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2015-10-01

Santhera Pharmaceuticals Holding AG: Santhera launches Raxone® in its first EU market

Santhera Pharmaceuticals Holding AG / Santhera launches Raxone® in its first
EU market. Processed and transmitted by NASDAQ OMX Corporate Solutions. The
issuer is solely responsible for the content of this announcement.
Liestal, Switzerland, October 1, 2015 - Santhera Pharmaceuticals (SIX: SANN)
announces that it is today launching Raxone®for the treatment of Leber's
Hereditary Optic Neuropathy (LHON) in Germany, its first and largest EU
market. LHON is a rare inherited mitochondrial disease that usually leads
rapidly to profound and permanent blindness.

"The introduction of Raxone in Germany is a major step forward for LHON
patients who now have an effective treatment option" saidGiovanni Stropoli
, Santhera's Chief Commercial Officer for Europe. "We are particularly proud
as Raxone is also the first approved treatment for any mitochondrial disease,
a therapeutic area which is in the focus of our Company. Germany is our first
and largest EU market but product availability is anticipated in additional
countries in the immediate future."

"Mitochondrial disease treatments have been elusive for a long time. The
availability of Raxone for patients with LHON is changing the paradigm and
also raises hopes for other mitochondrial disorders," saidThomas Klopstock
, MD, Professor of Neurology at the University of Munich, LHON researcher and
coordinator of the German network for mitochondrial disorders, mitoNET. "LHON
patients usually become blind in young adulthood, which entails not only a
personal and medical, but also a socioeconomic burden. With Raxone, we can
now offer a treatment option which greatly improves the chances for
significant recovery of visual acuity."

"As an organization representing the interests of patients affected with LHON,
we are very excited that an approved medication is finally available for the
treatment of this devastating disease," emphasizedClaus-Peter Eisenhardt
, President of the German Patient Advocacy of patients with mitochondrial
diseases, within the German Society of Muscular Diseases (DGM). "We are
grateful to the European regulatory authorities, who, after careful
evaluation of all available data, approved Raxone and made LHON a treatable
disease."

Raxone is an oral medication, authorized at a daily dose of 900 mg (given as 2
tablets three times a day with food), for the treatment of visual impairment
in adolescent and adult patients with LHON. Treatment should be initiated and
supervised by a physician with experience in LHON. Efficacy data come from
Santhera's randomized, placebo-controlled RHODOS trial and from the open
label Expanded Access Program, which together have demonstrated that vision
loss can be mitigated or reversed in patients treated with Raxone.

About Leber's Hereditary Optic Neuropathy and the Therapeutic Use of Raxone

LHON is a heritable genetic disease causing blindness. The disease presents
predominantly in young, otherwise healthy adult males as rapid, painless loss
of central vision, usually leading to permanent bilateral blindness within a
few months of the onset of symptoms. About 95% of patients harbor one of
three pathogenic mutations of the mitochondrial DNA, which cause a defect in
the complex I subunit of the mitochondrial respiratory chain. This defect
leads to decreased cellular energy (ATP) production, increased reactive
oxygen species (ROS) production and retinal ganglion cell dysfunction, which
cause progressive loss of visual acuity and blindness.

Raxone (idebenone), a synthetic short-chain benzoquinone and a cofactor for
the enzyme NAD(P)H:quinone oxidoreductase (NQO1), circumvents the complex I
defect, reduces and scavenges ROS, restores cellular energy levels in retinal
ganglion cells and promotes recovery of visual acuity.

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's lead product Raxone®is authorized in the
European Union for the treatment of Leber's Hereditary Optic Neuropathy
(LHON). Santhera is developing Raxone®/Catena®in two additional indications,
Duchenne Muscular Dystrophy (DMD) and primary progressive Multiple Sclerosis
(ppMS), and omigapil for Congenital Muscular Dystrophy (CMD), all areas of
high unmet medical need. For further information, please visit the Company's
websitewww.santhera.com.

Raxone®and Catena®are trademarks of Santhera Pharmaceuticals.

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| For further information, contact: |
| Thomas Meier, PhD, Chief Executive Officer Christoph Rentsch, Chief Financial Officer |
| Phone +41 61 906 89 64 Phone +41 61 906 89 65 |
| thomas.meier@santhera.com christoph.rentsch@santhera.com |
| |
| US investor contact: US Public Relations contact: |
| Hans Vitzthum, LifeSci Advisors, LLC Deanne Eagle, Planet Communications |
| Phone +1 212 915 2568 Phone +1 917 837 5866 |
| hans@lifesciadvisors.com deanne@planetcommunications.nyc |
------------------------------------------------------------------------------------------
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 Launch Germany
http://hugin.info/137261/R/1955888/712314.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

HUG#1955888

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