Orion Corporation Stock Exchange Release
6 February 2007 at 12.20
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 Orions 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.
Simdax (levosimendan)
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.
Orion Corporation
Jukka Viinanen Olli Huotari
President and CEO Senior Vice President, Corporate Functions
Contact person:
Jukka Viinanen, President and CEO, Orion Corporation, phone +358 10
426 3710
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Homepage: www.orion.fi