Stock Exchange Release, 26 January 2006 at 08.30 am
In accordance with the information received by Orion Corporation from Abbott Laboratories, the license holder of levosimendan (Simdax), the situation of the progress by Abbott with intravenous levosimendan is updated as follows:
Abbott is currently discussing revisions to the summary of the product characteristics, SPC, with the Swedish Medical Products Agency, Läkemedelsverket, to reflect data from recent studies. Sweden is the reference member state in the mutual recognition procedure (MRP), the new drug approval procedure applied to Simdax in the EU.
Additionally, Abbott is meeting with the regulatory authorities of other European countries, such as France, Germany and the UK, where Simdax is not approved, to discuss the process for regulatory authorisation.
Additionally, Abbott is meeting with the regulatory authorities of other European countries, such as France, Germany and the UK, where Simdax is not approved, to discuss the process for regulatory authorisation.
For the U.S. regulatory approval process, Abbott is finalising the data analysis, continuing discussions with the FDA, and is exploring options for next steps in the U.S.
Levosimendan (Simdax) is Orion's proprietary compound for the treatment of acute decompensated heart failure. Under a renewed licensing agreement concluded in April 2004, Abbott took over the large-scale Phase III clinical trials with the intravenously administered formulation of the compound. Abbott also received extended marketing rights to the product. The agreement was announced by Orion in a stock exchange release of 15 April 2004. Considerable milestone payments included in the agreement are subject to the granting of marketing approvals in certain countries. A US new drug approval will trigger a USD 42 million milestone payment to Orion. If a marketing authorisation is granted by both Germany and France, Orion will receive a milestone payment of USD 28 million. Orion emphasises that considerable risks are related to pharmaceutical research and that many uncertainties are included in the regulatory approval processes. Accordingly, it is not certain that the milestone payments will be realised.
The drug has already marketing authorisations in over 40 countries. A major new Phase III programme was conducted in 2003-2005 for further approvals in major markets like the USA, France, Germany, and the UK. The results of the REVIVE II and SURVIVE clinical studies were reported by Abbott at the AHA Scientific Seminars 2005 in mid November 2005, and they were communicated by Orion in the stock exchange releases of 14 and 16 November 2005.
Orion Corporation
Jukka Viinanen
President and CEO
Olli Huotari
General Counsel
Contact persons:
Jukka Viinanen, President and CEO, Orion Corporation, phone +358 10 429 3710
Anne Allo, VP, Investor Relations, phone +358 10 429 3735, gsm +358 50 429 3735
Distribution:
Helsinki Exchanges
Media
Publisher:
Orion Corporation
Corporate Administration
Orionintie 1A, 02200 Espoo
Homepage: www.orion.fi