No­vo Nordisk’s 'se­ma' whips Mer­ck’s di­a­betes drug ri­val in PhI­II as it reach­es for best-in-class rank­ing for GLP-1 group

No­vo Nordisk keeps rack­ing up stel­lar re­sults from its late-stage slate of tri­als test­ing the full po­ten­tial of oral semaglu­tide in treat­ing di­a­betes. And the work is draw­ing some wide-rang­ing ap­plause from an­a­lysts who be­lieve the Dan­ish biotech is on a clear course to mega-block­buster sta­tus, at the ex­pense of its ri­vals.

The re­sults to­day are from Pi­o­neer 4 and 7, demon­strat­ing su­pe­ri­or­i­ty over its own Vic­toza as well as Mer­ck’s Janu­via. As for the in­jectable GLP-1 Vic­toza, there was a match on blood sug­ar and a beat on weight loss, which will tip the scales in its fa­vor. As for Janu­via, oral se­ma beat it on both scores, giv­ing No­vo the win across the board.

“No­vo now has an oral GLP-1 which is at least as good (if not bet­ter) than Vic­toza on A1C and weight loss … but orals trump in­jecta­bles – there­by mak­ing it a very com­pelling of­fer­ing,” not­ed Ever­core ISI’s Umer Raf­fat. “In a sec­ond tri­al, the ef­fi­ca­cy pro­file held up vs Janu­via with twice as much A1C con­trol and 2+ kg weight loss be­yond what Janu­via pro­duced.” 

This is why Deutsche Bank is peg­ging semaglu­tide as a $5 bil­lion drug, mak­ing it a key part of No­vo’s pipeline as the ma­jors slug it out for mar­ket share.

No­vo’s shares $NVO surged 4% on the en­cour­ag­ing news.

The study’s bot­tom line on the da­ta:

— When ap­ply­ing the sec­ondary sta­tis­ti­cal ap­proach for week 26 and week 52, re­spec­tive­ly, peo­ple treat­ed with oral semaglu­tide ex­pe­ri­enced a re­duc­tion in HbA1c of 1.3% and 1.2% com­pared to 1.1% and 0.9% with Vic­toza® where­as place­bo de­clined by 0.1% and in­creased by 0.2%…. the Amer­i­can Di­a­betes As­so­ci­a­tion (ADA) treat­ment tar­get of HbA1c be­low 7.0% was achieved by 69% of peo­ple treat­ed with oral semaglu­tide, 63% of peo­ple treat­ed with Vic­toza and 18% of peo­ple treat­ed with place­bo af­ter 52 weeks; the dif­fer­ence be­tween oral semaglu­tide and place­bo was sta­tis­ti­cal­ly sig­nif­i­cant.

— (P)eo­ple treat­ed with oral semaglu­tide ex­pe­ri­enced a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in HbA1c of 1.4% com­pared to 0.7% with sitagliptin (Janu­via) at week 52. From a base­line HbA1c of 8.3%, 63% of peo­ple treat­ed with oral semaglu­tide achieved the tar­get HbA1c be­low 7% af­ter 52 weeks of treat­ment com­pared to 28% of peo­ple treat­ed with sitagliptin, and the dif­fer­ence was sta­tis­ti­cal­ly sig­nif­i­cant. The re­duc­tion in body weight of 2.9 kg with oral semaglu­tide was sta­tis­ti­cal­ly sig­nif­i­cant­ly greater at week 52 com­pared to 0.8 kg with sitagliptin.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.