Novo's semaglu­tide hand­i­ly whips Eli Lil­ly's Trulic­i­ty in a PhI­II di­a­betes show­down

Mads Krogs­gaard Thom­sen

No­vo Nordisk had some more up­beat pipeline news to re­port Wednes­day af­ter­noon, as re­searchers rolled out new Phase III da­ta show­ing their GLP-1 drug semaglu­tide — a would-be block­buster — beat out Eli Lil­ly’s Trulic­i­ty (du­laglu­tide) in a head-to-head show­down.

Of par­tic­u­lar note: No­vo’s drug sailed through SUS­TAIN 7 with com­pa­ra­ble in­stances of di­a­bet­ic retinopa­thy with the com­para­tor drug from Lil­ly. That may help qualm fears raised by ear­li­er study re­sults.

“(F)or me, the #1 fo­cus go­ing in­to this press re­lease was whether No­vo’s drug may have an im­bal­ance on retinopathies (based on find­ings from pri­or tri­al) … and it didn’t (best case for No­vo),” con­clud­ed Ever­core ISI’s Umer Raf­fat.

In­ves­ti­ga­tors test­ed two dos­es of semaglu­tide and Trulic­i­ty; 0.5 and 1.0 mgs com­pared to 0.75 and 1.50 mgs. Work­ing off a mean base­line for A1C of 8.2%, the two dos­es of semaglu­tide sliced that fig­ure by 1.5% and 1.8% com­pared to 1.1% and 1.4% for Trulic­i­ty. That led to sig­nif­i­cant­ly high­er rates of semaglu­tide pa­tients hit­ting their treat­ment goals than the ri­val drug.

Even bet­ter, the dif­fer­ences in weight gain were dra­mat­ic for semaglu­tide, which is head­ing in­to a Phase III obe­si­ty pro­gram with high hopes for the mar­ket to come. Av­er­age weight loss for the two dos­es were least twice as high with semaglu­tide than Trulic­i­ty, which will give this drug a clear ben­e­fit for large num­bers of over­weight di­a­bet­ics. At the high­er dose the av­er­age weight loss with 6.5 ki­los com­pared to 3.0 ki­los.

No­vo has this drug un­der re­view at the FDA and EMA af­ter a full slate of clin­i­cal stud­ies.

Lil­ly ex­ecs won’t like the com­pe­ti­tion, if it wins ap­proval. The drug was its top-per­form­ing new drug in 2016, earn­ing $337 mil­lion. No­vo, mean­while, has proven to be a tough com­peti­tor in the mas­sive di­a­betes mar­ket, but has al­so been feel­ing the pain of pric­ing pres­sure that has af­flict­ed all the big play­ers, in­clud­ing Sanofi.

“The su­pe­ri­or glu­cose con­trol and weight loss achieved with semaglu­tide com­pared to du­laglu­tide in this tri­al re­in­forces the un­prece­dent­ed re­sults ob­served in the en­tire SUS­TAIN pro­gramme” said Mads Krogs­gaard Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer of No­vo Nordisk. “We are ex­cit­ed about the po­ten­tial of semaglu­tide to set a new stan­dard for treat­ment of type 2 di­a­betes.”

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Large advertisements for the drug Vivitrol decorate the walls of Grand Central Station on June 15, 2017 in New York City. (Photo: Andrew Lichtenstein via Getty)

FDA slaps down Alk­er­mes for mis­lead­ing Viv­it­rol ads — don't for­get vul­ner­a­bil­i­ty to opi­oid over­dose

The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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