AMARIN REPORTS Q2 2010 RESULTS
Dublin, Ireland and Mystic, CT, USA, August 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 2011and 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.
Conference Call and Webcast Information
Amarin will host a conference call today, August 10, 2010 at 4:00 pm UTC/GMT + 1 hour (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. For both dial in numbers please use account number is 286 and conference id 350729. 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 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. Patient enrolment and randomization in this trial has been completed at 229 patients, which the Company expects will be sufficient to demonstrate statistical significance in accordance with the trial protocol. The primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. 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 MARINE Study is Harold Bays, M.D., Medical Director Louisville Metabolic and Atherosclerosis Research Center, Kentucky.
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 the study. The primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. The Principal Investigator of the ANCHOR study is Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, Texas. No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.
In both the MARINE and ANCHOR 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 MARINE and ANCHOR 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 for AMR101 in 2012. The Company expects that its current financial resources are sufficient to finance its planned operations through the filing of this NDA for AMR101 seeking approval for the indication being studied in the MARINE trial while also seeking reference in the 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 has a cardiovascular Outcomes 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 Outcomes study, the Company will need to seek additional financing, through a commercial partner or otherwise, to finance the study. Importantly, the results of an Outcomes study are not required for FDA approval of this broader indication for AMR101. In addition, an outcome study is not required by the SPA covering the indication being studied in the MARINE trial.
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two 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 are conducted 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.
Investor Contact Information:
John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
Lee M. Stern
The Trout Group
In U.S. +1 (646) 378-2922
International Media Contact Information:
Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
This press release contains forward-looking statements, including statements about the timing of clinical trial recruitment, enrolment and randomization, the timing of announcement of results from these trials, the timing of filing an NDA for AMR101 and the potential indications and market opportunity for AMR101 if approved by the U.S. Food and Drug Administration. 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 the likely need for additional capital to fund future operations; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that historical enrolment and randomization rates may not be predictive of future results; uncertainties relating to the timing of data collection and analysis for the 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 most recent 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.