Orion - Company announcement
ORION WITHDRAWS THE US APPLICATION FOR EXTENDING THE INDICATION OF STALEVO®. 21 OCT 2009
ORION CORPORATION STOCK EXCHANGE RELEASE 21 October 2009 AT 05.15 pm EET
Orion withdraws US application for extending the indication of Stalevo®
Orion Corporation has withdrawn the US application for extending the current US indication of its proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to patients with early Parkinson's disease. The withdrawal is based upon Orion's assessment of findings from clinical studies with Stalevo, i.e. FIRST-STEP and STRIDE-PD, which indicate that Stalevo does not provide a consistent risk/benefit profile for the early Parkinson's disease patient population at the dosing regimen tested. In early March 2009, Orion withdrew the corresponding EU application.
In the USA, Stalevo is currently indicated to treat patients with idiopathic Parkinson's disease to substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual products and to replace immediate-release carbidopa/levodopa when certain patients experience the signs and symptoms of end-of-dose "wearing-off".
Previous stock exchange releases dealing with the above-mentioned studies and related actions have been published by Orion on 24 January 2008, 15 April 2008, 24 February 2009 and 6 March 2009. These releases are available on the Orion's homepage, address http://www.orion.fi/en/News-and-media/Stock-exchange-releases/Archive/
Timo Lappalainen Olli Huotari
President and CEO Senior Vice President, Corporate Functions
Professor Reijo Salonen, SVP, Pharmaceutical R&D, phone +358 50 966 3647
Orion is an innovative European, R&D-based, pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients as well as diagnostic tests. Orion's pharmaceutical R&D focuses on developing medicines for the central nervous system diseases, critical care and oncology as well as inhaled products for the Easyhaler® platform.
The Group's net sales in 2008 amounted to EUR 711 million and the company invested EUR 90.0 million in research and development. At the end of 2008, the Group had a total of 3,300 employees, of whom 2,700 worked in Finland and the rest 600 in other European countries. Orion's Shares A and B are both listed on the NASDAQ OMX Helsinki. For more information, please visit: http://www.orion.fi/english/.
Orionintie 1A, FI-02200 Espoo