demand

[rccola335]

wall street posted on yahoo that on the MDS facebook forum many people reporting difficulty getting drug due to demand
-hopefully it is to better demand than expected and can be addressed quickly

[biopearl123]

Could explaine Anil’s departure, if supply pipeline not ready for anticipated demand?

[biopearl123]

RC can you post copies of the relevant posts here?

[rccola335]

Many people on the FB forum, "Fight Myelodysplastic Syndrome (MDS) Low Risk" are waiting for Rytelo to be available. Apparently, the manufacturer can't keep up with the demand.

[rccola335]

would make a lot of sense with regard to Anil - can't go through all these years of work and know that hematologist probably have some patients that they have been waiting for imetlestst and then you dont have enough supply - hopefully no issues in getting the drug to people in the studies because it could invalidate some patients in the study

[biopearl123]

Here's an interesting tid bit, while researching the shelf life of Imetelstat or should I say Rytelo, to see if storage might be an issue re availability (pretty sure Geron stockpiled plenty of med prior to approval, so it would be really interesting to see where the bottleneck is, if the posts RC referenced are correct) and I came upon this:

"Manufactured for:
Geron Corporation
919 E. Hillsdale Blvd., Suite 250
Foster City, CA 94404
Manufactured by (188 mg vials):
Catalent Indiana, LLC
1300 S Patterson Drive
Bloomington, IN 47403

Manufactured by (47 mg vials):
Patheon Italia, S.p.A
2° Trav. SX Via Morolense, 5
03013 Ferentino (FR), Italy

This info was in the FDA posting at the time of approval. No mention of South Korea which I found interesting. Perhaps the South Korea lead we had was or is involved in some of the "upstream" manufacturing. Otherwise I would think for quality control reasons manufacturing, fill and finish etc would take place under one roof. I don't think we were aware of either of these sites being involved with drug production. Interesting that the different doses are not made in the same production facility. Just thought I'd add to the confusion. bp

[biopearl123]

FWIW here's what ChatGPT has to say:

"Imetelstat, marketed as Rytelo, is specifically manufactured at Catalent’s Bloomington, Indiana facility and another site located in Ferentino, Italy (Patheon Italia, S.p.A.). These sites are responsible for the sterile production and packaging of Imetelstat for intravenous use. The Bloomington facility in Indiana is particularly involved in the manufacturing of the 188 mg vials, while the Italian site handles the production of the 47 mg vials.

These facilities play a crucial role in ensuring the quality and scalability of biologic drugs like Imetelstat, which require specialized handling and manufacturing processes.

For further detailed information, you might want to consult Catalent’s official website or related pharmaceutical industry publications."

[rccola335]

that's strange - the south korean plant was a big issue - didn't they loan some money to that facility

[kmall]

Talk about interesting......

https://www.fiercepharma.com/pharma/cat ... vo-nordisk

"The Bloomington facility is one of three Catalent fill-finish sites—along with facilities in Anagni, Italy, and Brussels, Belgium—that Novo Nordisk is set to acquire for $11 billion. That deal materialized alongside the news that Novo Holdings, which operates under Novo Nordisk’s owner the Novo Nordisk Foundation, will lay out $16.5 billion to acquire Catalent in full."

Nice dig BTW Bp. -Kmall

[jingledsassy]

Hmmm didn't the South Korean plant add on to double their production capacity a couple years back.....seems like I remember that......

[FC4364]

Jingle,

Remember that as well. In fact, if memory doe's server here, believe there was quite an article about them that was put out highlighting how they had significantly increased capacity in order to meet anticipated demand, Couple of years ago, I believe.

[biopearl123]

FC, yes that was for a large plant to make oligos, but Imetelstat was not mentioned specifically. We thought there probably was a connection but never knew for sure.

[kmall]

This has certainly been an interesting turn of events as far as manufacturing is concerned. ST Pharma in Banwol Korea was the manufacturing facility for Imetelstat during Geron's collaboration with Janssen. P3 production was continued by Janssen, so it was natural to assume a handoff in the manufacturing process. To solidify this thought process, Geron's $25M tranche loan was announced the exact same week as ST Pharma's $25M Oligonucleotide facility expansion. In true Geron form, throw all of that out the window and get hit by the curve ball you never saw coming. -Kmall

[kmall]

FC - This has the link I think you had mentioned above......

Sat Sep 03, 2022 10:32 pm

Sidenote: it appears as if ST Pharma's new Oligonucleotide facility in Banwol, Korea has passed USA FDA Inspection as of August 1, 2022.

In case anyone here doesn't recall, ST Pharma in Korea was the manufacturer of Imetelstat for the duration of the P2 IMerge and P2 IMbark Clinical Trials under the Geron/Janssen collaboration.

http://www.koreabiomed.com/news/article ... dxno=14300

"ST Pharm has been only able to export raw materials of oligonucleotide treatment for clinical trial use to the U.S. so far.

