Amarin Announces Completion of Dosing in a Fixed-Dose Combination Study With Vascepa(R) and a Leading Statin
BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has completed dosing and pharmacokinetic sampling in a study to test a fixed-dose combination of Vascepa® (icosapent ethyl) capsules and a leading statin. The clinical name for this combination product is AMR102. Prior to commencement of the study, Amarin opened an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration which
became effective after the standard 30-day review.
The purpose of this AMR102 study is to determine the bioavailability of the EPA (eicosapentaenoic acid) and statin components when taken as a fixed-dose combination product, relative to the individual reference agents taken concomitantly. Statin bioavailability from both the fixed-dose and concomitant regimens will also be compared with that from the reference statin taken alone in healthy subjects. Additionally, pharmacokinetic data from this study will be examined to explore relationships between in vitro dissolution data and in vivo pharmacokinetic data. The study is designed as a randomized, open-label, multiple dose, parallel-group study in 48 healthy subjects conducted at a single site in the United States.
"This study is aimed at expanding the potential commercial application of Vascepa by leveraging the clinical successes of the MARINE and ANCHOR trials, namely effective triglyceride lowering without increasing LDL-C," stated Joseph Zakrzewski, Amarin's Chairman and Chief Executive Officer. "Amarin's goal is to identify ways for patients to simplify their lipid management by developing a single therapy that offers the powerful triglyceride lowering effects of Vascepa combined with one of the most prescribed statin products."
Amarin looks forward to analyzing the results from this study and expects to communicate such results in the first half of 2013.
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. For more information about Vascepa visit www.amarincorp.com. For more information about Amarin visit www.amarincorp.com.
The Amarin Corporation plc logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13817
This press release contains forward-looking statements, including statements about the potential efficacy, safety and therapeutic benefits of Amarin's product candidates, clinical trial results, the expecting timing for the release of clinical results, the clinical importance and impact of Vascepa on cardiovascular health, Amarin's plan to expand the commercial potential of Vascepa, and the status of potential future products. 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 related 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.
Amarin's product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials. Nothing in this press release should be construed as promoting the use of such product candidates.
CONTACT: Amarin Contact Information:
Stephen D. Schultz
Senior Director, Investor Relations
and Corporate Communications
In U.S.: +1 (860) 572-4979 x292
Source: Amarin Corporation plc
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