Novo's new tri­al re­sults stoke block­buster hopes, with oral semaglu­tide scor­ing again in Phase II­Ia

No­vo Nordisk is build­ing a block­buster case for its di­a­betes drug semaglu­tide, trot­ting out Phase II­Ia tri­al re­sults Mon­day that show its new pill ver­sion of the drug worked bet­ter than place­bo at re­duc­ing weight and blood sug­ar in pa­tients. Should the oral ver­sion reach the mar­ket, No­vo would gain an edge in the Type 2 di­a­betes mar­ket to com­pete with Eli Lil­ly’s ri­val drug Jar­diance.

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-5, put an oral ver­sion of the drug up against a place­bo in 324 peo­ple with Type 2 di­a­betes and mod­er­ate re­nal im­pair­ment. The study pri­mar­i­ly looked at how No­vo’s pill in­flu­enced 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 tri­al nailed its pri­ma­ry end­point, with semaglu­tide demon­strat­ing a sta­tis­ti­cal­ly sig­nif­i­cant and su­pe­ri­or im­prove­ment in HbA1c com­pared to place­bo. The drug al­so achieved sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in body weight, the com­pa­ny said in a re­lease.

Mads Krogs­gaard Thom­sen

“The re­sults from Pi­o­neer-5 showed that oral semaglu­tide is ef­fi­ca­cious and has a sol­id safe­ty pro­file in peo­ple with type 2 di­a­betes and mod­er­ate re­nal im­pair­ment, there­by fur­ther ex­pand­ing the sol­id clin­i­cal pro­file of oral semaglu­tide,” said Mads Krogs­gaard Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer of No­vo Nordisk. “Re­nal im­pair­ment is a se­ri­ous di­a­betes com­pli­ca­tion and peo­ple with this con­di­tion have lim­it­ed oral an­ti-di­a­bet­ic treat­ment op­tions, and if ap­proved oral semaglu­tide rep­re­sents an ef­fi­ca­cious new so­lu­tion for these peo­ple.”

The new da­ta come just a few months af­ter semaglu­tide nailed a head-to-head com­par­i­son to Boehringer In­gel­heim and Eli Lil­ly’s Jar­diance, an oral SGLT2-in­hibitor ap­proved back in late 2016.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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