Amarin Announces Positive Results of Phase 1 Clinical Trial Measuring the Bioavailability of a Fixed-Dose Combination of Vascepa(R) and a Statin Compared to Concomitant Administration
June 21, 2013
AmaNew Patent Allowances From MARINE and ANCHOR Trials for Fixed-Dose Combination
BEDMINSTER, N.J., and DUBLIN, Ireland, June 21, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the results from a Phase 1 clinical trial that compared bioavailability of components from a fixed-dose combination of its flagship product, Vascepa® (icosapent ethyl), plus rosuvastatin, to concomitant administration of the two agents independently, and to rosuvastatin alone. "The encouraging results of this pharmacokinetic study represent a crucial step in the plan to solidify a fixed-dose formulation of Vascepa capsules with statins," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin.
In the multiple-dose study of 48 healthy volunteers, AMR-102 (the fixed-dose combination of icosapent ethyl and rosuvastatin, a leading statin) was assessed versus simultaneous administration of the individual agents, as well as versus rosuvastatin monotherapy, on pharmacokinetic measurements in order to show feasibility of the fixed-dose combination. The results proved promising, as there was no inhibition of either the rosuvastatin bioavailability, or of the bioavailability of the active metabolite EPA from Vascepa, observed with the fixed-dose combination product compared to the other arms of the trial.
The AMR-102 test formulation was well tolerated. No serious adverse events were reported in the Phase 1 trial, nor was there an increase in reported side effects with either the fixed-dose combination, or the arm given co-administration of the two agents, versus those who received rosuvastatin alone.
In the ANCHOR trial, Vascepa showed robust reductions in TGs and a broad range of other lipid parameters on top of optimized statin therapy, including atorvastatin, simvastatin, and rosuvastatin. Based on these encouraging efficacy results from ANCHOR, technical considerations, and market research, rosuvastatin was selected for this initial proof-of-principle pharmacokinetic study. The results of this Phase 1 study with rosuvastatin and Vascepa also bode well for the feasibility of applying this fixed-dose combination approach to a broader range of statins. 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.
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. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com. Forward-looking statements 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.
Vascepa has been approved for use by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa and AMR102 are under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as marketing the use of Vascepa or AMR 102 in any indication that has not been approved by the FDA.
CONTACT: Amarin contact information:
Joseph Bruno Investor Relations and Corporate Communications Amarin Corporation In U.S.: +1 (908) 719-1315 firstname.lastname@example.org