Orion's Simdax gets mixed EU opinion

Orion Pharma has received favorable mutual recognition decisions forits acute heart failure treatment, Simdax (levosimendan), which has been on the Swedish market since October last year, in eight European Union countries (Finland, Spain, Italy, Iceland, Greece, Luxemburg, Norway and Portugal). However, the firm has had to withdraw its application in seven European countries after failing to win recognition for Simdax in the Netherlands, Ireland, the UK, France, Germany, Denmark and Belgium. This means the company's sales from Simdax in the coming years will fall short of expectations, and the news led to a 12.4% fall in Orion's share price to 19.7 euros ($17.67). Jyrki Mattila, the company's president, said: "we will discuss with the authorities of the countries in question the further actions needed to obtain approvals."

Further applications for additional marketing authorizations have been and will be submitted in South America, Asia and Europe's non-EU area in 2001, and some marketing authorizations are expected within the next few months. Abbott Laboratories has exclusive marketing rights to Simdax, which is an intravenously-administered calcium sensitizer. The drug lowers the strain on the heart by dilating veins, arteries and coronary vessels, whilst increasing the pump function, without raising oxygen consumption or the risk of arrhythmias which are associated with other intravenous agents that treat this condition.