Man­u­fac­tur­ing roundup: AGC Bi­o­log­ics to man­u­fac­ture di­a­betes ther­a­py; Cam­brex caps ac­qui­si­tion of Snap­drag­on Chem­istry

The Wash­ing­ton-based CD­MO AGC Bi­o­log­ics has been tapped to man­u­fac­ture the type 1 di­a­betes treat­ment Tzield from Proven­tion Bio.

AGC Bi­o­log­ics will pro­duce Tzield at its Seat­tle pro­tein bi­o­log­ics site. It was cho­sen af­ter AGC helped to guide the prod­uct through process per­for­mance qual­i­fi­ca­tion (PPQ) man­u­fac­tur­ing and val­i­da­tion batch­es, and, ul­ti­mate­ly, FDA ap­proval. Tzield is the on­ly im­munomod­u­la­to­ry treat­ment ap­proved to de­lay the on­set of Stage 3, type 1 di­a­betes in chil­dren and adults aged eight and old­er.

De­tails about the size of the con­tract or how many dos­es AGC will man­u­fac­ture were not im­me­di­ate­ly avail­able. The Seat­tle fa­cil­i­ty has mul­ti­ple man­u­fac­tur­ing lines and has been pro­duc­ing bi­o­log­ics for more than 30 years.

“This achieve­ment demon­strates our Seat­tle site’s in­creas­ing track record in com­mer­cial man­u­fac­tur­ing, which is aligned with AGC Bi­o­log­ic’s pur­pose of bring­ing hope to life,” said Kevin In­g­ham, gen­er­al man­ag­er of AGC Bi­o­log­ics’ Seat­tle site, in a press re­lease.

Cam­brex com­pletes API man­u­fac­tur­er ac­qui­si­tion

Cam­brex closed its ac­qui­si­tion of the in­gre­di­ent pro­duc­er Snap­drag­on Chem­istry, net­ting the lat­ter’s two fa­cil­i­ties in Waltham, MA, in the deal.

Snap­drag­on Chem­istry main­ly man­u­fac­tures ac­tive phar­ma­ceu­ti­cal in­gre­di­ents, us­ing au­toma­tion tech­nol­o­gy and its pro­pri­etary equip­ment in the process. The deal al­so in­cludes Snap­drag­on’s 70+ em­ploy­ees join­ing Cam­brex.

Cam­brex said in a news re­lease that it plans to use the new ac­qui­si­tion to grow its port­fo­lio of “spe­cial­ized so­lu­tions” for phar­ma­ceu­ti­cal man­u­fac­tur­ing and bol­ster over­all ca­pa­bil­i­ties. The CD­MO is al­so sink­ing more funds in­to ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) de­vel­op­ment in gen­er­al, as it has fin­ished the first part of a $30 mil­lion ex­pan­sion at its API man­u­fac­tur­ing fa­cil­i­ty in the city of High Point, NC.

“With Snap­drag­on’s depth of sci­en­tif­ic ex­per­tise in API process de­vel­op­ment, I’m cer­tain our cus­tomers will see the ben­e­fits of this com­bi­na­tion and be de­light­ed to work with Snap­drag­on’s team,” said Cam­brex’s CEO Tom Loe­wald in the re­lease.

Eye­Point Phar­ma­ceu­ti­cals an­nounces new 40,000-square-foot fa­cil­i­ty

Mass­a­chu­setts-based Eye­Point Phar­ma­ceu­ti­cals is plan­ning a brand-new fa­cil­i­ty to pro­duce two of its prod­ucts. Eye­point will be in­volved in the cus­tom de­sign and con­struc­tion of the 40,000-square-foot man­u­fac­tur­ing fa­cil­i­ty in North­bridge, MA, to man­u­fac­ture its in­trav­it­re­al eye im­plant Yu­tiq along with a sec­ond im­plant, EYP-1901, in clin­i­cal stud­ies.

The fa­cil­i­ty, which will be built and man­aged by VE Prop­er­ties IX, is ex­pect­ed to be op­er­a­tional in the sec­ond half of 2024. It will have 45 em­ploy­ees with­in the next five years and have enough room for any ad­di­tion­al growth, an Eye­Point spokesper­son said in an email to End­points News. The lease terms were not dis­closed.

