Santhera Provides Update on Clinical/Regulatory Processes with SNT-MC17/Idebenone for the Treatment of Friedreich's Ataxia

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Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical
company focused on neuromuscular diseases, today gave an update on
the clinical and regulatory processes surrounding the
commercialization of SNT-MC17/idebenone for the treatment of
Friedreich's Ataxia. The Company requested reexamination of the
negative opinion by the CHMP regarding Sovrima® (idebenone), despite
the progress of its ongoing Phase III trials. As previously
announced, the advanced status of Santhera's Phase III trials
appeared to have prevented a review by the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMEA)
on the Company's Marketing Authorization Application (MAA) under the
EMEA Guideline on Clinical Trials in Small Populations, as requested
upon filing of the MAA in 2007. Meanwhile, Health Canada has
published the product monograph of Catena® (idebenone), subsequent to
the July 24 approval of the drug to treat symptoms of Friedreich's
Ataxia under a Notice of Compliance with Conditions.

Despite the good progress of the ongoing phase III studies, Santhera
requested reassessment of the CHMP's initial negative opinion on an
EU approval. The Company has 60 days starting from the day of the
CHMP opinion to forward detailed grounds for requesting
reexamination. For the procedure, the CHMP will appoint a different
rapporteur and, as requested by Santhera, consult with a specialist
Scientific Advisory Group for specific questions.

In Europe, the MICONOS (Mitochondrial Protection With Idebenone In
Cardiac Or Neurological Outcome Study) Phase III trial has currently
enrolled 182 patients, i.e. approx. 90% of the patients needed to
complete recruitment and is on track for full enrollment in 2008.

In the United States, the IONIA (Idebenone effects On Neurological
ICARS Assessments) Phase III trial has currently enrolled 48
patients. It was agreed with the US Food and Drug Administration
under a Special Protocol Assessment process to recruit a minimum of
51 patients but to include more patients if available. Given the
current prospects for patient availability, Santhera and its US
clinical investigators believe that the study can enroll about 60 to
65 patients by early Q4 2008.

Klaus Schollmeier, Chief Executive Officer of Santhera, commented:
"Together with our European marketing partner Takeda, we concluded
that requesting reexamination of the initial CHMP opinion is a
feasible option for making this important drug available as a
controlled pharmaceutical product to patients throughout Europe as we
are allowed to do in Canada following the recent marketing
authorization under conditions for Catena® in that country. We are
aware of the challenges of such reexamination processes, but we
believe that the clinical benefit afforded to Friedreich's Ataxia
patients was underestimated in the initial assessment."

About Friedreich's Ataxia

Friedreich's Ataxia is a rare but severe genetic neuromuscular
disorder that results in the degeneration of an individual's nerve
and muscle tissue. This disorder causes loss of muscle control,
uncoordinated movements, muscle wasting and thickening of heart walls
which frequently leads to a shortened life span. Friedreich's Ataxia
affects both Caucasian males and females equally and it is estimated
that about 20,000 patients suffer from the disease in North America
and Europe. Average life expectancy for Friedreich's Ataxia patients
is limited to approximately 35 to 50 years.

The disorder results from a genetic defect in the gene encoding for
frataxin. Reduced levels of this protein ultimately result in
impaired energy production in mitochondria, the cells' energy
production centers, and elevated oxidative stress. Tissues that have
the highest need for energy, in particular nerve and cardiac tissues,
are primarily affected by frataxin deficiency resulting in
pathological changes in heart muscle anatomy and function and loss of
nerve cells.

* * *

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, an area of high unmet medical need
which includes many orphan indications with no current therapy.
Santhera currently investigates three compounds in five
clinical-stage development programs. The Company's first product,
SNT-MC17/idebenone, has received a marketing approval with conditions
from Health Canada to treat Friedreich's Ataxia and will be marketed
under its brand name Catena®. The product is also under review by
health authorities in the EU and in Switzerland, while in the United
States, a pivotal Phase III trial is recruiting patients. The
compound has also shown efficacy in a Phase II clinical trial as a
potential treatment for Duchenne Muscular Dystrophy. For further
information, please visit the Company's website www.santhera.com.

Sovrima® is a trademark of Takeda Pharmaceuticals in the European
Union and Switzerland.
Catena® is a trademark of Santhera Pharmaceuticals, registered in
Canada and the United States.

Please check also www.emea.europa.eu/pdfs/human/euleg/5074505en.pdf
for further details on such reexamination procedures.

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

Disclaimer/Forward-looking statements

This communication does not constitute an offer or invitation to
subscribe for or purchase any securities of Santhera Pharmaceuticals
Holding AG. This publication may contain certain forward-looking
statements concerning the company and its business. Such statements
involve certain risks, uncertainties and other factors which could
cause the actual results, financial condition, performance or
achievements of the company to be materially different from those
expressed or implied by such statements. Readers should therefore not
place undue reliance on these statements, particularly not in
connection with any contract or investment decision. The company
disclaims any obligation to update these forward-looking statements.

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Santhera Pharmaceuticals Holding AG
Hammerstrasse 47 Liestal
Switzerland

WKN: A0LCUK; ISIN: CH0027148649; Index: SPI, SPIEX, SSCI;
Listed:
Main Market in SWX Swiss Exchange;
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