Amarin (AMRN) Reports Encouraging Phase I Data of Vascepa + Rosuvastatin; Gets USPTO NoA

Amarin Corporation plc (Nasdaq: AMRN) announced 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.

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