Orion is in negotiations about the extra study with the drug's license holder Abbott. Simdax is an is an Orion-originated compound which it licnesed to Abbott in 2004.
Orion and Abbott are discussing the sharing of the costs of the study. Orion has said it could contribute a total of E20 million of the costs, provided that the prerequisites for conducting the study are reasonable and acceptable on the basis of a consultation by with the FDA. The consultation has been tentatively agreed to start in March 2007.
Orion said that due to many open questions about the possible study it could not estimate the impact on its cash flow at this stage.
Discussions regarding further registration through the European mutual recognition procedure will be begun by Abbott in the third quarter of 2007, Orion said.