Santhera's Omigapil Receives Orphan Drug Designation from FDA and EMEA

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Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical
company focused on neuromuscular diseases, announces today that the
US Food and Drug Administration (FDA) has granted orphan drug
designation to SNT-317/omigapil for treatment of Congenital Muscular
Dystrophy. This severe, genetically determined neuromuscular
condition frequently affects infants or young children with
life-threatening progressive muscle weakness. The decision from the
FDA follows shortly after the European Medicines Agency (EMEA)
granted orphan drug designation for the two most common subtypes of
the disease.

Orphan drug legislation in the United States and the European Union
are designed to encourage pharmaceutical companies to develop
treatments for rare conditions. The FDA and the EMEA define orphan
diseases as affecting fewer than 200,000 individuals (US) or no more
than 5 in 10,000 (EU). Products eligible for orphan drug status enjoy
market exclusivity of up to seven (US) and ten (EU) years following
the date of marketing approval. Additional incentives include tax
credits, fee waivers for regulatory submissions and others.

In 2007, Santhera licensed omigapil from Novartis for development in
Congenital Muscular Dystrophy and other neuromuscular diseases. Tests
in a disease-relevant model have shown that SNT-317/omigapil prevents
apoptosis and ameliorates the pathology of laminin-alpha 2 deficient
muscular dystrophy. Preclinical data will be presented at the
upcoming 13th International World Muscle Society Congress in
Newcastle, United Kingdom, from September 29 to October 2, 2008.

About Congenital Muscular Dystrophy
Congenital Muscular Dystrophy refers to a group of inherited
neuromuscular disorders which frequently affects infants or young
children with life-threatening progressive muscle weakness. The best
epidemiological estimate approximates one patient in every 20,000 to
50,000 newborn children. Congenital Muscular Dystrophy is
characterized by progressive loss of muscle tissue or hypotonia which
in severe forms can already affect newborns ("floppy infant
syndrome"). Other symptoms include loss of body weight, skeletal
deformations and respiratory distress. Complications associated with
the disorder cause immobility at young age and early mortality. The
most common subtypes are Ullrich Congenital Muscular Dystrophy (UCMD)
and Bethlem Myopathy (BM), caused by mutations in one of the three
collagen VI genes, and MDC1A which is caused by mutations in the gene
encoding laminin-alpha 2, a protein in the extracellular matrix of
muscle cells. No pharmacological therapy is currently available or in
advanced clinical development for Congenital Muscular Dystrophy.
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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.

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

For further information, contact

Thomas Meier, Chief Scientific Officer
Phone: +41 (0)61 906 89 87
thomas.meier@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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