That's the other shoe that will drop just like they did in the previous MARINE Patents trial. Only this time we hope our counsel will be ready for schenanegans like cropped tables. 

$AMRN Good Morning my Friends. Here’s my quick take on yesterday’s CC & PR:

1. I believe the $20:1 r/s is a strategy to induce HF’s into investing (most require at least $5), but most importantly, I believe it’s a tactic for appealing to BP’s for M&A. The optics of a sub $1 stock for M&A is not attractive.

2. In that regard I believe negotiations are already being conducted behind closed doors. I think the most likely suitors are:

a. Novartis: Amarin has been noticed rubbing shoulders with Novartis in Spain, and Italy and I believe they would love to control the Residual CVD Market
b. Novo Nordisk needs an anti-inflammatory CV drug to complement Ozempic’s CV benefit.
c. AstraZeneca needs to protect Brilinta from generics.

3. Look for new data to drop at ACC 2025 in April, news from France? More clarity on China, and maybe the LR-eTEPA patent will be approved.

I believe the tides are shifting and patience is needed. It might be prudent to trim large positions for investments elsewhere to build dry powder for later??
GL2A.

This is how we get the US IPE market back!

Here’s a quick illustration that distinguishes the differences in the uptake of EPA between VASCEPA®’s current formulation and the forthcoming LR-EtEPA formulation. The current formulation (Plain-EPA) is delivered through the Portal Vein Delivery System. In this system the first pass is through the liver which absorbs a significant amount of the EPA thus diluting the uptake at the target organs.

On the other hand, the Lymphatic Delivery System bypasses the liver and delivers directly to the target organs. The process is described in the LR-EtEPA patent application (WO2023146984). This new formulation can deliver from 170-296% more EPA to affected organs than the Portal Vein System. This could increase drug compliance, reduce the number of daily doses, cut Rx prices 50-75% and very importantly, incorporate easily with a Statin + VASCEPA® one a day combo pill!

https://www.linkedin.com/feed/update/urn:li:activity:7304103848942456832?commentUrn=urn%3Ali%3Acomment%3A%28activity%3A7304103848942456832%2C7304580635988307971%29&dashCommentUrn=urn%3Ali%3Afsd_comment%3A%287304580635988307971%2Curn%3Ali%3Aactivity%3A7304103848942456832%29

https://www.linkedin.com/posts/michael-everts-34799334_the-pleiotropic-effects-of-ipe-residual-activity-7303042029205209088-yWNy?utm_source=social_share_send&utm_medium=member_desktop_web&rcm=ACoAAAdDmycBzT_CwLIulyFqANe8SLMF4KH2Odo

R3i:

https://www.linkedin.com/posts/r3ifoundation_r3i-residualrisk-residualriskreduction-activity-7290005794429779968-R-U-?utm_source=social_share_send&utm_medium=member_desktop_web&rcm=ACoAAAdDmycBzT_CwLIulyFqANe8SLMF4KH2Odo

Our Friend Peter Libby has just been named the new President of R3i Foundation (Residual Risk Reduction) https://www.linkedin.com/company/r3ifoundation/posts/?feedView=all

$AMRN This is Interesting:
Today, Esperion announced a partnership with CSL Seqirus to commercialize NEXLETOL and NEXLIZET in Australia and New Zealand. This is the same partner $AMRN uses in Australia & NZ. Hummm

Austria (our latest P&R approval: IHD & Stroke Stats show a huge potential patient population for VAZKEPA

Nuke, Thanks for the kind words. I actually started a job for O'Reilly Auto Parts (ORLY) as a "Parts Runner thanks to my retirement fund. Check out their stock! Every now and then I send AMRN some of my slides with a subtle hint about employing me. Nothing yet.

