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.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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