Skip to content

Orion launching proprietary medicine again: Simdax (Levosimendan) approved in Sweden for severe heart failure

Through its unique mechanism of action, calcium sensitisation, the drug revitalises the failing heart by decreasing the workload of the heart while improving the pump function, providing a favourable long-term prognosis.

Swedish authorisation to serve as a reference for additional EU approvals

Orion Pharma is launching Simdax in Sweden within the next two weeks. Additional marketing authorisations within the EU will be applied for through the mutual recognition procedure, the Swedish approval serving as a reference.
Orion Pharma estimates Simdax to be authorised in most EU countries in the course of next year. Registration applications will also be submitted in many countries outside the EU already during 2001.

"Simdax is already the seventh innovative proprietary product among Orion Pharma's drug discoveries. Considering its favourable therapeutic profile, Simdax could become one of the leading products for Orion Pharma, along with the Parkinsonian drug entacapone", estimates Jyrki Mattila, President of Orion Pharma. "The unique mechanism of action represents a novel treatment approach in acute heart failure", Jyrki Mattila says.

The patent protection for Simdax reaches far over the decade. The basic patent is valid until 2012 in Europe and 2013 in the USA, and extensions are possible.

Innovative mechanism for action provides new hope

Simdax is a new medicinal product developed by Orion Pharma for patients with severe heart failure who require intravenous treatment to support the function of the heart. It belongs to a new category of drugs, so-called calcium sensitisers. The active substance, levosimendan sensitises the heart muscle filaments to calcium. Thereby the force of the heart is increased without increasing the oxygen consumption or risk of arrhythmias, i.e. severe disturbances of heart rhythm.

Levosimendan also dilates veins, arteries, and coronary vessels, thereby taking away part of the workload of the heart and also increasing the blood flow. In this way, levosimendan reduces stress on the heart and protects the cardiac tissue against further damage.

Current agents, adrenergic beta agonists and phosphodiesterase inhibitors, used for short-term intravenous treatment of acute decompensated heart failure improve the heart's pumping force by increasing the intracellular calcium levels in the heart muscle. The use of these agents may be associated with often fatal arrhythmias. Levosimendan does not increase intracellular calcium levels at therapeutic doses. In the clinical studies levosimendan treatment was not associated with increased risks of these serious adverse events.

Effective and well tolerated

According to the product characteristics approved by Sweden, Simdax is indicated for the treatment of heart failure with poor tissue perfusion. It is to be used as an add-on therapy when conventional medication alone is not sufficient.

The research and clinical data from altogether 1,300 patients shows that Simdax is an effective and safe agent in the up to 24-hour short-term treatment of hospitalised patients with worsening of chronic heart failure and patients with a new onset of heart failure after acute myocardial infarction.
Simdax has been shown to improve patient outcomes in several ways during follow-up periods of up to 6 months. Its beneficial effects are sustained far beyond the short treatment, and the prognosis of the patient is improved. It increases the contractile force of the heart muscle without affecting the diastolic function adversely. It has a favourable effect on the cardiac output and pulmonary capillary wedge pressure. Moreover, it has been shown not to increase the risk of death in patients with decompensated heart failure compared to placebo, in contrast to many inotropic agents.

Simdax is also well tolerated. The most common drug-related adverse events are headache and hypotension (both 5%).

To be marketed by Orion Pharma and Abbott

Orion Pharma will market Simdax in Germany, France, the United Kingdom and Ireland, Sweden, Denmark, Finland, Norway, Iceland, Hungary, Russia, and the Ukraine. In other countries, marketing rights are exclusive to Abbott Laboratories, a US based healthcare company with strong global engagement in hospital products. Also Precedex (dexmedetomidine), a sedative for patients in intensive care discovered by Orion Pharma has been licensed to Abbott. Precedex was launched in the USA half a year ago.

For the U.S. registration of Simdax, an additional comparative clinical Phase 3 trial is being designed.

Orion Corporation

Jukka Viinanen
President and CEO

Pauli Torkko
Executive Vice President

Background information

Heart failure, a disease that kills

Heart failure refers to the impairment of the haemodynamic and neurohormonal mechanism of the human body to compensate disorders in the blood and fluid circulation and to maintain the necessary balance in the circulation.
"Decompensated" is the severest form of heart failure, reflected as excessive fluid build-up in the lungs and the veins leading to the heart. The patient is exhausted and short of breath, the legs are swollen and the patient is incapable of physical activity. This form of heart failure is a serious, life-threatening condition in which the patient has a high risk of death, therefore requiring urgent emergency care. The prognosis is poor. About 60% of the patients die within 3 years of the first acute incidence.

Episodes of severe cardiac impairment are common among patients with advanced heart disease and among those who have suffered a recent heart attack.
More than 1.6 million individuals worldwide, many of them elderly, are hospitalised each year with a primary diagnosis of decompensated heart failure. For all age groups, the incidence is higher in men than in women. The incidence increases with age. The prevalence in the population aged 65 and older is steadily increasing, at an annual rate of about 2%.
In the five largest European markets (France, Germany, Italy, Spain and the UK) the number of annually treated acute decompensated heart failure events is in the region of 750,000. In the USA, the corresponding figure is around 900,000.
About 18-20% of patients suffering from the severest forms of heart failure survive for 5 years. About 10-20% of patients with decompensated heart failure die during hospital treatment.

Simdax has been studied in more than 1,300 patients

Simdax has been evaluated on the basis of studies in more than 1,300 patients. Four major clinical trials have been conducted:
- a placebo-controlled dose-finding trial involving 151 patients with stable heart failure
- a dose-titration trial in 146 hospitalised patients with decompensated heart failure symptoms
- a comparison with dobutamine in 203 patients with severe heart failure
- a placebo-controlled trial in 504 patients hospitalised with decompensated heart failure following an acute myocardial infarction.
Contact person:
Jyrki Mattila, President, Orion Corporation, Orion Pharma,
phone +358 9 429 3003
Orion Corporation
Orionintie 1, 02200 Espoo, Finland

Corporate communications and investor relations:
Anne Allo, Senior Manager
Phone +358 9 429 3735
Fax  +358 9 429 2801
Home page: