Amarin Commences First Clinical Trial In Cardiovascular Program
Amarin Corporation has commenced a phase I clinical safety and efficacy trial in volunteers. The trial will evaluate the co-administration of ultra-pure ethyl EPA and niacin on niacin induced flushing. Flushing is a common side effect of niacin treatment which significantly limits patient compliance.
Niacin is a treatment is used to increase High Density Lipoprotein (HDL) and modestly decrease triglyceride levels in dyslipidemia orcholesterol management. Ultra-pure ethyl EPA has been prescribed in Japan for over 15 years for the treatment of triglyceride lowering. Ultra-pure ethyl EPA is known to have several additional beneficial effects in cardiovascular disease.
Rick Stewart, Chief Executive Officer commented, "The initiation of this study is significant because it marks the commencement of Amarin's cardiovascular development program and potentially addresses a major medical need. Niacin is a valuable addition to the treatment of dyslipidemia but its principal drawback is flushing."
Mr. Stewart continued, "Amarin's cardiovascular program capitalizes on the known therapeutic benefits of ultra-pure EPA in cardiovascular disease and is a logical extension from Amarin's existing therapeutic base for ultra-pure EPA and its derivatives. By using ultra-pure EPA and niacin together, both HDL and triglycerides can be managed. We believe this combination can be a useful therapeutic proposition. We are fortunate to have the know-how, the intellectual property, the resources and the ability to draw on an extensive knowledge network in cardiovascular disease and look forward to continuing to report our progress with these exciting new programs."
Amarin intends to develop its dyslipidemia and metabolic syndrome cardiovascular development pipeline and will seek partners to further develop and commercialize if efficacy is proven.
Amarin's Cardiovascular Development Program
Amarin's cardiovascular development strategy is to capitalize on the known therapeutic benefits of unsaturated fatty acids in cardiovascular disease. Amarin plans to utilize its extensive know-how, intellectual property and experience in lipid science to develop a series of products targeting the vascular system.
Amarin intends to commence a series of clinical trials with AMR 101 (97% pure EPA) for the treatment of metabolic syndrome and dyslipidemia. AMR 101 is believed to impact on a number of biological factors all of which contribute to vascular remodelling where endothelial dysfunction exists. Endothelial dysfunction is a condition that underlies vascular disease. Patients with cardiovascular disease often suffer from multiple conditions. The most prevalent type is hypertension, or high blood pressure, with 85% of U.S. Coronary Heart Disease (CHD) patients suffering from this condition. Over 50% of U.S. CHD patients have concomitant dyslipidemia, including elevated blood cholesterol levels.
It is estimated that total U.S. pharmaceutical sales in the cardiovascular segment in 2006 were approximately $43.7 billion. The dyslipidemia market, excluding statins, was estimated at approximately $2.2 billion in 2006, representing a compound annual growth rate of 31% since 2002. The major driver of this growth is believed to be an overall broadening of dyslipidemia treatment beyond reduction in Low Density Lipoprotein (LDL) cholesterol.