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
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) capsulesVascepa® (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.
- 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).
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