31 August,
2008, Lysaker, Norway: 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]
Dr. Roberto Marchioli
from Laboratory of Clinical Epidemiology of Cardiovascular Disease, Consorzio Mario Negri Su will
present top-line data from the GISSI-HF study on
Monday 1 September at 15:00 CET. The presentation will be held at NH München Neue
Messe, Eggenfeldener Strasse 100, D-81929 Munich (Germany). The presentation
will also be webcast live over the internet and can be accessed at www.pronova.com.
The company will host a telephone conference call which will open up for
Q&A on the scientific findings of the data immediately after the
presentation.
To participate, please dial:
Norway Toll Free: 800 19640
UK Toll Free: 0800 028 1299
UK Toll/International Dial In: +44
(0) 20 7806 1968
USA Toll Free: 1888 935 4577
The following conference ID is
required: 4403377
For further information, please contact:
|
Hilde
Steineger, Head of IR
|
+47
48 00 42 40
|
|
Tomas
Settevik, CEO
|
+47
22 53 48 61
|
|
Jonathan
Birt, Financial Dynamics
|
+44 751 559
7858
|
To download high resolution
images please see www.pronova.com/media.
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.
For further information please visit www.gissi.org.