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Dukesking, yes I think that any settlement agreement resulting in a challenge against a key patent being dismissed can be viewed as good news. For same reasons folks often say Amarin should have settled before the Nevada trial: because any trial/review of intellectual property claims adds risk and may result in unexpected consequences as new light is shown on the claims, science backing, and historical record of the invention's development. Hikma settled because it was to their advantage to do so... we just don't know what those advantages are due to the closed door negotiations and confidentiality of the settlement agreement. It must be more than just getting a $22,500 refund. Hard to speculate what else the two parties agreed to. In last earnings call, I believe Amarin reiterated their intentions to appeal the dismissed Hikma infringement case, but it appears that because of Judge Andrews handling of the case they are unable to do so for quite some time (until Amarin-Healthnet part of case is completed). So perhaps Amarin was able to drop some other threatened actions they could have taken in the meantime. I'm certain Amarin will continue to aggressively protect their REDUCE-IT indication from infringement, however that plays out (currently seems to be targeting the payor rather than the GV manufacturers since Judge Andrews would not allow a GSK-Teva type skinny label infringement claim).
Sleven, the challenged patent was (challenge terminated): "Stable pharmaceutical composition and methods of using same" and appears to be one of the encapsulation patents in the infringement suit that was dismissed for Hikma but not Healthnet. Some have said that the Inter Partes Review, filed by Hikma before Judge Andrews dismissed the infringement case against Hikma, was filed to add settlement negotiating leverage in the event the case was not dropped. Perhaps the settlement agreement was something like "we will drop the PTAR IPR if you agree to not appeal the infringement suit"? Hikma submitted a great number of exhibits in December in support of their request for review so perhaps they believe they have grounds to mount a challenge. The docket alarm site allows viewing of at least the titles of those exhibits, and has links so the exhibits themselves are likely part of the public record if someone more knowledgeable wanted to dig in to see what's there.
It also looks like a timing issue was raised as docket alarm lists under upcoming events:
Even if the litigation goes forward, by the time the Board decides whether to institute in May/June 2022, the case will still be in fact discovery, which closes August 18, 2022, and expert reports will not be due for another four months, on September 19, 2022. The district court has scheduled a trial for October 30, 2023. [This would be the Amarin-Healthnet trial, and there was much discussion on iHub that Amarin cannot appeal the infringement case against Hikma until after that case is settled.]
https://patents.google.com/patent/US8642077B2/en
We claim:
1. A method of reducing triglycerides in a subject with mixed dyslipidemia on statin therapy comprising, administering to the subject a pharmaceutical composition comprising about 2500 mg to 5000 mg per day of ethyl eicosapentaenoate and not more than about 5%, by weight of all fatty acids, docosahexaenoic acid or its esters to effect a reduction in fasting triglyceride levels in the subject.
2. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in LDL-C of at least 5% compared to placebo control.
3. The method of claim 1 wherein the subject exhibits a reduction in fasting triglycerides of at least 15% compared to placebo control.
4. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 20% compared to placebo control.
5. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 25% compared to placebo control.
6. The method of claim 1 wherein the subject exhibits a reduction in fasting VLDL-C compared to placebo control.
7. The method of claim 1 wherein the subject exhibits a reduction in fasting VLDL-C of at least 5% compared to placebo control.
8. The method of claim 1 wherein the subject exhibits a reduction in hs-CRP compared to placebo control.
9. The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C compared to placebo control.
10. The method of claim 1 wherein the subject exhibits a reduction in total cholesterol compared to placebo control.
11. The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C, total cholesterol and VLDL-C compared to placebo control.
12. The method of claim 1 wherein the subject exhibits a reduction in oxidized LDL-C compared to placebo control.
13. The method of claim 1 wherein the subject exhibits a reduction in lipoprotein associated phospholipase A2 compared to placebo control.
14. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 500 mg to about 1.5 g of ethyl eicosapentaenoate.
15. The method of claim 14 wherein the dosage units are capsules.
16. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 900 mg to about 1 g of ethyl eicosapentaenoate.
17. The method of claim 16 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 1 g of ethyl eicosapentaenoate.
18. The method of claim 17 wherein the dosage units are capsules.
19. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids.
In Nov. 2021, Hikma petitioned for an Inter Partes Review by US Patent Office Patent Trial and Review (PTAR) Board in effort to invalidate Amarin patent 8,642,077 B2.
