FDA approves Stalevo (TM) for treatment of Parkinson's disease

Stalevo contains levodopa, the most widely used agent for Parkinson's disease, pluscarbidopa and entacapone. While carbidopa reduces the side effects of levodopa,entacapone optimizes its benefits, permitting Parkinson's disease patients to have animproved ability to perform everyday tasks and a reduction in symptoms associated withthe disease.

Within one to two years, almost 50 percent of Parkinson's disease patients receivinglevodopa therapy begin to notice that their levodopa lasts for shorter periods of time, aphenomenon known as "wearing off."1 In about 15 to 20 percent of patients, "wearing off"becomes extreme and disabling. Eventually, the effect of a levodopa dose may decreasefrom eight hours when patients begin levodopa therapy to only one to two hours."Levodopa is recognized as the cornerstone of Parkinson's disease therapy, but its longtermuse is limited by its reduced ability to fully control Parkinson's disease symptoms,"said Warren Olanow, MD, professor and chairman, Department of Neurology, MountSinai School of Medicine in New York City. "By blocking the enzymatic breakdown oflevodopa, Stalevo provides more levodopa to the brain for a longer period of time.Potential patient benefits include simpler, more convenient dosing and more "on" time,during which Parkinson's symptoms are well-controlled and daily activities are improved.""We are proud to introduce a product like Stalevo which can enhance the daily lives ofmany people with Parkinson's disease," stated Paulo Costa, president and CEO, NovartisPharmaceuticals Corporation. "As the fourth Parkinson's drug Novartis has introduced inthe United States, Stalevo is a clear example of our company's ongoing commitment to theParkinson's community."

The effectiveness of levodopa administered with carbidopa and entacapone in the treatmentof Parkinson's disease was established in three 24-week multicenter, randomized, doubleblind placebo-controlled trials in patients with Parkinson's disease experiencing "wearingoff". In these trials, patients benefited from increased "on" time, reduced "off" time,improved motor function and daily activities such as patients' ability to walk, dress, andmaintain hygiene. The most common side effects of Stalevo therapy are dopaminergic innature (e.g. dyskinesia, nausea). These side effects may be manageable with alteration inthe drug dosing schedule. Other common side effects include diarrhoea, hyperkinesias, urine discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain and hallucinations.

 

About Parkison's disease

Parkinson's disease, a chronic and progressive neurological condition, affects more than1% of people over 65 years old. While its cause is unknown, the symptoms of Parkinson'sdisease are primarily the result of degeneration of dopaminergic cells, or neurons, in thesubstantia nigra, a part of the brain that controls and modulates movement. Symptomsinclude limbs that tremble; slowness of movement; stiffness and rigidity of limbs and gait orbalance problems. As the disease progresses, these symptoms usually increase and impact aperson's ability to work and function.Stalevo will be marketed in the United States by Novartis Pharmaceuticals Corporationand manufactured by Orion Pharma.This release contains certain "forward-looking statements", relating to the Group'sbusiness, which can be identified by the use of forward-looking terminology such as "canexpect", or similar expressions, or by express or implied discussions regarding potentialfuture sales of Stalevo. Such statements reflect the current views of the Group with respectto future events and are subject to certain risks, uncertainties and assumptions. There canbe no guarantee that Stalevo will reach any particular sales levels. In particular,management's expectations could be affected by, among other things, new clinical data;unexpected clinical trial results; unexpected regulatory actions or delays or governmentregulation generally; the company's ability to obtain or maintain patent or otherproprietary intellectual property protection; competition in general; and other risks andfactors referred to in the Company's current Form 20-F on file with the US Securities andExchange Commission. Should one or more of these risks or uncertainties materialize, orshould underlying assumptions prove incorrect, actual results may vary materially fromthose described herein as anticipated, believed, estimated or expected.Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered inBasel, Switzerland, Novartis Group companies employ about 77 200 people and operate inover 140 countries around the world. For further information please consult http://www.novartis.com.