2009-07-31 13:30:11 CEST

2009-07-31 13:31:13 CEST


REGULATED INFORMATION

English
Orion - Company Announcement

Orion comments on ANDA filed by Sandoz Inc. for a generic version of Orion's proprietary drug Precedex® (dexmedetomidine hydrochloride 100 mcg base/ml ) in the United States



Orion Corporation Stock Exchange Release Jul 31st 2009 at  2.30 p.m.

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

Orion Corporation has been informed that an Abbreviated New Drug
Application (ANDA) has been filed by Sandoz Inc. with the U.S. Food
and Drug Administration (FDA) seeking authorisation to produce and
market generic versions of Precedex® (dexmedetomidine hydrochloride
100 mcg base/ml) in the United States.  Precedex®, originated by
Orion Corporation and marketed in the United States by Hospira, Inc,,
is approved for continuous IV sedation of initially intubated and
mechanically ventilated patients in the intensive care setting for up
to 24 hours and in non-intubated patients requiring sedation prior to
and/or during surgical and other procedures.

At this point, the ANDA review process is just beginning and the
realisation of generic competition is neither certain nor imminent.

Sandoz's ANDA for dexmedetomidine contains so-called Paragraph IV
certifications challenging Orion's U.S. Patent No.4,910,214 and
Orion's and Hospira's commonly owned patent U.S. Patent No.
6,716,867.  Both patents cover Precedex and are 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
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 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.


Orion Corporation

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


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



Statements in this news release other than historical information are
forward-looking statements 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
2008.



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