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Amarin Announces Publication of Case Study Results Describing Reductions in Multiple Lipid Parameters for Individual Hyperlipidemic Patients Switched to Vascepa(R)
|By Marketwired .
|June 11, 2014 07:00 AM EDT
BEDMINSTER, NJ and DUBLIN, IRELAND--(Marketwired - June 11, 2014) - Amarin Corporation plc (NASDAQ: AMRN), 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
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra-pure omega-3 fatty acid product comprising not less than 96% EPA and is available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
This press release contains forward-looking statements, including statements about the potential efficacy, safety and therapeutic benefits of Amarin's product candidates, Amarin's clinical trial results, including statements about the clinical importance of certain parameters and the impact and potential impact of Vascepa on such parameters. 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 uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, including the risk that historical clinical trial results may not be predictive of future results if replicated in larger patient populations and that studied lipid parameters may not have clinically meaningful effect or support regulatory approvals. 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.
Availability of other information about Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), 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 we post 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 information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
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.
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