Whalatane
49分前
N7. thx for that note re the extra oxygen atom in OLC
Formula representation: It's sometimes written as La2(CO3)O2, which clearly shows the extra oxygen atoms not present in regular lanthanum carbonate3.
Properties: The extra oxygen likely contributes to OLC's improved characteristics, such as:
Higher phosphate-binding capacity
Lower pill burden
Potentially better patient adherence7
Manufacturing: OLC is produced through a specific calcination process of lanthanum carbonate hydroxide at temperatures between 400°C and 700°C, typically around 550°C2. This process likely contributes to the formation of the extra oxygen bonds.
The presence of this extra oxygen atom in oxylanthanum carbonate is a key factor in its development as a next-generation phosphate binder for treating hyperphosphatemia in chronic kidney disease patients.
Re the bold areas ...isnt that what U want from the new Vascepa formulation ...lower pill burden , potentially better patient adherence ?
Expect at least a MARINE level trial
Amarin's MARINE trial was a 12-week study12. Specifically, it was a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study designed to evaluate the efficacy and safety of AMR101 (later known as Vascepa or icosapent ethyl) in patients with very high triglyceride levels13.
Key Details
Duration: 12 weeks
Design: Multi-center, placebo-controlled, randomized, double-blind
Purpose: To evaluate the efficacy and safety of AMR101 (2 grams and 4 grams) in patients with fasting triglyceride levels =500 mg/dL
Patient Population: 229 patients were randomized in this study1
Primary Endpoint: Percentage change in triglyceride level from baseline after 12 weeks of treatment1
The MARINE trial was notable for being the largest study ever conducted with omega-3 fatty acids in treating patients with very high triglycerides (>500 mg/dL) at the time7.
Kiwi
Skipperdog11
3時間前
Sleven- I received a letter the other day from Florida Blue that stated (in part)............
"Prime Therapeutics, LLC. a national Pharmacy Benefit Manager (PBM), has been retained by Florida Blue and Health Options, Inc., (HOI) to perform drug benefit management services for specific therapeutic drug classes.
Prime received your benefit request for the prescription drug indicated below.
Following receipt of this request, a review was conducted in order to determine whether the requested prescription drug is covered under the terms of your Pharmacy Program Endorsement and any applicable Amendments.
After a complete review of all pertinent details regarding this request, a decision was made to approve the request for benefit coverage. The approval for VASCEPA 1GM CAPSULE up to 120 capsules per 30 days will be effective from 11/13/24 and ends 12/13/2025."
Letter ends with the instruction to refer to my medication guide quarterly for any updates.
Whalatane
3時間前
JR. I expect it would take AMRN up to 3 yrs to get a new formulation approved and on the market ...and they would need to follow a similar path as UNCY .
Getting the Marine indication would be pretty straight forward . Getting the R-IT indication would probably require a large long double blinded placebo controlled trial
JMO
Unicycive Therapeutics has achieved several key milestones in the development of oxylanthanum carbonate (OLC):
Preclinical Development: OLC demonstrated potent phosphate-lowering capacity in preclinical models, showing three-fold greater efficacy compared to other treatments in a CKD model1.
FDA Alignment: The company gained alignment with the FDA on the overall data package required for a New Drug Application (NDA), including the proposed clinical study design5.
Pivotal Clinical Trial:
Enrollment of the first patient began in December 2023.
The trial is designed to evaluate 60 participants with chronic kidney disease on dialysis2.
Topline data Q2 2024.
Bioequivalence Study:
A study demonstrating OLC's bioequivalence to Fosrenol was published in Clinical Therapeutics1.
The study enrolled 80 participants, with 75 completing all doses1.
NDA Submission and Acceptance:
Unicycive submitted the New Drug Application for OLC4.
The FDA accepted the NDA on November 11, 2024.
PDUFA Date: The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
Commercial Preparation: The company is preparing for a potential commercial launch in the second half of 2025, pending FDA approval6.
These milestones showcase OLC's progression from preclinical studies through late-stage clinical development and regulatory review, positioning it as a potential new treatment option for hyperphosphatemia in chronic kidney disease patients on dialysis.
Kiwi
JRoon71
4時間前
I think we will get a better sense for their intentions from the Q4/2024 CC. If we have continued to erode revenue and market share, they might have to think hard about starting the BB. Especially if we do not add meaningful enough revenue in Europe to offset it. I would anticipate an additional $5-7M in EU & RoW revenues this quarter (above last quarter), so that's likely not enough to offset US revenue losses. And with nothing from China, Italy, France, and RoW in the near future (meaning the next few quarters), as well as no milestone payments coming, cashflow will remain tight for the foreseeable future. More likely than not that we will see some cash erosion in Q4 (though I doubt it will be substantial - I would predict $10-15M).
I wish they would publish 3-month Cashflows instead of 9-months.
For the last 9 months, they are down around $15M in cash/investments. But they also have a $34M inventory benefit, which really means they burned almost $50M cash this year operationally, if they hadn't had such a glut of inventory. Burn-off of inventory should continue to help their cash position, but only to a certain extent, because they still have purchase requirements with their suppliers.
JRoon71
4時間前
Agreed. And from the chart, it only appears we are seeing Q1 market share. But again, the chart is a bit vague because of how it is labeled. I am assuming we continued to shed some market share in the last 3 quarters, as patients lost insurance coverage of V.
