EMBARGOED UNTIL 5:00 P.M. (EST), APRIL 16, 2002

IMPORTANT NEW STUDY SHOWS REQUIP® SLOWS THE LOSS OF DOPAMINE FUNCTION IN PARKINSON'S DISEASE

Dopamine Function Loss is Marker of Parkinson's Disease Progression

TORONTO, Ontario (Tuesday, April 16, 2002) -- The D2/D3 dopamine agonist ReQuip® (ropinirole) significantly slows the loss of dopamine function when compared to the older generation treatment for Parkinson's Disease levodopa (L-dopa), according to the results of the important new REAL-PET study1, announced today at the Annual Meeting of the American Academy of Neurology (AAN) in Denver, Colorado.

This study provides clear evidence that ReQuip slows the loss of dopamine function in the brain when compared to traditional treatment with L-dopa. Loss of dopamine function is a key indicator, or surrogate marker, of Parkinson's Disease progression.

"The results of this study are very exciting. ReQuip has been shown to slow the progression of dopamine dysfunction associated with Parkinson's Disease. This was demonstrated in both the striatum and the basal ganglia," commented Professor David Brooks, lead investigator and Hartnett Professor of Neurology at the Faculty of Medicine, Imperial College of Science, Technology and Medicine, Hammersmith Hospital, London, UK. "These results should certainly stimulate debate about the way we treat early Parkinson's Disease."

The REAL-PET (ReQuip as Early Therapy versus L-dopa - PET) study is a multicentre, double-blind, parallel-group trial using a state-of-the-art computer brain imaging technique called three-dimensional positron emission tomography (3D PET), specifically designed to evaluate changes in 18F-dopa uptake (a surrogate marker for the quantity of functioning dopaminergic brain cells). The study randomised 186 early Parkinson's Disease patients in a 1:1 ratio for two years of treatment with either ReQuip or L-dopa.

"The results of the REAL-PET study should have a significant impact on treatment approaches for Parkinson's Disease," said Dr. Mandar Jog, Study Investigator, Neurologist, London Health Sciences Centre, London, Ontario. "For the first time we are seeing a real demonstration of a medication that not only treats the symptoms of the disease, but that can slow the progression of Parkinson's."

The primary endpoint of the study was the change in putamen 18F-dopa uptake between the outset of the trial and after two-years of treatment. Based on an analysis carried out at the lead clinical investigation site, Hammersmith Hospital in London, UK, of all PET scans, reduction in putamen 18F-dopa uptake was up to 35 per cent less in the brains of patients treated with ReQuip compared to L-dopa. This means that the loss of functioning dopamine neurons in the areas of the brain involved with Parkinson's Disease was up to 35 per cent less in patients receiving ReQuip compared to L-dopa.

The secondary outcomes included the incidence of dyskinesia (involuntary, jerky movements), motor scores, global assessments of clinical functioning and adverse events. The study demonstrated a significantly reduced risk of the dyskinesia in individuals treated with ReQuip, compared to L-dopa. ReQuip-treated patients had a ten times lower risk of experiencing dyskinesia than those in the L-dopa group (three per cent compared to 27 per cent respectively). These results are consistent with the findings of an earlier study by Rascol et al2.

REQUIP

ReQuip is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's Disease. ReQuip is a second-generation D2/D3 dopamine agonist and is generally well tolerated. The most commonly reported side effects associated with early therapy in clinical trials were nausea, dizziness, somnolence, headache, peripheral edema, vomiting, syncope, fatigue and viral infection. As adjunct therapy in clinical trials, the most commonly reported side effects were: dyskinesia, nausea, dizziness, somnolence and headache.

A PROGRESSIVELY DISABLING DISEASE

Parkinson's Disease is a devastating, chronic neurological condition characterised by progressive disabling disturbances in movement and balance. It is understood to be caused by loss of dopamine in the neurons (nerve cells) in parts of the brain such as the substantia nigra, which plays a central role in the voluntary control of movement. The results are characteristic symptoms such as bradykinesia (slowness of movement), muscle stiffness, tremor, and balance and gait problems.

According to the World Parkinson's Disease Association, more than four million people worldwide suffer from Parkinson's Disease, making it the most common neurodegenerative disease after Alzheimer's. In Canada, 100,000 people currently suffer from Parkinson's Disease.

ABOUT GLAXOSMITHKLINE

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. In Canada, GlaxoSmithKline employs approximately 1,800 people and is a top 20 investor in Canadian research and development, contributing more than $100 million annually. The company is also one of the top 10 corporate charitable donors, investing more than $6.5 million annually and is recognized as one of the 50 best companies to work for in Canada.

For additional information, or an interview with a Canadian investigator, please contact:

Bev Warford/Lisa Morlock

Edelman Public Relations

Tel.: (416) 979-1120, ext. 305/234

Carlo Mastrangelo

Manager, Corporate Communications

GlaxoSmithKline Inc.

Tel.: (905) 819-7129

ReQuip® is a registered trademark, used under license by GlaxoSmithKline Inc.

References:

  1. Whone A L, Remy P, Davis M R, et al. The REAL-PET Study: slower progression in early Parkinson's disease treated with ropinirole compared with L-dopa. 54th Annual Meeting of the American Academy of Neurology, Denver, 2002.
  2. Rascol O, Brooks D J, Korczyn A D, et al, for the 056 Study Group. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or L-dopa. New England Journal of Medicine 2000; 342: 1484-91

NOTES FOR CANADIAN JOURNALISTS

About Parkinson's Disease

  • Approximately 100,000 Canadians suffer with Parkinson's Disease.
  • The often debilitating symptoms include tremor, stiffness, slowness of movement, impaired balance, personality changes, weakness, stooped posture, fatigue, joint discomfort, difficulty writing, soft speech, constipation, sleep disturbance and reduced facial expression.
  • The incidence of Parkinson's Disease peaks at the age of 60, however it can affect people at any age. Approximately 10 per cent of cases affect those under age 40, and as many as 20 per cent may be diagnosed under the age of 50.

About REAL-PET

  • A two-year, multicentre, randomized, double-blind, parallel-group trial, designed to test the hypothesis that the dopamine agonist ropinirole (ReQuip) could delay disease progression in early Parkinson's.
  • REAL-PET involved 186 previously untreated patients with early-stage Parkinson's Disease (Hoehn and Yahr Stages 1-11). Patients were recruited from 34 centres in Austria, Canada, France, Germany, the UK and the USA.
  • Canadian REAL-PET study sites were located in Vancouver, Edmonton, London, Hamilton and Toronto.
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