Amarin Announces Publication of Case Study Results Describing Reductions in Multiple Lipid Parameters for Individual Hyperlipidemic Patients Switched to Vascepa(R)

 BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- Amarin Corporation plc, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the publication of a retrospective analysis of patient cases that examined the effect on lipid parameters in hyperlipidemic patients who were switched from Lovaza® (omega-3-acid ethyl esters) capsules, a mixture of omega fatty acids, to Vascepa® (icosapent ethyl) capsules, the only pure-EPA prescription omega-3 product, to potentially achieve better outcomes in triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) levels.1 During the studied period, most of the 14 patients switched to Vascepa experienced reductions in levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C).

The publication, titled, "A Retrospective Case Series of the Lipid Effects of Switching from Omega-3 Fatty Acid Ethyl Esters to Icosapent Ethyl in Hyperlipidemic Patients," was authored by Richard S. Castaldo, MD, is now available electronically through Postgraduate Medicine (available at: https://postgradmed.org/doi/10.3810/pgm.2014.05.2775) and is scheduled for print publication in the May 2014 issue. Dr. Castaldo conducted a retrospective chart review at 4 medical practice locations in Western New York of 14 treated patients who were initially diagnosed with high TG levels, or hyperlipidemia, and whose lipid parameters were measured two or more months after being switched to 4 g/day EPA -only Vascepa from 4 g/day Lovaza. The patients ranged from 45 to 79 years of age and were on their same prescription lipid-lowering background medication at the same dose throughout the studied period, with 10 patients on a statin, and 4 patients on a cholesterol absorption inhibitor. After being switched from Lovaza to Vascepa, 12 patients experienced a decrease in TG and LDL-C levels and 13 patients experienced a decrease in TC and non-HDL-C levels. Changes in high-density lipoprotein cholesterol (HDL-C) levels were also assessed, but the results were mixed, with no change in 1 patient, decreases in 9 patients, and increases in 4 patients. Dr. Castaldo's chart review also found Vascepa to be well tolerated with a safety profile consistent with that referenced in the U.S. Food and Drug Administration (FDA) approved label for Vascepa.

"We have heard many anecdotal reports of the success physicians have had with Vascepa since its launch last year," said Steven B. Ketchum, Ph.D., President of Research and Development of Amarin. "The results published by Dr. Castaldo provide important hypothesis generating evidence of the potential benefit of treating patients with EPA-only Vascepa that requires additional study for substantiation. These real-world results are exciting and encouraging when considered alongside the findings of the pivotal Phase 3 studies conducted with Vascepa, which demonstrated that EPA-only Vascepa reduced TG levels without increasing levels of bad cholesterol, LDL-C, in patients with high and very high triglyceride levels."

Important information on related clinical trials and study result limitations

The results of Phase 3 studies of Vascepa, the MARINE and ANCHOR studies, were published online in the American Journal of Cardiology in June 2011 and July 2012, respectively, and are available electronically through PubMed (available at: http://www.ncbi.nlm.nih.gov/pubmed/21683321 for the MARINE clinical study and http://www.ncbi.nlm.nih.gov/pubmed/22819432 for the ANCHOR clinical study).

Vascepa® (icosapent ethyl) capsules, Lovaza® (omega-3-acid ethyl esters) capsules, Omtryg™ (omega-3-acid ethyl esters A) capsules, and Epanova® (omega-3-carboxylic acids) capsules are each FDA approved for the same indication, with each product having different labeled safety and efficacy information based on underlying clinical data sets that are publicly available in their respective FDA-approved labeling.¹ Vascepa, Lovaza, and Epanova are all approved by FDA for their specified use based on prospective blinded randomized studies compared to placebo. Omtryg was approved for its use by FDA based on a three-arm study that included Lovaza and placebo arms. The most recent FDA reviewed study results of Lovaza are included in the FDA-approved label for Omtryg.

FDA-reviewed and labeled clinical trial results of Lovaza, Omtryg, and Epanova, all of which are mixtures of multiple omega acids, including EPA, DHA and other components, reflect increases in LDL-C levels in studied populations. No prospective blinded randomized head-to-head studies have been conducted between Vascepa and any other product, and there can be no assurance that the results published in the above retrospective case study review could be repeated in other studies or that the results shown in the case study review could be obtained for patients switched to Vascepa from other TG-lowering therapies.

In addition to its currently approved indication, Vascepa is under various stages of development for potential use in indications that have not been approved by the FDA. Most patients with records reviewed in the published study were not in the patient population in which Vascepa is approved for use by the FDA. Amarin had no role in individual case study selection in the review, including the initial triglyceride levels of studied patients. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA or promoting the superiority of Vascepa to any other prescription product.

Amarin provided financial support for Dr. Castaldo's work on the case study review and the related publication.

About Vascepa ®  (icosapent ethyl) capsules

Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.

Indications and Usage
•Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
•The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information for Vascepa
•Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components and should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
•The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM

¹ Vascepa® is a registered trademark of the Amarin group of companies. Other trademarks used are not affiliated with Amarin. Lovaza® is a registered trademark of the GlaxoSmithKline group of companies. Omtryg™ is a trademark of Trygg Pharma AS. Epanova® is a registered trademark of the AstraZeneca group of companies. Full prescribing information for each product can be found through the FDA website at http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm.

Source: Amarin Corporation plc