Company Press Release

SOURCE: National Parkinson Foundation

Parkinson's Cases in 21st Century Likely to Increase as Baby Boomers Age
and Diagnosis Improves; Increasing Functional Time is a Critical Goal of
Parkinson's Therapy

NEW YORK, April 26 /PRNewswire/ -- Parkinson's disease, a debilitating
neurological disorder affecting an estimated 1.5 million Americans, will
be on the increase in the next century. While this disease is most
common among people over 60, many are also diagnosed in their 50s and
40s. In support of Parkinson's Awareness Month in April, leading
neurologists are alerting Americans that the aging of the baby boomer
generation, an increase in life expectancy, and more precise diagnosis
will cause the number of Parkinson's patients to grow substantially.

Parkinson Population to Grow in the Next Century

Currently, 60,000 new cases of this progressive movement disorder are
diagnosed each year. One of every 100 Americans over the age of 60 has
PD. By 2020, when the over-60 population grows to 54 million, another
half million people are expected to be affected by this potentially
debilitating disease.

``In addition to the growing 60-plus population, more patients are being
diagnosed in their 50s and even 40s,'' says Lisa Shulman, MD, assistant
professor of neurology at the University of Miami and co-director of the
National Parkinson Foundation Center of Excellence in Miami. ``This is
because we now have a better understanding of Parkinson's disease and
its early signs and symptoms.''

According to the National Parkinson Foundation, one third of patients
develop symptoms before age 50 and 10 percent are diagnosed before age
40.

Originally described as the ``shaking palsy'' by James Parkinson (whose
birthday, April 14, has become World PD Day) in 1817, Parkinson's
disease symptoms tend to emerge gradually over several years. At first,
patients may find they are becoming clumsy or slow. Sometimes, people
attribute their symptoms to ``arthritis'' or simply getting
older. Eventually, however, most Parkinson's disease patients find that
their balance becomes impaired or that it becomes increasingly difficult
to accomplish simple movements like standing up from a chair.

Common symptoms of this debilitating condition include: tremors,
generally in the hands and feet; rigidity; stooped posture; bradykinesia
(slow movement) and loss of balance. Other symptoms may include a
mask-like facial expression, shuffling gait, decrease in arm swing,
difficulty swallowing, slurred speech and difficulty with hand
movements.

Extending ``On-Time'' Key in Today's Parkinson's Therapy

Extending ``on-time'' -- periods of relatively good functioning -- is
the critical goal of today's Parkinson's therapy as symptoms advance.
``Off-time,'' marked by periods of relatively poor functioning, can have
dramatic consequences for patients, especially if they mean loss of
mobility or speech.

``New medications that provide more functional time may enable patients
to continue doing what they want and need to do for themselves and with
loved ones,'' says Dr. Shulman.

Current Drug Treatments: How They Work

Parkinson's disease may be one of the most baffling and complex of the
neurological disorders. Although researchers continue to explore the
causes of the disease, a cure has yet to be found. Currently, there are
medications available that can extend the functional time of Parkinson's
patients.

Since its introduction in 1968, levodopa has been the gold standard in
Parkinson's therapy. Parkinson's symptoms correlate with a decrease in
dopamine in the substantia nigra portion of the brain. Levodopa, the
chemical precursor to dopamine, works because it is effectively
converted to dopamine in the brain. Today, levodopa is almost always
given in combination with carbidopa, which makes levodopa more
effective. Approximately 80 percent of all Parkinson's patients now take
levodopa/carbidopa therapy.

However, over time, as Parkinson's disease progresses, higher or more
frequent doses of levodopa are needed to relieve symptoms, which can
lead to an increase in side effects, such as nausea, vomiting,
involuntary movements and hallucinations in some patients. The newest
class of therapy to emerge to relieve Parkinson's symptoms,
C.O.M.T.- inhibitors, work in conjunction with levodopa/carbidopa to
enhance and extend the benefits of levodopa.

C.O.M.T.-Inhibitors

TASMAR®, the first C.O.M.T.-inhibitor introduced last year, provides
smoother and more sustained levels of levodopa to the brain. Although
the precise mechanism of action is unknown, this is believed to
translate into more consistent and greater effects on the symptoms of
Parkinson's disease. In clinical trials, patients with fluctuating
symptoms who were given 100 mg. of TASMAR three times a day gained a
daily average of approximately 1.7-2 hours of ``on-time,'' periods of
relatively good functioning. In addition, patients experienced
significant improvements as measured in clinical investigators' global
assessments.

``Advanced patients with Parkinson's disease fluctuate between periods
when they are nearly immobile and periods when they are able to function
well,'' says Dr. Shulman. ``Medications such as Tasmar help to extend
their functional time, which can mean the difference between
independence and dependency on a caregiver.''

TASMAR ordinarily should be used as adjunctive therapy in patients on
levodopa/carbidopa who are experiencing symptom fluctuations and who are
not responding satisfactorily to or are not appropriate candidates for
other adjunctive therapies, because of the risk of potentially fatal
acute fulminant liver failure. TASMAR should not be initiated in
patients with clinical evidence of liver disease or elevated liver
enzymes and should be discontinued if substantial clinical benefit is
not seen within three weeks. Patients with severe dyskinesia or dystonia
should be treated with caution.

Patients should have baseline liver monitoring with follow-up monitoring
every two weeks for the first year, every four weeks for the next six
months and every eight weeks thereafter. Liver monitoring may not
prevent liver failure; however, early detection and immediate drug
withdrawal are believed to enhance the likelihood of recovery.
Patients should be advised to self- monitor for signs of liver disease.
TASMAR should be discontinued in patients whose liver enzyme levels
exceed the upper limit of normal or who exhibit signs and symptoms
suggesting onset of hepatic (liver) failure.

In clinical trials, adverse events reported when TASMAR was administered
in combination with levodopa/carbidopa were dyskinesia, nausea, sleep
disorders, dystonia, anorexia, diarrhea, somnolence, excessive
dreaming, muscle cramps, orthostatic complaints, dizziness, headache,
and hallucination and confusion. Diarrhea was the adverse event that
most commonly led to discontinuation of therapy.

TASMAR may potentiate the dopaminergic side effects of levodopa and may
require decreasing the dose of levodopa. However, some of these side
effects may persist despite levodopa dose adjustment. TASMAR should
not be used by patients taking nonselective MAO-A inhibitors, but may be
used by patients on MAO-B inhibitors.

Other important prescribing information is printed on the product
labeling. For more detail, see prescribing materials.

There is still a long way to go to finding a cure for this devastating
illness. However, until a cure is found, experts believe that early
diagnosis, improved medications and rehabilitation strategies will help
Parkinson's patients live a full and more enjoyable and productive life.

Copyright © 1999 PRNewswire.
--
Judith Richards, London, Ontario, Canada
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