FYI: There are nearly 2.3 million existing cases of adults with IHD or a stoke survivor. This is clearly an unmet clinical need. Slowly, but surely European regulatory agencies are recognizing the unique and distinct benefits of VAZKEPA®

FYI: Some smaller (Population wise) countries that have approved VAZKEPA® for P&R. Ischemic Heart Disease & Stroke INCIDENCE Numbers for 2021 reached over 273,000. This is clearly an unmet clinical need. Slowly, but surely European regulatory agencies are recognizing the unique and distinct benefits of VAZKEPA®

FYI: Some smaller (Population wise) countries that have approved VAZKEPA® for P&R. Ischemic Heart Disease & Stroke Death Numbers for 2021 reached nearly 100,000. This is clearly an unmet clinical need. Slowly, but surely European regulatory agencies are recognizing the unique and distinct benefits of VAZKEPA®

Coming soon: REDUCE-IT EPA, More evidence that It’s the EPA Stupid!

https://www.linkedin.com/feed/update/urn:li:ugcPost:7301017818332823552?commentUrn=urn%3Ali%3Acomment%3A%28ugcPost%3A7301017818332823552%2C7301245985811247104%29&dashCommentUrn=urn%3Ali%3Afsd_comment%3A%287301245985811247104%2Curn%3Ali%3AugcPost%3A7301017818332823552%29

Just a Reminder: REDUCE-IT following ACS:

Results:
Icosapent ethyl reduced the incidence of the first primary composite outcome by 37% (HR 0.63; 95% CI 0.48–0.84, P = .002) and total primary composite outcomes by 36% (RR 0.64; 95% CI 0.45–0.90, P = .01) (Figure 1). Absolute risk reduction in first primary outcome with IPE was 9.3%, (18.7% vs. 28.0%), number needed to treat (NNT) being 11 (95% CI 7–28).

Conclusions:
In this post hoc subgroup analysis of REDUCE-IT, IPE dramatically reduced the risk of ischemic events in high-risk, statin-treated patients with recent ACS (<12 months), without excess bleeding. This supports the initiation of IPE in REDUCE-IT-eligible patients as soon as possible after ACS.

thanks. I'll look into this! I had a secondary MOS: 54B US Army Chemical Operations Specialist

Any job openings where you work?

Highly unlikely that Judge Andrews would once again dismiss this case with a SJ. IMO this goes to Discovery.

Update: in 2019 I decided to retire. I had a big fat IRA balance thanks to $AMRN. Now , at 76yo I’m starting over again at $12/hr (ugh!) just to pay the bills. Wish us all luck!

In that regard I've contacted the Senate HELP committee several times to request a change in HWA to include the indication on every Tx form. Crickets. 

Hello my Amarin Friends,
I’ve been very busy this past week writing a White Paper summarizing REDUCE-IT’s post-hoc Subgrouup Analysis Titled: “20-Ways to REDUCE-IT with VASCEPA® / VAZKEPA®.” It includes at least 20 studies highlighting the pleiotropic benefits of IPE and the multi-factorial MOAs. Everything you ever wanted to know about REDUCE-IT but was afraid to ask (wink-lol) along with striking images, Links to the original publications, References, a Power Point slide deck and much more.

Below you will find a link to my Google Drive. Here’s what to look for:

1- My White Paper in both Microsoft Word (*.docx) and Adobe (*.pdf) formats.
2- A Power Point Slide deck that has individual Text Figures. (*.pptm)
3- Another pdf file of those (Slides)
4- A separate folder that contains the text Figure images in (*.PNG) format.

ENJOY.
P.S. I sent this to Dr. Bhatt and Amarin

https://drive.google.com/drive/folders/1O7DnSCocB2Bi2-ZyWT5jd5BI2PNTcKR1?usp=sharing

https://www.linkedin.com/feed/update/urn:li:ugcPost:7299504699450224641?commentUrn=urn%3Ali%3Acomment%3A%28ugcPost%3A7299504699450224641%2C7299537491496210432%29&dashCommentUrn=urn%3Ali%3Afsd_comment%3A%287299537491496210432%2Curn%3Ali%3AugcPost%3A7299504699450224641%29

Hello my $AMRN Friends! The December 2024 English Prescribing Data (EPA) for England is now available at:
https://opendata.nhsbsa.net/dataset/english-prescribing-data-epd

As usual I have filtered and downloaded this data for VAZKEPA® and a few selected non-statin LLT’s. My Summary Report for December and Full Year 2024 in pdf format can be found here:
https://drive.google.com/file/d/1nXaV3pmKRO3e7p8ShMm1FROUli-oSdZ-/view?usp=sharing

