Advertisement
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.
Advertisement
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."
Conference Call and Webcast Information
Amarin will host a conference call today, May 13, 2010 at 3:00 pm GMT (11:00 am Eastern Time). To participate in the call, please dial (201) 689-8565 from outside the U.S. and (877) 407-0778 within the U.S. The conference call can also be heard live via the investor relations section of the Company's website at www.amarincorp.com.
A replay of the call will be available via the Company's website.
About AMR101 Phase 3 Clinical Trials
The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy. Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders). The trial aims to recruit approximately 650 patients into clinical sites in the United States. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. The Company also seeks to demonstrate that AMR101 does not result in a statistically significant increase in LDL (low density lipoprotein) cholesterol compared to statins alone. The Principal Investigator of the MARINE Study is Harold Bays, M.D., Medical Director Louisville Metabolic and Atherosclerosis Research Center, Kentucky. No prescription omega-3 based drug is currently approved in the U.S. for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.
The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dL. Patients in this trial are characterized as having very high triglyceride levels. The trial aims to recruit approximately 240 patients from clinical sites in multiple countries, including Finland, India, The Netherlands, Russia, South Africa and the United States. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period. Results from the extension period are not required for regulatory approval. The Principal Investigator of the ANCHOR study is Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, Texas.
In both the ANCHOR and MARINE trials, all patients undergo a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization, prior to randomization into the 12-week double-blind treatment period. Both the ANCHOR and MARINE trials received Special Protocol Assessment (SPA) agreements in 2009 from the U.S. Food and Drug Administration (FDA).
The Company expects to file an NDA in 2012. The Company expects that its current financial resources are sufficient to finance its planned operations through the filing of an NDA for AMR101 seeking approval for the indication being studied in the MARINE trial with reference in label to treatment of high triglyceride levels in statin-treated patients who have mixed dyslipidemia as studied in the ANCHOR trial. The Company expects that its current financial resources are sufficient to cover planned operations through the filing of an NDA for this indication.
In order to potentially obtain a broader indication for AMR101 based on the ANCHOR trial results, the Company's SPA for the ANCHOR trial requires that the Company have an outcome study substantially underway at the time of the NDA filing. If the Company elects to seek this separate indication in its initial NDA filing and commence an outcome study, the Company will need to seek additional financing, through a commercial partner or otherwise, to finance the study. The results of an outcome study are not required for FDA approval of the broader indication and an outcome study is not required for the indication being studied in the MARINE trial.
About Amarin
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (ethyl icosapentate), which has commenced patient enrollment in two pivotal Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials were designed under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.
Disclosure Notice
This press release contains forward-looking statements, including statements about the timing of clinical trial recruitment, enrollment, wash-out and randomization, the timing of announcement of results from these trials and the timing of filing an NDA for AMR101 and the indication for such NDA filing, and statements regarding the safety, efficacy and indication of AMR101 if approved by the U.S. Food and Drug Administration, statements about clinician expectations and statements about the adequacy of capital resources. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and existing capital obligations; uncertainties associated generally with research and development, clinical trials and related regulatory approvals, in particular uncertainties regarding recruitment, enrolment, wash-out and randomization rates for the Company's ANCHOR and MARINE trials; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and other matters can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
-- 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
SOURCE Amarin Corporation plc
