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Novartis (NVS) And Orion Pharma Launch First Parkinson's Disease Study To Explore Potential Of Delaying Motor Complications With Stalevo(R)



10/19/2005 5:11:55 PM

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 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] Myllyl�¤ 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, Ã?Â?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.

Novartis International AG

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, NovartisGlobal Media Relations, Tel +41-61-324-3018 (direct), or+41-79-596-1408 (mobile), john.gilardi@group.novartis.com


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