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Orion Pharma's heart failure drug Simdax to be approved in eight european countries

Orion Corporation Orion Pharma has received favourable mutual recognition decisions concerning heart failure medication Simdax (levosimendan) in eight European countries: Finland, Spain, Italy, Island, Greece, Luxemburg, Norway, and Portugal. Mutual recognition decisions precede the actual marketing authorisations, which are expected in the coming months. Orion sought mutual recognition of the previously given Swedish marketing authorisation in all EU countries, but during the mutual recognition procedure Orion withdrew its application in the Netherlands, Ireland, Great Britain, France, Germany, Denmark and Belgium. Indicated for the treatment of acute heart failure, intravenously administered, Orion Pharma's innovative product Simdax decreases the workload of the heart and increases the pumping force through a unique mechanism. The long-term prognosis of a patient receiving Simdax therapy is favourable.
After the marketing authorisations become effective, Orion Pharma will market Simdax in addition to Finland also in Sweden, Norway and Island and Orion Pharma's partner Abbott in Italy, Spain, Greece, Luxemburg, and Portugal. Applications for additional marketing authorisations have been and will be submitted in several countries in South America, Asia and Europe's non-EU area in 2001. Particularly because Germany, France and Great Britain will not in the near future be markets of Simdax, Orion Pharma's sales from Simdax in the coming years will considerably fall short from the expectations.
"Simdax is for over ten years the first approved medication for the therapy of severe heart failure and its unique mechanism of action represents a completely novel treatment approach in acute heart failure", Orion Pharma's President Jyrki Mattila says.
"We are pleased that after the coming registrations in many European countries the treatment of heart failure will take a big leap forward. Naturally we are, however, disappointed that we had to withdraw our application from certain big EU countries. We will discuss with the authorities of the countries in question the further actions needed to obtain approvals, Jyrki Mattila continues.
The patent protection for Simdax reaches over the next decade. The molecule patent on levosimendan is valid in Europe until year 2012 and in the US until 2013; and extensions are possible.
Simdax is a new medicine developed and patented 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, calcium sensitisers. The active substance, levosimendan increases the pump function of the heart without increasing the oxygen consumption or risk of arrhythmias. Levosimendan also dilates veins, arteries, and coronary vessels, thereby removing part of the workload of the heart and increasing the blood flow. In this way, levosimendan reduces stress on the heart and protects the cardiac tissue against further damage. The current intravenous agents used in treatment of acute heart failure, adrenergic beta agonists and phosphodiesterase inhibitors, improve the pumping force of the heart by bringing more calcium into the heart muscle cells. The use of these agents may be associated with arrhythmias, which are often fatal. Levosimendan does not increase the level of intracellular calcium at the therapeutic doses. In the clinical studies levosimendan treatment was not associated with increased risk of arrhytmias.
According to the approved summary of product characteristics, Simdax is indicated for short-term treatment of acutely decompensated severe chronic heart failure. It is to be used when conventional heart failure medications alone are not sufficient.
The results from studies on altogether 1,300 patients show that short-term, up to 24-hour Simdax therapy is effective and safe for patients with decompensated chronic heart failure who need hospital care. The study results on treatment of heart failure after acute myocardial infarction are also favourable. The beneficial effects of Simdax after short-term therapy are longterm and patient prognosis is improved. Simdax treatment increases the contractile force of the heart muscle without affecting the diastolic function. It increases cardiac output and reduces pulmonary capillary wedge pressure. The studies that compared Simdax to a placebo revealed that Simdax does not increase the risk of death of patients with decompensated heart failure. Many inotropic agents lack such proof.
Simdax is also well tolerated. The most common drug-related adverse events are headache and hypotension (both reported in 5% of patients treated with Simdax).
Orion Pharma will, after receiving the actual marketing authorisations in the coming weeks and months, launch Simdax in Finland, Norway and Iceland. In Italy, Spain, Greece, and Portugal, Abbott Laboratories, a US based healthcare company with strong global engagement in hospital products, has exclusive marketing rights for Simdax. The drug has been on the Swedish market since October 2000.
Orion Corporation
Jukka Viinanen
President and CEO
Pauli Torkko
Executive Vice President
Orion Corporation
Orionintie 1, 02200 Espoo, Finland
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