I am able to see the docket filings now and see that in December petitioner Hikma submitted many exhibits. On 3/10/22, Amarin and Hikma mutually agreed to terminate the review. Hikma has requested a partial refund.
Patent Trial & Appeal Board Inter Partes Review Terminated?
Hikma vs Amarin IPR2022-00215
Anyone have full access to this? Came up in partial Google search results:
Decisions and Orders of the Patent and Trial Appeal Board
https://www.docketalarm.com/cases/PTAB/IPR/New_Inter_Partes_Reviews/
4 days ago – Status Terminated. Tech Center 1600. Petitioner. Hikma Pharmaceuticals USA Inc. Patent Owner. Amarin Pharmaceuticals Ireland Limited.
https://www.docketalarm.com/cases/PTAB/Decisions_and_Orders/
2 days ago – Hikma Pharmaceuticals USA Inc. v. Amarin Pharmaceuticals Ireland Limited
IPR2022-00215 3/14/2022. Termination Decision: Pre-DI settlement: Termination...
To read further websites say "Login to view this docket sheet"
At https://www.docketalarm.com/cases/PTAB/IPR2022-00215/Hikma_Pharmaceuticals_USA_Inc._v._Amarin_Pharmaceuticals_Ireland_Limited/
can read behind account registration box:
Filed Nov. 30, 2021
Judges: Christopher Paulraj, Michael Valek, and Tina Hulse
Case Type: Inter Partes Review
Status: Terminated
Orange Book 202057
Challenged Patent 13/768,906
Patent No. 8,642,077
Tech Center 1600
Inventors: Mehar Manku, Ian Osterloh, Pierre Wicker, Rene Braeckman, Paresh Soni
Last Updated: 1 day, 23 hours ago
was able to create account for fuller screen view:
Yes, Current Opinion in Cardiology is listed as peer reviewed.
That doesn't guarantee the reviews were rigorous.
Journals are ranked by impact factors and citation indicators.
Nissen's publication is not in a top journal.
Rank by Journal Impact Factor (from Clarivate Journal Citation Reports)
100/142 (3rd Quartile)
Journals within a category are sorted in descending order by Journal Impact Factor (JIF) resulting in the Category Ranking below. A separate rank is shown for each category in which the journal is listed in JCR. Data for the most recent year is presented at the top of the list, with other years shown in reverse chronological order.
For comparison, NEJM where REDUCE-IT was published has a JIF of 91.253 and JCI of 26.14
https://www.nejm.org/doi/full/10.1056/NEJMoa1812792
And impact factors of top 10 journals in Cardiac & Cardiology category are shown below:
Another CME course April 7 in Alberta, Canada
(Posted this one earlier today on ST)
From 7:00 – 8:30 pm on Thursday, April 7, 2022, cardiologist Dr. Kevin Bainey will present Icosapent Ethyl (IPE) in Cardiovascular Disease: Knowledge Translation on the New Canadian Dyslipidemia Guideline. In this sponsored session, Dr. Bainey will describe the persistent cardiovascular risk (PCVR) that remains in statin-treated patients and identify elevated triglycerides (TGs) as a marker of PCVR in statin-treated patients. He will review the evidence for cardiovascular event reduction in statin-treated patients with elevated TGs and describe a recent non-statin therapy for cardiovascular event reduction in these patients. Finally, Dr. Bainey will outline novel cardiovascular risk management therapies for statin-treated patients with PCVR.
https://rxa.ca/member-exclusive-webinar/
Another CME course April 7 in Europe
Seems Amarin has been working hard to reach more physicians… so many of these courses have been popping up.
https://pace-cme.org/2022/03/11/cv-risk-reduction-beyond-statin-therapy-exploring-the-role-of-icosapent-ethyl/
CV risk reduction beyond statin therapy: Exploring the role of icosapent ethyl
EBAC accredited symposium at ESC Preventive Cardiology 2022
AGENDA - APR. 7, 2022 - ONLINE
If you are attending ESC Preventive Cardiology 2022 online you are cordially invited to attend this EBAC accredited symposium.
