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New evidence demonstrates early use of Stalevoģ improves quality of life and may provide long-term benefits in patients with Parkinsonís disease


WEBWIRE

First quality of life (QoL) study in early phase Parkinsonís disease shows significant improvements with Stalevo Ė an enhanced levodopa therapy - in both QoL and control of Parkinsonís disease symptoms1
ēEarlier initiation of enhanced levodopa therapy could provide benefits that cannot be achieved if treatment is delayed2
ēParkinsonís disease - 6.3 million people affected worldwide3 - shortens life expectancy and causes significant decline in the quality of life4

Kyoto, October 31, 2006 Ė New data shows that Stalevo* significantly improves quality of life in patients with Parkinsonís 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 Societyís (MDS) 10th International Congress of Parkinsonís Disease and Movement Disorders in Kyoto, Japan.
ďThese data provide important insight into the management of Parkinsonís disease and again highlights the benefits that earlier treatment initiation may provideĒ said Professor Anthony H. Schapira, Department of Clinical Neurosciences, Royal Free Hospital, London. ďThe results presented today show that enhanced levodopa therapy can significantly improve quality of life and symptom control in Parkinsonís disease patients. The results from the earlier initiation of enhanced levodopa therapy are of great interest and should stimulate further research in this area.Ē
Parkinsonís disease is a progressive and degenerative neurological disease4 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 Ė 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.
* Stalevo is an enhanced levodopa therapy containing levodopa/carbidopa/entacapone

ďThe results of the study are very exciting for people with Parkinsonís 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 Parkinsonís diseaseĒ commented Mary Baker, Patron and Immediate Past President of the European Parkinsonís Disease Association (EPDA). "The data offers genuine hope and demonstrates that patients may continue to enjoy good quality of life despite having PD.Ē
A further pooled analysis of three comparably designed, double-blind, placebo controlled Phase III studies5,6,7 and their long-term open-label extensions8 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 Parkinsonís 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-AP1 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 Parkinsonís 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 Parkinsonís 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 Parkinsonís 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 Parkinsonís 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 levodopa5, 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.

About Parkinsonís disease
Parkinsonís disease is a chronic and progressive neurological condition that affects 6.3 million people worldwide. While their cause is unknown, PD symptoms are primarily the result of a degeneration of dopaminergic neurons in the substantia nigra, a part of the brain that controls and modulates movement.
Symptoms include limbs that tremble, slowness of movement, stiffness and rigidity of limbs and gait or balance problems. As the disease progresses, these symptoms usually increase and impact a personís ability to work and function.
About Orion
Orion Corporation (OMX: ORNAV, ORNBV) is one of the leading pharmaceutical companies in the northern Europe.
Orion develops, manufactures and markets pharmaceuticals, active pharmaceutical ingredients and diagnostic tests for global markets. Pharmaceuticals generate about 95% of the Groupís net sales, of which proprietary patented pharmaceutical innovations contribute a considerable part. The core therapy areas in Orionís product and research strategy are central nervous system disorders, cardiology and critical care and hormonal and urological therapies.
Stalevoģ and Comtessģ / Comtanģ, treatments originated by Orion for Parkinsonís Disease, are the largest products by sales in Orionís portfolio. In the global marketing of these products Orion collaborates with Novartis.
For further information please consult www.orion.fi.
Supplementary material to this press release is available on the website www.orion.fi.

References:
1 Movement Disorder Society of Australia Clinical Research & Trial Group and QUEST-AP Study Group. A randomized, double-blind study to compare the effect on quality of life of levodopa/carbidopa/entacapone (Stalevoģ) with levodopa/carbidopa in patients with Parkinsonís disease with no or minimal, non disabling motor fluctuations. Poster presented at Movement Disorder Societyís 10th International Congress of Parkinsonís Disease and Movement Disorders in Kyoto, Japan. P437.
2 Nissinen H, Kuoppamaki M, Leinonen M. Early vs. delayed initiation of levodopa/DDC!/entacapone leads to superior 5-year efficacy in Parkinsonís disease patients, initially receiving traditional levodopa/DDCI therapy. Poster presented at Movement Disorders Societyís 10th International Congress of Parkinsonís Disease and Movement Disorders in Kyoto, Japan. P962.
3 EPDA Website: www.epda.eu.com/patientGuide/LWP_1_01_whatIsPD.shtm last accessed 16.10.06
4 Schapira AHV and Obeso J. Timing of treatment initiation in Parkinsonís disease. A need for reappraisal? Annals of Neurology. Feb 2006; 559-62.
5 Rinne UK, Larsen JP, et al. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Nomecomt Study Group. Neurology 1998; 51 (5): 1309-14.
6 Parkinson Study Group. Entacapone improves motor fluctuations in levodopa-treated Parkinsonís disease patients. Ann Neurol. 1997; 42 (5): 747-55.
7 Poewe WH, Deuschl G, et al. Efficacy and safety of entacapone in Parkinsonís disease patients with suboptimal levodopa response: a 6 month randomized placebo-controlled double blind study in Germany and Austria (Celomen study). Acta Neurol Scand 2002; 105 (4): 245-55.
8 Larsen JP, Worm-Petersen J, et al. The tolerability and efficacy of entacapone over 3 years in patients with Parkinsonís disease. Eur J Neurol 2003; 10 (2): 137-46
9 Olanow CW, Obeso JA and Stocchi F. Continuous dopamine-receptor treatment of Parkinsonís disease: scientific rationale and clinical implications. Lancet Neurol 2006; 5: 677-87.
10 Brooks DJ, Sagar H, and the UK-Irish Entacapone Study Group. Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinsonís disease: a randomised, placebo controlled, double blind, six month study. J Neurol Neurosurg Psychiatry. 2003;74:1071-79.



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