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SMLâs CDMO customer, Unicycive Therapeutics, Inc. has reported positive results from pivotal clinical trial of Oxylanthanum Carbonate (OLC), a NCE molecule.
SML has partnered with Unicycive to provide end-to-end CDMO services right from development & supply of APIs to finished dosage form.
Apart from the supply arrangement, SML is expected to receive US$ 10 million as milestone income spanning over filing, approval and launch of the product. Additionally, in anticipation of increased product demand Unicycive will also fund the establishment of new manufacturing block at Shilpaâs site.
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A note on this CDMO product
First lets understand the basic of what is a phosphate binder (OLC is a phosphate binder) and what does it do
- In very simple words, patients with diabetes are sometimes not able to excrete the phosphate they consume during their meals, resulting in an elevated serum phosphate. This happens to patients with Chronic Kidney Disease.
- If your phosphate levels are too high, it can remove calcium from your bones, which makes them brittle. It can also cause calcium deposits in your eyes, lungs, heart and blood vessels, which increase your risk of heart attack, stroke and death over time.
- Binders are basically used to reduce the phosphate absorption, they need to be taken with each meal, and need to be taken lifelong.
There are 7 types of phosphate binder as of date
- Sevelamer carbonate
- calcium acetate
- sucroferric oxyhydroxide
- ferric citrate
- tenapanor
- lanthanum carbonate
- oxylanthanum carbonate (Unicyciveâs molecule, under approval)
Sanofi is the market leader here, selling renvela (sevelamer), and has also licensed fosrenol (lanthanum carbonate) to Shire international.
- renvela is only sold in the US, while fosrenol is widespread generic.
Now why is OLC better then the other 5
-
Patient compliance- according to the market research in US by nephrologists patient compliance increases significantly with reduced pill burden. The below shows the superiority of OLC. In very simple words, Unicycive has been able to develop some patented nanoparticle tech, through which they are shrinking the size of the pills.
renvela requires the highest number of pills to be consumed per day, but still is the highest seller.
Fosrenol although has similar effect, the tablet is bigger and with more AEs -
Adverse event profiles (AEs)- in simple words AEs are the side effects
The OLC treatment-related AEs reported in â„5% of patients were diarrhea (9%) and vomiting (6%) which also compares favorably to Fosrenol and other phosphate binders on the market.
As can be seen from the above, again the top seller is way worse then OLC, even the rest are significantly higher then OLC. -
In terms of tolerability, OLC had a low rate of discontinuation due to adverse events (AEs) with only 2/86 patients (3.5%) discontinuing from the Study.
- The low discontinuation rate for OLC compares favorably to a discontinuation rate due to AEs of 14% for Fosrenol (the nearest competitor based on data)
-
Phosphate binding coefficient- as i explained above, the binder absorbs the phosphate, so binding coefficient in very simple words is per gram of medication absorbing the phosphate content in the body. The higher the absorption the better
as can be seen from above, lanthanum (OLC) is able to absorb the highest volume of phosphate, while Sevelamer (renvela) is absorbing the least.
The above also qualifies Fosrenol as an effective medication as lanthanum is also used in this. -
Oxylanthanum carbonate has the lowest daily phosphate binder dose volume and the smallest volume required to bind 1 g of phosphate compared to all other commercially available phosphate binders.
-
OLC versus SVH-
LDC is OLC, SVH is Selevamer
LDC had more reduction of urine phosphorus/creatinine ratio compared to SVH and control
Now a thing to be noted is that, even after availability of 6 FDA-approved phosphate binders, hyperphosphatemia remains uncontrolled in an estimated 75% of US dialysis patients.
Maybe this is because of lower patient compliance, as explained above, or these medications arenât as effective, or that this disease or illness isnât much cared about.
The only one comparable to OLC is Fosrenol, it is comparable across factors like the no.of tables to be consumer per day, the AEs, the volume required, the absorption.
- need to understand how will they upsell OLC against fosrenol, which being a widespread generic i would assume will be very cheap to OLC.
As we saw above Fosrenol is a lot better then the other binders (excluding OLC), still renvela is the top selling product and Fosrenol doesnât seem to have been picked up much, this raises doubts as to if fosrenol couldnât switch renvela, why will OLC.
- i am really not able to understand why is renvela the top seller, with so many inefficiencies and issues.
As of todayâs call, the US market alone is 1 billion dollars, and from the data shared above we can clearly see the superiority of OLC against other binders, hence one would expect a quick turnover of products. This also somehow reflects in the confidence of Unicycive, with them willing to fund a whole capex worth $6.5 million with Shilpa, with a contract consisting of binding volumes for 4years
- something more around the total market- approximately 40% of patients on dialysis are unable to achieve adequate serum phosphate control as defined by established KDOQI treatment guidelines1. The UNI-OLC-201 study was representative of the U.S. dialysis patient population.
the above data is from the clinical research data of Unicycive and some other sources.
invested here since lower levels, hence biased
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