No­vo Nordisk's new obe­si­ty da­ta tip the scales in semaglu­tide's fa­vor as land­mark piv­otal pro­gram looms

No­vo Nordisk has rolled out new da­ta points to back its be­lief that their new­ly ap­proved GLP-1 di­a­betes drug semaglu­tide al­so has the in­side track on a block­buster des­ig­na­tion for obe­si­ty.

No­vo’s re­searchers took cen­ter stage at the En­docrine So­ci­ety’s an­nu­al con­fer­ence in Chica­go with a new round of Phase II num­bers show­ing that the drug spurred weight loss of up to 13.8% among a group of obese adults.

Al­to­geth­er 83% of peo­ple treat­ed with semaglu­tide 0.4 mg lost greater than or equal to 5% of their body weight — com­pared to 23% with place­bo and 66% with li­raglu­tide (Sax­en­da) 3 mg, which al­so fac­tored in the study. Right at 2 of every 3 pa­tients lost at least 10% of their body weight, com­pared to 10% in the place­bo arm and half that in the li­raglu­tide group.

Mads Krogs­gaard Thom­sen

No­vo Nordisk al­ready has sol­id ef­fi­ca­cy da­ta on weight loss among the di­a­bet­ics it treat­ed dur­ing its de­vel­op­ment pro­gram for the drug, which helped in­spire the com­pa­ny to make a big in­vest­ment in obe­si­ty.

Those col­lec­tive num­bers help set the stage for a big Phase III piv­otal pro­gram, which in­cludes 4,500 obese pa­tients and a mas­sive car­dio out­comes study in­volv­ing 12,500 peo­ple.

No­vo has set out to win in a field where there’s been noth­ing but dis­ap­point­ment and fail­ure for more than a decade. Just a few days ago Orex­i­gen was forced to file for bank­rupt­cy af­ter rack­ing up in­ad­e­quate sales of Con­trave. And that drug had al­ready beat­en out Qsymia and Belviq, two oth­er ther­a­pies from the same class of biotechs that com­pet­ed for the FDA’s at­ten­tion 5 years ago. Con­trave al­so out­per­formed No­vo’s Sax­en­da, which has a more mod­est im­pact on weight.

No­vo has plans to go be­yond semaglu­tide, work­ing on com­bi­na­tion ther­a­pies that may be able to trim as much as 25% of body weight, which would ri­val the per­for­mance of some pop­u­lar weight-loss pro­ce­dures.

Some an­a­lysts es­ti­mate the drug could be worth more than $2 bil­lion a year in sales 5 years from now. And No­vo will like­ly tout the weight loss that di­a­bet­ics can ex­pect as they launch a ma­jor mar­ket­ing cam­paign trig­gered by the FDA’s ap­proval of the drug last De­cem­ber as Ozem­pic. In this field man­u­fac­tur­ers look for every ad­van­tage they can get to beat the com­pe­ti­tion, which in this case is pri­mar­i­ly Eli Lil­ly and Sanofi.

“In line with our long-term com­mit­ment, we plan to start the STEP phase 3 clin­i­cal de­vel­op­ment pro­gramme lat­er this year to ex­plore the po­ten­tial of once-week­ly semaglu­tide as a treat­ment for peo­ple with obe­si­ty,” said Mads Krogs­gaard Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer of No­vo Nordisk.

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.

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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

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:

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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.

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.

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