Santhera's Ongoing Studies Prevent CHMP Review under Small Patient Populations Guideline - Company Expects Negative CHMP Opinion on MAA for SNT-MC17/Idebenone in Friedreich's Ataxia

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Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical
company focused on neuromuscular diseases announced today that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMEA) has informally advised Santhera that it would
not support a positive opinion for the Marketing Authorization
Application (MAA) for SNT-MC17/idebenone to treat patients with
Friedreich's Ataxia at this time. According to the information
received, Santhera's ongoing phase III trials prevented the CHMP from
reviewing the Company's application under the EMEA Guideline on
Clinical Trials in Small Populations as requested by Santhera in its
MAA filing. The Company's understanding is that the Committee
believes it cannot approve the drug before data from at least one of
Santhera's advanced phase III clinical programs in Europe and the
United States are submitted for review.

In clinical studies submitted to the CHMP as part of the approval
process, SNT-MC17/idebenone showed statistically and clinically
relevant improvements in Friedreich's Ataxia patients, as measured by
Activities of Daily Living scores as well as in cardiac and
neurological functions. The CHMP Joint Assessment Report supports the
safety profile, preclinical data and technical development of
SNT-MC17/idebenone as sufficient to potentially meet its criteria for
approval. However, the CHMP concluded that Santhera had not submitted
a sufficient set of data demonstrating a clear positive risk/benefit
balance for approval under the Committee's standard clinical review
guidelines. The MAA filing was based primarily on positive pediatric
data generated in the NICOSIA (NIH COllaboration with Santhera in
Ataxia) study, a collaborative trial with the US National Institutes
of Health, analyzing a variety of neurological and cardiac outcome
measures and was supported by evidence from several academic trials
in a wider population that demonstrated efficacy in the treatment of
cardiac hypertrophy in Friedreich's Ataxia patients.

Klaus Schollmeier, Chief Executive Officer of Santhera, commented:
"The possible negative CHMP opinion is obviously disappointing and
surprising as well. Based on earlier discussions, we had expected to
qualify for the EMEA Guideline on Clinical Trials in Small
Populations. When we submitted the MAA, our European phase III
clinical trial MICONOS was running, but we were very concerned about
our enrollment prospects. At that time, our US phase III trial IONIA
had not even yet started. We kept the Committee informed about the
status of both trials throughout the MAA filing process. It seems
that our success in gathering additional data has been working
against us. Together with our partner Takeda, we will evaluate our
options for making SNT-MC17/idebenone available as a controlled
pharmaceutical product to Friedreich's Ataxia patients in Europe as
soon as feasible".

The EMEA has a formal process whereby the MAA sponsor may request
reexamination of the CHMP's initial negative opinion, including a
review of the dossier by an independent specialist Scientific
Advisory Group. If Santhera requests such a review, a final opinion
could be rendered within approximately six months. Santhera together
with its marketing partner Takeda are evaluating this option
carefully. If this alternative is pursued, the appeal must be
submitted within the next 15 days from the official CHMP opinion.

Update on ongoing Phase III clinical trials
In Europe, the MICONOS (Mitochondrial Protection With Idebenone In
Cardiological Or Neurological Outcome Study) phase III trial has
currently enrolled approximately 90% of the patients needed to
complete recruitment and is on track for full enrollment by the end
of 2008.

In the United States, the IONIA (Idebenone effects On Neurological
ICARS Assessments) phase III trial has currently enrolled 41
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 final study will include
about 60 to 65 patients.

Pipeline Status and Updated Financial Guidance
Santhera will provide information on the status of its entire
development pipeline and to update on financial guidance as part of
its Half-Year Financial Results Report on August, 22, 2008.

Conference call
At 19.00 CET / 18.00 UKT / 13.00 EST on July 24, 2008, Santhera will
host a conference call. People interested in participating may join
the teleconference facility using the following dial-in in
Switzerland +41 52 267 07 36. The conference call will be recorded
for playback and is available one hour after the conference call ends
and for 20 days under +41 52 267 07 00 (reference no. 668713).

The Company was informed by the CHMP at 18:36 CET and acknowledges
the late-breaking nature of this news. Management will be available
after the call as well as all day Friday to respond to questions from
anyone who missed the opportunity to participate in the live
teleconference conference.

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 both 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 (INN: 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.
SNT-MC17/idebenone has also shown efficacy in a phase II clinical
trial as a potential treatment for the indication Duchenne Muscular
Dystrophy. 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, 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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