Can No­vo’s block­buster push on obe­si­ty drug semaglu­tide suc­ceed where oth­ers failed?

An­a­lysts have some high ex­pec­ta­tions for No­vo Nordisk’s weight drug semaglu­tide, but they’re no high­er than the ones held by No­vo’s ex­ec­u­tive team.

Pegged as a po­ten­tial $2.2 bil­lion drug in 5 years in one re­cent as­sess­ment, No­vo ex­ecs dur­ing Wednes­day’s Q2 call re­viewed the Phase II obe­si­ty da­ta they had nailed down in June, out­lin­ing plans for a loom­ing Phase III that they be­lieve can show their GLP-1 drug can knock off up to around 15% of an obese per­son’s weight rel­a­tive to place­bo.

Lars Fruer­gaard Jor­gensen

In the mid-stage study, re­searchers tracked an av­er­age 17.8 kilo­gram (39 pound) weight loss from an av­er­age base­line weight of 111 ki­los, or 244 pounds, for all the pa­tients in the drug arm who com­plet­ed the one-year tri­al. That’s a 16.2% weight loss in the drug group, com­pared to 2.3% in the place­bo arm.

Their oth­er weight drug Sax­en­da is gen­er­al­ly re­lied on to knock off 5% to 10% of a per­son’s weight, mark­ing this new drug’s po­ten­tial to set a “new ef­fi­ca­cy stan­dard for an­ti-obe­si­ty med­i­cines,” in the words of R&D chief Mads Krogs­gaard Thom­sen in the call.

Five years ago a group of new weight drugs were wind­ing their way through the FDA ap­proval process. They made it, af­ter clear­ing some high hur­dles for drugs aim­ing at a big mar­ket, but the com­mer­cial re­cep­tion for the mar­gin­al weight loss they could be ex­pect­ed to de­liv­er was aw­ful. Are­na bailed on Ei­sai, leav­ing it with Belviq, Take­da dropped out of their Orex­i­gen pact and ri­val Vivus was left sell­ing Qsymia with a hand­ful of reps, with rev­enue falling.

No­vo thinks much bet­ter ef­fi­ca­cy can as­sure re­al suc­cess, and the phar­ma com­pa­ny is plan­ning to mount a new and even more am­bi­tious roll­out, if the Phase II da­ta hold up.

Sig­nif­i­cant­ly, No­vo is al­so re­ly­ing on a good safe­ty pro­file so far in obe­si­ty, with­out any ev­i­dence of reti­nal dis­ease, which has popped up in their di­a­betes study.

CEO Lars Fruer­gaard Jor­gensen al­so con­firmed that they are tak­ing the high­er, once-week­ly dos­es in­to Phase III, which will launch next year. In his words:

Yes, so we ba­si­cal­ly plan to con­duct a three, as you cor­rect­ly stat­ed, us­ing a once week­ly ap­pli­ca­tion and as we have done al­so in type two di­a­betes in more than 8,000 in­di­vid­u­als. The ba­sis for cal­cu­lat­ing the dose is ob­vi­ous­ly the usu­al ben­e­fit/risk as­sess­ment and since there were no un­ex­pect­ed risks or ad­verse events or side ef­fects as­so­ci­at­ed with semaglu­tide oth­er than those re­lat­ed to GLP-1 ag­o­nists ther­a­py, it’s ob­vi­ous that we will go to­wards the high­er end of the dose range.

And I can in­form you that go­ing in­to more de­tail that at both the high­est dos­es, 1.3 and 1.4, we are speak­ing to the tune of 15 to 17 plus kilo­gram weight loss af­ter a 1-year treat­ment in those pa­tients who com­plete. So that is what we are ex­pect­ing. And Sax­en­da in that very tri­al per­formed like it should do, giv­en the kind of ef­fi­ca­cy lev­el that we have seen in the SCALE stud­ies. So this is a new lev­el of ef­fi­ca­cy which is why we are al­ready now plan­ning for the Phase III pro­gram.

This time around No­vo says it can be dif­fer­ent. And it could use a new block­buster now as the di­a­betes mar­ket un­der­goes some marked changes.

Michel Vounatsos, Getty Images

Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

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Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

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Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

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With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

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Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.