DMF for SAN HQ GMP accepted by the US FDA
THU, SEP 21, 2023 08:12 CET Report this content
Tromsø, Norway, 21th September 2023 – ArcticZymes Technologies ASA (OSE:AZT) announces that Salt Active Nuclease High Quality GMP grade (SAN HQ GMP) has passed the DMF filing Type II with the US Food and Drug Administration (FDA) and has received the acknowledgement letter with the Master File number 29754 as a reference.
This means that ArcticZymes can provide its customers with a Letter of Authorization (LoA) for their product registrations with the US FDA upon request. AZT anticipates commercial launch of SAN HQ GMP in Q4 2023.
https://news.cision.com/arcticzymes-technologies/r/dmf-for-san-hq-gmp-accepted-by-the-us-fda,c3838812
Tromsø, Norway, 21th September 2023 – ArcticZymes Technologies ASA (OSE:AZT) announces that Salt Active Nuclease High Quality GMP grade (SAN HQ GMP) has passed the DMF filing Type II with the US Food and Drug Administration (FDA) and has received the acknowledgement letter with the Master File number 29754 as a reference.
This means that ArcticZymes can provide its customers with a Letter of Authorization (LoA) for their product registrations with the US FDA upon request. AZT anticipates commercial launch of SAN HQ GMP in Q4 2023.
https://news.cision.com/arcticzymes-technologies/r/dmf-for-san-hq-gmp-accepted-by-the-us-fda,c3838812
Redigert 21.09.2023 kl 08:27
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rufus01
21.09.2023 kl 09:13
2647
Der kom den ja, litt raskere enn jeg hadde forventet. Håper og tror dette vil være starten på en reprising for AZT! :)
JosefK
21.09.2023 kl 09:23
2594
First things first: Jobb nummer en må bli å utkonkurrere Benzonase. Så får kursen legge nuller til etterhvert 🤓
Lordstock
21.09.2023 kl 10:12
2469
As I understand it the advantage of SAN HQ is that it works well in salty and cold conditions. Now that we have DMF, will clients start work in salty and cold conditions more or is the revenue potential in SAN HQ coming more from taking market share from Benzonase directly as in applying SAN HQ is same conditions as Benzonase ?
Lordstock
21.09.2023 kl 10:18
2444
The question is really, i guess, what are the applications of SAN HQ GMP and what would that salty market potential be ? How much is Benzonase use in Salty conditions, that would easily be won by SAN HQ GMP. Did someone post estimates of this previously ?
JosefK
21.09.2023 kl 12:52
2283
I think it’s a far stretch to predict what individual customers will do. My interpretation is that they could replace benzonase without doing anything and achieving a better result, based on this study https://aiche.onlinelibrary.wiley.com/doi/full/10.1002/btpr.3342 and various company data https://arcticzymes.com/products/enzymes/salt-active-nuclease-high-quality-bioprocessing-grade/
Now will they? No. I don’t think the established products will. While I think new products will have a greater chance.
Of course, this is what I think. But I find it impossible to predict a certain behavior in a diversified group. But I think I have seen enough of the established to know they won’t change a thing.
It is the new stuff that I think will make waves. And keep in mind 200 have at least <1 year experience, a 100 has >1 year experience and at least 60 more than 5 years experience. Some of those are close to phase 3 or in the process of phase 3 trials. And I suspected some are approved, but that’s only the gut feeling talking.
Lordstock
21.09.2023 kl 16:47
2094
Thanks for the links.
I agree , no one will change process on established products.
Also agree that growing SAN HQ revenues from R/D through clinical trial is most likely. Bottom up so to say.
I find this company hard to analyse as there is little transparency to prices and volumes sold, no acces to who the clients are and their need for the products.
But somewhere I have in my notes that SAN HQ has a 2% market share currently. So we are looking at a +/- 2B NOK market.
Would be lovely to see some analyst report on this one.
What TAM or blue sky revenue estimates are you people using ?
I agree , no one will change process on established products.
Also agree that growing SAN HQ revenues from R/D through clinical trial is most likely. Bottom up so to say.
I find this company hard to analyse as there is little transparency to prices and volumes sold, no acces to who the clients are and their need for the products.
But somewhere I have in my notes that SAN HQ has a 2% market share currently. So we are looking at a +/- 2B NOK market.
Would be lovely to see some analyst report on this one.
What TAM or blue sky revenue estimates are you people using ?
Elverhøi16
22.09.2023 kl 12:20
1795
Doblingpotensiale her på mellomlang sikt. Ser ut til at vi et på bunn. Bedring på q3 kan reprise aksjen.
Redigert 22.09.2023 kl 12:20
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Jan Raa
23.09.2023 kl 01:43
1586
It is a significant step forward for AZT to have the Drug Master File for Salt Active Nuclease accepted by FDA in the US. I was surprised that the approval process was not subject to obstructions and delays, taken into account that it is a powerful company within the pharmaceutical sector that is the producer of the very enzyme which will be replaced by SAN. Knowing how this system works, it tells me that equally powerful biomanufacturing companies are in support of the AZT application to FDA, and are ready (finally) to replace the nuclease they use today with the superior SAN in their biomanufacturing processes. The implications for AZT are promising.
BIF78
23.09.2023 kl 06:47
1545
Tak for din indlæg, Jan. Det vægter meget højt for mig, at få præciseret betydningen af godkendelsen fra en med så stor branchekendskab og enorm viden om produkterne. Denne præcisering og alt det spændende JosefK graver frem gør at jeg har stor tro på fremtiden. Kursen skal nok komme meget højere op igen. Nu vil jeg skynde mig at købe mere inden det sker😊