli­na,” the re­lease said. “Both of these fa­cil­i­ties will be built faster and at a low­er cost than tra­di­tion­al plants, and both al­so will uti­lize cut­ting-edge tech­nolo­gies to be more ef­fi­cient and en­vi­ron­men­tal­ly friend­ly than tra­di­tion­al plants.”

Am­gen did not re­spond to a re­quest for com­ment Wednes­day.

The North Car­oli­na fa­cil­i­ty will cre­ate more than 350 jobs and is set to be op­er­a­tional by 2025, the com­pa­ny said. Con­struc­tion will start in 2021 and be com­plet­ed by 2029, and new hires will in­clude en­gi­neers, tech­ni­cians, qual­i­ty, man­age­ment and ad­min­is­tra­tive roles.

In­cen­tives in­clude a job de­vel­op­ment grant from the state worth around $12.6 mil­lion, and an­oth­er $22.8 mil­lion in in­cen­tives from Wake Coun­ty and the Hol­ly Springs lo­cal gov­ern­ment. The grants are con­tin­gent up­on hir­ing and in­vest­ment mile­stones. The av­er­age salary of the new po­si­tions added is ex­pect­ed to reach near­ly $120,000, close to dou­ble what the cur­rent av­er­age is in Wake Coun­ty.

“World-class com­pa­nies like Am­gen are very se­lec­tive when they eval­u­ate busi­ness lo­ca­tions and they on­ly choose places that pro­vide the best sup­port for their op­er­a­tions,” Gov. Roy Coop­er said in a press re­lease. “To­day’s de­ci­sion proves once again that North Car­oli­na re­mains a pre­mier lo­ca­tion for the most in­no­v­a­tive biotech com­pa­nies in the in­dus­try.”

Fu­ji­film Diosynth joined the ex­pan­sion par­ty in Hol­ly Springs in March with the an­nounce­ment of a $2 bil­lion plant of its own. A month ear­li­er, Gilead opened an of­fice for fi­nance, IT and hu­man re­sources op­er­a­tions in the area.

Am­gen’s ex­pan­sion marks the 47th life sci­ences project to come to North Car­oli­na since 2017, Coop­er said in an event.

San­dra Ro­driguez-Tole­do

“Cam­bridge and Boston bet­ter look out be­cause North Car­oli­na is com­ing,” Coop­er said.

Robert Keny­on, Am­gen’s VP of man­u­fac­tur­ing, will be the site lead for the new fa­cil­i­ty. He told the N&O that Am­gen will be the first ten­ant in the Friend­ship In­no­va­tion Park and that the site will have sin­gle-use tech­nol­o­gy, which pro­vides flex­i­bil­i­ty to man­u­fac­ture dif­fer­ent drugs.

“We are ex­cit­ed to be mak­ing this in­vest­ment in Hol­ly Springs and be­com­ing an im­por­tant part of the com­mu­ni­ty,” Keny­on said in a re­lease. “Be­yond be­ing a vi­brant busi­ness en­vi­ron­ment, the area of­fers a skilled, trained, and di­verse tal­ent pool that we know will help Am­gen main­tain its long his­to­ry of serv­ing pa­tients.”

Am­gen is al­so in­vest­ing $365 mil­lion in­to a new man­u­fac­tur­ing plant in New Al­bany, OH, 18 miles north­east of Colum­bus, to fur­ther its as­sem­bly and pack­ag­ing ca­pa­bil­i­ties. That site will be 270,000 square feet, and be housed in the New Al­bany In­ter­na­tion­al Busi­ness Park. VP of site op­er­a­tions San­dra Ro­driguez-Tole­do will move from Puer­to Ri­co to Ohio to over­see the new fa­cil­i­ty.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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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

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.

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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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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