Catal­ent lands 2 new part­ner­ships, in­clud­ing for glioblas­toma drug; US drops $153M in­to pan­dem­ic pre­pared­ness

It’s been a qui­et few weeks for one of the busiest CD­MOs out there, but Catal­ent broke its lull with the an­nounce­ment of two part­ner­ships this week.

Cur­tana Phar­ma­ceu­ti­cals, an Austin, TX-based pre­clin­i­cal com­pa­ny, an­nounced a part­ner­ship with the man­u­fac­tur­er Thurs­day to make CT-179, its drug ther­a­py for glioblas­toma, medul­loblas­toma and oth­er brain can­cers.

CT-179 is a se­lec­tive small mol­e­cule in­hibitor of LIG2, a tran­scrip­tion fac­tor es­sen­tial to ear­ly brain de­vel­op­ment but of­ten not ex­pressed in adult brain cells. The de­vel­op­ment will take place at Catal­ent’s San Diego fa­cil­i­ty.

Catal­ent is al­so div­ing fur­ther in­to the world of cannabid­i­ols as it has un­der­tak­en a fea­si­bil­i­ty study for the de­vel­op­ment of a CBD anes­thet­ic pre­med­ica­tion.

The can­di­date would use Zy­dis, Catal­ent’s oral­ly dis­in­te­grat­ing tablet tech­nol­o­gy that dis­pers­es al­most in­stant­ly in a pa­tient’s mouth with­out wa­ter. JOS Phar­ma­ceu­ti­cals signed on to pro­vide its CBD ex­tract­ed from cer­ti­fied hemp to help de­vel­op se•d8, a wafer that would pro­vide awake se­da­tion for anes­the­sia ad­min­is­tered dur­ing cataract surgery and MRIs. The freeze-dried tablet will be stud­ied at Catal­ent’s 250,000-square-foot fa­cil­i­ty Swin­don, UK fa­cil­i­ty, and fo­cus on es­tab­lish­ing proof of con­cept and a pro­to­type.

Catal­ent’s Zy­dis tech­nol­o­gy will al­low for quick, easy ad­min­is­tra­tion, Catal­ent’s Pres­i­dent of Oral and Spe­cial De­liv­ery Jonathan Arnold said in the re­lease.

US De­part­ment of Com­merce awards $153M to pro­mote man­u­fac­tur­ing in­no­va­tion

US Sec­re­tary of Com­merce Gi­na Rai­mon­do has award­ed the Na­tion­al In­sti­tute for In­no­va­tion in Man­u­fac­tur­ing Bio­phar­ma­ceu­ti­cals two awards to­tal­ing $153 mil­lion to help aid fu­ture pan­dem­ic pre­pared­ness, she an­nounced Wednes­day.

NI­IM­BL is de­signed to ac­cel­er­ate vac­cine, mon­o­clon­al an­ti­body and gene ther­a­py pro­duc­tion. The first award will pro­vide $70 mil­lion over five years and al­low NI­IM­BL to de­vel­op a flex­i­ble, scal­able and cost-ef­fec­tive process that’s self-suf­fi­cient. The sec­ond will give $83 mil­lion over three years from the Amer­i­can Res­cue Plan to sup­port R&D to pre­vent and pre­pare for fu­ture out­breaks.

“I am so pleased that NI­IM­BL will con­tin­ue to bring to­geth­er or­ga­ni­za­tions of all types to help strength­en our na­tion through bet­ter pan­dem­ic pre­pared­ness and a more ag­ile man­u­fac­tur­ing in­dus­try,” Rai­mon­do said in a press re­lease.

Gen­tiBio to ben­e­fit from Forge’s AAV and man­u­fac­tur­ing

Gen­tiBio has part­nered with Forge Bi­o­log­ics to use its ade­no-as­so­ci­at­ed vi­ral vec­tor process and GMP man­u­fac­tur­ing ser­vice for its can­di­dates to treat au­toim­mune, al­loim­mune, au­toin­flam­ma­to­ry and al­ler­gic dis­eases.

The pro­gram will use both Forge’s Blaze Vec­tor plat­form and HEK 293 Sus­pen­sion Ig­ni­tion Cells. Man­u­fac­tur­ing will hap­pen at Forge’s 175,000-square-foot fa­cil­i­ty in Colum­bus, OH, dubbed The Hearth.

“We are thrilled to part­ner with Forge Bi­o­log­ics and their ex­pe­ri­enced team to fur­ther de­vel­op our lead en­gi­neered Treg pro­gram and take a crit­i­cal step in ad­vanc­ing our ther­a­pies to pa­tients in need,” Andy Walk­er, Gen­tiBio’s Chief Tech­nol­o­gy Of­fi­cer, said in a state­ment. “Forge of­fers a broad ar­ray of ser­vices rang­ing from process de­vel­op­ment to GMP man­u­fac­tur­ing, mak­ing them a strong part­ner for Gen­tiBio’s cell ther­a­pies with ca­pac­i­ty to sup­port Gen­tiBio as we ad­vance pro­grams through clin­i­cal de­vel­op­ment.”

Eli Lil­ly ac­quires NC land for po­ten­tial ex­pan­sion

It seems that every­one else is build­ing in North Car­oli­na’s Re­search Tri­an­gle, so Eli Lil­ly seems to be prepar­ing for that fu­ture as well.

The com­pa­ny an­nounced it has ac­quired an­oth­er 102 acres for $33.16 mil­lion across three pieces of land next to its cur­rent man­u­fac­tur­ing site in the park.

“We have pur­chased ad­di­tion­al land im­me­di­ate­ly ad­ja­cent to our site un­der con­struc­tion,” Eli Lil­ly said in a state­ment to the Tri­an­gle Busi­ness Jour­nal. “This land pur­chase fur­ther em­pha­sizes our com­mit­ment to RTP and al­lows for fu­ture ex­pan­sion op­por­tu­ni­ty.”

Lil­ly has plans to man­u­fac­ture di­a­betes drugs in the Raleigh-Durham area, it said in 2020, but did not dis­close where.

US ex­er­cis­es op­tion for small­pox vac­cine

De­spite the chaos caused by the last US col­lab­o­ra­tion with Emer­gent BioSo­lu­tions, the fed­er­al gov­ern­ment has ex­er­cised an op­tion to have the New Jer­sey-based CD­MO sup­ply dos­es of small­pox vac­cine to the na­tion­al stock­pile.

The op­tion was ex­er­cised as part of the drug­mak­er’s 10-year con­tract, worth about $182 mil­lion, The Wall Street Jour­nal re­port­ed.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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