2008-11-03 07:30:19 CET

2008-11-03 07:30:59 CET


REGULATED INFORMATION

English
Orion - Company Announcement

Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® in the United States



Company states the realisation of generic competition is still
neither certain nor imminent

Orion Corporation has been informed that an Abbreviated New Drug
Application (ANDA) has been filed by Wockhardt Limited (Wockhardt)
with the U.S. Food and Drug Administration (FDA) seeking
authorisation to produce and market a generic version of Stalevo®
(specifically 12.5/200/50 mg strength of
carbidopa/entacapone/levodopa) in the United States. Stalevo is an
enhanced levodopa treatment originated by Orion Corporation and
marketed in the United States by its exclusive licensee, Novartis,
for the treatment of Parkinson's disease.  At this point, the ANDA
review process is just beginning and the realisation of generic
competition is neither certain nor imminent.
Orion previously sued Wockhardt for patent infringement when it
challenged certain Orion U.S. patents as part of an earlier filed
ANDA on a generic version of Orion's proprietary drug, Comtan®
(entacapone). That action is pending in the District Court for the
District of Delaware.  Wockhardt's ANDA for Stalevo contains
so-called Paragraph IV certifications challenging Orion U.S. patents
Nos. 5,135,950; 5,446,194; 6,500,867; and 6,797,732 covering Stalevo
and listed in the Orange Book, the FDA's official listing of approved
drug products.
Paragraph IV certifications are not uncommon in the U.S.  Orion is,
together with Novartis, currently evaluating its legal options to
protect its rights. Under the U.S. system, if a patent owner brings a
lawsuit against an ANDA applicant within a certain time limit, there
will be a 30-month stay of final FDA approval. During that time, the
FDA can give only a tentative approval to the ANDA applicant unless
the applicant obtains a favorable decision on all challenged patents
in the lawsuit.

ABOUT ORION
Orion is dedicated to treating and preventing disease by discovery
and developing innovative medicinal treatments. In 2007, Orion
generated net sales of EUR 683.6 million and invested EUR 98.5
million in research and development. The number of employees is
approximately 3,300. Orion corporate headquarters are in Espoo,
Finland.  For more information, please visit:
http://www.orion.fi/english/.

Orion Corporation


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


Contact persons:
Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426 3054




Statements in this news release other than historical information are
forward-looking statement subject to risks and uncertainties. Actual
results could differ materially depending on factors such as the
availability of resources, the timing and effects of regulatory
actions, the strength of competition, the outcome of litigation and
the effectiveness of patent protection. Additional information
regarding risks and uncertainties is set forth in Annual Report for
2006.




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