The application file will be resubmitted after the currently ongoing clinical studies with Simdax have been completed and the promising preliminary results confirmed.
In the first quarter of 2003 Orion Pharma received the first pilot results of Phase 3 study with Simdax (levosimendan) for the treatment of acute heart failure being carried out in the USA. Due to the encouraging pilot results BfArM agreed to review them. After the careful evaluation of these pilot results, BfArM, however, decided to wait for the final results of the US study.
Orion Pharma is conducting a large Phase 3 clinical study programme with levosimendan in the USA and Europe with an aim to seek marketing approval for Simdax in the USA and in those EU countries which have not yet approved the product. The results of the programme are estimated to be available in the summer of 2005. Simdax is already authorised for use in over 30 countries.
Orion Corporation
Jukka Viinanen Risto Miettunen
President and CEO Executive Vice President
President and CEO Executive Vice President
Contact persons:
Jukka Viinanen, President and CEO, Orion Group, phone +358 10 429 3710
Risto Miettunen, President, Orion Pharma, phone +358 10 429 4299
Publisher:
Orion Corporation
Corporate Administration
Orionintie 1, 02200 Espoo
Homepage: www.orion.fi
Heikki Vuonamo, Corporate VP, Communications
Phone +358 10 429 4967
Distribution:
Helsinki Exchanges
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Helsinki Exchanges
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