Amarin provides progress update on MARINE and ANCHOR trials for treating elevated triglyceride levels

Aug 10 2010

Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reports a financial update as of June 30, 2010.  In addition, the Company provides a progress update of its MARINE and ANCHOR trials, the two on-going Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.  

• MARINE trial patient randomization completed with top-line results expected in early 2011
• ANCHOR trial patient randomization now >50% complete with top line results expected in  2011
• Financial resources sufficient to complete both Phase 3 clinical trials and submit an NDA for AMR101

Q2 Financial Update

Amarin's cash balance as of June 30, 2010 was approximately $37.6 million.  The Company expects that its current financial resources are sufficient to cover planned operations through completion of the ongoing ANCHOR and MARINE Phase 3 clinical trials, the reporting of results from these trials and, assuming clinical trial success, the submission of an NDA.  

During the three months ended June 30, 2010, net cash outflows were approximately $6.8 million, including approximately $5.3 million paid in connection with the Company's two Phase 3 clinical trials.

The Company's cash outflows during the quarter were partially offset by approximately $1.5 million in net proceeds received from the exercise of warrants. The warrants were exercised by three investors.  The warrant exercises, at exercise prices from $1.00 to $1.50 per share, resulted in the issuance of 1,044,937 new shares during the quarter ended June 30, 2010.  

Clinical Trial Update

Around the beginning of 2010, Amarin initiated two Phase 3 clinical trials (MARINE and ANCHOR) to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations. As separately reported, patient enrollment and randomization to dosing (2 grams, 4 grams and placebo) has been completed in the MARINE trial.  Amarin expects to report preliminary top-line results from the MARINE trial early in 2011, towards the early part of the range of guidance provided previously.

As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial have been enrolled and randomized to dosing.  Consistent with previous guidance, the Company anticipates completing enrollment and randomization of ANCHOR in 2011 and also anticipates reporting top-line results from the ANCHOR trial in 2011.  

"We are excited to be within approximately six months of being able to review and report the results of the MARINE study.  The progress that we have made in both pivotal trials is very encouraging. Being positioned to report results in 2011 for these trials is earlier than we initially expected. This acceleration is a tribute to the commitment, experience and enthusiasm of our employees, clinical investigators and CRO," commented Dr. Declan Doogan, Interim Chief Executive Officer of Amarin Corporation.