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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.