Orion - Company announcement
ORION WITHDRAWS THE EU APPLICATION FOR EXTENDING THE INDICATION OF STALEVO®. 6 MARCH 2009
ORION CORPORATION STOCK EXCHANGE RELEASE 6 March 2009 AT 14.00 pm
Orion withdraws EU application for extending the indication of Stalevo®
With this release, Orion Corporation updates information provided earlier in the stock exchange release of 24 February 2009 on the regulatory implications of the results of STRIDE-PD, a clinical study aimed to provide support for extending the current EU indication of Orion's proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to early Parkinson's disease. Orion has decided to withdraw its EU application for extending the indication. This withdrawal is based upon the Rapporteurs' assessment indicating that the data provided to date were insufficient to support approval of this indication and the company is unable to provide additional clinical data to the EMEA within the given timeframe.
Stalevo is currently indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor (DDCI) treatment. Applications for extending the indication of Stalevo to patients requiring initiation of levodopa therapy have been under review by the EMEA and the FDA since April 2008 based on the favourable results from FIRST-STEP, a study conducted in North America and Europe by Novartis, Orion's marketing partner for the product. The FDA has requested additional data in order to complete its review.
Timo Lappalainen Olli Huotari
President and CEO Senior Vice President, Corporate Functions
Dr. Reijo Salonen, SVP, Pharmaceutical R&D, phone +358 50 966 3647 (as of 16.00 pm EET)
Anne Allo, VP, Communications, phone +358 10 426 3735 (until 16.00 pm EET)
Orion is a European pharmaceuticals and diagnostics company dedicated to treating and preventing disease by discovering and developing innovative medicinal treatments and diagnostic tests for global markets. Orion is engaged in human and veterinary drugs, active pharmaceutical ingredients and diagnostic tests. In 2008, Orion's net sales were € 710.7 million. Operating profit was € 184 million, and the company invested € 99 million in pharmaceutical research and development. The number of employees is about 3,100. Orion corporate headquarters are in Espoo, Finland. Orion is listed on NASDAQ OMX Helsinki. For more information, please visit: http://www.orion.fi/english/.
Orionintie 1A, FI-02200 Espoo