Orion updates progress with Simdax (i.v. levosimendan):
Orion considers to carry part of the costs of a possible additional study
Orion Corporation and Abbott are continuing negotiations concerning a possible additional Phase 3 clinical study with intravenously administered levosimendan (Simdax), for which Abbott is the license holder under an agreement with Orion. The two companies are also discussing on the sharing of the costs of the possible study. Orion has announced that it considers to contribute by carrying a total of EUR 20 million of the costs during the study provided that the prerequisites for conducting the study are reasonable and acceptable on the basis of the upcoming consultation by Abbott and Orion with the FDA, tentatively agreed to start in March 2007.
Due to the many still open questions concerning the scope and timelines of the possible study, the timings of the study and possible payments as well as the impacts on Orion's cash flows can not be estimated at this stage. Orion emphasises that the realisation of the study and the agreement between Orion and Abbott on the study is uncertain.
Orion will inform about the solution of the matter as soon as it has been reached.
Discussions regarding further registration through the European mutual recognition procedure will be begun by Abbott in the third quarter of 2007.
Levosimendan is an Orion-originated compound for acute decompensated heart failure. Under a renewed licensing agreement concluded and communicated on 15 April 2004, Abbott took over the development programme of the intravenously administered formulation of the compound and received also extended marketing rights to the product (trade name Simdax). Levosimendan is already authorised in over 40 countries.
Jukka Viinanen Olli Huotari
President and CEO Senior Vice President, Corporate Functions
Jukka Viinanen, President and CEO, Orion Corporation, phone +358 10 426 3710
Orionintie 1A, 02200 Espoo