Boehringer Ingelheim Receives Recommendation From EU Scientific Committee for Sifrol(R)/ Mirapexin(R) (Pramipexole) for the Treatment of Restless Legs Syndrome (RLS)

Ingelheim, Germany (ots/PRNewswire) -

- For Non-US Healthcare Professional Media

Boehringer Ingelheim announced today that that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMEA) has issued a positive opinion recommending approval of
Sifrol(R) / Mirapexin(R) (pramipexole) for the treatment of Restless
Legs Syndrome (RLS) in the European Union. Pramipexole is a dopamine
agonist currently approved for the treatment of Parkinson's Disease.
A supplementary new drug application (sNDA) has been filed with the
US Food and Drug Administration (FDA) to include treatment of RLS in
the US label also.

"Restless Legs Syndrome is a common yet very under-diagnosed
condition which adversely affects the lives of millions of people
worldwide. Global epidemiologic and quality of life studies show a
significant impact on RLS-patients' quality of life, comparable to
that of cardiovascular diseases [1]. The recommendation from the EU
scientific committee will be welcomed by the clinical community as it
reflects recognition of the need for effective treatment options for
the many patients who are suffering from this debilitating
condition." Professor Claudia Trenkwalder, Department of Clinical
Neurophysiology, University of Goettingen, Goettingen, Germany,
commented.

"Boehringer Ingelheim is committed to improving the lives of
patients suffering from Restless Legs Syndrome," said Dr. Andreas
Barner, member of the Board of Managing Directors of Boehringer
Ingelheim and responsible for Research & Development and Medicine.
"The recommendation from the CHMP is a major step towards an approval
for pramipexole in the European Union. A final decision from the
European Commission could be expected in the second quarter of 2006.
Pramipexole is already well established in the treatment of
Parkinson's Disease - our hope is that soon RLS patients will be able
to benefit from the efficacy of pramipexole in controlling not only
the symptoms of RLS, but also in reducing the high impact of the
disease on patients' quality of life."

If approved, this pharmaceutical treatment for Restless Legs
Syndrome will be marketed throughout the European Union by Boehringer
Ingelheim.

The CHMP Opinion stated that Sifrol(R)/Mirapexin(R) tablets are
indicated for the symptomatic treatment of moderate to severe
idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base
(0.75 mg of salt).

Efficacy in treating RLS

The registration programme for pramipexole included more than
1,000 patients in Europe and the United States. These study results
have confirmed that pramipexole provides rapid relief from symptoms
after just one week of starting treatment. Pramipexole is highly
efficacious at the starting dose of 0.125mg single dose per day and
up to 0.75mg single dose per day[2] and is well tolerated
[3],[4],[5].

The efficacy and tolerability of pramipexole in RLS continues to
be investigated in a comprehensive clinical trials programme with
more than 1,000 patients, to further assess the therapeutic potential
in this condition.

About Restless Legs Syndrome (RLS)

RLS is a neurological disorder characterised by an uncontrollable
urge to move the legs, usually accompanied by unpleasant and
sometimes painful sensations in the legs. RLS affects up to ten
percent of the population aged between 30 and 79 years[6] and around
one-third of sufferers experience symptoms more than twice weekly
causing moderate to severe distress[7]. The motor-restlessness
worsens during the evening and night causing difficulty initiating
and maintaining sleep. The sleep disruption can lead to excessive
daytime sleepiness and compromise work performance. RLS also has
considerable impact on social activities that require immobility.

About pramipexole

Pramipexole, a compound from Boehringer Ingelheim research, is
currently approved for the treatment of the signs and symptoms of
idiopathic Parkinson's Disease, as monotherapy or in combination with
levodopa. The most commonly reported adverse reactions in early and
late Parkinson's disease in clinical trials were dizziness,
dyskinesia, headache, insomnia, somnolence, constipation, nausea,
hallucinations visual, orthostatic hypotension and fatigue. Patients
have reported falling asleep without perceived warning signs during
activities of daily living, including operation of a motor vehicle,
which sometimes resulted in accidents. As also described in the
literature for antiparkinsonian dopamine replacement therapy, cases
of behavioural changes have been reported.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 144 affiliates in 45 countries and nearly
36,000 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 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro
while spending nearly 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

[1] Abetz L et al Evaluating the quality of life of patients with
restless legs syndrome Clin Ther 2004; 26(6) 925-935

[2]. Oertel W, Stiasny-Kolster K. Early and persistent effect of
pramipexole in RLS patients already with the starting dose. Movement
Disorders 2005, 20 (Suppl 10): S58-S59

[3]. Winkelman J; Sethi K; Kushida C; Becker P; Mahowald M.
Pramipexole is efficacious and safe in treating RLS patients: results
of a 12 weeks placebo controlled, fixed dose study. Sleep Med2005; 6
(Suppl 2): S74

[4]. Partinen M; Hirvonen K; Alakuijala A; Jama L; Terttunen J.
Rapid relief from RLS symptoms with pramipexole: results of a large
polysomnographic study. Neurology 2004; 63 (8):1545

[5]. C. Trenkwalder, K. Stiasny-Kolster and the German
RLS-Pramipexole Study Group. Sustained efficacy of Pramipexole in
Restless Legs Syndrome. Sleep Med 2005; 6 (Suppl 2): S73

[6]. Phillips B et al Epidemiology of restless legs symptoms in
adults Arch Intern Med 2000; 160(14): 2137-2141

[7]. Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell,
TJ Ferini-Strambi L, et al. Restless legs syndrome prevalence and
impact: REST general population study. Arch Intern Med 2005; 165
:1286 -1292

ots Originaltext: Boehringer Ingelheim
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Contact:
CONTACT: Ursula Bardon, Corporate Division Communications, Boehringer
Ingelheim GmbH, 55216 Ingelheim, Phone: +49-6132-77-2622, Fax:
+49-6132-72-2622