Santhera Presents Clinical Efficacy Data of SNT-MC17 in DMD at the American Academy of Neurology Annual Meeting

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Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical
company focused on neuromuscular diseases, announces today that the
positive efficacy data from a 12-month Phase II clinical trial with
SNT-MC17 (INN: idebenone) in Duchenne Muscular Dystrophy (DMD) are
being presented at the 60th American Academy of Neurology (AAN)
Annual Meeting in Chicago, first, in a poster session on April 15 and
later, in a highlight session on April 17. The efficacy data on
cardiac and respiratory function provide the basis for a planned
pivotal clinical development program expected to start later in 2008.

Prof Gunnar Buyse, principal investigator of the DELPHI trial, will
present the results of this study (P02.115: "Double-Blind Randomized
Controlled Trial of SNT-MC17/Idebenone in Duchenne Muscular
Dystrophy"; Abstract 1736) at the 60th AAN Annual Meeting during the
Poster Session on April 15 from 11:30 am to 2:30 pm In addition, this
paper has been selected by the organizing committee for inclusion in
the session "Neuromuscular, EMG, and Autonomic Disorders Scientific
Topic Highlights at the 60th AAN Annual Meeting" on April 17 from
6:00 to 7:00 pm.

In the DELPHI trial patients on SNT-MC17/idebenone improved during
the 52-week treatment period on the primary endpoint, peak systolic
radial strain of the left ventricular (LV) inferolateral cardiac
wall, the region of the heart that is most severely affected in DMD
patients. Expressed as percent change from baseline, the patient
group treated with SNT-MC17/idebenone improved by 104% which was
significantly different from placebo treated patients who improved
only by 29% (p=0.03). In addition, peak systolic longitudinal strain
of the LV lateral-mid cardiac region also improved significantly,
indicating a beneficial effect of SNT-MC17/idebenone on early and
systolic myocardial dysfunction in DMD.

Secondary outcome measures of this study also included respiratory
function tests. Direct measures of respiratory weakness (peak
expiratory flow, maximal inspiratory pressure) improved in patients
on SNT-MC17/idebenone, indicating efficacy of SNT-MC17/idebenone to
improve early signs of respiratory weakness and insufficiency. For
example, peak flow expressed as percentage of the predicted value for
patients on SNT-MC17/idebenone improved by 2.8% while patients on
placebo deteriorated by 8.5% (p=0.042).

Prof Gunnar Buyse, associate professor of pediatrics and child
neurology at the University of Leuven and principal investigator of
the study, comments: "These are the first indications of clinical
efficacy of SNT-MC17/idebenone on functional cardiac and respiratory
parameters in DMD. It is particularly encouraging to see that
SNT-MC17/idebenone may protect from the potentially life-threatening
complications in DMD patients. The positive results provide a clear
basis for further clinical development studies to confirm the
potential therapeutic benefit of SNT-MC17/idebenone for this
devastating neuromuscular disease."

About the DELPHI (Duchenne Efficacy Study In Long-Term Protocol Of
High Dose Idebenone) trial

The 12-month Phase II trial has evaluated the efficacy and
tolerability of treatment with SNT-MC17/idebenone at a dose of
450mg/day compared to placebo in children with DMD. In total 21
patients, aged 8 to 16 years, with cardiac dysfunction were enrolled
in the double-blind, randomized, place-controlled study conducted at
the University of Leuven, Belgium. Thirteen patients received
SNT-MC17/idebenone while eight patients were randomized to the
placebo group. There were no drop-outs in the study and the
compliance was very good. Importantly, there was no difference in the
safety and tolerability of SNT-MC17/idebenone compared to placebo
underlining the excellent safety profile of the compound in
particular also in a pediatric population. Clinical efficacy of
SNT-MC17/idebenone was demonstrated on functional cardiac and
respiratory parameters (including the primary endpoint), that are
sensitive markers of cardiac disease and respiratory insufficiency.

About Duchenne Muscular Dystrophy (DMD)

DMD is the most common and a devastating type of muscular
degeneration and results in rapidly progressive muscle weakness. It
is a genetic, degenerative disease that is inherited in an X-linked
recessive mode. DMD affects approximately 30,000 patients in the USA,
EU, and Japan and its incidence is approximately 1 in 3,500 live born
males. Women can be carriers of DMD but usually exhibit no symptoms.
DMD is characterized by a complete loss of the protein dystrophin,
leading to progressive muscle weakness and wasting. The average age
of onset is between 3 and 5 years of age with a loss of ambulation in
teenage patients. Dilated cardiomyopathy and respiratory failure are
commonly associated with this chronic disease leading to early
morbidity and mortality in DMD patients.

* * *

About Santhera

Santhera Pharmaceuticals (SWX: SANN) is a Swiss specialty
pharmaceutical company focused on the discovery, development and
marketing of small-molecule pharmaceutical products for the treatment
of severe neuromuscular diseases. Santhera's vision is to become a
leading specialty pharmaceutical company offering therapies for a
number of indications in this area of high unmet medical need which
includes many orphan indications with no current therapy.

Santhera currently has five clinical-stage development programs,
three of which are investigating its lead compound, SNT-MC17 (INN:
idebenone), for the treatment of Friedreich's Ataxia (FRDA), Duchenne
Muscular Dystrophy (DMD) and Leber's Hereditary Optic Neuropathy
(LHON). Another clinical program is investigating JP-1730 (INN:
fipamezole) for the treatment of Dyskinesia in Parkinson's Disease
(DPD) in cooperation with Juvantia, the compound's owner. The fifth
program comprises SNT-317 (INN: omigapil) in Congenital Muscular
Dystrophies (CMD), a compound in-licensed from Novartis. For the most
advanced program, SNT-MC17 in FRDA, the Company has applied for
marketing authorization in the EU, Switzerland and Canada. In the US,
the compound is in Phase III clinical development for FRDA. The other
clinical programs are in Phase II. For further information, please
visit www.santhera.com.

For further information, contact

Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52
klaus.schollmeier@santhera.com

Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
barbara.heller@santhera.com

Thomas Staffelbach, VP Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.com

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Santhera Pharmaceuticals Holding AG
Hammerstrasse 47 Liestal
Switzerland

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