Amarin will apply for approval of cholesterol drug candidate AMR101 earlier on strong Ph III results

US/Irish biopharmaceutical firm Amarin (Nasdaq: AMRN), yesterday reported positive, statistically significant top-line results from the MARINE study, its first Phase III clinical trial of lead fish oil-based drug candidate AMR101, causing its stock to rocket 62% to $5.75 in early trading on Monday.

The MARINE study, investigating AMR101 as a treatment for very high triglycerides (≥500 mg/dL), met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the firm's rights to this product through 2030.

Based on the timing and nature of these results, Amarin intends in 2011 to submit a New Drug Application to the US Food and Drug Administration seeking approval to market and sell AMR101. The firm’s previous guidance projected 2012 for the NDA submission. The company further added that, based on the positive results of the MARINE trial, Amarin has advanced additional patent claims to add to its growing portfolio of US and international intellectual property claims related to AMR101.