Replies to post #425593 on Amarin Corp Plc (AMRN)

[JRoon71]

Hard enough persuading him to take a low dose of a small generic statin let alone 4 large capsules of EPA each day ...that his insurance may not cover anyway. " ...a little reality chk .

Agreed......

New formulation
New formulation
New formulation

This is the way.

[Laurent Maldague]

Setting aside the obvious motive to knock down the price of Vazkepa, and doing my best to follow the G-BA's logic:
They claim that IPE's efficacy is unproven for patients who have lowered their LDL-c to 55mg/dL (Reduce-IT's median LDL-C before and after was roughly 70mg/dL IIRC). If this claim is true, IPE's benefit would not "stack" with ezetimibe, and the two compete. This still leaves a problem for the German argument, because IPE confers 25%RRR vs ezetimibe's 6% RRR. This is the part where they throw in the mineral oil uncertainty to further "level the playing field" between the two agents.

Anyways, regarding the LDL-c arguments, I believe at the time of submission and discussion, there wasn't an official < 55mg/dL subgroup analysis. Looking at the NEJM article for Reduce-IT, I see this tertile breakdown, where the lowest tertile is <67 mg/dL. The trend strongly suggests <55mg/dL wouldn't make a difference, but that info hasn't been analyzed and published.


That's why Bhatt's presentation in April is so important, it directly challenges the G-BA's point, to the digit. As for the mineral oil arguments, we've accumulated more evidence since (RESPECT, Bhatt's mediation analysis at ESC 2023, in vitro studies by Mason comparing corn oil/MO/epa/dha). I'd love to see something become of the real world data done by the VA hospital researchers, and obviously you and I both want to see MITIGATE.

I'm with you that UK/EU is what will drive the valuation for the eventual BO. Italy/France/Germany and then sold.

[Jasbg]

Whala,

Personally I think the US is lost

No way the US market is lost - IMO.
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What is the main reason 'in the first place' - that Brands have a protection period ? Its because 'The Brand had the to pay for the research leading up to FDA approval (like for Vascepa also the big R-I trial) - right.

In principle Amarin today - has no more expenses pr. produced bottle than generics (or they could move production to India - to level the costs compared to generics).
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And then we are back to the AG debate. Even Du dicaster Amarin still hold the Brand name VASCEPA - so let say they vent into the market saying to everyone involved - we will match any generic price - with our AG Brand Vascepa.

You would expect AG part of total prescriptions to rise fast - wouldn't you ?

And lets imagine that Amarin AG Vascepa - aggressively regaining big parts of the US market this way - what is to stop them using a few dollars on some Marketing' - telling everyone that Original Brand Vascepa - is now on the market at generic prices ?

In theory you should be able to make prescriptions rise fast this way - pushing generics out' at the same time !

Wouldn't that be something to celebrate 🙂