Thursdsay, April 7, 2022: 16:10 – 16:55 hrs CEST
Educational Objectives
Understand the key findings of large-scale omega-3 fatty acid clinical trials and how this information relates to reducing ASCVD events in clinical practice
Apply recent clinical trial evidence of icosapent ethyl on a case-by-case basis for patients with established CVD who are on statins and at risk of further CV events
Identify barriers to the implementation of effective, long-term management of ASCVD
Agenda
Introduction Ulrich Laufs, MD - Leipzig, Germany
Assessing residual cardiovascular risk in patients already treated with statin therapy Alberto Zambon, MD - Padua, Italy
Exploring the role of icosapent ethyl based on current clinical evidence Wouter Jukema, MD - Leiden, The Netherlands
Icosapent ethyl: What are the most likely mechanisms of benefit? Chris Packard, MD - Glasgow, United Kingdom
Discussion All faculty
More information will follow soon.
CME Accreditation
This programme is accredited by the European Board for Accreditation of Continuing Education for Health Professionals (EBAC) for 1 hour of external CME credit(s). Each participant should claim only those hours of credit that have actually been spent in the educational activity. The Accreditation Council for Continuing Medical Education (ACCME®) and EBAC have recognized each other’s accreditation systems as substantially equivalent.
Funding
This symposium is supported by an unrestricted educational grant from Amarin.
Adopting the New Therapeutic “Lineup” to Manage ASCVD
https://medtelligence.net/live-events/adopting-the-new-therapeutic-lineup-to-manage-ascvd-central/13162/
Live Meeting
3.00 available credits
Information
April 04, 2022
05:45 PM - 09:30 PM CDT
Marriott Marquis Houston
1777 Walker Street, Houston, Texas, United States
Overview
Managing patients with established CVD presents challenges in our practice every day. These patients may have had a prior stroke or MI and are at a very high risk of future life-threatening CV events. Join our expert faculty to hear the latest data on new and emerging statin adjuncts presented in a highly relevant and clinically applicable format. Barriers to the optimal management of ASCVD risk in many patient types (ethnicity/race/sex) will be addressed, and solutions to effectively manage such challenges in your everyday clinical practice will be provided.
Learning Objectives
After participating in this educational activity, participants should be better able to:
Understand the key findings of large-scale omega-3 fatty acid clinical trials and how this information relates to reducing ASCVD events in clinical practice
Apply recent clinical trial evidence of EPA on a case-by-case basis for patients with established CVD who are on statins and at risk of further CV events
Identify barriers to the implementation of effective, long-term management of ASCVD
Target Audience
This activity is designed to meet the educational needs of primary care physicians and community pharmacists.
Commercial Support
This activity is supported by an independent educational grant from Amarin Pharma, Inc.
Syllabus coming soon!
5:45 PM–6:30 PM
Registration and Dinner
6:30 PM–6:35 PM
Welcome, Introductions, Program Overview
Christie Ballantyne, MD
Program Chair
6:35 PM–6:45 PM
Burden of Heart Disease Today
Christie Ballantyne, MD
6:45 PM–7:05 PM
Atherogenic Dyslipidemia and New Approaches to Risk Assessment for ASCVD
Gregory Pokrywka, MD
7:05 PM–7:30 PM
REDUCE-IT Clinical Trials and Omega 3 Fatty Acids for ASCVD Risk Reductions
Karol Watson, MD
7:30 PM–7:45 PM
Panel Discussion
All faculty
7:45 PM–8:00 PM
Break
8:00 PM–8:15 PM
Recent Evidence from REDUCE-IT Sub-studies
Karol Watson, MD
8:15 PM–8:35 PM
Differential Biological Effects of Omega-3 Fatty Acids
Gregory Pokrywka, MD
8:35 PM–8:55 PM
Role of Pharmacist in Establishing Lipid Intervention
Joseph Saseen, PharmD, BCPS, BCACP
8:55 PM–9:10 PM
Panel Discussion
All Faculty
9:10 PM–9:25 PM
Clinical Approaches to Personalizing Medical Management of ASCVD Risk Factors
All Faculty
9:25 PM–9:30 pm
Closing Comments, Adjourn
Karol Watson, MD
More on "cardiometabolic" and "obesity"
Searching several past earnings call and healthcare conference transcripts, KM frequently describes Vascepa as a cardiometabolic product. The last annual report uses the word "cardiometabolic" several times: "Our plan is to file three waves of regulatory submissions for approval of VASCEPA in 20 additional countries in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA." and the last earnings call and investor slides also have "Gain access to ~20 ADDITIONAL COUNTRIES to reach the top 50 cardiometabolic markets in the world"
Less frequently used is word "obesity" which did not appear in the Mar. 7 Cowen Health Care Conference transcript, the Mar. 1 earnings call transcript, or the Jan. 11 J.P. Morgan Healthcare Conference transcript, but did show up in the Nov. 3, 2021 earnings call slides & transcript:
where Slide 11 on Diversification lists "Ongoing systematic review of potential assets in cardiometabolic and obesity spaces."