“This new fa­cil­i­ty pro­vides us with sig­nif­i­cant man­u­fac­tur­ing ca­pac­i­ty to ac­cel­er­ate the clin­i­cal de­vel­op­ment and fu­ture com­mer­cial pro­duc­tion for EYP-1901, as well as sup­port glob­al de­mand for our U.S. FDA and Chi­na NM­PA-ap­proved ther­a­py, YU­TIQ. This strate­gic in­vest­ment in a com­mer­cial scale fa­cil­i­ty re­flects our com­mit­ment to EYP-1901, YU­TIQ and the fo­cus on build­ing a strong pipeline for long-term share­hold­er val­ue,” said Eye­point CEO Nan­cy Lurk­er in a press re­lease.

The Eye­point spokesper­son al­so point­ed out that the fa­cil­i­ty will on­ly man­u­fac­ture those two prod­ucts for now, and did not dis­close the vol­ume of pro­duc­tion.

Up­per­ton Phar­ma So­lu­tions breaks ground on $18M+ fa­cil­i­ty in Not­ting­ham

UK CD­MO Up­per­ton Phar­ma So­lu­tions kicked off con­struc­tion of its new de­vel­op­ment and man­u­fac­tur­ing head­quar­ters in the city of Not­ting­ham, UK. The 50,000-square-foot fa­cil­i­ty plans to be ful­ly op­er­a­tional by the end of the year.

Up­per­ton an­nounced last May that the fa­cil­i­ty will be a 10-fold in­crease from its cur­rent man­u­fac­tur­ing space, along with 10 man­u­fac­tur­ing suites, and will cost around £15 mil­lion ($18.6 mil­lion) and is ex­pect­ed to cre­ate 150 jobs by the end of 2024. The fa­cil­i­ty will be near its cur­rent head­quar­ters and ex­pand Up­per­ton’s ca­pac­i­ty and scale of pro­duc­tion.

“This plant has been in the plan­ning for al­most twelve months, so to see the plans fi­nal­ized and work start on the site is huge­ly sat­is­fy­ing not on­ly to us as a busi­ness but al­so for our cus­tomers as we can now of­fer them a seam­less tran­si­tion from ear­ly de­vel­op­ment to clin­i­cal tri­als and com­mer­cial man­u­fac­tur­ing, all at the one site,” said Up­per­ton CEO Nik­ki Whit­field, in a state­ment.

Forge Bi­o­log­ics brings on three new VPs

Ohio-based Forge Bi­o­log­ics is bring­ing in three new VPs in­to its lead­er­ship team.

First, Forge is bring­ing in Chris McPher­son as vice pres­i­dent of GMP man­u­fac­tur­ing. McPher­son has 25 years of in­dus­try ex­pe­ri­ence in com­mer­cial bi­o­log­ics man­u­fac­tur­ing, tech trans­fer and oth­er ar­eas of ex­per­tise. Be­fore Forge, McPher­son worked for com­pa­nies such as Guil­ford Phar­ma­ceu­ti­cal, Cam­brex Bio­science, WuXi AppTec, Biotest Phar­ma­ceu­ti­cal and Sam­sung Bi­o­log­ics.

Taleen Bar­soumi­an will be vice pres­i­dent of client de­vel­op­ment at Forge, lead­ing its client de­vel­op­ment strat­e­gy and “new busi­ness op­er­a­tions.” Bar­soumi­an was pre­vi­ous­ly the US di­rec­tor of sales and busi­ness de­vel­op­ment for Cell and Gene at the Barkey Cor­po­ra­tion and has 18 years of ex­pe­ri­ence in the busi­ness.

Adam Davis now is the vice pres­i­dent of an­a­lyt­i­cal de­vel­op­ment and leads the in-house an­a­lyt­i­cal de­vel­op­ment and test­ing team. Davis joined Forge in 2020 af­ter serv­ing as the di­rec­tor of man­u­fac­tur­ing at Abeona Ther­a­peu­tics. He was al­so the man­u­fac­tur­ing sci­en­tist at Bio­Marin Phar­ma­ceu­ti­cals.

