Is Xanomeline used as an API in any other medicine.???
Are there any other manufacturers for Xanomeline???
Formulator for Karxt??
Its different to be a innovator of a new drug and its entirely different to be a innovator of Block Buster drug.
Similarly its different to be a CDMO partner/API supplier of innovator drug and a a CDMO partner/API supplier of Block Buster innovator drug.
Xanomeline was first discovered in a therapeutic development collaboration between Eli Lilly & Co. and Novo Nordisk pharmaceutical companies in the early 1990s.[2][3] Eli Lilly led the first clinical development effort of xanomeline through a phase 2 clinical trial to test the hypothesis that it would improve cognition in patients suffering from cognitive decline observed in Alzheimer’s disease [11] and later in a small placebo-controlled study in schizophrenia. Xanomeline’s development was discontinued primarily due to cholinergic side effects observed in clinical studies.[12] Further development was enabled through a novel co-formulation strategy with the peripherally restricted muscarinic antagonist, trospium, to quell the peripheral cholinergic side effects.[5] This new dual drug formulation is currently called KarXT.
Xanomeline is available as Xanomeline oxalate.
There are different suppliers/manufacturers of Xanomeline oxalate like
· Application of the substance / the mixture:
Xanomeline (LY 246708) can be used for the research of schizophrenia.
Current availability of the product is for research use and Not for human or veterinary diagnostic or therapeutic use.
Apparently it seems that Xenomaline is presently being manufactured only on a very small scale and specificaly for research work only and as such there are neither commercial scale producers nor there is commercial scale end use in Pharma. We have to find out how difficult or easy it is to scale up the production from lab level to commercial level and at what cost it can be scaled up, as the alternate sourcing should commercially benefit Karuna.
It can therefore be safely assumed that Xanomeline API is presently not being used in any of the commercial drug. We can safely presume that Neuland should have a first mover advantage and is at least 2-3 years ahead of any other proposed commercial scale manufacturer of Xanomeline API.
As already covered by @akash8844 Neuland has done backward integration for production of RSM required for API to ensure high quality and low cost. Infact, it has gone one step further and established 3 domestic secure sources for the RSM’s starting material. This further strengthens the position of Neuland and also stickiness with innovator.
A simple search on the Volza suggest that the Neuland has highest shipments of Xanomeline followed by Regis which is distant 2nd.
Sharing recent interview of Sumeet Nagar of Malbar Investments
Please do watch from 6 Minutes onwards till minutes for detailed discussion on Neuland
Hope you find this useful.
dr.vikas
Thanks a lot for Sharing this, very helpful
Interestingly, this acquisition of land is over and above the capacity increase announced in November, 2023 in unit-3.
Management has many times indicated in the concalls that they would do the capex only when they get clear visibility from their customers. Interesting times ahead.
Management emphasizing that value systems & ethics are in core of Neuland Labs.
Mr Rao has ensure that these values are imbibed in the culture of his family and the Company. This gives a lot of confidence to the investors.
Please check out the detailed discussion on many pharma companies with Neuland also.
https://x.com/unseenvalue/status/1751024868202528774?s=20
Here is the YouTube link for the same.
Hope you find this useful
Where can I register for the upcoming earnings call?
You have to check out their BSE / NSE filings / call their Investor Relations number, which you will find on their website.
Hope it helps
dr.vikas
Thank you. The filing has the date of Feb 08 but no registration link.
If anyone has the registration link for the upcoming please do share it here.
Pls share your thoughts on promoter selling
Thanks for asking this Q.
Sajal Kapoor sir answers in one of the Twitter spaces. I am sharing the YouTube link for the same.
Please watch the timeline from 24 minutes onward.
Hope it helps.
dr.vikas
Please check this
Hope this helps
This investment of Bristol Myers Squibbin Karuna is big and betting big on this drug KarXT. It appears Neuland labs will be at advantage, however the quantum of benefit and the timelines are not yet out,
Management may provide some clarity on revenue potential of KARXT drug in concal. Karxt drug is just a feather in the cap and since it is claimed to be a block buster drug, there will be lot of recognition for Neuland in Big pharma and Company may get lot of new deals. Over a period of 2 to 3 years we may see significant increase in number project molecules in which Neuland will be working. As discussed earlier in this forum, the nature of business is lumpy, however ever year the base will increase as evident from last several years.
Disclosure : Invested and adding in SIP.
Q3 FY24 results -
YoY Revenue growth is 46% and PAT growth is 166%.
