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Novartis and Orion Pharma Launch First Parkinson's Disease Study to Explore Potential of Delaying Motor Complications With Stalevo(R)

Basel, Switzerland (ots/PRNewswire)

- Parkinson's Patients Who Require the Start of Levodopa Therapy
May  Be Eligible to Participate in This Study
Novartis and Orion Pharma announced that they are launching
STRIDE-PD (STalevo Reduction In Dyskinesia Evaluation). This major
study in Parkinson's disease (PD) seeks to investigate if, when used
as an initial therapy, the optimized levodopa medication Stalevo
(containing levodopa, carbidopa and entacapone) delays the onset of
motor complications, such as dyskinesias, in comparison with the
traditional formulation of levodopa/carbidopa.
STRIDE-PD will enroll approximately 740 patients at 70 centers in
14 countries: Austria, Belgium, Canada, France, Finland, Germany,
Greece, Italy, Spain, Sweden, Turkey, Switzerland, the United Kingdom
and the United States of America. Patient recruitment has started in
September and is estimated to continue for 12 months. The first study
results are expected in 2007.
Patients with PD between 30 and 70 years of age who have been
diagnosed within the last five years prior to study initiation and
who require the start of levodopa therapy to manage their symptoms
may be eligible to participate in this two-year study.
"The importance of the STRIDE-PD study could be major. If the
study shows that Stalevo is superior to traditional
levodopa/carbidopa therapy in the time to onset of dyskinesias, this
could change the current treatment paradigm completely," said
Professor Werner Poewe, Chair of the Department of Neurology at
Innsbruck University, Austria. "We would then use Stalevo from the
very first day in patients needing levodopa treatment."
Levodopa is the most effective and most widely used symptomatic PD
treatment and has remained the "gold standard" of care for nearly 40
years. The vast majority of people with PD eventually require
levodopa treatment to control their symptoms, even if they begin
their therapy with another drug. However, after several years of
treatment with levodopa, patients often begin to experience motor
complications, such as "wearing-off" (when the effect of one dose of
medication does not last until the next scheduled dose) and
dyskinesias.
Characterized by abnormal and involuntary movements, dyskinesias
are a major challenge for people with PD since they can result in
fragmented or jerky motions that are different from the rhythmic
tremor commonly associated with PD.
"We are very excited about the launch of STRIDE-PD. Dyskinesias
often become a serious problem for people with PD. Delaying the onset
of these motor complications would therefore offer a real improvement
in the quality of life for patients and their families," said Mary
Baker, President of the European Parkinson's Disease Association
(EPDA), United Kingdom.
For further information on STRIDE-PD, please also refer to
www.epda.eu.com.
About Stalevo
Stalevo (levodopa, carbidopa and entacapone) is a new and
optimized levodopa product with a longer duration of action compared
to traditional levodopa/carbidopa preparations.
Stalevo tablets are currently indicated for certain PD patients
who are experiencing "wearing-off" motor complications. In patients
with "wearing-off," clinical studies have shown that the addition of
entacapone to levodopa/carbidopa can significantly extend the
duration of benefit of each medication dose and enhance the PD
patients' ability to control body movements and perform basic
functions, such as walking and dressing.[1],[2]
The most common side effects of Stalevo therapy are dopaminergic
in nature (e.g. dyskinesia, nausea.) These side effects may be
manageable with alteration in the drug dosing schedule. Other common
side effects include diarrhea, hyperkinesias, urine discoloration,
hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain
and hallucinations. For full prescribing information, visit
www.stalevo.com.
Stalevo, developed by Orion Pharma, is marketed by Novartis and
Orion Pharma in their respective territories. Stalevo is available in
Austria, Belgium, Brazil, Denmark, Iceland, Ireland, Finland, France,
Germany, Greece, Luxemburg, the Netherlands, Norway, Spain, Sweden,
Switzerland, the United Kingdom and the United States.
About Parkinson's disease
PD is a chronic and progressive neurological condition that
affects 6.3 million people worldwide. One percent of people over the
age of 60 and two percent of people over the age of 80 suffer from
this disease.[3]
While their cause is unknown, PD 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.
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
person's ability to work and function.
This release contains certain forward-looking statements relating
to the Company's business, which can be identified by the use of
forward-looking terminology such as "to explore potential", "will",
"is estimated", "are expected", "could", "if ... could change",
"would", "is committed to" or similar expressions, or by express or
implied discussions regarding potential new indications or labeling
for Stalevo, or potential future sales of Stalevo, or regarding the
long-term impact of a patient's use of Stalevo. Such forward-looking
statements reflect the current views of the Company regarding future
events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with Stalevo to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Stalevo will be approved for any additional indications or
labeling in any market. Nor can there be any guarantee of potential
future sales of Stalevo. Neither can there be any guarantee regarding
the long-term impact of a patient's use of Stalevo. In particular,
management's expectations regarding commercialization of Stalevo
could be affected by, among other things, unexpected clinical trial
results; unexpected regulatory actions or delays or government
regulation generally; the Company's ability to obtain or maintain
patent or other proprietary intellectual property protection;
competition in general; government, industry and general public
pricing pressures, and other risks and factors referred to in the
Company's current Form 20-F on file with the US Securities and
Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
About Novartis
Novartis has been a leader in the neuroscience area for more than
50 years, having pioneered early breakthrough treatments for
Alzheimer's disease, Parkinson's disease, attention
deficit/hyperactivity disorder, epilepsy, schizophrenia and migraine.
Novartis continues to be active in the research and development of
new compounds, is committed to addressing unmet medical needs and to
supporting patients and their families affected by these disorders.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and
consumer health. In 2003, the Group's businesses achieved sales of
USD 24.9 billion and a net income of USD 5.0 billion. The Group
invested approximately USD 3.8 billion in R&D. Headquartered in
Basel, Switzerland, Novartis Group companies employ about 80 000
people and operate in over 140 countries around the world. For
further information please consult http://www.novartis.com.
References
[1] Myllylä V, Haapaniemi T, Hartikainen P, Nuutinen J, Rissanen
A, Kuopio A-M, Jolma T, Satomaa O, Kinnunen E, Kaakkola S. First
experiences of new triple combination of levodopa/carbidopa/
entacapone in the treatment of patienst with Parkinson's disease
(2003) Eur J Neurol 10:suppl1 (163(P2140).
[2] Brooks D, Agid Y, Østergaard K, Widner H and Oertel W, on
behalf of the TCINIT study group. A new triple combination tablet is
easy to initiate and provides improved symptom control in patients
with Parkinson's disease (2003) Eur J Neurol 10:Suppl1;241(P3108).
[3] Parkinson's Disease Fact Sheet, European Parkinson's Disease
Association.

Contact:

Contacts : Bettina Maunz, Novartis Pharma Communications, Tel
+41-61-324-7996 (direct), or +41-79-593-4278 (mobile),
bettina.maunz@pharma.novartis.com; John Gilardi, Novartis Global
Media Relations, Tel +41-61-324-3018 (direct), or +41-79-596-1408
(mobile), john.gilardi@group.novartis.com

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