“Ex­pand­ing our lead­er­ship team with these strate­gic hires, and the cal­iber of ex­pe­ri­ence each mem­ber brings, sup­ports our vi­sion for growth and the val­ue we pro­vide to our more than 30 part­ners as we con­tin­ue to ex­pand our lead­er­ship in gene ther­a­py de­vel­op­ment and man­u­fac­tur­ing,” said Forge CEO Tim­o­thy Miller, in a state­ment.

Kane­ka ex­pands Bel­gian site for mR­NA man­u­fac­tur­ing

The Japan­ese CD­MO Kane­ka will be in­creas­ing its pres­ence at its fa­cil­i­ty in Liège, Bel­gium to boost mR­NA man­u­fac­tur­ing ca­pa­bil­i­ties.

Kane­ka said in a press re­lease that it plans to start op­er­a­tions se­quen­tial­ly from the end of 2023, as well as in­vest­ing 2 bil­lion yen, or around $15.4 mil­lion, and have five times the cur­rent pro­duc­tion ca­pac­i­ty at the site. The CD­MO not­ed in its press re­lease that while mR­NA is cur­rent­ly be­ing used in Covid-19 vac­cines, it ex­pects mR­NA ap­pli­ca­tions in oth­er vac­cines and prod­ucts, and that de­mand will like­ly “in­crease dra­mat­i­cal­ly.”

“The de­mand for GMP man­u­fac­tur­ing of mR­NA will in­crease dras­ti­cal­ly with the ac­tive de­vel­op­ment of bio­phar­ma­ceu­ti­cal pipelines by phar­ma­ceu­ti­cal com­pa­nies world­wide,” the com­pa­ny said in the re­lease.

Kane­ka al­ready man­u­fac­tures plas­mid DNA, re­com­bi­nant pro­teins, oligonu­cleotides and oth­er drug sub­stances. It be­gan man­u­fac­tur­ing mR­NA in 2020.

Ex­per­ic adds lab space at New Jer­sey site

New Jer­sey-based CD­MO Ex­per­ic is ex­pand­ing its an­a­lyt­i­cal lab­o­ra­to­ry and ser­vices.

The new lab, based at Ex­per­ic’s head­quar­ters in Cran­bury, NJ, cov­ers 3,800 square feet and will sup­port its wider man­u­fac­tur­ing ser­vices as well as add more em­ploy­ees and equip­ment to the fa­cil­i­ty, the com­pa­ny said in a news re­lease.

“An­a­lyt­i­cal ser­vices are in­te­gral to every de­vel­op­ment project and drug sub­stance we work with. By ex­pand­ing our team and ca­pa­bil­i­ties, we can re­spond to clients more quick­ly and more cost-ef­fec­tive­ly while pro­vid­ing a more com­plete end-to-end so­lu­tion that clients want and need. With our busi­ness grow­ing rapid­ly, it be­came im­per­a­tive to ex­pand the lab­o­ra­to­ry,” said Justin La­combe, Ex­per­ic’s CEO in the re­lease.

Beck­man Coul­ter fin­ish­es first phase of its R&D hub in Col­orado

Beck­man Coul­ter Life Sci­ences has put the fin­ish­ing touch­es on the first phase of its new re­search and de­vel­op­ment hub in Love­land, CO.

The $10 mil­lion com­plex will house the com­pa­ny’s R&D ef­forts as well as al­low for 85 jobs to be cre­at­ed in the com­ing years, the com­pa­ny said in a press re­lease emailed to End­points. The com­pa­ny cur­rent­ly has a head­count of 140 in Love­land. The new com­plex in­cludes 56,000 square feet of of­fice space and a new “cus­tomer en­gage­ment cen­ter.”

The sec­ond phase of the project, which has just start­ed, will in­clude a 37,000-square-foot man­u­fac­tur­ing op­er­a­tion that will be at­tached to the of­fice. Ground­break­ing on the sec­ond phase will be­gin by the sec­ond quar­ter of 2023, with the ex­pec­ta­tion for it to be com­plet­ed in 2024.

Ed­i­tor’s Note: A cor­rec­tion has been made to the spelling of Taleen Bar­soumi­an’s name.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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