Orion - Company Announcement

Dexmedetomidine Phase III program completed with positive results

ORION CORPORATION      STOCK EXCHANGE RELEASE  20 APRIL 2010  AT 8.30 AM EET



The initial results of the MIDEX and PRODEX studies conducted by Orion
Corporation with dexmedetomidine indicate that dexmedetomidine met its first
primary endpoint in providing similar sedation in intensive care compared to
midazolam and propofol, the standard ICU (intensive care unit) sedative agents,
in patients requiring light to moderate sedation for mechanical ventilation. The
second primary endpoint, time to the end of mechanical ventilation of the
patients was statistically significantly reduced by dexmedetomidine compared to
midazolam but did not reach statistical significance compared to propofol.
Safety findings were consistent with the known effects of dexmedetomidine and no
significant new safety concerns were detected. Based on the overall positive
results, Orion plans to apply for a European marketing authorisation for
dexmedetomidine. Orion currently estimates that the file could be submitted to
the EMA (European Medicines Agency) by the end of 2010.



Study setting and initial results

Orion Corporation has conducted a clinical Phase III research program in ten
European countries comprising altogether 1,000 patients to evaluate
dexmedetomidine for sedation of long-stay intensive care patients, with a
purpose to receive European regulatory approvals for dexmedetomidine.

The program consisted of two very similar Phase III double-blind, randomised
clinical studies, MIDEX and PRODEX, comparing dexmedetomidine with standard
sedative drugs. The effectiveness of sedation and the duration of mechanical
ventilation were measured as the two primary endpoints in both studies.  The
MIDEX study compared dexmedetomidine against midazolam. In PRODEX, the
comparator was propofol.  Five hundred medical and surgical ICU patients
requiring light to moderate sedation to tolerate mechanical ventilation to a
maximum of 14 days were included in each study with an expected treatment period
of at least 24 hours and with a maximum dexmedetomidine dose of 1.4 μg/kg/hour.
After treatment, the patients were followed up for up to 45 days.



The initial results of both MIDEX and PRODEX studies indicate that
dexmedetomidine met it's first primary endpoint in providing similar sedative
efficacy compared to both midazolam and propofol. The other co-primary endpoint,
i.e. the time to the end of mechanical ventilation of the patients, was
statistically significantly reduced compared with patients sedated with
midazolam but did not achieve statistical significance compared to propofol.
Safety findings were consistent with previous data and, overall, no significant
new safety concerns were identified following up to 14 days treatment with
dexmedetomidine. Further analysis of the results of the studies is ongoing.



Dexmedetomidine

Dexmedetomidine is a sedative agent originated by Orion's pharmaceutical R&D.
The product is available as Precedex in the USA since 2000 and Japan since
2004, where the distributor is Hospira under Orion's license.  Dexmedetomidine
is a relatively selective alpha(2)-agonist which acts on the central nervous
system to produce sedation.  It is the only alpha(2)-agonist approved in the US
for continuous IV sedation of initially intubated and mechanically ventilated
patients during treatment in an intensive care setting, at a maximum dose of
0.7 μg/kg/hour for up to 24 hours. In the US, dexmedetomidine is, since 2008,
also indicated for sedation of non-intubated patients prior to and/or during
surgical and other procedures, at a maximum dose of 1.0 μg/kg/hour.





Orion Corporation



Timo Lappalainen          Olli Huotari

President and CEO       SVP, Corporate Functions





Contact persons:

Starting from 1 pm EET: Professor Reijo Salonen, Senior Vice President,
Pharmaceutical R&D, phone +358 50 966 3647

Until 1 pm:  Jari Karlson, CFO, phone +358 10 426 2883 or gsm +358 50 966 2883





Publisher:

Orion Corporation

Communications

Orionintie 1A, FI-02200 Espoo

Homepage: www.orion.fi <http://www.orion.fi/>









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 and diagnostic
tests. Orion's pharmaceutical R&D focuses on the following core therapy areas:
central nervous system drugs, cancer and critical care drugs, and Easyhaler(®)
pulmonary drugs. The Group's net sales in 2009 amounted to EUR 772 million. The
Company invested EUR 95 million in research and development. At the end of
2009, the Group had a total of 3,100 employees, of whom 2,500 worked in Finland
and 600 in other European countries. Orion's A and B shares are listed on NASDAQ
OMX Helsinki.





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