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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Nader Pourhassan, CytoDyn CEO (Photo by Jeff Kravitz/FilmMagic for CytoDyn’s Pro)

Cy­to­Dyn faces DOJ, SEC sub­poe­nas af­ter pro­mot­ing failed Covid-19 drug

The little, PR-happy drug company publicly called out by the FDA is now getting attention from both the SEC and the Department of Justice.

CytoDyn, a one-time penny stock that has gained both money and notoriety for aggressively pushing an old HIV drug as a treatment for Covid-19, disclosed in a regulatory filing Friday the SEC and DOJ have separately subpoenaed the company and “certain of its executives” as part of investigations into the company’s promotion and marketing practices.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Lan Huang, BeyondSpring CEO

Shares of Be­yond­Spring sky­rock­et on new, pos­i­tive can­cer drug tri­al re­sults

Sometimes results come along that shock even a biotech’s believers.

On Wednesday, BeyondSpring, a small New York biotech with an offbeat approach to immunotherapy, announced its lead drug significantly extended non-small cell lung cancer patients’ lives in a large trial. Although the company did not release the exact survival data, it said that nearly twice as many patients were alive after two years on the drug arm than on the standard-of-care arm.

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Pfiz­er puts the pres­sure on Eli Lil­ly's JAK in­hibitor Olu­mi­ant with new da­ta in alope­cia area­ta

As Eli Lilly looks to secure a win for its blockbuster Olumiant in alopecia areata, going where no JAK inhibitor has gone before, Pfizer is coming up from behind with Phase IIb/III results suggesting its own candidate can help regrow hair lost due to the autoimmune disease.

On Wednesday, Pfizer unveiled topline results from the ALLEGRO trial, which enrolled 718 patients 12 years and older with alopecia areata, a condition that can cause sudden, severe and patchy hair loss. While the patients’ episodes of alopecia areata varied in length, they all had one thing in common: They had lost at least half the hair on their scalps.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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Samantha Du, Zai Lab CEO (Zai Lab)

Saman­tha Du's Zai Lab inks sur­pris­ing re­search col­lab with Schrödinger for DNA dam­age drug

Headed by Samantha Du, Chinese oncology specialist Zai Lab has made no qualms about its aggressive in-licensing strategy to drive Western drugs into regional markets. That strategy has been profitable so far, but that doesn’t mean Du’s team isn’t willing to try something new.

In a surprising volte-face, Zai Lab has signed its name to a research collaboration with physics-based discovery outfit Schrödinger looking for an oncology candidate targeting the DNA damage repair pathway, the partners said Wednesday.