Di­a­betes gi­ant No­vo said to con­sid­er up to 3,000 lay­offs as US pric­ing storms gath­er: re­port

“Un­cer­tain and un­pre­dictable mar­kets” are forc­ing No­vo Nordisk to con­sid­er drop­ping its longterm fi­nan­cial tar­get and cut­ting 3,000 jobs from its glob­al work­force, ac­cord­ing to a lo­cal me­dia re­port.

Bors­en, a Dan­ish busi­ness news­pa­per, cit­ed anony­mous sources in re­port­ing that the gi­ant di­a­betes drug­mak­er plans to un­veil its cost-cut­ting pack­age along­side sec­ond quar­ter re­sults in Au­gust. Ac­cord­ing to the sources, the plan would in­clude an ad­just­ment of its growth fore­cast, which No­vo put at 5% as re­cent­ly as May.

The gath­er­ing wind­storms in the US on drug pric­ing, es­pe­cial­ly as they re­late to No­vo Nordisk’s bread and but­ter in­sulin prod­ucts, are re­port­ed­ly a con­cern lead­ing to the new plan; the com­pa­ny ac­knowl­edged last month these pres­sures would cut its 2019 sales by 1% or 2%.

“The neg­a­tive el­e­ment is the re­port on the long-term fi­nan­cial tar­get, be­cause if true that would mean some­thing has changed since May,” Syd­bank an­a­lyst Soren Lontoft Hansen told Reuters.

Lars Fruer­gaard Jør­gensen

A spokesper­son de­clined to com­ment on “spec­u­la­tions,” but point­ed out that CEO Lars Fruer­gaard Jør­gensen has pre­vi­ous­ly stat­ed in the me­dia that “we as part of our plans for 2019 will de­ter­mine how to make up for the ef­fect of the in­creased part D re­bates through, for ex­am­ple, in­creased sales and cost sav­ings.” The state­ment went on:

It’s pre­ma­ture to dis­cuss what these plans may look like, be­cause the Part D re­bate is on­ly one of many fac­tors that we need to take in­to ac­count when plan­ning for the fu­ture. We are op­er­at­ing in a dy­nam­ic en­vi­ron­ment that brings new chal­lenges and op­por­tu­ni­ties every day, which means we con­tin­u­al­ly as­sess and ad­just plans as need­ed. And when­ev­er we make im­por­tant de­ci­sions, we will com­mu­ni­cate them at the ap­pro­pri­ate time.

The re­port — which sent shares down 4% in pre-mar­ket trad­ing — comes as No­vo Nordisk has been pump­ing out bull­ish news for the past few months, in­clud­ing new col­lab­o­ra­tions on the stem cell ther­a­py front, a li­cens­ing deal in hema­tol­ogy, and en­cour­ag­ing da­ta paving a piv­otal path to obe­si­ty for its new­ly ap­proved GLP-1 di­a­betes drug semaglu­tide.

If the in­for­ma­tion is ac­cu­rate, though, it would mark the sec­ond time No­vo has dis­ap­point­ed in­vestors in two years.

The 5% growth pre­dic­tion that forms the base­line to­day was in fact half of what No­vo promised in­vestors back in ear­ly 2016. When it ditched the 10% guid­ance, its shares were bat­tered, falling by 19%. And that was on the heels of an an­nounce­ment that the com­pa­ny had to axe 1,000 staffers in its R&D or­ga­ni­za­tion.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

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

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

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

Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,400+ biopharma pros reading Endpoints daily — and it's free.