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Santhera Launches CATENA® in Canada

Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




Santhera Pharmaceuticals (SWX: SANN), a Swiss specialty
pharmaceutical company with a focus on neuromuscular diseases,
announced today the launch of CATENA® (idebenone) in Canada. The drug
is indicated for the treatment of Friedreich's Ataxia, a rare
neuromuscular disease that results in the degeneration of nerve and
muscle tissue. Catena is the first and only approved therapy in
Canada to treat this devastating genetic disorder. Santhera believes
that there are a few hundred Friedreich's Ataxia patients in Canada
with a higher density in the Quebec Province, where the prevalence
ranks among the highest concentrations in North America. The Company
is working with physicians, patient advocacy groups, government
agencies and insurance companies in order to quickly provide Catena
to the patients. First prescriptions are being processed.

Dr. Bernard Brais, Neurogeneticist at Notre-Dame Hospital and
associate Professor of Neurology at University of Montreal in
Montreal, Quebec, commented: "For more than 30 years researchers in
Canada have contributed to our growing understanding of Friedreich's
Ataxia. I am excited to finally be able to prescribe a treatment to
my patients for their progressive neurological disorder. It is nice
to see that a company like Santhera is putting so much effort in
ensuring that Catena be recognized as the first treatment for this
orphan disease."

Dr. Durhane Wong-Rieger, President of CORD, the Canadian Organization
for Rare Disorders (www.raredisorders.ca) said: "We salute the
arrival of Catena and Health Canada's approval of this important
drug. It is now essential that governments, insurers and treatment
centers combine their efforts and assist Friedreich's Ataxia patients
in accessing this new therapeutic advancement."

Brenda Dixon, former President of BC Ataxia Society
(www.bcataxia.org), currently Vice-President and a Friedreich's
Ataxia patient herself, said: "The launch of a first approved therapy
is a major event for the whole Friedreich's Ataxia community in
Canada. We all have been longing for this moment for many years. It
is good to see companies like Santhera develop drugs for patients
with rare diseases, an often forgotten patient population."

"The launch of Catena in Canada is a first in many aspects: Catena is
our first product and Canada its first market. More importantly, for
the first time ever, physicians can prescribe an approved, safe and
efficacious therapy to patients suffering from Friedreich's Ataxia",
commented Klaus Schollmeier, Chief Executive Officer of Santhera.
"Everyone at Santhera is energized to bring this important drug to
Friedreich's Ataxia patients, and we managed to be on the Canadian
market ahead of our original schedule. We are already experiencing
great support from all parties involved and the first signals
indicate that our expectations for Canada will be exceeded in all
aspects."

Catena is indicated in Canada for the treatment of symptoms of
Friedreich's Ataxia in two dose therapies: A lower dose of 450 mg/day
for patients weighing 45 kg or under and 900 mg/day for patients
weighing over 45 kg. Based on clinical judgment, treating physicians
can use the higher dose therapy, i.e. 1,350 mg/day for patients under
45 kg and 2,250 mg/day for patients above 45 kg body weight. Catena
is supplied in polyethylene bottles containing 90 (the initial launch
package size), 180, 270 and 450 tablets, containing 150 mg idebenone
each.

Catena has received a marketing approval with conditions (NOC/c) from
Health Canada and is marketed in Canada by Santhera's wholly-owned
subsidiary, Santhera Pharmaceuticals (Canada), Inc. Catena is
distributed through a specialty pharmacy model that allows product to
be shipped directly to patients' homes.

* * *

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.
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.



--- End of Message ---

Santhera Pharmaceuticals Holding AG
Hammerstrasse 47 Liestal
Switzerland

WKN: A0LCUK; ISIN: CH0027148649; Index: SPI, SPIEX, SSCI;
Listed:
Main Market in SWX Swiss Exchange;
Copyright © Hugin AS 2008. All rights reserved.



 
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