Amarin Successfully Completes All Remaining Clinical Studies for AMR101 NDA
MYSTIC, Conn. and DUBLIN, Ireland, Aug. 1, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, announced today the successful completion of all remaining studies required for the Company's planned new drug application (NDA) for AMR101 for the treatment of patients with very high triglycerides (≥500 mg/dl). Completion of these studies is a key step in the Company's plans to submit an NDA for AMR101 by the end of September.
The Company previously announced that it achieved all primary endpoints in its two pivotal Phase 3 clinical trials, both of which have SPA agreements with the FDA (MARINE and ANCHOR), and completed all pre-clinical studies. The Company has now successfully completed all clinical pharmacology studies needed to characterize AMR101. Furthermore, the Company believes that it has met all of the requirements for the submission of a complete package of studies for the NDA for the treatment of patients with very high triglyceride levels. All findings from these clinical pharmacology studies were consistent with the Company's expectations with no AMR101-related inhibition in metabolism of the drugs studied. These results reinforce the Company's perspective from its Phase 3 clinical trials that the overall safety profile of AMR101 is comparable to placebo.
"The completion of these final studies clears the way for our NDA submission by the end of next month," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The Amarin team is now focused on completing the final work for the AMR101 NDA package, and we are looking forward to moving into the regulatory review process."
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (≥500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 intentionally excludes DHA, which is
believed to result in increases in LDL-C. AMR101 demonstrated a safety profile comparable to placebo in two complete Phase 3 clinical trials.
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 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010, and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>200 and <500mg/dL] with mixed dyslipidemia), as reported on April 18, 2011. Both the MARINE and ANCHOR trials were 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.
This press release contains forward-looking statements, including statements about the timing of NDA submission, the results of clinical and non-clinical studies and the efficacy, safety, benefits and potential market positioning of AMR101. 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, non-clinical studies, clinical trials and related regulatory approvals; the risk that SPAs are not a guarantee that FDA will accept an NDA or approve a product candidate upon submission; uncertainties regarding regulatory approval
generally and the requirements for approval; 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 10-K and its most recent Quarterly Report on Form 10-Q. 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 information contained in this press release is for investor communication purposes and not for promotion of the use
of AMR101 which product candidate is not approved for marketing or sale. 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.
CONTACT: Investor Contact Information:
Stephen D. Schultz
Investor Relations and Corporate Communications
In U.S.: +1 (860) 572-4979 x292
Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
Media Contact Information:
David Schull or Martina Schwarzkopf, Ph.D.
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile)
Source: Amarin Corporation plc
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