From transcript:
Obesity/cardiometabolic space/CVD/endothelium/Vascepa links
New paper "Targeting the vasculature in cardiometabolic disease"
Published March 15, 2022
Author is consultant for Pfizer
This new paper provides more scientific insights into links between obesity and “cardiometabolic space” & potential here for icosapent ethyl we’ve heard KM refer to recently.
EVAPORATE study of IPE & low-attenuation plaque cited
MINI REVIEW article - Artificial Intelligence Advancements in the Cardiovascular Imaging of Coronary Atherosclerosis
https://www.frontiersin.org/articles/10.3389/fcvm.2022.839400/full
Front. Cardiovasc. Med., 21 March 2022
“There are a number of important ongoing applications of plaque quantification. Budoff et al. (35) demonstrated that in CAD patients with elevated triglyceride levels and already taking a statin, icosapent ethyl significantly decreased the volume of low-attenuation plaque compared to placebo over an 18 month period. The application of well-validated AI guided approach to atherosclerosis quantification may enable important advances in assessing the response to preventive therapies.”
35. Budoff MJ, Muhlestein JB, Bhatt DL, Le Pa VT, May HT, Shaikh K, et al. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: a prospective, placebo-controlled randomized trial (EVAPORATE): interim results. Cardiovasc Res. (2021). 117:1070–7. doi: 10.1093/cvr/cvaa184
Not sure why authors didn’t cite final EVAPORATE results… available here:
https://academic.oup.com/eurheartj/article/41/40/3925/5898836
Nissen cannot let go of his grudge… not healthy for that poor man’s heart
https://journals.lww.com/co-cardiology/abstract/9000/n_3_polyunsaturated_fatty_acids_for_cardiovascular.98823.aspx
Poor fella also can’t get his work accepted in a reputable widely circulated journal or afford the modest open source publication charges, hence his vial has only limited access (need subscription or must buy to read)
Reducing residual cardiovascular risk in Europe: Therapeutic implications of European medicines agency approval of icosapent ethyl/eicosapentaenoic acid
https://www.sciencedirect.com/science/article/abs/pii/S0163725822000663
“In addition to robust efficacy data, multiple cost-utility studies across several countries indicate that IPE/EPA is a cost-effective treatment option that is favorably situated relative to some common willingness-to-pay thresholds.“
76655
SEC finally doing something to help Amarin:
Residual cardiovascular risk: what is the role of icosapent ethyl?
CardioVascular Virtual Topics 2022 (#CVVT2022)
10 May 2022 livestream on YouTube
https://secardiologia.es/multimedia/directos-online/ciclos/cvvt-2022/13125-sesion-2
PARTICIPANTS
Prof. José Luis Zamorano
Hospital Universitario Ramón y Cajal, Madrid (Spain)
Prof. Alberto Zambon
University of Padova (Italy)
CV residual risk: what is this? Role of lipids and inflammation and how to identify the patient
Prof. John Chapman
Pitié-Salpétrière Hospital, Paris (France)
Icosapent Ethyl MoA: what do we know?
Prof. Xavier Garcia-Moll
Hospital de la Santa Creu i Sant Pau, Barcelona (Spain)
Icosapent Ethyl: Evidence and guidelines recommendations
SEC= Sociedad Española de Cardiología, that is!
ggwpq, thanks for the suggestion. Done.
Needed: Statin enhancers to improve absolute risk reduction
Reducing LDL cholesterol with statins is not enough. Amarin should leverage this new meta-analysis to promote need for and benefits of Vascepa!
