BEDMINSTER, NJ AND DUBLIN, IRELAND–(Marketwired – June 06, 2016) – Amarin Corporation plc (NASDAQ: AMRN) today announced that brand-new data related to Vascepa® (icosapent ethyl) will certainly be presented at the upcoming American Diabetes Association (ADA) 76th Scientific Sessions in brand-new Orleans (June 10-14) and published as an abstract in the Diabetes® Abstract Book.
The poster presentation is a post-hoc analysis of Type 2 diabetes patients from Amarin’s ANCHOR trial who, despite statin therapy, have actually persistent higher triglyceride levels. The 12-week ANCHOR trial studied the effects of Vascepa in adult patients at higher risk for cardio ailment along with persistent higher triglyceride levels (≥200 mg/dL and <500 mg/dL) after constant statin therapy.
Presentation short article is as follows:
- Poster Presentation #173-P, Category 12-E Clinical Therapeutics/brand-new Technology-Oral Agents: Effects ofIcosapent Ethyl on Lipoprotein Particle Concentration and Size in Statin-Treated Patients along with Persistent higher Triglycerides: ANCHOR Patients along with Diabetes Mellitus — (Authors: Eliot A. Brinton, MD, FAHA, FNLA, Christie M. Ballantyne, MD, Harold E. Bays, MD, et al.)
- The poster will certainly be on display from Saturday, June 11 starting at 10 a.m. CDT to Monday, June 13 at 2 p.m. CDT, along with the author presentation scheduled for Sunday, June 12, between 12:00 – 2:00 p.m. CDT.
Additional data that was accepted by the ADA Scientific Sessions Preparation Committee and will certainly be published in the Diabetes® Abstract Routine is titled: “Eicosapentaenoic Acid, yet not others TG-lowering Agents, Reversed Hyperglycemia-Induced Rat Endothelial Cell Dysfunction and Enhanced the Rewards of Atorvastatin Energetic Metabolite Ex Vivo” (Authors: R. Preston Mason, PhD, Robert F. Jacob, PhD, Hazem Dawoud, MS, Haidar Alhumaid, MS, et al.). This was an ex vivo experiment looking at the effects of eicosapentaenoic acid ± atorvastatin Energetic metabolite (ATM) relative to niacin or fenofibrate in glomerular endothelial cells from rats exposed to higher glucose.
About VASCEPA® (icosapent ethyl) capsules
VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid typically known as EPA in ethyl-ester form. Vascepa is not fish oil, yet is derived from fish through a stringent and complex FDA-regulated manufacturing process created to effectively get rid of impurities and isolate and protect the single molecule Energetic ingredient. Vascepa is known in scientific literature as AMR101.
FDA-approved Indication and Usage
- VASCEPA (icosapent ethyl) is indicated as an adjunct to diet plan to reduce triglyceride (TG) levels in adult patients along with major (≥500 mg/dL) hypertriglyceridemia.
- The effect of VASCEPA on the risk for pancreatitis and cardio mortality and morbidity in patients along with major hypertriglyceridemia has actually not been determined.
Important Safety short article for VASCEPA
- VASCEPA is contraindicated in patients along with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any sort of of its components.
- Use along with caution in patients along with known hypersensitivity to fish and/or shellfish.
- The the majority of common reported side reaction (incidence >2% and better compared to placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported side reaction >3% and better compared to placebo.
- Patients receiving treatment with VASCEPA and others drugs affecting coagulation (e.g., anti-platelet agents) must be monitored periodically.
- In patients along with hepatic impairment, monitor ALT and AST levels periodically throughout therapy.
- Patients must be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
- Adverse events and product complaints might be reported by calling
1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING short article can easily BE Located AT WWW.VASCEPA.COM.
Vascepa has actually been approved for Usage by the United States Meals and Drug Administration (FDA) as an adjunct to diet plan to reduce triglyceride levels in adult patients along with major (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of improvement for potential Usage in others indications that have actually not been approved by the FDA. Nil in this press release must be construed as promoting the Usage of Vascepa in any sort of indication that has actually not been approved by the FDA.
About Amarin
Amarin Corporation plc is a biopharmaceutical firm focused on the commercialization and improvement of therapeutics to enhance cardio health. Amarin’s product improvement routine leverages its extensive experience in lipid science and the potential therapeutic Rewards of polyunsaturated fatty acids. Amarin’s clinical routine entails a commitment to the ongoing REDUCE-IT cardio outcomes study. Vascepa® (icosapent ethyl), Amarin’s first FDA-approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For much more short article Regarding Vascepa, visit www.vascepa.com. For much more short article about Amarin, visit www.amarincorp.com.
Forward-looking statements
This press release contains forward-looking statements, including statements Regarding the potential efficacy and therapeutic Rewards of Vascepa and EPA, including implications Regarding the potential clinical importance of the findings presented. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could create actual outcomes to differ materially from those described or projected herein consist of uncertainties associated generally along with research on biomarkers believed to be relevant in the treatment of cardio disease, research and improvement and clinical trial risk generally, including the risk that study outcomes might not be predictive of future outcomes and that studied parameters might not have actually clinically meaningful effect. A further list and description of these risks, uncertainties and others risks associated along with an investment in Amarin can easily be Located in Amarin’s filings along with the U.S. Securities and Exchange Commission, including its the majority of recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to position undue reliance on these forward-looking statements, which speak just as of the date hereof. Amarin undertakes no obligation to update or revise the short article contained in this press release, whether as a result of brand-new information, future events or circumstances or otherwise.
Availability of others short article about Amarin
Investors and others must note that we communicate along with our investors and the public using our firm website (www.amarincorp.com), our investor relations website (http://ift.tt/WSMd0q), including yet not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The short article that we write-up on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the short article that we write-up on these channels, including our investor relations website, on a routine basis. This list of channels might be updated every now and then on our investor relations website and might consist of social media channels. The materials of our website or these channels, or any sort of others website that might be accessed from our website or these channels, shall not be deemed incorporated by reference in any sort of filing under the Securities Act of 1933.
