Publication Highlights Potential of Santhera's Oral MC4-Receptor Antagonist Program for Treatment of Cancer Cachexia

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Santhera Pharmaceuticals (SIX: SANN), a Swiss specialty
pharmaceutical company focused on orphan neuromuscular diseases,
announced today the peer-reviewed publication of preclinical data on
melanocortin 4 (MC4)-receptor antagonists for potential treatment of
Cancer Cachexia (severe muscle wasting) in PLoS ONE (Publication
Library of Sciences ONE [1]). The Company's new orally active
compounds significantly increase food intake in healthy animals and
prevent cancer-induced body weight loss in disease-relevant models.
In vivo data of Santhera's MC4-receptor antagonist program will also
be presented at the upcoming National Meeting and Exhibition of the
American Chemical Society in Salt Lake City, UT [2; 3].

Data published in PLoS ONE refer to two non peptidic and chemically
unrelated MC4-receptor antagonists (tool compounds SNT207707 and
SNT209858) that are orally active and cross the blood brain barrier.
Both compounds were found to distinctly increase food intake in
healthy mice. Moreover, in mice carrying a C26 adenocarcinoma
repeated oral administration almost completely prevented the
development of cachexia, i.e. significantly reduced tumor-induced
weight loss, and showed beneficial effects on lean body mass and fat
mass. In contrast to previously reported peptidic and small-molecule
MC4-receptor antagonists, the compounds described here can be applied
orally and, therefore, offer a considerable advantage for the
treatment of cachexia patients.

Thomas Meier, Chief Scientific Officer of Santhera, said: "Treatment
of Cancer Cachexia with MC4-receptor antagonists offers a promising
therapy option for this severe and often deadly metabolic syndrome.
The prevention of body weight loss in disease-relevant models and the
distinct increase in food intake position this compound class as
potential therapy for Cancer Cachexia. Over the last few months, we
have achieved a breakthrough in efficacy and oral bioavailability
with a new generation of compounds in two chemical families.
Meanwhile, we have a strong back-up program for our lead compounds
available and we are confident to select a clinical candidate in due
course."

Santhera anticipates entering into the clinic with its lead compound
in 2010. The Company has initiated partnering activities to build a
strategic alliance for further development and commercialization of
the program.

About cachexia syndrome and MC4-receptor antagonists
Cachexia (Greek for "poor condition") syndrome is one of the most
debilitating and life-threatening aspects of cancer and other severe
chronic illnesses. The syndrome is associated with anorexia (lack of
appetite), fat and muscle tissue wasting, psychological distress and
a progressively decreasing quality of life. Cachexia is characterized
by major metabolic abnormalities and maladaptations such as reduced
food and energy intake, increased resting energy expenditure and
accelerated catabolism. Typically, the involuntary weight loss in
excess of 5% in 12 months cannot be compensated for by increased food
intake, which results in wasting of both adipose and skeletal muscle
tissue and poor physical performance.

The exact nature of the underlying processes remains largely unknown,
however, appetite regulating peptides, pro-inflammatory cytokines and
other regulatory peptides are considered to be major factors. One
pathway by which cytokines can induce anorexia is via an increase of
pro-opiomelanocortin (POMC) gene expression in hypothalamic feeding
circuits, leading to an enhanced production of alpha-melanocyte
stimulating hormone (alpha-MSH), a strong inhibitor of appetite. The
MC4-receptor in the hypothalamus is a crucial target in the pathway
through which alpha-MSH exerts its appetite inhibiting effects. AgRP
(agouti related protein) or small molecule MC4-receptor antagonists
enhance food intake, reduce energy expenditure and catabolic
activity. Accordingly, an interruption of this signaling pathway by
means of MC4-receptor antagonists is seen as a promising treatment
option for cachexia.

Cancer Cachexia affects about one million patients in the North
America and Europe. Up to 80% of cancer patients suffer from the
syndrome which accounts for approximately 20% of cancer deaths.
Despite this high unmet medical need, no effective treatments are
available. Currently used pharmacological interventions have limited
utility or produce severe side-effects. The potential market size of
the Cancer Cachexia market is estimated to be above USD 1 billion.

References
[1] Weyermann P, Dallmann R, Magyar J, Anklin C, Hufschmid M, et al.
(2009) Orally Available Selective Melanocortin-4 Receptor Antagonists
Stimulate Food Intake and Reduce Cancer-Induced Cachexia in Mice.
PLoS ONE 4(3): e4774. doi:10.1371/journal.pone.0004774. March 2009,
Volume 4, Issue 3, e4774.

[2] Soeberdt M. et al., Synthesis and evaluation of a novel, potent
and selective, orally bioavailable melanocortin-4 receptor antagonist
for the treatment of cancer cachexia (MEDI 068);
[3] Weyermann P. et al., Discovery and in vivo efficacy of a novel,
selective, and orally bioavailable Melanocortin-4 receptor antagonist
for the treatment of cancer cachexia (MEDI 090).
Both posters will be presented at the American Chemical Society's
237th National Meeting and Exhibition, March 22 to 26, 2009, Salt
Lake City, UT.

* * *
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's first product, Catena®, has received marketing
approval from Health Canada to treat Friedreich's Ataxia. The drug is
investigated in two fully recruited pivotal trials in the United
States and in Europe. The same compound has also shown efficacy in a
clinical trial as a potential treatment for Duchenne Muscular
Dystrophy. For further information, please visit the Company's Web
site www.santhera.com.

Catena® is a trademark of Santhera Pharmaceuticals.

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
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Switzerland

WKN: A0LCUK; ISIN: CH0027148649; Index: SPI, SPIEX, SSCI;
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