Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported selected financial results for the fiscal quarter ended March 31, 2010 and provided a progress update of the Company's ANCHOR and MARINE trials, the two pivotal Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.
- Progress in pivotal trials ahead of previously disclosed schedule: expect to report top line results in 2011, ahead of prior guidance of 2012
- Financial resources sufficient to cover planned operations through to filing of an NDA
Q1 Financial Update
Amarin's cash balance as of March 31, 2010 was approximately $44 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 filing of an NDA.
During the three months ended March 31, 2010, net cash outflows were approximately $8 million, including approximately $5 million paid in connection with the ramp-up and support of the Company's two Phase 3 clinical trials, including the commencement of enrollment for these trials which occurred near the start of 2010, as well as for support of general operations. First quarter net cash outflows also included approximately $3 million in payments associated with scaling-down Amarin's operations in Europe, which action is consistent with the previously announced decision to consolidate Amarin's R&D headquarters in the United States, and payment of U.K. stamp tax and registration costs associated with the financing completed in 2009.
Amarin Corporation plc is currently a foreign private issuer for U.S. Securities and Exchange Commission (SEC) reporting purposes. In accordance with SEC rules applicable to foreign private issuers, Amarin currently reports its financial results in accordance with International Financial Reporting Standards ("IFRS") and is not required to file a quarterly report with the SEC on Form 10-Q. However, during fiscal 2010 the Company plans to transition to U.S. generally accepted accounting principles (U.S. GAAP) and in so doing provide more extensive financial reporting in future periods.
Clinical Trial Update
Near the start of 2010, Amarin initiated two pivotal Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations (the ANCHOR and MARINE trials). Both trials have progressed well since then and the Company now expects to complete enrollment of these trials in 2011. As a result of this progress, Amarin expects to report preliminary top-line results of these trials in 2011, ahead of previously stated guidance of preliminary results reported in 2012.
As of the date of this release, nearly all of the targeted clinical sites for the ANCHOR trial (80 clinical sites, all in the U.S.) have been activated and over 150 of the 650 patients targeted for the trial have been randomized into the study. Additionally, over 75% of the targeted clinical sites for the MARINE trial (approximately 50 clinical sites located in India, Finland, The Netherlands, Russia, South Africa and the U.S.) have been activated and over 100 of the 240 patients targeted for the trial have been randomized into the study.
"We are very pleased with the progress being made in these two pivotal trials. We believe AMR101 has the potential to be a best-in-class prescription omega-3 drug for treating patients with very high triglycerides or high triglycerides with mixed dyslipidemia," commented Dr. Declan Doogan, Interim Chief Executive Officer of Amarin Corporation. "Elevated triglycerides are increasingly being recognized as an important independent risk factor for cardiovascular disease. We are encouraged by the progress we are making and by the enthusiasm for these trials from the investigators. We believe this reflects a growing interest in the active management of elevated triglyceride levels and the expectation that AMR101 possesses an appropriate benefit-risk profile. Amarin is focused on completing patient enrollment into these trials as quickly as possible."
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