Rac­ing to grab mar­ket share in di­a­betes, No­vo touts its oral semaglu­tide win over Jar­diance in PhI­I­Ia tri­al

No­vo Nordisk’s oral di­a­betes drug semaglu­tide is bear­ing down on one of its ri­vals — out­per­form­ing Jar­diance (em­pagliflozin) in a Phase II­Ia tri­al that could set No­vo up to snatch more of the type 2 di­a­betes mar­ket.

Semaglu­tide, first ap­proved as an in­jectable by the FDA late last year un­der the brand name Ozem­pic, falls in the block­buster class of drugs known as GLP-1s. This lat­est tri­al, called Pi­o­neer 2, put an oral ver­sion of the drug up against Boehringer In­gel­heim and Eli Lil­ly’s Jar­diance, an oral SGLT2-in­hibitor ap­proved back in late 2016. The study pri­mar­i­ly looked at how No­vo’s pill com­pared at in­flu­enc­ing lev­els of gly­cat­ed haemo­glo­bin (HbA1c), an im­por­tant mea­sure for drug­mak­ers hop­ing to low­er the risk of heart fail­ure and oth­er com­pli­ca­tions as­so­ci­at­ed with high blood sug­ar over time.

The 52-week, open la­bel tri­al test­ed 14 mg of No­vo’s drug semaglu­tide com­pared with 25 mg of em­pagliflozin in 816 peo­ple with type 2 di­a­betes. The tri­al nailed its pri­ma­ry end­point, with semaglu­tide demon­strat­ing a sta­tis­ti­cal­ly sig­nif­i­cant and su­pe­ri­or im­prove­ment in HbA1c com­pared to em­pagliflozin. No­vo made a point to note that they mea­sured the da­ta in two ways: (1) a pri­ma­ry sta­tis­ti­cal ap­proach (re­quired by reg­u­la­tors) that eval­u­at­ed the drug’s ef­fect re­gard­less of whether pa­tients dis­con­tin­ued the treat­ment or had to use “res­cue” med­ica­tions” dur­ing the tri­al; (2) de­scrib­ing the ef­fect while on treat­ment and with­out the use of res­cue meds.

When mea­sur­ing the da­ta the pri­ma­ry way, the drug failed to hit one of its sec­ondary out­comes: weight loss, a new mar­ket op­por­tu­ni­ty No­vo hoped to tap. But when ap­ply­ing their sec­ondary ap­proach to analy­sis, No­vo re­port­ed the 14 mg dose demon­strat­ed weight loss of 4.7 kg at 52 weeks com­pared to 3.8 kg when on em­pagliflozin for the same pe­ri­od.

Mads Krogs­gaard Thom­sen

Al­so when ap­ply­ing the sec­ondary sta­tis­ti­cal ap­proach, 72% of peo­ple treat­ed with semaglu­tide hit the Amer­i­can Di­a­betes As­so­ci­a­tion tar­get of HbA1c be­low 7% , while on­ly 47% of pa­tients on em­pagliflozin hit this tar­get.

In the tri­al, oral semaglu­tide was well-tol­er­at­ed and had a safe­ty pro­file con­sis­tent with GLP-1-based ther­a­py. No­tably, though, the pro­por­tion of pa­tients who quit treat­ment due to ad­verse events was 11% on semaglu­tide, com­pared with on­ly 4% on em­pagliflozin.

“Pi­o­neer 2 is an im­por­tant mile­stone in the clin­i­cal de­vel­op­ment of oral semaglu­tide and we look for­ward to fur­ther un­der­stand­ing the clin­i­cal pro­file of oral semaglu­tide in the re­main­ing Pi­o­neer tri­als,” Mads Krogs­gaard Thom­sen, No­vo’s chief sci­ence of­fi­cer, said in a state­ment.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.

Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.

UP­DAT­ED: Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.

In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.