ADAGIO trial results show Azilect® slows progression of Parkinson's disease

Lundbeck's partner Teva Pharmaceutical Industries Ltd. has announced
today that results of the phase III ADAGIO trial were presented
during the 12th Congress of European Federation of Neurological
Societies (EFNS) in Madrid, Spain. The ADAGIO study showed that
Parkinson's disease patients who took Azilect® (rasagiline) 1mg
tablets once-daily upon entry into the trial, demonstrated a
significant improvement compared to those who initiated therapy with
the drug nine months later. The 1mg dose met all three primary
endpoints, as well as the secondary endpoint, with statistical
significance.

The primary analysis included three hierarchical endpoints based on
Total-UPDRS (Unified Parkinson's Disease Rating Scale) scores: A)
superiority of slopes in weeks 12-36 (-0.05; p=0.013, 95%CI
-0.08,-0.01), B) change from baseline to week 72 (-1.7 units;
p=0.025, 95%CI -3.15,-0.21), and C) non-inferiority of slopes (0.15
margin) in weeks 48-72 (0.0; 90%CI -0.04,0.04). The safety profile of
Azilect® seen in the ADAGIO study was similar to previous experience
with Azilect®.

Main results were presented at the congress by Professor Olivier
Rascol, M.D., Ph.D., Department of Clinical Pharmacology, University
Hospital, Toulouse, France, one of two principal investigators of the
trial."The rigorous trial design and the fact that all three primary
endpoints were met with statistical significance reinforce the
quality of the data, supporting the potential for Azilect® to have an
effect on disease progression," said Prof. Rascol. "The successful
outcome of the study provides further rationale for the early use of
Azilect® among Parkinson's disease patients," he added."Delaying disease progression is the most important unmet need in the
management of Parkinson's disease," stated Prof. C. Warren Olanow,
professor and chairman of the Department of Neurology at the Mount
Sinai School of Medicine, New York, NY, and ADAGIO co-principal
investigator. "The ADAGIO study, the first of its kind, was
prospectively designed to demonstrate if Azilect® can slow down the
progression of Parkinson's disease.  Results of the study show that
early treatment with once-daily rasagiline 1mg tablets provided
significant clinical benefits that were not obtained by those
patients where initiation of Azilect® therapy was delayed by nine
months."

The ADAGIO study, one of the largest conducted in Parkinson's
disease, included 1,176 patients with very early Parkinson's disease
in 14 countries and 129 medical centers who were randomized to
receive rasagiline 1 or 2 mg/day for 72 weeks (early start) or
placebo for 36 weeks followed by rasagiline 1 or 2 mg/day for 36
weeks (delayed start).

Description of the trial results can be found online
(http://www.abstracts2view.com/ana) in the abstract submitted by
Prof. Olanow and Prof. Rascol to the 133rd Annual Meeting of the
American Neurological Association, Salt Lake City, UT, September
21-24, 2008. Prof. Olanow will be presenting these results during the
Works in Progress poster session on Tuesday, September 23, 2008. The
abstract was also chosen to be presented orally by Prof. Olanow on
Tuesday from 11:45am-noon.

The results of the ADAGIO trial are expected to be submitted to the
regulatory authorities in Europe with the aim to have the results
incorporated into the label for AzilectÒ.

Lundbeck markets Azilect® in Europe, jointly with Teva in a number of
countries. In addition Lundbeck markets Azilect® in some countries
outside Europe.

About the study
ADAGIO is a randomized, multi-center, double-blind,
placebo-controlled, parallel-group study prospectively examining
rasagiline's potential disease-modifying effects in 1,176 patients
with early, untreated Parkinson's disease. Patients from 129 centers
in 14 countries were randomized to early-start treatment (72 weeks
rasagiline 1 or 2 mg once daily) or delayed-start treatment (36 weeks
placebo followed by 36 weeks rasagiline 1 or 2 mg once daily [active
treatment phase]). The primary analyses of the trial were based on
change in total UPDRS (Unified Parkinson's Disease Rating Scale) and
included slope superiority of rasagiline over placebo in the
placebo-controlled phase, change from baseline to week 72, and
non-inferiority of early-start vs. delayed-start slopes during weeks
48-72 of the active phase. UPDRS is the most commonly used rating
scale to assess disease status.

About Azilect®
Azilect® 1mg tablets (rasagiline tablets) are indicated for the
treatment of the signs and symptoms of Parkinson's disease both as
initial therapy alone and to be added to levodopa later in the
disease.

For more information on Azilect®, please visit www.azilect.com.

About Parkinson's disease
Parkinson's disease is an age-related degenerative disorder of the
brain. Symptoms can include: tremor, stiffness, slowness of movement,
and impaired balance. An estimated four million people worldwide
suffer from the disease, which usually affects people over the age of
60.

The content of this release will have no influence on the Lundbeck
Group's financial result for 2008.

Lundbeck contacts


Investors:                 Media:

Jacob Tolstrup             Jens Harder Højbjerg
Director                   Media Relations Manager
+45 36 43 30 79            +45 36 43 28 33

Palle Holm Olesen
Head of Investor Relations
+45 36 43 24 26


Stock Exchange Release No 354 - 26 August 2008

About Lundbeck
H. Lundbeck A/S is an international pharmaceutical company engaged in
the research and development, production, marketing and sale of
pharmaceuticals for the treatment of psychiatric and neurological
disorders. In 2007, the company's revenue was DKK 11 billion
(approximately EUR 1.5 billion or USD 2.0 billion). The number of
employees is approx. 5,300 globally. For more information, please
visit www.lundbeck.com.