Trimetazidine

STOCKHOLM, Sweden, September 6 /PRNewswire/ -- - EMEA gives go-ahead for Coversyl(R) (perindopril) indication in stable CAD and marketing authorisation for Procoralan(R) (ivabradine), the first exclusive heart-rate reducing agent

Servier announced today at the European Society of Cardiology (ESC) two major advances that will potentially help millions of patients with coronary artery disease (CAD).

The ACE inhibitor Coversyl(R) (perindopril) received a positive opinion from the EMEA (European Medical Evaluation Agency) recommending the extension of its licence indication for the treatment of patients with stable coronary artery disease (CAD) to reduce the risk of cardiac events in patients with a history of MI and / or revascularisation. The FDA has now also approved a label extension for perindopril for a similar indication in the US(i). This new indication is in addition to Coversyl's well-established position as an effective antihypertensive agent.

Servier's pipeline drug Procoralan(R) (ivabradine), the first pure heart rate-lowering agent, also received an EMEA positive opinion for the treatment of chronic stable angina in patients with normal sinus rhythm who have a contraindication or intolerance to beta-blockers. Procoralan is the first selective and exclusive If inhibitor and provides an important new approach to the management of angina. Unlike beta-blockers, the most common treatment for angina, Procoralan exclusively reduces heart rate and is therefore associated with fewer unwanted effects.

Coversyl new indication

The EMEA gave the green light to approve the new indication for Coversyl based on the results of EUROPA (The European Trial on Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease), a landmark trial involving 12,218 patients with stable CAD and without heart failure which showed that Coversyl significantly cuts the risk of cardiovascular mortality and non-fatal MI by 20% compared to placebo (p=0.0003).1 In the EUROPA study, patient received 8 mg of Coversyl in addition to standard preventive therapy.

New EUROPA data

Further features of Coversyl's cardiovascular protective properties were confirmed by new data from EUROPA presented at this year's ESC meeting. In a subgroup of EUROPA patients (n=7,096) who had a precisely-measured left ventricular ejection fraction (mean LVEF=57%), Coversyl reduces the risk of CV death, non fatal MI and cardiac arrest by 16% (p<0,03). Additional analysis demonstrates that the beneficial effect of Coversyl 8 mg was independent of cardiovascular risk level, baseline blood pressure, concomitant treatments (betablockers, lipid lowering drugs) or history of previous revascularisation, reinforcing the specificity of EUROPA results in comparison with HOPE, ACTION and PEACE.2-4

"The results from the EUROPA trial have extremely important clinical implications and the new indication for Coversyl in CAD will help doctors improve prognosis in CAD patients, even in those with relatively low risk, beyond that achievable with existing standard therapy", points out Professor K Fox, M.D, Royal Brompton Hospital, London, UK and chairman of the EUROPA trial. "Perindopril therapy should be considered in addition to other preventive treatments, even in the absence of heart failure, marked reduction in LV function or risk factors for all CAD patients."

Procoralan: first in new class

Heart rate reduction has been a therapeutic goal in angina treatment for many years. However, existing treatments do not exclusively reduce heart rate and their use is often associated with unwanted pharmacological actions and poor tolerability. In contrast, Procoralan exclusively reduces heart rate by a specific action on the sino-atrial node.5 It does not interfere with the contractility of the heart, atrioventricular conduction and ventricular repolarisation.

The drug has been studied in more than 5,000 patients and the clinical findings show that Procoralan has both anti-anginal and anti-ischemic efficacy. Comparable efficacy has been established when compared to both beta-blockers and calcium channel blockers in two large, randomised, double-blind, controlled studies.6 Procoralan has demonstrated an excellent tolerability profile with a very low rate (1%) of withdrawals.7,8

"Heart rate reduction is widely recognised as an important approach for the prevention and treatment of angina, and pure heart rate reduction with ivabradine provides a promising new alternative to current treatment", says Professor Fox. "This novel new agent is effective and very well tolerated and is one of the most important advances in cardiovascular treatment over the last two decades."

Servier and cardiovascular medicine

Servier has a long-standing interest in the field of cardiovascular disease and is unique among global pharmaceutical companies in that all the cardiovascular products it has introduced have stemmed from its own research efforts.

Coversyl is the company's leading product and is available in 118 countries worldwide. Perindopril is marketed in 118 countries under the trade names COVERSYL(R), COVEREX(R), ACERTIL(R), PRESTARIUM(R), PREXANIL(R), PREXUM(R), COVERENE(R), COVERSUM(R), PROCAPTAN(R) and marketed by Solvay Pharmaceutical and CV Therapeutics under the trade name of ACEON(R) in the US.

Procoralan has received the EMEA go-ahead and should receive approval before the end of 2005. The clinical development programme for Procoralan is ongoing and the drug is being investigated for risk prevention in CAD and other indications.

Servier's cardiovascular profile also includes Vastarel MR(R) (trimetazidine) for stable angina, Hyperium(R) (rilmenidine), Natrilix(R) (indapamide) and Preterax(R) (perindopril / indapamide) for hypertension.

Note for editors:

(i) EMEA marketing authorisation for Coversyl new indication and Procoralan received on 31.7.05. US FDA new indication approval received on 23.8.05.

References

1) Fox KM; European trial on reduction of cardiac events with perindopril in stable coronary artery disease investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery diseased: randomized, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet 2003;362:782-8

2) Bertrand ME et al. Effects of Perindopril on long-term outcome of patients with coronary artery disease and preserved left ventricular function - the EUROPA study. Poster. ESC 2005

3) Deckers JW et al. Treatment benefit by perindopril in patients with stable coronary artery disease at different levels of risk. Abstract no. 3663, ESC 2005

4) Ceconi C et al. Effect of perindopril in patients with stable coronary disease: results on inflammatory and thrombosis markers of the pertinent study. Abstract no. 3665, ESC 2005

5) Bucchi A, Baruscotti M, DiFrancesco D. Current-dependent block of rabbit sino-atrial node If channels by ivabradine. J Gen Physiol 2002;120:1-13

8) Borer JS. Nature Clinical Practice. Cardiovascular Medicine. Vol 1#2, 2004.

CONTACT: For further information, please contact: Moira Gitsham, tel +33-5-46-00-08-20, mob: +33-6-20-74-01-92, moira.gitsham@toniclc.com Matthew Kent, tel +44-207-798-9900, mob: +44-789-987-6685, matthew.kent@toniclc.com

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