FROM> PR Newswire
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/10
-26-2004/0002309670&EDATE=

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

    BASEL, Switzerland, October 26 /PRNewswire-FirstCall/ --
    - 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
http://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 http://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] MyllylC$ 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, C stergaard 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.


SOURCE Novartis International AG

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