- New evidence demonstrates early use of Stalevo?improves quality of
life and may provide long-term benefits in patients with Parkinson's
disease
* First quality of life (QoL) study in early phase Parkinson's
disease shows significant improvements with Stalevo – an enhanced
levodopa therapy - in both QoL and control of Parkinson's disease
symptoms (1)

* Earlier initiation of enhanced levodopa therapy could provide
benefits that cannot be achieved if treatment is delayed (2)

* Parkinson's disease - 6.3 million people affected worldwide (3) -
shortens life expectancy and causes significant decline in the
quality of life (4)

Kyoto, October 31, 2006 – New data shows that Stalevo (*)
significantly improves quality of life in patients with Parkinson's
disease with no or minimal motor fluctuations, when compared to
traditional levodopa therapy. In addition, new analysis suggests
that patients treated earlier with enhanced levodopa therapy
experienced an immediate and sustained improvement in symptom
control that was not achieved when treatment was delayed by 6
months. The new findings were presented today at the Movement
Disorder Society's (MDS) 10th International Congress of Parkinson's
Disease and Movement Disorders in Kyoto, Japan.

"These data provide important insight into the management of
Parkinson's disease and again highlights the benefits that earlier
treatment initiation may provide" said Professor Anthony H.
Schapira, Department of Clinical Neurosciences, Royal Free Hospital,
London.

"The results presented today show that enhanced levodopa therapy can
significantly improve quality of life and symptom control in
Parkinson's disease patients. The results from the earlier
initiation of enhanced levodopa therapy are of great interest and
should stimulate further research in this area."

Parkinson's disease is a progressive and degenerative neurological
disease (4) for which there is currently no cure; it affects all
cultures and races, with an estimated worldwide prevalence of 6.3
million people. (3)

The QUEST-AP (QUality of Life Evaluation of STalevo Asia Pacific)
(1) is the first double-blind study of its kind to compare the
effect of Stalevo with traditional levodopa on QoL in early phase PD
patient population with no or minimal, non-disabling motor
fluctuations. The study has been conducted in collaboration between
MDS Australia Clinical Research & Trial Group and Novartis Australia
and it demonstrates that – even after only 12 weeks of treatment -
Stalevo significantly improves QoL compared to traditional levodopa
therapy. The treatment effect was particularly significant for
emotional wellbeing, social relationships, communication and stigma.
In addition, Stalevo therapy resulted in significant improvements at
week 12 in UPDRS Part I-III and Part II (ADL). The results support
the early use of Stalevo in PD patients who require levodopa
therapy.

"The results of the study are very exciting for people with
Parkinson's and their families alike. PD can be devastating, yet the
data presented today shows that Stalevo can really help improve the
emotional and social aspects of Parkinson's disease" commented Mary
Baker, Patron and Immediate Past President of the European
Parkinson's Disease Association (EPDA). "The data offers genuine
hope and demonstrates that patients may continue to enjoy good
quality of life despite having PD."

A further pooled analysis of three comparably designed, double-
blind, placebo controlled Phase III studies (5,6,7) and their long-
term open-label extensions (8) suggests that levodopa-treated
patients who receive enhanced levodopa therapy early, experienced
immediate benefits which were sustained for up to five years. During
the five year period, patients whose treatment was delayed by 6
months were unable to catch up the superior symptom control achieved
in the earlier start patients.

Together, this study and analysis suggest that earlier initiation of
an enhanced levodopa therapy not only could provide better quality
of life and symptom control for Parkinson's patients at the present
time, but delaying the initiation of an enhanced levodopa therapy
may limit the ultimate benefits that patients could achieve both in
the short and long term.

The QUEST-AP Study

The QUEST-AP (1) study was a randomized, double blind, parallel-
group, multinational study comparing the effect on quality of life
of Stalevo with traditional levodopa therapy in 184 early phase
Parkinson's disease patients with no or minimal, non-disabling motor
fluctuations.

It is the first double-blind study to use QoL as a primary outcome
measure in PD demonstrating improved QoL in early phase PD patients.

Patients were enrolled between July 2005 and March 2006 at 10 sites
in Australia, 3 sites in Taiwan, 4 sites in Thailand and 2 sites in
the Philippines. The primary outcome measure was QoL as assessed by
the Parkinson's Disease Questionnaire (PDQ-8). Secondary outcome
measures were the Unified PD Rating Scale (UPDRS) also including the
measurement of activities of daily living (ADL). The results
demonstrate that Stalevo improves significantly several aspects of
functioning and well-being which adversely affect patients with
Parkinson's disease.

The results show that patients on Stalevo had a significant mean
improvement in their PDQ-8 score vs. traditional levodopa therapy
(p=0.021). The treatment effect of Stalevo was particularly
significant for emotional wellbeing, social relationships,
communication and stigma of the PDQ-8 items. In addition, Stalevo
therapy resulted in significant improvements at week 12 in UPDRS
Part I-III total scores (p=0.047) and UPDRS Part II (ADL) (p=0.032).
These results suggest that Stalevo offers significant improvements
in QoL in the early phase of PD.

Enhanced levodopa therapy: early vs. delayed start analysis

Earlier treatment with enhanced levodopa therapy (levodopa, DDCI and
entacapone) also showed to be beneficial when compared to
traditional levodopa according to an analysis of research on 488
patients. (2) The five-year retrospective analysis evaluated the
effect of early vs. delayed start of enhanced levodopa therapy on
long-term efficacy (5 years) in PD patients already receiving PD
medication.

Early initiation of enhanced levodopa therapy in comparison to
traditional levodopa therapy resulted in, and maintained, superior
symptom control over 5 years, compared with a delayed-start therapy
regimen, as assessed by the UPDRS Part III motor score (p<0.05).

Consistent with these results, when adjusted for the duration of PD
at baseline, the between group difference in UPDRS III scores was
also significant (p<0.001). The analysis suggests that early
introduction of enhanced levodopa therapy in patients treated with
traditional levodopa provides superior benefit that cannot be
achieved if treatment is delayed. (2)

About Stalevo

Stalevo (levodopa/carbidopa/entacapone) is an enhanced levodopa
therapy for the treatment of Parkinson's disease indicated for those
patients experiencing wearing-off motor complications. 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 brain9. Stalevo provides
enhanced symptom control throughout the day vs . traditional
levodopa (5, 6, 7,10) and the efficacy of Stalevo is maintained
during long-term treatment. (8) Stalevo, developed by Orion
Corporation Orion Pharma, is marketed by Novartis and Orion Pharma
in their respective territories.

31.10.2006(Kauppalehti Online) -