Orion withdraws US application for extending the indication of
Stalevo®
(Thomson Reuters ONE) - Orion - Company announcementORION WITHDRAWS THE US APPLICATION FOR EXTENDING THE INDICATION OFSTALEVO®. 21 OCT 2009ORION CORPORATION STOCK EXCHANGE RELEASE 21 October2009 AT 05.15 pm EETOrion withdraws US application for extending the indication ofStalevo®Orion Corporation has withdrawn the US application for extending thecurrent US indication of its proprietary drug Stalevo® (levodopa,carbidopa and entacapone) to patients with early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 fromclinical studies with Stalevo, i.e. FIRST-STEP and STRIDE-PD, whichindicate that Stalevo does not provide a consistent risk/benefitprofile for the early Parkinson's disease patient population at thedosing regimen tested. In early March 2009, Orion withdrew thecorresponding EU application.In the USA, Stalevo is currently indicated to treat patients withidiopathic Parkinson's disease to substitute for immediate-releasecarbidopa/levodopa and entacapone previously administered asindividual products and to replace immediate-releasecarbidopa/levodopa when certain patients experience the signs andsymptoms of end-of-dose "wearing-off".Previous stock exchange releases dealing with the above-mentionedstudies and related actions have been published by Orion on 24January 2008, 15 April 2008, 24 February 2009 and 6 March 2009. Thesereleases are available on the Orion's homepage, addresshttp://www.orion.fi/en/News-and-media/Stock-exchange-releases/Archive/Orion CorporationTimo Lappalainen Olli HuotariPresident and CEO Senior Vice President, CorporateFunctionsContact person:Professor Reijo Salonen, SVP, Pharmaceutical R&D, phone +358 50 9663647About OrionOrion is an innovative European, R&D-based, pharmaceutical anddiagnostic company with a special emphasis on developing medicinaltreatments and diagnostic tests for global markets. Orion develops,manufactures and markets human and veterinary pharmaceuticals, activepharmaceutical ingredients as well as diagnostic tests. Orion'spharmaceutical R&D focuses on developing medicines for the centralnervous system diseases, critical care and oncology as well asinhaled products for the Easyhaler® platform.The Group's net sales in 2008 amounted to EUR 711 million and thecompany invested EUR 90.0 million in research and development. At theend of 2008, the Group had a total of 3,300 employees, of whom 2,700worked 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/.Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoowww.orion.fiThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 21.10.2009 - 16:15 Uhr
Sprache: Deutsch
News-ID 7205
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