Boehringer Ingelheim's Pramipexole (Mirapexin(R)/Sifrol(R)) Shown to Improve Depressive and Motivational Symptoms in Parkinson's Disease

Kyoto, Japan (ots/PRNewswire) -

- Further Therapeutic Potential of Pramipexole to be Investigated
in New Disease-Modification Trial

- For non-US Healthcare Media

New data presented today from a meta-analysis* of nearly 1,300
Parkinson's disease (PD) patients indicate that pramipexole
(Mirapexin(R) /Sifrol(R)) has a beneficial effect on depressive and
motivational symptoms in PD.(1) This confirms findings from
previously published clinical trials,(2,3,4) and is in addition to
its established efficacy in controlling motor symptoms. These
findings are of particular interest as mood symptoms in PD can affect
up to 50 percent of the patient population.(1,5) The data were
presented at the 10th International Congress of Parkinson's Disease
and Movement Disorders (MDS) in Kyoto, Japan.

"We frequently hear from people living with Parkinson's disease
that it is not necessarily the motor symptoms they find the most
challenging," said Mary Baker, Patron and Immediate Past President,
European Parkinson's Disease Association (EPDA). "Low mood, concern
about the future and lack of motivation can have even more impact on
their quality of life and the lives of those who care for them."

The results of the meta-analysis showed that depressive symptoms
of PD (measured using the UPDRS scale) significantly improved in 61.0
percent of patients treated with pramipexole compared to only 40.5
percent of patients treated with placebo.(1) Moreover, motivation
also significantly improved in 64.8 percent with pramipexole compared
to only 42.4 percent treated with placebo.(1) These results provide
additional insights in the potential anti-depressant effects of
pramipexole in treating PD-related mood symptoms - in addition to its
efficacy in motor control - suggesting only one medication might be
needed to treat the broad spectrum of PD-related symptoms.

Depressive and motivational symptoms are an intrinsic part of
Parkinson's disease and are associated with reduced dopaminergic
activity.(1) In up to 30 percent of cases, depression may even
manifest itself as the first symptom of PD, preceding the onset of
motor symptoms.(5) Thus, it is a crucial factor in early diagnosis of
the condition.

The effect of early versus delayed pramipexole treatment to be
explored

Also launched at the MDS Congress today was a new global clinical
trial, PROUD (Impact of Pramipexole On Underlying Disease) (6),
designed to examine whether there is an advantage to treating PD with
pramipexole early after onset of symptoms, in order to slow or
postpone future disability i.e. disease modification. 740 patients
will be enrolled in this trial with results being expected in March
2008. At present there are no therapies that have been demonstrated
clearly to postpone or slow the progressive disability of PD.

"Currently, common practice is to initiate drug therapy for
Parkinson's disease when symptoms have caused disability," said
Anthony Schapira, MD, Professor of Clinical Neurosciences, Royal Free
& University College Medical School. "However, we would like to
better understand how best to help patients who present with the
symptoms of early PD. Based on our clinical experience to date with
pramipexole in all stages of the disease, the study will also help to
assess the potential of pramipexole to treat this group of patients."

The data presented at the MDS Congress confirm pramipexole's
efficacy in treating both the depressive and motivational symptoms in
PD as well as the motor symptoms of the condition. In addition, the
PROUD trial will investigate its possible disease-modifying effect
and help to gain a better understanding of the full potential of
pramipexole in treating PD.

About Parkinson's Disease

Parkinson's disease is the second most common chronic neurological
disorder in older adults after Alzheimer's. Its worldwide prevalence
is estimated to be approximately one to two percent of those over 65
years.(6,7) Although traditionally PD is associated with motor
symptoms (such as tremor, rigidity, slowed motion, imbalance,
shuffling gait, loss of facial expression), the non-motor symptoms,
including depressive symptoms, pain, cognitive impairment and sleep
disorders can be significant. The symptoms can vary from patient to
patient, but worsen over time.

