Amarin also announced today that the United States Patent and Trademark Office (USPTO) has published notification of Reasons for Allowance for Amarin's U.S. Patent Application Serial Number 13/540,319 titled "Pharmaceutical Compositions Comprising EPA and a Cardiovascular Agent and Methods of Using the Same." Notification of Reasons for Allowance typically precedes a formal Notice of Allowance, which signifies that the USPTO has made a determination to grant a patent from an application. The claims in this application cover a method of treating mixed dyslipidemia, based on Amarin's ANCHOR trial, with a fixed-dose formulation of Vascepa and any statin.
"These claims from the ANCHOR fixed-dose formulation, along with other recently allowed and granted patents that cover a fixed dose combination product from the MARINE trial give Amarin a strong IP position for AMR-102," said Zakrzewski. Each such patent would have a term that expires no earlier than in 2030.
Amarin plans to continue its development of AMR-102, which could become the first combination omega-3/statin product in the lipid lowering market. Amarin intends to launch this first-of-its-kind combination product around the same time that generic rosuvastatin is expected to be available in the United States, subject to further positive clinical development and regulatory approval of AMR-102.
(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
Important Safety Information for Vascepa
- 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.
- 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
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
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This press release contains forward-looking statements, including statements about whether the subject patent applications would issue and adequately protect Vascepa and AMR-102 against competition, the expiration date of the pending patents, Amarin's intent to launch AMR-102, the timing of such launch, and the plan for further positive clinical development and regulatory approvals of Vascepa, AMR-102 and other combinations of Vascepa and other leading statins. 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 events that could interfere with the issuance of a patent, or once issued, the continued validity or enforceability of a patent; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing Vascepa without violating the intellectual property rights of others; uncertainties associated generally with research and development, clinical trials and related regulatory submissions and 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.