CHMP Confirms Original Opinion on Santhera's SNT-MC17/Idebenone for Treatment of Friedreich's Ataxia

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Santhera Pharmaceuticals (SIX: SANN), a Swiss specialty
pharmaceutical company focused on neuromuscular diseases, announced
today that the European Medicines Agency (EMEA) has informally
advised that it would maintain its negative opinion on the Company's
Marketing Authorization Application (MAA) for SNT-MC17/idebenone in
Friedreich's Ataxia. According to the information received, the
Committee for Medicinal Products for Human Use (CHMP) of the EMEA in
its reexamination concluded that it cannot support an early approval
at this point in time but rather prefers to wait until additional
data from at least one of Santhera's two pivotal trials become
available for review. The Company has two Phase III studies running
and both these trials have achieved their recruitment target.
Santhera intends to file for marketing authorization in the United
States and in the European Union next year.

Klaus Schollmeier, Chief Executive Officer of Santhera, commented:
"Our success in making additional data available in the near future
has been the major obstacle throughout the regular review process as
well as the reexamination. The confirmation of the original CHMP
opinion is obviously a disappointment but not a surprise. As a result
of today's decision, Friedreich's Ataxia patients in the European
Union must continue to wait for the first controlled pharmaceutical
product to treat their devastating disease. We confirm our commitment
to make this important drug available to patients in Europe and in
the United States as we are already able to do in Canada."

Meanwhile, Santhera's two Phase III trials are both recruited. In
Europe, the twelve-month MICONOS (Mitochondrial Protection With
Idebenone In Cardiac Or Neurological Outcome Study) trial has
achieved the enrollment of 204 Friedreich's Ataxia patients and will
be closed to recruitment shortly. In the United States, the last
patient was randomized into the IONIA (Idebenone effects On
Neurological ICARS Assessments) trial on October 31, 2008. A total of
70 Friedreich's Ataxia patients have been enrolled into this
six-month study. Subject to positive outcome of the IONIA trial,
Santhera expects to file a New Drug Application with the US Food and
Drug Administration (FDA) before the end of 2009. In the United
States, the program has been granted fast track status by the FDA in
2007. A new MAA is planned to be submitted to the EMEA within the
same timeframe.

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About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty
pharmaceutical company focused on the discovery, development and
commercialization 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 (INN: idebenone), has received a marketing approval with
conditions from Health Canada to treat Friedreich's Ataxia and is
marketed under its brand name CATENA®. The product is also under
review in Switzerland, while two pivotal clinical trials in the
United States and in Europe have recently achieved their enrollment
targets. 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.

CATENA® is a trademark of Santhera Pharmaceuticals, registered in
Canada and the United States.

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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