Orion withdraws EU application for extending the indication of Stalevo®



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.


Orion Corporation



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


Contact persons:
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)



About Orion
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/.


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