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| |  Comtan (Entacapone) Now Available in Canada for Parkinson’s Disease DORVAL, QC -- October 4, 2001 -- Novartis Pharmaceuticals Canada Inc. announced today the availability of Comtan® (entacapone), a new medication for the treatment of Parkinson's Disease (PD). Worldwide clinical studies and experience involving more than 80,000 patients have demonstrated that Comtan, when used in conjunction with the gold standard treatment, levodopa/carbidopa(1), is effective in helping to enhance treatment and manage the symptoms of the disease for patients who experience “wearing-off” of the benefits of levodopa towards the end of their dose. Comtan belongs to a new class of drugs called catechol O-methyltransferase (COMT) inhibitors. Carbidopa is an agent commonly administered along with levadopa in order to block one of the enzymes that breaks down levadopa, thus allowing more levadopa to reach the brain. However, breakdown of levadopa by other enzymes still occurs. "One of the challenges of treating Parkinson's Disease is that over time levodopa loses its ability to deliver smooth control of symptoms. As the disease progresses, many patients will experience 'wearing-off,' which is the return of PD symptoms prior to the next scheduled dose of levodopa," explained Dr. Mark Guttman, Director, Centre of Movement Disorders in Markham and Assistant Professor at the University of Toronto. "By including a COMT inhibitor, the amount of levodopa reaching the brain can be markedly enhanced and wearing-off can be reduced. This results in increased 'on' time, the goal of Parkinson's treatment." "On time" refers to periods of relatively good function, marked by patients' ability to perform common but important daily activities such as walking, speaking, writing and dressing. Parkinson's Disease is a progressive, neurodegenerative disorder that is characterized by tremor, rigidity, slowness of movement and difficulty with balance. There is no cure for Parkinson's Disease, nor is there any known cause. Today in Canada, it is estimated that 100,000 people suffer with Parkinson's Disease. Parkinson's Disease occurs when there is not enough of the naturally occurring neurotransmitter, dopamine, in the brain. Levodopa converts to dopamine, however a number of enzymes, including the COMT enzyme, break it down before it reaches the brain. As Parkinson's Disease progresses, the benefits received from levodopa tend to shorten and patients will more frequently experience 'off' time due to “wearing-off” between doses of levodopa/carbidopa. Some of the common “wearing-off” symptoms that re-emerge before the patient's next dose of levodopa/carbidopa include poor coordination, shuffling while walking, problems getting in and out of a car, stiffness on rising out of a chair, difficulties buttoning a shirt, problems tying shoes and fatigue. When “wearing-off” occurs, it is often necessary to increase the dose and/or frequency of levodopa or add a controlled release preparation in hope that enough levodopa may consistently reach the brain. While dosage manipulations may be effective, they can have limitations, which is why some physicians look for options to extend the benefits of levodopa therapy. COMT inhibitors work with levodopa by blocking the COMT enzyme thus reducing the breakdown of levodopa before it reaches the brain. "Comtan improves the standard regimen, making optimal use of levodopa and allowing patients to benefit from increased motor function and extended periods of improved daily activities," added Dr. Guttman. "This allows patients to continue pursuing activities they enjoy which, in turn, may improve quality of life for them, as well as for their families and caregivers." Comtan, taken simultaneously with each levodopa/carbidopa dose helps to provide a more continuous benefit of levodopa therapy. The simultaneous dosing can also help simplify patients' daily medication schedule as many patients are prescribed multiple therapies to treat Parkinson's Disease. In worldwide, multi-center trials involving nearly 700 patients, Comtan, administered with each dose of levodopa/carbidopa, improved motor performance in patients with Parkinson's and significantly increased the amount of 'on' time patients had each day when compared to patients treated with levodopa/carbidopa alone. The two pivotal Phase III studies are known as SEESAW (Safety and Efficacy of Entacapone Study Assessing Wearing Off), conducted by the Parkinson Study Group (PSG) in North America and NOMECOMT (Nordic Multicenter Entacapone COMT Trials), conducted by the Nordic Study Group in Scandinavia. Both studies demonstrated that Comtan helped improve motor function in patients who showed deteriorating response to levodopa, particularly on important activities of daily living such as speaking, writing, walking and dressing.
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