Findings in the OMEGA study presented

 

Data from the OMEGA trial were presented at the American College of Cardiolgy Annual Meeting, 30 March 2009. The trial included 3851 patients with a recent myocardial infarction (MI) in an acute treatment setting (3-14 days) and was substantially underpowered due to a lower than expected mortality rate.

 

The OMEGA trial was designed to investigate the effects of acute treatment with Zodin® (Omacor®) (1g/day), in 3851 patients with a recent MI on Sudden Cardiac Death (SCD) in a one year follow up, randomized, double-blind, placebo controlled trial. Zodin® is believed to exert anti-arrhythmic effects. The OMEGA trial was conducted to further elucidate this mechanism of action. Patients were randomized 3-14 days after the MI and received optimal concurrent medical treatment. The primary endpoint of the study was the rate of SCD within 12 months. The sample size in OMEGA was pre-specified, and all patients were followed for a fixed time period of 12 months.

 

The results showed that there were 28 (1.5 per cent) cases of SCD in the Zodin® group and 29 (1.5 per cent) cases of SCD in the placebo group. The difference between the two groups was not statistically significant (p = 0.84). None of the secondary endpoints were significantly different between the two treatment groups.

 

The sample size in OMEGA was pre-specified. The mortality rate was however much lower than expected, resulting in the statistical power of the study being dramatically reduced. The rate of total death in the OMEGA patient population was as low as 4.2 per cent, and the rate of SCD as low as 1.5 per cent, approximately only 57 per cent of what was postulated when the study was designed. This study is registered with ClinicalTrials.gov, number NCT00251134.

 

Dr. Göran Gannedahl, vice president medical and regulatory affairs and R&D commented:

"OMEGA was designed to investigate the short term effect of Zodin® in an acute setting. The hypothesis of Zodin's anti-arrhythmic properties remains as one of the important explanatory mechanisms for the reductions in cardiovascular deaths associated with Zodin® treatment."

 

Zodin®, the only EU- and FDA-approved omega-3 derived prescription drug has been shown to be an efficacious and safe drug for the reduction of mortality and morbidity.  Zodin® is approved and prescribed both as an adjunct to diet for the treatment of elevated levels of triglycerides, hypertriglyceridemia (very high triglycerides have been linked to a number of cardiovascular diseases) and for MI patients within three months post-MI.

 

 

 

-- Ends --

 

Dr. Jochen Senges from Herzzentrum, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany presented top-line data from the OMEGA study on 30th March 2009 at the American College of Cardiology, Orlando, Florida (US).

 

 

Pronova BioPharma is a global leader in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products.  Pronova BioPharma's first commercialized product is branded as Omacor® in a number of countries throughout Europe and Asia and as LovazaTM in the United States.  The product is manufactured at the Company's plant in Sandefjord, Norway using a unique and complex process.  An additional manufacturing plant is under construction in Kalundborg, Denmark and is expected to be operational in first quarter 2010.

 

Omacor/Lovaza is the first and only EU- and FDA-approved omega-3 derived prescription drug.  The drug is prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known as hypertriglyceridemia (HTG), a form of dyslipidemia (or disorder of lipid metabolism).  Very high triglycerides have been linked to a number of cardiovascular diseases.  Omacor is also approved in key European and certain Asian markets for the secondary prevention of post-myocardial infarction, or Post-MI, the period following the initial survival of a heart attack.

 

Omacor/Lovaza has been demonstrated in a number of clinical trials to be a potent triglyceride-lowering agent as a monotherapy.  It has been documented to be efficacious, safe, and highly complementary to other lipid-lowering agents, such as statins. In addition, Pronova BioPharma is involved in various projects to develop Omacor/Lovaza in a number of cardiovascular indications, including as a combination therapy with statins for mixed dyslipidemia which management believe represents a major market opportunity for the Company.

 

Pronova BioPharma's global network of license and distribution partners includes: GlaxoSmithKline PLC (US), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others).  The combined sales force from this network focused on the sale of Omacor/Lovaza is approximately 2,650 sales representatives.

 

Omacor/Lovaza was launched in 2005 in the US and in major European markets, such as France and Spain. IMS Health reports that global end-user sales of the product have increased from US$144 million in 2005 to US$778 million in 2008.  The current annual run rate for end-user sales is estimated at US$953 million (as of December 2008), and the Company estimates that approximately 750,000 patients are currently on a prescription for Omacor/Lovaza.

 

Pronova BioPharma had revenues of NOK 1,302 million and EBITDA of NOK 603 million in 2008. The company is listed at Oslo Børs.