Published: 2010-04-01 11:37:02 CEST
Orion
Company Announcement
Orion comments on FDA release on Stalevo
Orion - Stock Exchange Release

ORION CORPORATION: Orion comments on FDA
release on Stalevo


ORION CORPORATION STOCK EXCHANGE RELEASE     1 April
2010      AT 12.38 EET


Orion comments on FDA release on Stalevo

Referring to
the release published by the US Food and Drug Administration (FDA)
on 31 March
2010 concerning the safety review of Orion's drug
Stalevo
(levodopa/carbidopa/entacapone) , Orion provides the following
comment:

As stated by the FDA in the release, a safety review of Stalevo is
ongoing due
to the STRIDE-PD study results. The release highlights that, at
this time, no
new conclusions or recommendations about the use of this drug
have been made.
According to FDA, patients should not stop taking their
medication unless
directed to do so by their healthcare professional.

The FDA
also states that its communication is in keeping with FDA's commitment
to
inform the public about its ongoing safety review of drugs and that the
agency
will update the public as soon as the review is complete.

Orion has informed
about the results of the STRIDE-PD study in a stock exchange
release on 24
February 2009. In the said release, the safety and tolerability
findings of the
study were provided as follows:

Safety and tolerability
The known
gastrointestinal disorders of nausea and diarrhea were more frequently
reported
with Stalevo. Preliminary results indicate that, although the frequency
of
ischemic heart disease events in STRIDE-PD was similar compared with
previous
entacapone studies as well as the incidence noted in a similarly-aged
general
population, less events of myocardial infarction were observed in
the
carbidopa/levodopa group. Overall, the occurrence of neoplasm was similar
in
both treatment groups, but there were less cases of prostate cancer and
more
cases of skin cancer in the carbidopa/levodopa group. These imbalances are
being
investigated, and discussion with the regulatory authorities is
ongoing.


At this stage, Orion has no further details to add to the already
published
information concerning Stalevo and the results of the STRIDE-PD
study. Orion has
no information of when the safety evaluation will be
completed.


Orion Corporation


Timo Lappalainen                   Olli
Huotari
President and CEO                 SVP, Corporate Functions


Contact
person:
President and CEO Timo Lappalainen, phone +358 10 426 3692, gsm +358
50 966 3692



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



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