2008-01-02 07:45:20 CET

2008-01-02 07:45:38 CET


REGULATED INFORMATION

English
Orion - Company Announcement

Orion comments on new challenge by Sun Pharmaceutical Industries Ltd., India, of Orion's U.S. Patent No. 5,446,194 covering its proprietary drug Stalevo® in the United States


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

Orion Corporation has been informed that Sun Pharmaceutical
Industries Ltd., India (Sun), has amended its Abbreviated New Drug
Application (ANDA) with the U.S. Food and Drug Administration (FDA)
seeking authorisation to produce and market generic versions of
Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of
carbidopa/levodopa/entacapone) in the United States. Sun's amendment
to its ANDA involves a Paragraph IV challenge to Orion's U.S. Patent
No. 5,446,194.  The ANDA review process has recently just begun and
the realisation of generic competition is neither certain nor
imminent. 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.
Sun previously filed Paragraph IV certifications against Orion's U.S.
Patents 6,500,867 and 6,797,732, and Orion subsequently sued Sun
(November 2007) in the United States for patent infringement. Of the
six Orion patents listed in the FDA's Orange Book, three have not
received Paragraph IV certifications from Sun (U.S. Patent Nos.
4,963,590, 5,112,861, and 5,135,950), and the latest of these expires
31 October 2010.
Paragraph IV certifications are not uncommon in the USA.  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 2006, Orion
generated sales of EUR 641.1 million, invested EUR 84.1 million in
research and development and employed approximately 3,060 people
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:
Timo Lappalainen, President and CEO, phone +358 10 426 2138
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