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.

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
Overview
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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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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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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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.

Nick Plugis, Avak Kahvejian, Cristina Rondinone, Milind Kamkolkar and Chad Nusbaum. (Cellarity)

Cel­lar­i­ty, Flag­ship's $50M bet on net­work bi­ol­o­gy, mar­ries ma­chine learn­ing and sin­gle-cell tech for drug dis­cov­ery

Cellarity started with a simple — but far from easy — idea that Avak Kahvejian and his team were floating around at Flagship Pioneering: to digitally encode a cell.

As he and his senior associate Nick Plugis dug deeper into the concept, they found that most of the models others have developed take a bottom-up approach, where they assemble the molecules inside cells and the connections between them from scratch. What if they opt for a top-down approach, aided by single-cell transcriptomics and machine learning, to gauge the behavior of the entire cellular network?

Sanofi’s big week in­cludes a promis­ing PhI­II for an or­phan dis­ease drug, with plans for a pitch to the FDA

The biopharma R&D food chain is paying off with a plan at Sanofi to pitch regulators on a new drug for an orphan disease called cold agglutinin disease.

The pharma giant ushered out a statement Tuesday morning — after it spelled out plans to radically restructure the company, abandoning cardio and diabetes research altogether — saying that their C1s inhibitor sutimlimab had cleared the pivotal study.