2009-10-21 16:15:13 CEST

2009-10-21 16:16:16 CEST


REGULATED INFORMATION

English
Orion - Company Announcement

Orion withdraws US application for extending the indication of Stalevo®



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Orion Corporation has withdrawn the US application for extending the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/


Orion Corporation



Timo Lappalainen                  Olli Huotari
President and CEO               Senior Vice President, Corporate
Functions


Contact person:
Professor Reijo Salonen, SVP, Pharmaceutical R&D, phone +358 50 966
3647



About Orion
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/.


Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo
www.orion.fi