![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Wednesday, July 05, 2017 9:53:56 AM
We previously highlighted that the success of canakinumab in the ph3 CANTOS outcomes trial suggests that reducing inflammation can reduce CV events. Since Vascepa also has anti-inflammatory effects, we see this as an encouraging sign for AMRN's ongoing REDUCE-IT outcomes trial. If Vascepa's anti-inflammatory effects contributed to the positive results seen in the JELIS outcomes trial, then there's a few reasons we would expect a greater benefit from inflammation in REDUCE-IT. Recall that JELIS was an open-label outcomes trial conducted in Japan that showed a 19% Relative Risk Reduction for Vascepa compared to placebo. 1. Vascepa dosing is higher in REDUCE-IT than in JELIS – In REDUCE-IT, 4g of Vascepa is given daily, compared to 1.8g in JELIS. We expect this higher dose to contribute to a greater anti-inflammatory effect in REDUCE-IT than JELIS. This is because in both the ANCHOR and MARINE studies of Vascepa the 4g dose arm had more than a 3x lowering in the inflammatory patient population to REDUCE-IT], and -36% for 4g vs. -10% for 2g in MARINE). 2. Statin dosing is higher in REDUCE-IT than in JELIS – In both REDUCE-IT and JELIS, all patients in both arms are treated with statins. However, in JELIS patients received just 10mg of pravastatin or 5mg of simvastatin compared to the more typical dose ranges in the US of 10-80mg and 10-40mg respectively. This is an important difference that could lead to a greater decrease in inflammation in REDUCE-IT than JELIS, because in ANCHOR patients on 2g Vascepa and low dose statins (resembling JELIS) had a 10% increase in CRP (not statistically significant), compared to the 4g Vascepa and medium/high dose statin groups (resembling REDUCE-IT) which had a 23-29% decrease in CRP (p < 0.05). 3. Fish intake is likely lower in REDUCE-IT than in JELIS – We expect the worldwide REDUCE-IT trial will have lower dietary fish intake compared to JELIS which was solely conducted in Japan, a country that reportedly has above average fish consumption. Since the active ingredient of Vascepa is EPA, which is found in fish, this could lead to a greater benefit on CRP and other measures in REDUCE-IT than JELIS, in which participants likely had higher baseline levels of EPA. Finally, some remarks on readthrough from the REVEAL outcomes trial of the CETP inhibitor anacetrapib to several stocks in our coverage. We see the positive results announced last week as providing another example that supports drugs can show an outcomes benefit on top of statins, which is encouraging for REDUCE-IT, and FGEN's outcomes trials of Roxadustat.
Recent AMRN News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 12:05:56 PM
- Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- Amarin to Report Fourth Quarter and Full Year 2023 Financial Results and Host Conference on February 29, 2024 • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/12/2024 01:00:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:31:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:22 PM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • CAFI • Jun 13, 2024 8:45 AM