PRONOVA BIOPHARMA ASA 
By The First-in-Human clinical trial is a double-blind, placebo-controlled, single and multiple oral dose study to investigate the safety, tolerability and pharmacokinetics of PRC-4016. The study, conducted in healthy volunteers, will be performed in the UK. Results are expected in the first quarter of 2012.
PRC-4016 is the first of a number of new chemical entities to emerge from Pronova BioPharma's research into omega-3 fatty acid derivatives since the launch of the blockbuster drug Omacor®. The drug is a structurally modified omega-3 fatty acid, which has been shown to have potent triglyceride and bad (non-HDL) cholesterol lowering effects while raising good (HDL) cholesterol in pre-clinical studies.
The clinical profile targets both primary and secondary dyslipidemia associated with cardiovascular and metabolic disease, and in particular combined dyslipidemia characterised by elevated triglycerides, low good (HDL) cholesterol and elevated bad (non-HDL) cholesterol. Combined dyslipidemia has been shown to play an important role in the development of cardiovascular diseases. The prevalence of dyslipidemia across the seven largest pharmaceutical markets is estimated at approximately 270 million people with diagnosis rates of approximately 35-40 per cent.
Morten Jurs, CEO of Pronova BioPharma, commented, "This is an important milestone for Pronova BioPharma and for the development of our pipeline of omega-3-derived products. We believe PRC-4016 has an optimal profile to set new standards in the treatment of dyslipidemia, where there is a significant medical need for approaches capable of reducing triglycerides and non-HDL-C levels in the blood while raising levels of HDL-C. Current approaches do not achieve all of these goals and have a narrow therapeutic window as well as unwanted side effects."
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About Pronova BioPharma
Pronova BioPharma is a global leader in research, development and manufacture of lipid therapies derived from nature.
Omacor®, also known as Lovaza(TM) in the US market, and Zodin®, Seacor®, Esapent®, and Eskim® elsewhere, is the first commercialised product developed from Pronova BioPharma's active pharmaceutical ingredient (API).It is also the first and only EU and U.S. FDA-approved Omega 3-derived prescription drug. Pronova BioPharma estimates that 1.4 million cardiovascular patients, with elevated levels of triglycerides and/or having suffered a heart attack, are currently on a prescription for one of the branded products containing its API.Marketing and distribution of Pronova BioPharma's key product is currently licensed to both local and global pharmaceutical companies. In 2009, the product reached blockbuster status with sales over USD 1 billion in the current 8 major markets and in 2010 it grew a further 19 percent to USD 1 260 million, according to IMS Health. It is currently marketed in 56 countries with potential launch in a further 30 countries.Pronova BioPharma is developing several new patentable lipid derivatives. The most advanced Lipid Derived Pharmaceutical programme is in the area of dyslipidemia, the abnormal concentration of lipids and/or lipoproteins in the blood.Pronova BioPharma's headquarters are located at Lysaker (Oslo) in Norway, while production takes place in manufacturing facilities at Sandefjord in Norway and in Kalundborg, Denmark. The company's shares are listed on Oslo Børs with the ticker code PRON.For further information contactHamed Brodersen, VP Investor Relations and Communications
Tel: +47 40 46 81 10Gøran Gannedahl, VP Medical & Regulatory Affairs and Research & Development
Tel: +47 91 55 26 26This information is subject of the disclosure requirements acc.