Individual slides (4 total) and the report and the original PowerPoint presentation can be found here:
https://drive.google.com/drive/folders/1J9FpKEZRPkcYFRRMy3ytmdNwAg52YTxH?usp=sharing

Slide # 1: Line graph of monthly Rx for single dose (capsules/pills) prescribed in England from 2021-2024.
Slide # 2: Table/Graph 2024 monthly comparative of VAZKEPA® vs. OMACOR (Omega-3 mixed EPA/DHA).
Slide # 3: 2024 VAZKEPA® Actual monthly Reimbursements
Slide # 4: 2024 distribution and sum of VAZKEPA® caps across English Geographic Regions.

I’m providing no commentary, just the data. ENJOY!

IMO, The Supreme's are far too busy and not interested in taking up a case that has not yet been adjudicated. They'll let this play out.

Good Question. I've been on VASCEPA for over a decade. I usually take my morning dose without breakfast. About a year ago my blood draw measured AA, EPA and DHA (6.40, 4.30, 1.90). I need to get my AA down, but my EPA is good.

There is no FAFO going on in Spain!

They are dead serious (pun intended) in reducing the prevalence of CVD in Spain and $AMRN is a part of that consortium.

We have learned from multiple studies including this one that it’s not about the placebo or even about the TG’s. 

The drugs used in PROMINENT & STRENGTH failed to achieve any of their Endpoints in spite of having higher TG reductions than REDUCE-IT. It doesn’t surprise me at all that patients with mild to moderate hypertriglyceridemia did not express similar magnitudes of CV risk.

 As I’ve been saying, in my non-professional  opinion, It’s not about the TG’s, it’s the EPA Stupid!

Happy Valentine's Day From CaptBeer!

BREAKING:
As reported earlier on ST by @CostanzaGeorge and @SanDiegoLiving:

The SmPC at the European Medicines Agency (EMA) has approved variations in the 2025 labeling Guidelines for VAZKEPA® by expanding the Mechanisms of Action (MOA) beyond TG reduction and finally putting to rest the Mineral Oil Placebo conspiracy!

Grand Rounds at Brigham & Women’s Hospital. After 50 years, what have we learned about LLT’s (Lipid Lowering Therapies)? This is an excellent presentation that focuses mainly, but not solely on LDL-c reduction and the CVE benefits when Lower is Better.

However, it’s NOT just about LDL-c. At the 43-minute mark he brings up REDUCE-IT Primary EP results (25% RRR, NNT 21, p=0.00000001). Then at the 44-minute mark he brings up STRENGTH which showed no benefits.

WHY? It’s the EPA Stupid! (No caveat for mineral oil, finally someone who gets it.)

If you want a history of LDL-c lowering therapies this presentation is worth the time (about an hour)

https://bwhav.hosted.panopto.com/Panopto/Pages/Viewer.aspx?id=e3a3fd72-7313-484f-9b5e-b27500e8f828

The French HAS Transparency Committee are a bunch of morons.

VASCEPA, "It Works"
Here are 5-Possible Ways:

The Atherogenic Triad: Significant RR with VASCEPA!

High TG's >150 mg/dl
Low HDL <35 mg/dl
Elevated sdLDL >46 mg/dl

Just a reminder in case you forgot!

DYK that elevated lipoprotein(a) (Lp(a)) levels are causally and independently associated with increased CV risk and that oxidized forms are even more predictive of CVE’s than non-oxidized forms?? Furthermore, EPA inhibits Lp(a) oxidation by 57% (p<0.001), and oxidized LDL by 81% (p<0.001)

https://academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.3886/7838965?searchresult=1

The only study that I'm aware of is the one that Mochida did in Japan which demonstrated bioequivalence superiority of branded EPADEL over generics. Keep in mind that encapsulation of EPADEL is not the same as Amarin's patented capsule.

https://www.scirp.org/pdf/fns_2020101414003866.pdf

Hello, my Amarin Friends, nothing to do while waiting for the Super Bowl? Check this out:
I decided to ask three (3) simple questions about Lipid Lowering Therapies to three (3) popular AI-Bots. Here are the Questions:

edited

I like it. I just wish we could shake the "Fish Oil" moniker.