Man­u­fac­tur­ing roundup: As­traZeneca and Sam­sung ink $350M deal; Michi­gan CD­MO com­pletes ex­pan­sion

Sam­sung’s biotech arm and As­traZeneca are look­ing to work to­geth­er on a con­tract man­u­fac­tur­ing agree­ment.

Ac­cord­ing to a re­port from Ko­rea’s Yon­hap News Agency, Sam­sung Bi­o­log­ics has signed a let­ter of in­tent with As­traZeneca on a co­op­er­a­tion deal val­ued at an es­ti­mat­ed $350 mil­lion, but no oth­er de­tails on the deal were avail­able.

Sam­sung Bi­o­log­ics told Yon­hap that the com­pa­nies ex­changed a sep­a­rate let­ter of in­tent last year to col­lab­o­rate on bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing, but now the col­lab­o­ra­tion has grown due to in­creased de­mand from As­traZeneca.

The two com­pa­nies do have a his­to­ry of work­ing to­geth­er as in 2020, both Sam­sung and As­traZeneca an­nounced a long-term sup­ply agree­ment that was val­ued at around $330.8 mil­lion.

So­ci­etal CD­MO sells some of its land in Geor­gia 

So­ci­etal CD­MO’s Geor­gia plant is go­ing to have some new neigh­bors but not an­oth­er man­u­fac­tur­ing plant or in­dus­tri­al site.

The com­pa­ny said that it will sell ap­prox­i­mate­ly 121 acres of lake­front land to a home­builder for over $9 mil­lion. The land is lo­cat­ed next to its man­u­fac­tur­ing fa­cil­i­ty in Gainesville, Geor­gia, and is be­ing sought for res­i­den­tial de­vel­op­ment. So­ci­etal CD­MO ex­pects the sale to close in the sec­ond half of 2023 and in­tends to use the cash to pay down some debt.

“Our own­er­ship of these ap­prox­i­mate­ly 121 acres of lake­front prop­er­ty pro­vides So­ci­etal CD­MO the unique op­por­tu­ni­ty to mon­e­tize a valu­able, non-core busi­ness as­set and uti­lize the cap­i­tal that is gen­er­at­ed to off­set a por­tion of the com­pa­ny’s debt. We be­lieve that this is a par­tic­u­lar­ly pru­dent move in light of the chal­leng­ing eco­nom­ic en­vi­ron­ment that is cur­rent­ly im­pact­ing not on­ly those in the life sci­ences in­dus­try but the broad­er glob­al mar­ket,” said So­ci­etal CD­MO’s CFO Ryan Lake, in a state­ment.

That is not the on­ly re­al es­tate move the com­pa­ny is mak­ing as it is al­so fo­cused on the sale and lease­back of its build­ings and a por­tion of the com­pa­ny’s re­main­ing land on its Gainesville cam­pus. The com­pa­ny said that dis­cus­sions with pos­si­ble buy­ers are mov­ing for­ward and is aim­ing to close the sale and lease back the deal by the end of 2022.

The com­pa­ny ex­pects the to­tal pro­ceeds from both re­al es­tate trans­ac­tions to be be­tween $40 and $50 mil­lion.

Roost­er­Bio and AGC Bi­o­log­ics to col­lab­o­rate on cell and ex­o­some ther­a­py man­u­fac­tur­ing

CD­MO AGC Bi­o­log­ics has formed a strate­gic part­ner­ship with Roost­er­Bio, a sup­pli­er of hu­man mes­enchy­mal stem/stro­mal cells (hM­SCs) to cre­ate an end-to-end so­lu­tion for the de­vel­op­ment and pro­duc­tion of hM­SC and ex­o­some-based ther­a­peu­tics.

The deal will have Roost­er­Bio de­vel­op the cells and ex­o­some ther­a­pies, with AGC Bi­o­log­ics do­ing the man­u­fac­tur­ing work. How­ev­er, the specifics of the deal have not been re­vealed yet and more news on the mat­ter is ex­pect­ed to drop in the com­ing months.

“AGC Bi­o­log­ics is hap­py to be part­ner­ing with Roost­er­Bio. (Roost­er­Bio has) a re­li­able method for pro­duc­ing en­gi­neered cells and ex­o­somes that can help de­vel­op­ers cre­ate life-sav­ing ther­a­pies When you com­bine their work and ex­per­tise with AGC Bi­o­log­ics’ sci­en­tif­ic knowl­edge and glob­al man­u­fac­tur­ing ser­vices, it cre­ates a com­pre­hen­sive of­fer­ing that can help these de­vel­op­ers save time and mon­ey and get their treat­ments in the hands of pa­tients in need.”  said Patri­cio Massera, CEO of AGC Bi­o­log­ics in a state­ment.

Michi­gan man­u­fac­tur­er ex­pands its fa­cil­i­ty with new pro­duc­tion lines

Grand Riv­er Asep­tic Man­u­fac­tur­ing, which may be Bavar­i­an Nordic’s US-based part­ner in ramp­ing up mon­key­pox vac­cine sup­plies, com­mit­ted to a $50 mil­lion ex­pan­sion of its Grand Rapids, MI fa­cil­i­ty and re­cent­ly com­plet­ed the sec­ond phase.

The CD­MO has now in­stalled two new ster­ile fill­ing lines bring­ing the site to a to­tal of three sep­a­rate fill­ing lines. The site now has a fill­ing ca­pac­i­ty of 50 mil­lion units per year with space to serve more cus­tomers, the com­pa­ny said.

“Con­ti­nu­ity of tech­nol­o­gy across all our fill lines ben­e­fits our clients as their prod­ucts tran­si­tion from the clin­ic to the mar­ket. The ca­pa­bil­i­ties es­tab­lished at GRAM with new fa­cil­i­ties and equip­ment will bet­ter serve our clients fo­cused on high-val­ue bi­o­log­ic drug prod­ucts,” said Grand Riv­er CEO Tom Ross in a state­ment.

The com­pa­ny said it is now on the hunt for new cus­tomers and it is ready to move on to an­oth­er phase of its fa­cil­i­ty ex­pan­sion, es­ti­mat­ed to be com­plete in 2024. This will in­clude more fill­ing and fin­ish­ing ca­pac­i­ty.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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