Lars Fruergaard Jorgensen, Novo Nordisk CEO (Photographer: Chris Ratcliffe/Bloomberg via Getty Images)

No­vo Nordisk to spend $747M+ on ex­pan­sions and new fa­cil­i­ty in Den­mark

The Dan­ish phar­ma gi­ant No­vo Nordisk is mak­ing a ma­jor ex­pan­sion close to home.

The com­pa­ny an­nounced on Tues­day that it plans to in­vest 5.4 bil­lion Dan­ish kro­ner ($747.2 mil­lion) in­to ex­pand­ing its ex­ist­ing fa­cil­i­ties in its home­town of Bagsværd, Den­mark, a sub­urb of Copen­hagen. Those plans al­so in­clude the con­struc­tion of a new plant.

A No­vo Nordisk spokesper­son did not con­firm the size of the new plant to End­points News by press time. How­ev­er, they did tell End­points that de­spite the ex­pan­sion of ex­ist­ing fa­cil­i­ties, the man­u­fac­tur­ing of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) is cur­rent­ly on­go­ing to sup­port clin­i­cal tri­als. The ex­pan­sions are ex­pect­ed to be fi­nal­ized and ful­ly op­er­a­tional in Au­gust of next year for pu­rifi­ca­tion. The new fa­cil­i­ty, which is cen­tered around fer­men­ta­tion and re­cov­ery, is ex­pect­ed to be fi­nal­ized in Au­gust 2024.

No­vo Nordisk al­so plans to cre­ate more ca­pac­i­ty for R&D ac­tiv­i­ties and the pro­duc­tion of APIs, main­ly to sup­ply its clin­i­cal tri­als as well as pro­vide room for fu­ture de­vel­op­ment for its in­jecta­bles and oral med­i­cines, in­clud­ing in the di­a­betes and obe­si­ty treat­ment space, ac­cord­ing to the spokesper­son.

“This in­vest­ment in ex­pand­ing our clin­i­cal API ca­pac­i­ty in Bagsværd is an im­por­tant step to en­sure the con­tin­u­ous progress of our de­vel­op­ment pipeline. In­creas­ing our API ca­pac­i­ty in R&D will be a key en­abler in bring­ing new in­no­va­tions to the mar­ket, and meet the fu­ture de­mand of our pa­tients,” said Jes­per Bøv­ing, se­nior vice pres­i­dent of CMC de­vel­op­ment at No­vo Nordisk, in a state­ment.

This is not the first time the com­pa­ny has dropped a mas­sive amount for API man­u­fac­tur­ing. Ac­cord­ing to the North Car­oli­na Biotech­nol­o­gy Cen­ter, the com­pa­ny in 2019 spent $1.8 bil­lion on a fac­to­ry meant for No­vo Nordisk’s di­a­betes med­i­cines at its site in Clay­ton, NC. The project mea­sured 833,000 square feet and was re­port­ed at the time to be the largest man­u­fac­tur­ing in­vest­ment in the state’s his­to­ry.

The in­vest­ment in Den­mark al­so comes as the com­pa­ny put two pro­grams in obe­si­ty and car­dio­vas­cu­lar dis­ease on the chop­ping block in its re­cent Q3 re­port. The com­pa­ny’s hop­ing for a Q4 re­bound for We­govy, its weight loss drug that ran in­to “un­prece­dent­ed de­mand” on top of man­u­fac­tur­ing is­sues last year.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.