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HEALTH CANADA APPROVES FIRST IN A NEW CLASS OF PARKINSONS DRUGS Fast-acting therapy offers new hope to 100,000 Canadians with devastating movement disorder TORONTO, Oct. 30 /CNW/ - Pharmaceutical developer Hoffmann-La Roche Limited (Roche Canada) announced today that Tasmar(R) (tolcapone), an important new medication for the treatment of Parkinsons, has received regulatory clearance from Health Canada. Tasmar is the first member of a new class of Parkinsons medicines called COMT-inhibitors. It works to prolong and enhance the action of levodopa in the brain, the current 'gold standard' in Parkinsons treatment, providing better and extended control of symptoms. There is no cure for Parkinsons so all treatments focus on improving the symptoms - primarily the loss of control over movement, tremor and muscle stiffness. "The availability of levodopa in the 1960s revolutionized the treatment of Parkinsons by restoring movement control to patients. However, as Parkinsons progresses, patients find they require higher and more frequent doses to control their symptoms," explained Dr. Donald Calne, Director, Neurodegenerative Disorders Centre at the University of British Columbia Hospital, Vancouver and Chair, Scientific Advisory Board of the Parkinson Foundation. "As the patient becomes more disabled, their symptoms fluctuate more widely during the day - this can mean going from complete mobility to, in some instances, not even being able to get out of a chair." "Tasmar is an important advance because in most patients it smoothes out the delivery of levodopa to the brain in a continuous fashion. This improves motor function and reduces the time patients are 'off', or having difficulty with movement. The smoother delivery of levodopa to the brain means fewer fluctuations between good movement control, or 'on' time," added Dr. Calne. "The benefits Tasmar brings to levodopa therapy can improve a patient's quality of life markedly," he continued. Treatment with Tasmar ----------- Tasmar is approved for use in combination with both levodopa/carbidopa and levodopa/benserazide combinations. Results from clinical trials involving Tasmar show that patients with more progressed Parkinsons, known as fluctuating patients, experienced a reduction of approximately 30 to 50 per cent in off time with Tasmar and a significant motor function improvement. For non-fluctuating patients (patients whose Parkinsons is in earlier stages) the clinical trial results showed that treatment with Tasmar resulted in a notable 20 per cent improvement in their ability to perform activities of daily living, and an overall improvement in motor performance. Tasmar begins working within one day. Patients can take the therapeutic dose immediately, in contrast to many Parkinson therapies where the dose must be gradually increased over weeks or months. Tasmar has a reasonable side effect profile. The most frequent adverse event that lead to discontinuation of therapy was diarrhea (only five to six per cent discontinued therapy as a result, versus one per cent on placebo). Tasmar is available in two strengths, 100 mg and 200 mg. "Tasmar was a breakthrough for me," recalls patient Derek Curwin, who was involved in the clinical trials of Tasmar and was diagnosed with Parkinsons five years ago. "I find that my 'on' time lasts longer now that I have added Tasmar to my treatment regimen. And when I do go 'off', I don't go as far 'off' as I used to. Tasmar has made control over my symptoms easier to manage." COMT-inhibitors enhance levodopa's effectiveness by blocking an enzyme known as catechol-O-methyltransferase, or COMT, which breaks down levodopa in the body. The blocking action of COMT-inhibition allows almost double the amount of levodopa to cross into the brain, and in a more continuous way. The result is enhanced control of the symptoms of Parkinsons. Devastating condition ----------- "We welcome any new treatment advances which could help the thousands of Canadian families who live with this devastating condition," said Trevor Williams, chief executive officer of the Parkinson Foundation of Canada. Parkinsons affects more than 100,000 Canadians, making it the leading movement disorder in the country. The condition occurs when cells in part of the brain which control muscle movement are lost, affecting all activities in a person's life. Even the simplest movements, such as getting out of a chair, become an overwhelming challenge. Despite intensive research, the cause of Parkinsons remains a mystery. Teresa Flowers, Director of Drug Information and Safety for Roche Canada commented: "At Roche, we have a long experience with Parkinsons having brought levodopa therapy to patients in the 1960s. We are very proud to see one of our most important research efforts now become available to ease the suffering of Parkinsons patients. Tasmar offers patients a remarkable improvement in their quality of life. We believe it will transform the way that Parkinsons is treated." With Canadian headquarters in Mississauga, Ontario, Hoffmann-La Roche - known as Roche - is today one of the world's leading healthcare companies. Represented in more than 50 countries, the company is involved in the manufacture and research of pharmaceuticals, vitamins, fine chemicals and diagnostic equipment. A leader in a number of fields, Roche Canada is currently targeting virology, immunology, cardiology, oncology and inflammatory diseases as priority areas of research. The company is also active in the areas of biotechnology, AIDS research, depression and dermatology. -0- 10/30/97 /For further information: Beth Wanlin, Manager, Public Relations, Hoffmann-La Roche, (905) 542-5803; In Toronto: Joanna Wilson, NATIONAL PharmaCom, (416) 586-0180; In Vancouver: David March, NATIONAL PharmaCom, (604) 684-6655 office, (604) 889-1935 cellular/CO: Hoffmann-La Roche Limited ST: Ontario IN: MTC SU: -30- CNW 10:47e 30-OCT-97