Seat­tle's AGC plots $194M in­vest­ment to dou­ble pro­duc­tion at Copen­hagen site in busy year for bi­o­log­ics

Bi­o­log­ics man­u­fac­tur­ing is an ex­pen­sive and com­pli­cat­ed process — but that hasn’t stopped some of the bio­phar­ma in­dus­try’s biggest play­ers from mak­ing big splash­es in re­cent years. Now, a Seat­tle-based CD­MO is drop­ping a ma­jor down pay­ment to dou­ble its pres­ence in the field.

Cit­ing an in­creased de­mand from glob­al part­ners, Seat­tle-based AGC Bi­o­log­ics will pour $194 mil­lion in­to flesh­ing out its bi­o­log­ics man­u­fac­tur­ing at its Copen­hagen site, the com­pa­ny said late last month. The rough­ly 204,000-square-foot ex­pan­sion in a new build­ing will al­low the glob­al CD­MO to dou­ble its ca­pac­i­ty for work with sin­gle-use biore­ac­tor mam­malian cell-cul­tures.

Patri­cio Massera

AGC Bi­o­log­ics will ex­pand the Copen­hagen site on ad­ja­cent land through the ad­di­tion of pro­duc­tion floors with 2,000-liter sin­gle-use biore­ac­tors, labs and of­fice spaces. The ex­pan­sion is ex­pect­ed to go on­line in 2023 as the com­pa­ny “con­tin­u­ous­ly look(s) for ways to ex­pand and ex­tend our ca­pa­bil­i­ties and ca­pac­i­ties for our cur­rent and fu­ture cus­tomers,” CEO Patri­cio Massera said in a news re­lease.

In re­cent months, AGC has con­tin­ued to roll out an am­bi­tious growth plan — in­clud­ing a fa­cil­i­ty in Boul­der, CO — and has tak­en an ac­tive role in the pro­duc­tion of a COVID-19 vac­cine. From the Copen­hagen fa­cil­i­ty, AGC Bi­o­log­ics will man­u­fac­ture Ma­trix-M, the ad­ju­vant com­po­nent of No­vavax’s coro­n­avirus vac­cine, NVX-CoV2373.

Al­so through its part­ner­ship with No­vavax, the com­pa­ny is work­ing at its Seat­tle fa­cil­i­ty to ex­pand Ma­trix-M sup­ply to en­sure vac­cine stock for the U.S.

AGC Bi­o­log­ics is far from the on­ly com­pa­ny seek­ing to ex­pand its im­pact. In mid-No­vem­ber, Ko­re­an biosim­i­lar gi­ant Cell­tri­on un­veiled plans to stick $453 mil­lion in­to build­ing a new re­search cen­ter and man­u­fac­tur­ing fa­cil­i­ty in In­cheon, Ko­rea. The news came less than a year af­ter the com­pa­ny green­lit a $514 mil­lion bi­o­log­ics plant in Chi­na.

Sam­sung Bi­o­log­ics al­so an­nounced this year that it would break ground on a $2 bil­lion, 2.5 mil­lion-square-foot “Su­per Plant” in In­cheon. CEO Tae Han Kim said in Sep­tem­ber that the plant — the com­pa­ny’s fourth — is an in­vest­ment in “a to­tal line re­fine­ment and ad­di­tion of new mid- and small-scale fa­cil­i­ties to en­sure pro­duc­tion ef­fi­cien­cy and pro­vide top-notch ser­vices to raise the bar even fur­ther to es­tab­lish our­selves as the lead­ing glob­al stan­dard.”

Sam­sung ex­pects man­u­fac­tur­ing there to be­gin in the lat­ter half of 2022.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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A French CD­MO looks to add even more cell and gene ther­a­py ca­pac­i­ty at a Paris-area site

French CDMO Yposkesi will build its second commercial cell and gene therapy facility in Corbeil-Essonnes, near Paris, the company announced last week.

The project is dubbed SKY, and will also develop a global resource for drug developers of ATMPs. It will cost about $71 million, and encompass 50,000 square feet upon completion. The Project will create 80 new jobs, and address a shortage in manufacturing capacity for companies looking to advance clinical trials and commercialize therapeutics, the press release said. The site will have two additional production lines and several 1,000-liter bioreactors.

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Covid-19 man­u­fac­tur­ing roundup: Smug­gled remde­sivir seized en route to Mex­i­co; As Sput­nik awaits WHO ap­proval, a Russ­ian plant rais­es con­cerns

Unauthorized versions of the Covid-19 drug remdesivir bound for distribution in Mexico were seized by US federal authorities, The Wall Street Journal reported.

The drug, which is manufactured by Gilead, has been counterfeited and is arriving in the US on planes from Bangladesh and India for patients willing to pay exorbitant asking prices. US Customs and Border Protection has captured more than 100 shipments, sources told the Journal.

Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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