Pronova BioPharma ASA Announces Significant Clinical Data presented at ESC: OMACOR Reduces Mortality and Hospitalisations in Patients with Congestive Heart Failure

Lysaker, Norway, August 31, 2008- Pronova BioPharma ASA (OSE: PRON.OL) ("Pronova BioPharma" or the "company") announces that the Phase III outcome trial GISSI-Heart Failure demonstrated that Omacor® reduced mortality and morbidity in patients with congestive heart failure (CHF).Both primary endpoints were met in the 7000 patient trial.  The results were presented today at the European Society of Cardiology (ESC) Hot Line session in Munich, Germany. The findings were also published in The Lancet.  
 
The GISSI-HF trial was designed and conducted by the Gruppo Italiano Studio Sopravvivenza Insufficienzia Cardiaca (GISSI) in Italy to investigate the clinical effects of a pharmaceutical prescription omega-3 product (marketed as Omacor®, LovazaTM, Seacor®, Esapent® and Eskim®, the only EU- and FDA-approved omega-3 derived prescription drug), in approximately 7000 patients with a clinical diagnosis of heart failure. The co-primary endpoints of the study were i) reduction of all-cause mortality, ii) reduction of all-cause mortality or hospitalisations for cardiovascular reasons, and both primary endpoints were met.
 
The study showed that the long-term administration of 1g per day of Omacor was effective and safe in reducing both all-cause mortality and hospitalisations for cardiovascular reasons compared to placebo.
955 (27 per cent) patients died from any cause in the n-3 PUFA (Omacor) group and 1014 (29 per cent) in the placebo group (relative risk reduction 9 per cent, p=0.041). 1981 (57 per cent) patients in the n-3 PUFA group and 2053 (59 per cent) in the placebo group died or were admitted to hospital for cardiovascular reasons (relative risk reduction 8 per cent, p=0.009). In absolute terms, 56 patients needed to be treated for 3.9 years to avoid one death or 44 patients in the same period of time to avoid one event like death or admission to hospital for cardiovascular reasons. In a per-protocol analysis performed in about 5000 full complier patients, the relative risk of death was reduced by 14 per cent (p 0.004). References: ESC presenter report at www.escardio.org and the scientific publication at www.lancet.com.
 
 "We have shown that n-3 PUFA treatment is effective and safe in a large population of patients with heart failure of any cause, who are receiving standard clinical care provided in hospitals and ambulatory facilities in Italy. Since we invited all cardiology centres operating in Italy to participate in the trial, and most did so, the results indicate what is likely to happen in the real world during the course of several years of polypharmacy care," the authors of the paper noted.
 
Omacor 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 post-myocardial infarction patients, where it has been demonstrated as an efficacious and safe drug for the reduction of mortality and morbidity. 
 
Tomas Settevik, Chief Executive Officer of Pronova BioPharma, commented:
"These latest findings represent an important step forward in the treatment of patients suffering from heart failure. With two million new cases of CHF diagnosed each year worldwide, the incidence of heart failure is increasing and it is the most rapidly growing cardiovascular disorder in the US. These results underline the potential of Omacor in the treatment of life-threatening cardiovascular diseases."
 
CHF is a condition in which the heart's function as a pump to deliver oxygen-rich blood to the body is inadequate to meet the body's requirements.  Approximately 1-2  per cent of the population suffer from CHF and it is estimated that more than 18 million patients have CHF in the US, UK, Germany, Spain, France, Italy and Japan.  50 per cent of all treated patients die within five years.[1]

About Congestive Heart Failure
 
Congestive heart failure (CHF) is a condition in which the heart's function as a pump to deliver oxygen rich blood to the body is inadequate to meet the body's needs.  Congestive heart failure can be caused by diseases that weaken the heart muscle, diseases that cause stiffening of the heart muscles or diseases that increase oxygen demand by the body tissue beyond the capability of the heart to deliver.
 
The current management of CHF consists of a standard regime of usually three or four drugs including ACE-inhibitors (Angiotensin II receptor blockers), Beta-adrenoreceptor blocking drugs (beta blockers), diuretics and aldosterone antagonists.  While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, very little controlled data are available concerning the role of dietary and metabolic approaches in the management/outcome of patients with heart failure.
 
About GISSI-HF Trial
 
The GISSI-HF trial was a large scale Phase III outcome trial, to investigate the effects of n-3 polyunsaturated fatty acids (n-3 PUFA) and rosuvastatin in patients with a clinical diagnosis of heart failure.  The study began in September 2002 and was designed to investigate the effect of Seacor (the brand name used to market Pronova BioPharma's Active Pharmaceutical Ingredient in Italy) and rosuvastatin on cardiovascular mortality and morbidity in patients with congestive heart failure. 
 
The study was a randomized, double-blind, placebo-controlled trial in 326 cardiology and 31 internal medicine centres in Italy.  It enrolled patients with chronic heart failure of New York Heart Association class II-IV, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to n-3 PUFA 1 g daily (n=3494) or placebo (n=3481) by a concealed, computerized telephone randomization system.  Patients were followed up for a median of 3.9 years (IQR 3.0-4.5).  Primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons.  Analysis was by intention to treat.  This study is registered with ClinicalTrials.gov, number NCT00336336.
 
About GISSI
 
In the 20 years since their beginning, the GISSI studies have obtained wide recognition in the international world of cardiology and are considered a methodological landmark.  The Gruppo Italiano Studio Sopravvivenza Insufficienzia Cardiaca (GISSI) is a collaboration between the  Mario Negri Institute, Consortio Mario Negri Sud and the Associazione Nazionale dei Medici Cardiologi Ospedalieri (ANMCO), is considered to be one of the most highly respected research teams in the cardiovascular field.  The GISSI has produced a series of large-scale clinical trials (GISSI 1, GISSI 2, GISSI 3, GISSI Prevention), that have involved more than 60.000 patients with myocardial infarction (AMI).
 
The GISSI Prevention trial in patients with a previous AMI assessed the effectiveness of a therapy with n-3 PUFA, vitamin E and a statin showing a reduction of mortality of 20 per cent in patients treated with n-3 PUFA.  In the last 20 years the in-hospital mortality due to AMI has been reduced for approximately the 30 per cent.
 

Posted: September 2008

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