And not sure if we could ever really get this data, but it would also be interesting to understand what % of patients that lost coverage for Vascepa, switched to generic, dropped use of IPE altogether, or continued using branded V and are now paying out of pocket. I would suspect it's some mix of all 3.
JRoon71
5時間前
Sleven, you are right. But it should be noted that we have also lost meaningful market share at the same time. As per Amarin's presentation (page 43), loss of market share stabilized in 2023, then accelerated in Q1 2024 (it's hard to tell exactly the timing from their chart, which is not labeled very well). It is likely that we are now at, or below, 50% market share. Hopefully we will see more updated numbers at their 2024 annual CC in Feb.
Still not terrible considering we have had zero reps and marketing since Q1 2023. We are essentially operating North America like a generic.
Number sleven
5時間前
RMB, That is what Amarin is attempting to do. Recently we lost CVS after a failed negotiation. Interestingly our CEO was gone soon after. If you are going to say that Amarin is loosing prescriptions, show the numbers. We have more than 50% of the US market. Do you think we have achieved this by charging more for our product? The PBM market is complicated and cut throat. They will strike a deal with whoever provides them with the most profit. This fight is killing our margins. That is what is, in turn, killing our revenue. How does Amarin intend to move forward? They have told us. They are opening up unimpaired markets. Sales in those markets have a healthy margin. These markets will, over time, allow Amarin to purchase higher volume of API at cheaper cost. At that point we can sell our product at a lower absolute price, with a better margin. That is what is happening. For the most part, this is not my opinion.
Sleven,
JRoon71
6時間前
RMB, I think it's a tough question to answer - I don't know how many different insurers Amarin negotiates with (as well as PBM's on behalf of insurers). And we also don't know what the contract terms are. From what I recall, some contracts are annual, some are multi-year, etc. So it's likely that pricing is all over the board right now. Also, some of the generics are quite large, and may include IPE as part of a "package deal" with PBM's. In other words, it doesn't necessarily mean that every generic product is going to be the best price in the market. PBM's probably get a "portfolio" of products from each generic manufacturer, and evaluate them as a whole. That's why some PBM's likely choose certain generic manufacturers over others.
JRoon71
7時間前
Thanks Sleven, and I think you are probably right on this:
I'm not sure if generic substitutions, for a new formulation, would be legit.
I'm not particularly worried about generics competing with the new formulation.
The biggest boon for Amarin is that they could actually begin a marketing campaign again in the U.S. And even if it took several years for the existing generic prescriptions to "fall off", Amarin could crush it with a marketing campaign for the new formulation.
If you look at the trajectory of Vascepa pre-Du (and prior to ending their marketing efforts), you can see that they were well on their way to huge numbers.
Number sleven
7時間前
JRoon, From what I can tell, it looks like the only requirement would be bio equivalence. I have more time today. I intend to look at what was required for other self emulsifying products. I'm not sure if generic substitutions, for a new formulation, would be legit. Different quantities of active ingredient.
I will post the guidance.
Sleven,
JRoon71
7時間前
RMB, I don't know that answer. My guess is no - as you said, this would seemingly be a material event.
As far as pricing, I don't think there is concern about undercutting on the AG price, as this would ONLY be for the MARINE indication...
The idea would be that we beat the generics on pricing for the MARINE indication, because that is a small population. And then there is no way for them to compete with the new formulation, as that would ONLY be for the R-It indication. Sure, generics could be prescribed off-label for it, but then it is FAR more clear when infringement is taking place.
Again, this is just how I am looking at it.
JRoon71
8時間前
Noelan,
My take all along on this, is that Amarin will roll out the new formulation as a totally new product in North America, with only the R-It indication. Half the pills, and lower cost to patients. Also lower cost of good sold (again, only roughly half the API being baked into it).
Then Amarin takes their "original" formulation, and rolls out the Authorized Generic at a lower price point than the existing generics. I think they need to do this, because there is still no guarantee that insurers will cover the "new" branded formulation. This is what essentially squeezes generics out of the market.
After that, then it's just about strategy for revenue maximization over time. Price point on the AG is not a chief concern (assuming we come in lower than the generics), as the primary goal is boxing out the generics.
I don't know enough about the new formulation or how the industry works to know if this is a feasible strategy. But it's just what I've cooked up in mind for quite some time.
And part of me also wonders if this is why Sarissa and Amarin have seemingly gone radio silent and have not appeared to do much strategically. They have been waiting for the new formulation to weave its way through the patent and FDA approval processes. Also why they keep "teasing" an AG, without actually doing it or committing to a timeline.
JRoon71
8時間前
Zip, I hope so. Their upcoming CC really should have some meat to it. It's essentially the last formal CC scheduled before the delisting deadline. I am hoping 2025 is a very different kind of year than 2024. It's sort of "do-or-die" for them. If they get delisted, there will be a massive dump of shares, driving the price down even further. And if they manage to maintain their listing, it means a more than 100% price increase in just a few months.
As I have stated before, part of me believes Sarissa is orchestrating this to drive the price down as far as possible. Not sure if it's so they can buy more, if Amarin can kick off the BB at the cheapest price possible, or a little of both.
No matter what happens, the next 3-4 month are going to be wild for us.
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