About pramipexole

Pramipexole (known in Europe under the trade names Sifrol(R) and
Mirapexin(R) and in the U.S.A. as Mirapex(R)) is a compound from
Boehringer Ingelheim research first licensed in 1997 for the
treatment of the signs and symptoms of idiopathic Parkinson's
disease, as monotherapy or in combination with levodopa. Pramipexole
was licensed in April 2006 throughout the European Union for the
symptomatic treatment of moderate to severe idiopathic Restless Legs
Syndrome (RLS) and is also approved in Australia, Brazil, Canada,
Mexico and others.

The most commonly reported adverse reactions in early and late
Parkinson's disease in clinical trials were dizziness, involuntary
movement, postural hypotension, constipation, hallucinations,
headache, difficulty falling asleep, sleepiness, nausea and fatigue.

The most commonly reported adverse reactions in clinical trials
for Restless Legs Syndrome were nausea, headache, and tiredness.

Pramipexole may cause patients to fall asleep without any warning,
even while doing normal daily activities such as driving. When taking
pramipexole hallucinations may occur and sometimes patients may feel
dizzy, sweaty or nauseated upon standing up. It should be noted that
impulse control disorders/compulsive behaviours may occur while
taking medicines to treat Parkinson's disease, including pramipexole.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 143 affiliates in 47 countries and almost
37,500 employees. Since it was founded in 1885, the family-owned
company has been committed to researching, developing, manufacturing
and marketing novel products of high therapeutic value for human and
veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro
while spending almost one fifth of net sales in its largest business
segment Prescription Medicines on research and development.

For more information please visit www.boehringer-ingelheim.com

Notes to Editor:

*The meta-analysis included 7 double-blind, placebo-controlled
pramipexole studies which all used Section 1 (mentation, behaviour
and mood) of the Unified Parkinson's Disease Rating Scale (UPDRS).(1)
Mean treatment was 151 days with pramipexole and 147 days with
placebo.(1)

The UPDRS scale(8) is a rating tool that was developed to provide
a comprehensive tool to follow the longitudinal course of PD-related
disability and impairment. The UPDRS is the most commonly used
instrument to capture multiple aspects of PD. It assesses both motor
disability (part II: activities of daily living) and motor impairment
(part III: motor section). In addition, part I addresses mental
dysfunction and mood, and part IV assesses treatment-related motor
and non-motor complications. A total score of 199 points is possible.
199 points represent the worst disability and 0 points no disability.

Disclaimer: Press release for international use. As to the
registration status in individual countries, please check with the
contact address indicated below or liaise with the country-specific
Boehringer Ingelheim affiliate.

References

1. Houben J et al. Pramipexole improves depressive and
motivational symptoms in Parkinson's disease. Abstract no. P575,
presented at MDS 2006; Kyoto, Japan.

2. Rektorova I et al. Pramipexole and pergolide in the treatment
of depression in Parkinson's disease: a national multicentre
prospective randomized study. Eur J Neurol. 2003;10:399-406

3. Barone et al. Pramipexole versus sertraline in the treatment of
depression in Parkinson's disease. A national multicenter
parallel-group randomized study. J Neurol 2006;253:601-607

4. Moeller JC et al. Long-term efficacy and safety of pramipexole
in advanced Parkinson's disease: results from a European multicenter
trial. Mov Disord. 2005;20:602-610.

5. Byrne R, Chaudhuri, KR. Depression: a key non-motor symptom of
Parkinson's disease. Progress in Neurology and Psychiatry (NY) 2006;
10(5):15-21.

6. Schapira AHV et al. Design of a randomized, placebo-controlled
trial of immediate vs deferred pramipexole for early-onset
Parkinson's disease. Abstract no. P511, presented at MDS 2006; Kyoto,
Japan.

7. de Rijk MC, Tzourio C, Breteler MM et al. Prevalence of
Parkinsonism and Parkinson's disease in Europe: the EUROPARKINSON
Collaborative Study. European Community Concerted Action on the
Epidemiology of Parkinson's disease. J Neurol Neurosurg Psychiatry
1997;62:10-5.

8. Fahn S, Elton RL. Recent Developments in PD. Vol. II;
Maximilian Healthcare Information Florham Park, NJ (1987), pp.
153-163, 293-304

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