Naturally derived

Omacor/Lovaza is the first commercialised product containing Pronova BioPharma’s active pharmaceutical ingredient (API). It is also the first and only EU and FDA -approved omega-3 derived prescription drug.

Healthcare professionals are asked to find more information about our product on www.omacor.com.

Pharmaceutical products containing our API are approved in the USA and certain European and Asian markets, and are prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known as hypertriglyceridemia (HTG). Very high triglycerides have been linked to a number of cardiovascular diseases. Products containing Pronova BioPharma’s API have also been approved in certain European and Asian markets for the secondary prevention of post-myocardial infarction (post-MI) in the period following the initial survival of a heart attack.

Lifesaving effect

Our API has been demonstrated, in a number of clinical trials, to be a efficacious and safe triglyceride-lowering agent in monotherapy as an adjunct to diet, or Post MI, in addition to other standard therapy. The pharmaceutical product has also been documented to be highly complementary to other lipid-lowering agents, such as statins, and it can be used in concomitant treatment for HTG and mixed dyslipidemia. The API is manufactured through a documented, unique and complex process which results in a concentration of at least 90 per cent omega-3 ethyl esters derived from high-grade fish oil.

Omacor/Lovaza differs widely from non-prescription omega-3 dietary supplements. The ingredient is purified and higher in concentration compared to omega-3 dietary supplements. Omacor/Lovaza has documented effects in large, randomised clinical trials. The product is encapsulated and distributed through a strong and global network of sales and marketing partners.

New areas of application

Our ambition is to launch new areas of application for our API. This includes new products as well as new indications. Collaborative projects are ongoing to develop the use of our API as a monotherapy for indications such as atrial fibrillation, heart failure and as part of primary prevention of cardiovascular disease in partients with type II diabetes. New results from a large phase III study showed that Omacor/Lovaza reduces mortality and morbidity in patients with congestive heart failure (CHF). Combination therapy projects for HTG and mixed dyslipidemia as a fixed-dose formulation with simvastatin is planned to enter Phase III in 2008. Pronova BioPharma is also involved in a number of projects and preclinical studies for next generation omega-3 derived products.