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2014-05-13

Santhera Pharmaceuticals Holding AG: Santhera Announces Successful Outcome of Phase III Study with Catena®/Raxone® in Duchenne Muscular Dystrophy

Santhera Pharmaceuticals Holding AG / Santhera Announces Successful Outcome of
Phase III Study with Catena®/Raxone® inDuchenne Muscular Dystrophy .
Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
Liestal, Switzerland, May 13, 2014
- Santhera Pharmaceuticals (SIX: SANN) announces today
that its Phase III DELOS study of orally administered Catena®/Raxone®(INN:
idebenone) in patients with Duchenne Muscular Dystrophy (DMD) met the primary
endpoint and achieved its primary objective of delaying the loss of
respiratory function compared to placebo
.

The Phase III, double-blind, placebo-controlled DELOS study randomized 65 DMD
patients who were 10-18 years of age and who were not using concomitant
corticosteroids. The study met the primary endpoint, the difference between
Catena®/Raxone®and placebo in the change from baseline to week 52 in Peak
Expiratory Flow (p=0.04). Peak Expiratory Flow is a measure of respiratory
muscle strength, the decline of which is a major contributing factor to
morbidity and mortality in DMD. Catena®/Raxone®(900 mg/day) was safe and well
tolerated with adverse event rates comparable to placebo. Other endpoint
analyses are ongoing and results of these will be disclosed shortly.

"We are thrilled by these results which are consistent with the findings of
our Phase II DELPHI and DELPHI Extension studies," commented Thomas Meier,
CEO of Santhera. "As acknowledged by clinicians and regulatory authorities,
preservation of respiratory function is a major benefit for patients with
DMD. On the basis of these results we will approach the US and European
authorities for discussions on the most expeditious regulatory pathway to
approval."

"I am very enthusiastic about the positive outcome for the DELOS trial. This
is tremendously good news for patients with DMD since it indicates that
Catena®/Raxone®can mitigate respiratory weakness and dysfunction," commented
Gunnar Buyse, M.D., Ph.D., Professor of Child Neurology at the University
Hospitals Leuven (Belgium) and Principal Investigator for the DELOS study.

Santhera holds global commercialization rights to the DMD program, which has
been granted orphan drug designation and patent protection in the US and EU.

About Catena®/Raxone®as Treatment of Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy is one of the most common and devastating types of
muscle de-generation and results in rapidly progressive muscle weakness. It
is a genetic, degenerative disease that is inherited in an X-linked recessive
mode with an incidence of approximately 1 in 3,500 live born males worldwide.
DMD is characterized by a complete loss of the protein dystrophin, leading to
cell damage, impaired calcium homeostasis, elevated oxidative stress and
reduced energy production in muscle cells. This results in progressive muscle
weakness and wasting and early morbidity due to respiratory failure.
Idebenone is a synthetic short-chain benzoquinone and a cofactor for the
enzyme NAD(P)H:quinone oxidoreductase (NQO1) capable of stimulating
mitochondrial electron transport and supplementing cellular energy levels.

* * *

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical
company focused on the development and commercialization of innovative
pharmaceutical products for the treatment of orphan mitochondrial and
neuromuscular diseases. Santhera develops Catena®/Raxone®as treatment for
patients with Leber's Hereditary Optic Neuropathy (LHON), Duchenne Muscular
Dystrophy (DMD) and primary progressive Multiple Sclerosis (ppMS), all of
them areas of high unmet medical need with no current therapies. Santhera
previously received temporary approval (cATU) for Raxone®in the treatment of
LHON in France and has recently submitted a Marketing Authorization
Application to the European Medicines Agency for the treatment of LHON in the
European Union. For further information, please visit the Company's
websitewww.santhera.com.

Catena®and Raxone®are trademarks of Santhera Pharmaceuticals.

For further information, contact
Thomas Meier, Chief Executive Officer
Phone: +41 61 906 89 64
thomas.meier@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.

News release DELOS
http://hugin.info/137261/R/1784768/611682.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Globenewswire

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