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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

An active pharmaceutical ingredient site in India has been handed a warning letter from the FDA, following an August 2021 inspection.

AuroLife Pharma’s Hyderabad site, which is part of the Aurobindo group of companies, was handed the letter in November. It’s the latest in a string of manufacturing woes the company has battled as of late.

Unit 1 of its Hyderabad site was inspected, and received an official action initiated notice from the FDA. “The company believes that this will not impact the existing business from this facility,” it said in a filing.

FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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