Evaluating the Association Between Low-Density Lipoprotein Cholesterol Reduction and Relative and Absolute Effects of Statin Treatment
A Systematic Review and Meta-analysis
https://www.healio.com/news/cardiology/20220314/metaanalysis-questions-strength-of-ties-between-statininduced-ldl-lowering-cv-outcomes
Reference:
Link between high cholesterol and heart disease ‘inconsistent’, new study finds. https://www.eurekalert.org/news-releases/946181 Published and accessed March 14, 2022.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790055
I have a feeling that's going to take a very long time...
$8B with current market cap at $1.183B gives BO price of $19.41.
8/1.183*2.87=$19.41
I've always thought it seemed reasonable to expect a buyout to eventually exceed the secondary $400M offering price of $18/share, even if just for the face-saving optics of it for GS, even if they've made back customer losses through options & trading sizable volatility.
https://investor.amarincorp.com/news-releases/news-release-details/amarin-prices-public-offering-american-depositary-shares-3
Amarin recovers amid positive views from Piper Sandler on European strategy
https://seekingalpha.com/news/3813782-amrn-stock-gains-with-positive-views-from-piper-sandler
Plausibility of short-selling by Sarissa Capital's trader?
EPA-EE purification by YMC America's MCSGP process
Not sure if Amarin's API suppliers use this method or not, but found this interesting... haven't seen much on IPE production methods.
Continuous purification: MCSGP and CaptureSMB—
industry disruptive technologies at https://www.ymcamerica.com/technologies/continuous-purification/
Newly published extensive review on role of inflammation in CVD and how specialized pro resolving lipid mediators (SPMs) help MITIGATE CVD progression
IMHO - This is the stuff Dr. Alex Denner fully understands and bases his investment in Amarin upon.
(This article belongs to the Special Issue The Twist and Turn of Lipids in Human Diseases)
Specialized Proresolving Lipid Mediators: A Potential Therapeutic Target for Atherosclerosis
Int. J. Mol. Sci. 2022, 23(6), 3133
Received: 3 February 2022 / Revised: 8 March 2022 / Accepted: 9 March 2022 / Published: 15 March 2022
https://www.mdpi.com/1422-0067/23/6/3133/htm
Got it…thanks!
Lizzy, could you elaborate on meaning of lock-up expiration? I don’t follow what that refers to. Thanks, dogn
Counted that Sofinnova portfolio lists 102 companies… if specialty is early stage firms e.g. without FDA approved products, one view is Amarin no longer fits in that category. More of a slow grinding growth story, especially if trying to continue signaling GIA to slowly build value with quick BP BO seemingly off the table for foreseeable future.
https://www.sofinnova.com/portfolio/
Take your profit and move on may make sense particularly with observation that Soffinova primarily invests in small biotech companies which have been very badly battered this past year as seen by 50% drop of SPDR S&P Biotech ETF XBI since Feb. 10, 2021 peak at $168, now under $85. Need to raise capital for substantial bargain shopping opportunities or just prudent fiscal management to offset these other massive losses. Difficult time for all biotech investors.
Jasbg,
Date seems to be correct as it refers to denial of Rule 24/60 filing, not Du’s decision invalidating Marine patents.
Sofinnova website portfolio lists Amarin investment in 2008 (price was under $1 then), same year Lars joined firm from Elan. https://www.sofinnova.com/portfolio/
I also recall that last time I checked his profile, Amarin was listed as an active company. I had posted once here or on ST that he was hoping to list it under “alumni” companies which I believe indicates they were successfully ushered through a buyout. Amarin is no longer shown.
https://www.sofinnova.com/team/lars-ekman-md-phd/
They didn’t lose money, and perhaps they just now see quicker and/or greater potential returns in other fledgling firms they are better positioned to place educated bets upon. Or for some reason continued holding presents some type of conflict of interest with whatever is unfolding for Amarin along with perhaps other investments.
Seems odd and discouraging for chairman of the board to sell Sofinnova’s position now, and certainly bad optics, but perhaps we’ll understand the full story only after the fact and it will make more sense in retrospect. Seems plausible to entertain an “emerging conflict of interest” theory?
Markman Advisors comments on GSK-Teva & relationship to Amarin-Hikma/Healthnet in this Feb. 18 blogpost by Zachary Silbersher https://www.markmanadvisors.com/blog/2022/2/18/what-is-at-the-heart-of-the-gsk-skinny-label-standoff-at-the-cafc
Sleven,
Interesting find. I was just myself looking a bit yesterday into status of the Matinas Biopharma (MTNB) omega-3 formulation, which - based on their lipid nanocrystal (LNC) platform in theory seems promising due to claimed greater bioavailability for use in something like a once per day treatment pill.
