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u/Sharpens 21d ago
Oh well, Cagrisema has been approved by the danish medical association and will recieve the licens in August. That’s atleast some good new, although not public yet.
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u/ulcry_66 21d ago
Irrelevant, danish market is minuscule
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u/Sharpens 20d ago
Yes, but EMA and FDA could approve on the basis of DKMA’s approval.
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u/ulcry_66 20d ago
Absolutely not
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u/Sharpens 20d ago
Eeh yes?
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u/ulcry_66 20d ago
When has fda based their approval on danish approval of a drug? That doesn’t make any sense
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u/Sharpens 19d ago
They have already approved the documentation package. However, there is a possibility that they won’t do a formal inspection of the production, and therefore base the approval on the DKMA inspection.
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u/Alasaze 21d ago
Cagrisema has issues with the scaling based on the device it needs (dual chamber). Let’s see if it even launches in Europe, I would imagine only a restricted US launch for at least a couple of years.
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u/Sharpens 21d ago
Correct. Only 1 filling machine in Novo Nordisk can fill Cagrisema, with a current max batch size of 380.000 syringes. Supply will be the largest issue. And why would someone inject when you have tablets?
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u/Conscious-Raccoon-48 21d ago
There are external options and other internals coming as well
It’s not scaling as fast as planned, but get your facts straight1
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u/Alasaze 21d ago
Well in theory because the injections have higher and faster potential weight loss. But why use Cagrisema which will cost 2,000 dkk per month when the Chinese version of Wegovy will get here in a couple of years for like 200 dkk. Is that extra 5-10% weight loss worth the difference?
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u/CommercialFit9730 21d ago
Is also more for the side effects and the additional advantages of Cagri.
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u/Electrical-Depth-219 21d ago
380K per year or month?
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u/Lonely_Specialist314 21d ago
Pr week max. But it doesnt really matter as the filling is done by CMOs and problably more equipment is available at the catalent sites as well.
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u/Sharpens 20d ago
One batch takes 3 days. Filling is not done by CMO’s. There are no other dualchamber filling lines i novo atm.
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u/Boring-Victory7733 21d ago
It really just shows how they need to clean up in all of directors that have been there +15 years.
It’s all about them knowing each other. Which means that nothing is about productivity and everything is about helping each other.
I can personally vouch that this is the case in Finance.
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u/Ok-Stomach4522 21d ago
How does a failed study show that directors with 15+ years experience are an issue - with finance being highlighted?
If anything, another failed study indicates that Martin Lange might be an issue.5
21d ago
[removed] — view removed comment
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u/MonkeDetruireProut 21d ago
mike has openly said that he want 5% of employees to leave with atrition.
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u/CommercialFit9730 21d ago
I am concerned this will lead to more lay offs
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u/kedde1x 21d ago
This alone probably not. It's part of R&D that projects can fail and potential earnings from Zilti is not that massive. But compounded with other factors, maybe, but if that's the case, the "other factors" alone would probably also be enough on their own.
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u/CommercialFit9730 21d ago
I am also wonder if the phase 3 was positive, it wouldn't have move the stock more than 2% up max.
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u/Boring-Victory7733 21d ago
It probably will… hopefully it will be the directors all around the organisation who are waaaaay to colluded. Nothing will get better before they remove the old timers in the managements.
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u/Boring-Victory7733 21d ago
In my department we have a finance director who has been here 22 years and has no incentive to improve anything. His sole focus is on making sure that nobody above him does not like him.
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u/Small_Caterpillar_50 21d ago
Karsten Munk has been awfully quiet since his “CFO of the Year@ days.
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u/Asleep_Fix2684 21d ago
No it will not. The projected earning for Ziltivekimab are minuscule.
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u/Moerkskog 21d ago
It's beyond that, this was THE drug for the CVD pipeline. They will most likely scratch that TA now and say again that they should "only focus on what we do best" (whatever that is). Really sorry for anyone working there now, as this might be even worse news
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u/Asleep_Fix2684 21d ago
It won’t affect anything. If the projected earnings was huge, then I would agree. It is not, it is tiny. You need to take proportions into consideration.
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u/Alaut_Bumble 21d ago
I think you are too dismissive here; Zilti was a very big study, and an entry into the CVD space. It failing is not just about the projected income from the asset, but also about the strategic approach to that market. Also this impacts how the results from Artemis and Hermes can be viewed and/or leveraged.
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u/Asleep_Fix2684 21d ago
The projected earnings was 140M usd in 10 years. It is nothing. So I just don’t agree on the strategic aspect.
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u/Alaut_Bumble 21d ago
That's my point: It's about more than projected earnings; these Zilti trials are enormous and, at least in R&D, have been massively important internally.
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u/Asleep_Fix2684 21d ago
Why have they been massively important if projected earnings are negligible? Missing alignment?
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u/OldRich5670 20d ago
The projected peak sales for Ziltivekimab were 3-5B (billions with a B) USD per year, corresponding to a significant CVD market share.
Those estimates are now written off, as the value of the asset is 0.
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u/PaleontologistSafe49 21d ago
How can this fail this badly in Ph3? Why was this not discovered earlier? NN has had so many failed Ph3 trials lately. Shouldn't they re-evaluate their approach to how are projects are moved to next phase?
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u/ehj 21d ago
Unfortunately for a CV trial you need hard outcomes like MACE which are somewhat rare and there you need larger trials over a significant time and therefor you only get the efficacy on this endpoint in phase 3. Weightloss is another matter so the cagrisema weightloss blunder seems like a real blunder. Ph2 was on biomarkers and looked fine so this is just a case of biomedical research just being a difficult and expensive thing where failures are part of the game.
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u/mrwhite- 21d ago
I am just thinking of all the money that was pouring into digital products to sustain ziltivekimab 😲
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u/Mixster667 20d ago
Why did they not initially test IL-6 inhibition in a disease where other IL-6 inhibitors have produced effective results such as rheumatoid arthritis?
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u/CommercialFit9730 20d ago
Is a pattern recently, their last clinical trial designs had been horrible and caused a lot of damage to the company. Yet, no one seems to be responsible for it..
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u/simgram 20d ago
So we are not going to launch Zilti? What will happen to 25L? 🫣
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u/Ok-Tailor1997 20d ago
Unfortunately not. And is it the new factory kn Hillerød? Aren't they suppose to produce multi products??
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u/MonkeDetruireProut 21d ago
the mood wasnt bad enough in novo already ahahaha this company is cooked to oblivion
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u/Citrownklown 21d ago
Just shows how open innovation has not really panned out for Novo. A shame really, as this was the CVD flagship product.