Boehringer Ingelheim Receives Approval From the European Commission for Mirapexin(R)/Sifrol(R) Prolonged-Release, Once Daily Tablet for the Treatment of Parkinson's Disease

Ingelheim, Germany (ots/PRNewswire) -

- New Formulation Brings the Established Efficacy of
Mirapexin(R)/Sifrol(R) to Patients With Parkinson's Disease in the
Convenience of a Once Daily Dose

Boehringer Ingelheim today announced that the
Mirapexin(R)/Sifrol(R) (pramipexole) new prolonged-release , once
daily tablet has been granted marketing authorisation by the
European Commission in all EU/EEA(*) countries for the treatment of
early and advanced idiopathic Parkinson's disease (PD). The approval
was based on the submission of clinical trial results showing that
the new formulation can offer an efficacy and safety profile
comparable to the immediate release tablet taken three times
daily.(1-6)

To view the Multimedia News Release, please click:

http://www.prnewswire.com/mnr/boehringeringelheim/39700/

In addition to clinical trial results that confirm the important
therapeutic benefits of the new formulation when administered in a
convenient once-a-day regimen, a further trial has shown that
patients already taking Mirapexin(R)/Sifrol(R) immediate release
tablets may easily be switched overnight to the
Mirapexin(R)/Sifrol(R) prolonged-release tablet, at the same daily
dose.(7,8)

"The European approval of the new formulation marks another big
step in meeting patients' needs and represents a milestone for this
worldwide highly successful treatment for Parkinson's disease. We are
very pleased that due to the robust evidence base, the regulatory
review experienced no delay, which will allow the first European
countries to already make the once daily tablet available to
patients," said Dr. Manfred Haehl, MD, Senior Vice-President Medicine
at Boehringer Ingelheim Corporate Headquarters. "In addition, the
data show that the prolonged-release Mirapexin(R)/Sifrol(R) tablet
causes less frequent fluctuations in the plasma concentration over 24
hours compared to the three times daily administration of the
immediate release tablet, an important aspect for physicians when
choosing the best treatment option for their patient."

Mary Baker, MBE, President of the European Federation of
Neurological Associations (EFNA) commented on the European approval
of the new formulation: "Most people with Parkinson's disease take
many different pills on a daily basis, to manage their PD symptoms
and other concomitant conditions. Being able to reduce their pill
burden without foregoing the effectiveness will be welcomed by
patients as well as by their care givers as it is expected that a
once-daily administration can improve patient adherence to their
treatment regimen."

A new drug application (NDA) for a once daily, extended release
formulation of pramipexole (marketed under the trade name Mirapex(R)
in the U.S.A.) is in review with the U.S. Food and Drug
Administration (FDA) for the treatment of Parkinson's disease
(currently available in the U.S.A. as immediate release formulation).

(*) all 27 Member States of the European Union plus Norway and
Iceland

For full version and references please visit http://www.boehringe
r-ingelheim.com/corporate/news/press_releases/index.asp.

ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Reinhard Malin, Corporate Division Communications,
Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Phone:
+49-6132-77 90815, Fax: +49-6132-72-6601, E-mail:
press@boehringer-ingelheim.com