However, the cGMP approval by the U.S. regulator has enabled large-scale exports for commercial use, the company said.

ST Pharm expects four FDA PAIs by the first half of 2023. This means FDA approval for novel drugs that ST Pharm supplies raw materials could be imminent.

The company said that the cGMP approval would bring a positive impact on future inspections and that ST Pharm’s sales would also increase should the novel drugs succeed in commercialization."

https://www.stpharm.co.kr/en/pr/all/st- ... by-usa-fda


ST Pharma first Asia FDA CGMP certification

https://www.stpharm.co.kr/en/pr/all/st- ... sia/page/3


This all seems to bode well for the future manufacturing/commercialization of Imetelstat.
-Kmall

_________________________________________________

Mon Sep 05, 2022 2:02 am

@Bp & Jingledsassy......

Not that I know for certain, but if Geron is continuing to subcontract ST Pharma for the manufacturing of Imetelstat, it is interesting that:

"ST Pharma expects four FDA PAIs by the first half of 2023. This means FDA approval for novel drugs that ST Pharm supplies raw materials could be imminent."

This is approximately the same timeframe Geron expects to submit FDA NDA for Imetelstat. As bucbeard mentioned earlier in this thread, Geron has certainly proven intent of "going it alone" if necessary. And from the wording of the ST Pharma PR, it sounds as if ST Pharma's intent is to produce a vast amount of oligonucleotides - which Imetelstat as you know is one of - for "large-scale exports for commercial use" to the US.

Judging by this 11/29/21 article - ST Pharma's expansion will go from a capacity of 1.5mole to 6.4mole.....to eventually 14mole with the addition of a second manufacturing facility.

https://www.contractpharma.com/contents ... -facility/

"In 2018, ST Pharm established its first oligonucleotide plant at Banwol campus with a production capacity of 1.5 mole per year. In 2020, the plant underwent further capacity expansion and when completed, ST Pharm will have a production capacity of 6.4 mole per year.

The establishment of the second oligonucleotide plant will provide a production capacity of 14 mole per year, which places ST Pharm among the world's largest CDMOs in oligonucleotide production in 2025, in terms of capacity"

For those of you who can/care to calculate the "mole" capacity rate for oligonucleotides into kilograms:

https://pubs.acs.org/doi/10.1021/ed5007376

For a layman, like myself......1.5 to 14 is approximately 9.33x greater.............


In terms of an ever-increasing market potential for Oligonucleotide therapy over the next 4yrs.......

https://www.prnewswire.com/news-release ... 32667.html

"Research & Market expects a rapid growth in oligonucleotide therapeutics market from $7.15 billion USD in 2021 to $18.8 billion USD in 2026 at a CAGR of 21.4 %. (Reference: Research and Markets, 2021, Oligonucleotide Synthesis Market Research Report)."

For a layman like myself, $7.15B to $18.8B is approximately 2.63x greater.............

Land Ho!!!! -Kmall

[kmall]

Many of the links above are non-existent.

This one on the future market for Oligonucleotide therapies estimates it being over $51B by 2029.

That's over 2.5x where it will be in 2026. It appears the pattern here is 2-3x growth rate every 5yrs or so (2021 $7.15B - 2029 $51.35B) -Kmall

https://www.databridgemarketresearch.co ... ics-market

[rccola335]

Once again - I do not have access to the support group people are referencing but Omar (I am sure most know him - he has been a cheerleader for Geron for years ) - he says people are being told it will be until November until they can have drug available

[kmall]

Imetelstat - a poster on the GERN Stocktwits board posted this yesterday - taken from the Q2 CC on 8/8/2024.......

"From the Q2 2024 Earnings Call, Andrew J. Grethlein -- Executive Vice President, Chief Operating Officer said;

"both dosage strengths of Rytelo, the 188 mg vial and 47 mg vials were available in our distribution channel for customers to order from specialty distributors as of June 27, 2024. Our distribution network is fully activated with our specialty distributor network actively supporting customer demand across hospitals and community oncology clinics. Across the contiguous 48 states, Rytelo is available to HCPs within 24 to 48 hours from our specialty distribution networks."

Perhaps the patients on the FB MDS site are waiting for insurance to approve??? According to the company they have no supply chain or manufacturing issues as of 8/8.....

I remember clearly hearing Mr. Grethlein covering this topic. What has been clear from the discussion the past 2 days here, and the ability to produce an Oligonucleotide like Imetelstat in multiple mol supplies, is that they will most likely need several manufacturers to meet demand. The fact that Novo Nordisk is acquiring one doesn't necessarily equate to a partnership or acquisition....but it certainly does hint that it is a strong possibility.

https://pubs.acs.org/doi/10.1021/ed5007376

https://www.databridgemarketresearch.co ... ics-market

Thanks for the reminder Imetelstat. -Kmall