Amarin Shares Topline Data from Partners Pivotal Phase 3 Study of VASCEPA® (Icosapent Ethyl) in Mainland China
Significant Reduction in Triglyceride Levels Without Low-Density Lipoprotein Cholesterol (LDL-C) Increase Compared to Placebo and Safety Profile Similar to Placebo Achieved with 4 Grams Per Day Dose of Icosapent Ethyl in Chinese Patients with Very High Triglycerides (>500 mg/dL) Results Support Upcoming Submission by Partner, Edding, Seeking Regulatory Approval in ChinaDUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today shared positive, statistically significant top-line results from Protocol Number EDPC003R01, a Phase 3 clinical trial of VASCEPA® (icosapent ethyl) conducted in China by Amarin partner, Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo. The findings are being prepared to support Edding’s dossier for seeking regulatory approval of VASCEPA in Mainland China.The EDPC003R01 trial was a multi-center, randomized, double-blind, placebo-controlled, 12-week pivotal study in adult patients in China with qualifying fasting triglyceride (TG) levels greater than or equal to 500 mg/dL and less than or equal to 2000 mg/dL. The median baseline TG levels in the study were 812 mg/dL and 837 mg/dL for the patients assigned to placebo (n=123) and 4 grams per day of VASCEPA (n=122), respectively. Prior to randomization into the 12-week double-blind treatment period, all patients underwent a six- to eight-week washout period of lipid altering drugs, as well as diet and lifestyle stabilization.The study’s primary endpoint, the percent change in TG levels from baseline to week 12, was met for the 4 gram per day VASCEPA dose group. The patient group assigned to 4 grams per day of VASCEPA showed a statistically significant median TG decrease of 19.9% (p1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%). * Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. * Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT VASCEPAPlaceboVASCEPA vs Placebo N = 4089 n (%)Incidence Rate (per 100 patient years)N = 4090 n (%)Incidence Rate (per 100 patient years)Hazard Ratio (95% CI) Primary composite endpoint Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)705 (17.2)4.3901 (22.0)5.70.75 (0.68, 0.83) Key secondary composite endpoint Cardiovascular death, myocardial infarction, stroke (3-point MACE)459 (11.2)2.7606 (14.8)3.70.74 (0.65, 0.83) Other secondary endpoints Fatal or non-fatal myocardial infarction250 (6.1)1.5355 (8.7)2.10.69 (0.58, 0.81) Emergent or urgent coronary revascularization216 (5.3)1.3321 (7.8)1.90.65 (0.55, 0.78) Cardiovascular death 174 (4.3)1.0213 (5.2)1.20.80 (0.66, 0.98) Hospitalization for unstable angina 108 (2.6)0.6157 (3.8)0.90.68 (0.53, 0.87) Fatal or non-fatal stroke98 (2.4)0.6134 (3.3)0.80.72 (0.55, 0.93)  Includes adjudicated cardiovascular deaths and deaths of undetermined causality.  Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential impact of VASCEPA in clinical use and expectations for regulatory filings and approval submissions. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and regulatory reviews. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.Availability of Other Information About Amarin Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.Amarin Contact Information Investor Inquiries: Investor Relations Amarin Corporation plc In U.S.: +1 (908) 719-1315 IR@amarincorp.com (investor inquiries)Solebury Trout email@example.comMedia Inquiries: Alina Kolomeyer Communications Amarin Corporation plc In U.S.: +1 (908) 892-2028 PR@amarincorp.com (media inquiries)________________________ 1 Bays HE, Ballantyne CM, Kastelein JJ et al. Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Patients with Very High Triglyceride Levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] Trial). Am J Cardiol. 2011;108:682-690.
GlobeNewswire · 11/19 23:30