This study looks at on-treatment EPA plasma levels, which have been correlated in REDUCE-IT to CVD benefits. I don't believe MTNB has looked beyond triglyceride lowering into CVD benefits, which would require a large, expensive CVOT like REDUCE-IT or STRENGTH, but one could extrapolate that if it's all about the EPA levels, similar results may be obtained.
The link you post appears to be an automatic update to the ENHANCE-IT clinical trial data to reflect March 4 publication of results ("Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number)." The "Actual Study Completion Date : January 18, 2021" is nearly 14 months ago. A direct link to the published paper is given, from which I found and browsed the full text article at:
https://www.ahajournals.org/doi/full/10.1161/JAHA.121.024176
The trial compared MAT9001 (= "Lypdiso") and Vascepa.
Lol likely nothing. I posted before noticing Per was re-elected, not newly elected as chairman, and before realizing GN was not a General Nutrition health supplements store where I fantasized he would now have power to banish all fish oil supplements forever and ever… my bad. No way in iHub to delete posts ha
Our newest director, Per Wold-Olsen, was [re-]elected as chairman of the board (& chairman of the Renumeration Committee) of GS Store Nord yesterday.
https://www.globenewswire.com/news-release/2022/03/09/2399931/0/en/Annual-General-Meeting-2022-GN-Store-Nord-A-S.html
https://www.gn.com/about/management
https://en.wikipedia.org/wiki/GN_Store_Nord
“GN Store Nord
In 1985, The Great Northern Telegraph Company changed its name to GN Store Nord (GN = Great Nordic) with the aim of creating a new group identity and organizing its businesses. … In March 1992, GN's new subsidiary Sonofon opened the first private mobile telephone network in Denmark. Although GN was not the only investor in Sonofon, it owned the majority of the shares. … In 2009, GN Audio (then GN Netcom) made a decision to globally market all its products under the same brand; Jabra (a company that GN had acquired in 2000). The purpose of consolidating all products under the same brand was to strengthen the company's position as the world's leading supplier of headsets. Today, GN Audio is a world leader in Unified Communications headsets, and within the last couple of years the company has managed to be the first at introducing a number of innovative products on the market. In 2014, the company launched the world's first sports headset with a built-in heart rate monitor. In addition, a series of noise cancellation headsets with a concentration zone has been launched, which are specially designed to improve employees’ ability to concentrate in noisy open offices. GN Hearing also got back on track. In 2010, the company revolutionized the industry by launching the world's first hearing aid with 2.4 GHz technology – a new wireless technology that was groundbreaking compared to the previous inductive technology. In 2014, GN Hearing changed the industry once more with the introduction of the world's first Made for iPhone hearing aid, which based on the 2.4 GHz technology enables the streaming of sound directly from an iPhone without any body-worn devices.
In October 2016, GN Audio acquired VXi Corporation, the manufacturer of both the VXi and BlueParrott headset brands. Products are to be rebranded Jabra.”
Since the end of 2008, GN's share price has increased by almost 1200% (December 2014)”
MITIGATE trial presentation leads off a Late-Breaking Clinical Trial Session at ACC22 co-chaired by Gregory Curfman, MD
Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials
Sunday, April 3, 8 – 9:15 a.m. ET
Main Tent, Hall D - Hot Topics Channel
MITIGATE: A Pragmatic Randomized Trial of Icosapent Ethyl for High Cardiovascular Risk Adults in an Era of Coronavirus Disease 2019
Authors: Andrew P. Ambrosy, Thida Tan, Rachel Thomas, Rishi Parikh, Daniel Stevens, Ryan Wi, Harshith Avula, Matthew Solomon, Van Selby, Jesse Fitzpatrick, Choon Goh, Jacek Skarbinski, Sephy Philip, Deepak Bhatt, Alan Go, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA, Kaiser Permanente Northern California - Division of Research, Oakland, CA, USA
Abstract is embargoed at this time.
