Orion Corporation has initiated the regulatory processes for seeking an expanded indication for Stalevo® (levodopa, carbidopa, entacapone) in the USA and Europe, based on the favourable results received from FIRST-STEP, a Phase III clinical study conducted in North America and Europe in patients with early Parkinson's Disease. The aim is to extend the indication of Stalevo to those early-stage patients whose Parkinson's Disease impairment requires the initiation of levodopa medication. Currently, Stalevo is indicated for patients with advanced Parkinson's Disease experiencing end-of-dose motor fluctuations, known as "wearing-off".
Orion Corporation will provide an update of the progress of the review process primarily in its quarterly financial reviews. The key results of the FIRST STEP study will be published today, 15 April 2008 at approximately 14:00 pm CET in a press release by Novartis, Orion's marketing partner for Stalevo and the sponsor of the study, in conjunction with a presentation at the Annual Meeting of the AAN (American Academy of Neurology) in Chicago. The press release will become available on the Novartis homepage www.novartis.com. Orion disclosed the positive primary endpoint in its stock exchange release on 24 January 2008.
Stalevo (levodopa/carbidopa/entacapone) is an enhanced levodopa therapy for the treatment of certain Parkinson's Disease patients experiencing wearing-off motor complications. Stalevo contains both a DDC inhibitor (carbidopa) and a COMT inhibitor (entacapone) that prevent the breakdown of levodopa and so provide a more continuous supply of levodopa to the brain. Stalevo provides enhanced symptom control throughout the day vs. levodopa/carbidopa. Stalevo, developed by Orion Corporation, is marketed by Novartis and Orion in their respective territories.
Orion Corporation is dedicated to treating and preventing disease by discovery and developing innovative medicinal treatments. In 2007, Orion Corporation generated sales of EUR 683.6 million, invested EUR 97.6 million in research and development and employed approximately 3,180 people. Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Dr. Aino Takala, VP, Strategic Planning and Innovation, phone +358 50 966 4503
Dr. Reijo Salonen, Senior VP, Pharmaceutical R&D, phone +358 50 966 3647. Dr. Salonen is in Chicago and can be accessed as of 15:00 pm EET, or 07:00 local time.
Orionintie 1A, FI-02200 Espoo