Orion - Company Announcement

Orion: Primary objective of STRIDE-PD study was not achieved

The result of the primary endpoint measured in STRIDE-PD, a clinical
study with Orion's proprietary drug Stalevo® (levodopa, carbidopa and
entacapone) in 747 patients with early Parkinson's disease (PD)
requiring levodopa treatment, demonstrates that Stalevo does not
delay the onset of involuntary movements, dyskinesia. The study was
aimed to provide support for extending the current EU indication to
early Parkinson's disease.

Stalevo is currently indicated for the treatment of adult patients
with Parkinson's disease and end-of-dose motor fluctuations not
stabilised on levodopa/dopa decarboxylase inhibitor (DDCI) treatment.
Applications for extending the indication of Stalevo to patients
requiring initiation of levodopa therapy are already under review by
the European Medicines Agency (EMEA) and the U.S. Food and Drug
Administration (FDA), based on the favourable results from
FIRST-STEP, a study conducted in North America and Europe by
Novartis, Orion's marketing partner for the product. Procedures have
been initiated with the health authorities to evaluate the
implications of the results received from STRIDE-PD on the ongoing
review processes.

STRIDE-PD study
The aim of the STRIDE-PD study (STalevo Reduction In Dyskinesia
Evaluation) was to evaluate, whether Stalevo (combination formulation
of levodopa/carbidopa/entacapone in one tablet), when used as initial
levodopa therapy for Parkinson's disease, would be able to delay the
time to the onset of involuntary movements (dyskinesia), when
compared with a standard formulation of levodopa/carbidopa. The
primary endpoint was the time to onset of dyskinesia.
STRIDE-PD was a multicenter, double-blind, randomized, flexible-dose
(200 to 1000 mg of levodopa) study with a variable treatment duration
of 134 to 208 weeks. The target daily dose was 400 mg levodopa given
as carbidopa/levodopa or Stalevo divided in four doses per day given
at 3.5-hour intervals. The study was performed from 2004 to 2008 in
collaboration with Novartis, Orion's marketing partner. A total of
747 patients were randomized at 77 centers (57 for Novartis, 20 for
Orion) in 14 countries in Europe and North America. The study
population consisted of early-stage Parkinson's disease patients who
required initiation of levodopa therapy. Other permitted concomitant
anti-parkinsonian medication included dopamine agonists, monoamine
oxidase type B inhibitors, and anticholinergics.

Primary and secondary efficacy endpoints
The objective of the STRIDE-PD study was to demonstrate, that Stalevo
given four times daily at 3.5 hours intervals delays the time to
development of dyskinesia in comparison to a standard formulation of
carbidopa/levodopa in Parkinson's disease (PD) patients warranting
initiation of levodopa treatment. The results of the study showed,
however, that the time to dyskinesia was statistically significantly
shorter in Stalevo-treated patients compared to
carbidopa/levodopa-treated patients.
The incidence of dyskinesia during the study period was higher in
Stalevo-treated patients in comparison to the carbidopa/levodopa
group. Wearing-off was reported more frequently in
carbidopa/levodopa-treated patients vs. Stalevo-treated patients.
Patients treated with Stalevo had slightly better PD symptom control
in comparison to carbidopa/levodopa-treated patients during the whole
study period.

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.


Orion Corporation


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



Contact person:
Dr. Reijo Salonen, SVP, Pharmaceutical R&D, phone +358 10 426 3647




Useful additional information

About Stalevo
Stalevo is a proprietary treatment for Parkinson's disease originated
and manufactured by Orion Corporation. It was approved in the US and
EU in 2003 for the treatment of adult patients with Parkinson's
disease and end-of-dose motor fluctuations not stabilized on
levodopa/dopa decarboxylase (DDC) inhibitor treatment. Stalevo
contains both a DDC inhibitor (carbidopa) and a COMT inhibitor
(entacapone) that prevent the breakdown of levodopa and so provide a
more continuous supply of levodopa to the brain. Stalevo tablets are
available in six different strengths, each with a 1:4 ratio of
carbidopa to levodopa and combined with 200 mg of entacapone in a
standard-release formulation. The product is now available in about
80 countries worldwide including all EU countries and the USA. Since
the launch, the cumulative exposure to Stalevo is more than 715,000
patient years.

The most common side effects of Stalevo are unwanted or
uncontrollable movements (known as dyskinesia), nausea, diarrhea,
excessive muscle movements (known as hyperkinesia), harmless
discoloration of urine, sweat and/or saliva; diminished or slow
movements (known as hypokinesia), abdominal pain, dizziness,
constipation, fatigue, pain, and hallucinations.

About Parkinson's disease
Parkinson's disease is a progressive disorder of the central nervous
system that affects over six million people worldwide including 1.5
million in the US alone. While their cause is unknown, the symptoms
of Parkinson's disease may include tremor, slowness of movement,
stiffness and rigidity of limbs and balance problems. The symptoms
are primarily the result of a degeneration of dopaminergic cells, or
neurons, in the substantia nigra, a part of the brain that controls
and modulates movement. As the disease progresses, these symptoms
usually increase and impact a person's ability to function. More
information about PD is available on, e.g., the homepage of the
European Parkinson's Disease Association, EPDA,
http://www.epda.eu.com/.

Dyskinesia in PD are involuntary movements associated with
dopaminergic drug therapies
Involuntary movements, also known as dyskinesia, are associated with
prolonged use dopaminergic therapies. The mechanisms behind
dyskinesia are not fully understood, but their emergence is believed
to be caused by changes in the neuronal network in the basal ganglia
area in the brain related to the implications of both Parkinson's
disease and its medicinal treatment.




About Orion
Orion is a European pharmaceuticals and diagnostics company dedicated
to treating and preventing disease by discovering and developing
innovative medicinal treatments and diagnostic tests for global
markets. Orion is engaged in human and veterinary drugs, active
pharmaceutical ingredients and diagnostic tests. In 2008, Orion's net
sales were € 710.7 million. Operating profit was € 184 million, and
the company invested € 99 million in pharmaceutical research and
development. The number of employees is about 3,100. Orion corporate
headquarters are in Espoo, Finland. Orion is listed on NASDAQ OMX
Helsinki. For more information, please visit:
http://www.orion.fi/english/.



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