https://accscientificsession.acc.org/en/Plan-Your-Program/Late-Breakers
https://www.abstractsonline.com/pp8/#!/10461/session/518
Just noticed that this session is co-chaired by Gregory D. Curfman, MD ... a strong advocate for Amarin & Vascepa... will likely ensure panel discussion doesn't veer off track but remains accurate, relevant, and supportive of our valuable asset
Co-author of:
Gregory Curfman, Deepak L Bhatt, Michael Pencina, "Federal judge invalidates icosapent ethyl patents - but on the basis of a common statistical mistake" Nat Biotechnol. 2020 Aug;38(8):939-941. doi: 10.1038/s41587-020-0616-y.
https://pubmed.ncbi.nlm.nih.gov/32760020/
and:
Curfman G, Shehada E. "Icosapent ethyl: scientific and legal controversies"
Open Heart 2021;8:e001616. doi:10.1136/openhrt-2021-001616
https://openheart.bmj.com/content/8/1/e001616
https://www.linkedin.com/in/gregory-curfman
Editor In Chief at Harvard Health Publishing; Deputy Editor of JAMA, the Journal of the American Medical Association
https://esc365.escardio.org/person/182553
Also one of 22 members of the Institute for Clinical and Economic Review (ICER) Midwest CEPAC (Comparative Effectiveness Public Advisory Council), Independent appraisal committee that found Vascepa to be cost effective: https://icer.org/news-insights/press-releases/cvd_final_report/
https://icer.org/who-we-are/people/independent-appraisal-committees/midwest-comparative-effectiveness-public-advisory-council-m-cepac/
https://icer.org/who-we-are/people/gregory-curfman-md/
74247
Some additional video highlights:
Final Dr. Leiter presentation on Practical Considerations to Manage ASCVD Risk at
Dukesking, I agree that these presentations highlight very solid & compelling evidence on the efficacy of IPE (Vascepa).
FWIW, the original at https://medtelligence.net/programs/cme/omega-3-icosapent-ethyl-and-stroke-reduction-in-atherosclerotic-vascular-disease/13545/ is slightly higher resolution making the more detailed slides easier to read.
Highlights for me: Lawrence Leiter presents an excellent review of the REDUCE-IT trial.
IPE is presented as a "New Chemical Entity for the Prevention of CV Events"
Indeed the same content, just found again in Dukesking's post #372081 on 3/2, originally posted by RAF
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168059733
Omega-3 Icosapent Ethyl and Stroke Reduction in Atherosclerotic Vascular Disease
Recorded Feb. 10, 2022, Virtual Satellite Symposium, 2022 International Stroke Conference
Posted today on AHAScienceNews YouTube channel:
Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE-IT PCI
Originally published 9 Mar 2022
https://doi.org/10.1161/JAHA.121.022937
Abstract
Background
Patients who undergo percutaneous coronary intervention (PCI) are at increased risk for recurrent cardiovascular events despite aggressive medical therapy.
Methods and Results
This post hoc analysis focused on the subset of patients with prior PCI enrolled in REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), a multicenter, randomized, double-blind, placebo-controlled trial of icosapent ethyl versus placebo. Icosapent ethyl was added to statins in patients with low-density lipoprotein cholesterol <100 mg/dL and fasting triglycerides 135–499 mg/dL. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. There were 8179 patients randomized in REDUCE-IT followed for a median of 4.9 years, and 3408 (41.7%) of them had a prior PCI with a median follow-up of 4.8 years. These patients were randomized a median of 2.9 years (11 days to 30.7 years) after PCI. Among patients treated with icosapent ethyl versus placebo, there was a 34% reduction in the primary composite end point (hazard ratio [HR], 0.66; 95% CI, 0.58–0.76; P<0.001; number needed to treat4.8 years=12) and a 34% reduction in the key secondary composite end point of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (HR, 0.66; 95% CI, 0.56–0.79; P<0.001; NNT4.8 years=19) versus placebo. Similarly, large reductions occurred in total coronary revascularizations and revascularization subtypes. There was also a 39% reduction in total events (rate ratio, 0.61; 95% CI, 0.52–0.72; P<0.001).
Conclusions
Among patients treated with statins with elevated triglycerides and a history of prior PCI, icosapent ethyl substantially reduced the risk of recurrent events during an average of ~5 years of follow-up with a number needed to treat of only 12.
Adding my thanks for your NICE detailed summary report, STS
-dogn