Santhera Receives First Product Approval: Health Canada Approves Catena® for Treatment of Friedreich's Ataxia

Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical
company focused on neuromuscular diseases, announced today that
Health Canada has approved with conditions SNT-MC17/idebenone for the
treatment of Friedreich's Ataxia. Health Canada's decision is the
first marketing authorization worldwide for any Friedreich's Ataxia
therapy. The new drug will be marketed in Canada under the brand name
Catena®. Santhera has established a wholly owned Canadian subsidiary,
Santhera Pharmaceuticals (Canada), Inc. recently incorporated in
Montréal, Quebec, to address the needs of Canada's several hundred
patients with this rare and severely progressive muscle disease.
Launch of Catena is anticipated for the end of October 2008.

In clinical studies submitted to Health Canada as part of the
approval process, Catena showed statistically and clinically relevant
improvements in Friedreich's Ataxia patients, as measured by
Activities of Daily Living scores as well as cardiac and neurological
functions. The approved product labeling allows for the treatment of
symptoms of Friedreich's Ataxia. Two doses are approved: a starting
dose of 450 mg/day for patients below 45 kg body weight and
900 mg/day for patients above 45 kg body weight whereby treating
physicians have an option to dose up to 1,350 mg/day for patients
below 45 kg body weight and up to 2,250 mg/day for patients of more
than 45 kg body weight if needed. Under the conditions of the Notice
of Compliance with Conditions, Santhera has agreed to submit
additional data from its ongoing phase III clinical trial in the
United States to confirm the efficacy of the therapy.

Klaus Schollmeier, Chief Executive Officer of Santhera said: "We are
very pleased about this market authorization by the Canadian
authority. Health Canada concluded that the data presented were
promising enough to allow Catena's approval for the benefit of
patients now while requiring confirmatory efficacy data when they
become available. Today's approval is a major milestone for the
Friedreich's Ataxia community in Canada and elsewhere. For the first
time, physicians will be able to offer patients an approved, safe and
efficacious therapy to treat their devastating disease." He
continued: "This first marketing authorization marks a significant
event for our Company, one that has been our goal since the inception
of Santhera in 2004. Today, Santhera's vision of offering therapies
for orphan indications is becoming reality. The entire team at
Santhera is energized by this success and is even further encouraged
to work towards approvals in other regions."

MJ Roach, VP Marketing & Sales and Santhera's General Manager for
North America, commented: "Canada's marketing authorization provides
an excellent foundation to establish a medical and marketing platform
in North America for the treatment of rare neuromuscular diseases in
general and for Friedreich's Ataxia in particular. The Canadian
market will also provide valuable insights for launching the product
in the United States, once the ongoing clinical trial is completed
and the product is approved. We look forward to working with
physicians in Canada who prescribe Catena to Friedreich's Ataxia
patients."

Update on ongoing phase III clinical trial
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.

Conference call
At 19.00 CET / 18.00 UKT / 13.00 EST on July 24, 2008, Santhera will
host a conference call. Anyone 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).

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 Catena®
Catena may be useful in the symptomatic management of patients with
Friedreich's Ataxia. The drug is believed to increase the supply of
energy to cells in the body. Additionally it has antioxidant
properties and may protect the cells in the body which are damaged by
the disease.

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

About Notice of Compliance with Conditions
A Notice of Compliance with Conditions (NOC/c) is an authorization to
market a drug in Canada issued by Health Canada, indicating that the
sponsor has agreed to undertake additional studies to confirm the
clinical benefit of the product. A market authorization under the
NOC/c policy allows Health Canada to provide earlier market access to
potentially life-saving drugs. Eligibility for an NOC/c is restricted
to promising new drug therapies intended for the treatment,
prevention or diagnosis of serious, life-threatening or severely
debilitating diseases or conditions for which a) there is no
alternative therapy available on the Canadian market or, b) where the
new product represents a significant improvement in the benefit/risk
profile over existing products. Once a sponsor provides satisfactory
evidence of the drug's clinical effectiveness, and all the conditions
agreed upon have been met, Health Canada will remove the conditions
associated with market authorization in favor of a full approval.

* * *

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 for the
same indication, 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
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Holding AG. This publication may contain certain forward-looking
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Copyright © Hugin AS 2008. All rights reserved.