Publication in BRAIN Highlights Medical Potential of Santhera's Catena® in Leber's Hereditary Optic Neuropathy

Santhera Pharmaceuticals Holding AG /
Publication in BRAIN Highlights Medical Potential of Santhera's Catena® in
Leber's Hereditary Optic Neuropathy
. Verarbeitet und übermittelt durch Thomson Reuters ONE.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich. Liestal, Switzerland, July 27, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today the publication of the results from its RHODOS clinical study in
Leber's Hereditary Optic Neuropathy (LHON) in BRAIN [1], a leading international
journal of clinical neurology. The authors concluded that treatment with Catena®
(idebenone) can prevent or reverse vision loss and blindness. LHON patients with
discordant visual acuity and in patients harboring G11778A or G3460A mutations
are the most likely to benefit from idebenone treatment. Data from the RHODOS
study are included in the filing of Santhera's Marketing Authorization
Application which is currently under review by the European Medicines Agency
(EMA).The publication in BRAIN, a leading international high-impact journal publishing
clinical neurology, reports on significant differences between idebenone and
placebo treatment in the first randomized controlled trial in the mitochondrial
disorder LHON. Data from the 6-months RHODOS study provide evidence that
idebenone ameliorated the visual outcome in affected patients enrolled in this
study. In the authors' opinion all prespecified secondary visual acuity
endpoints as well as subgroup and responder analyses pointed towards a
beneficial effect for idebenone. Based on this study the largest treatment
effect of idebenone was seen in patients harboring the G11778A or G3460A
mutations which account for approximately 80% of all European and North American
LHON cases. The study also showed that patients with discordant visual acuity
between the two eyes, who are at greatest risk of disease progression, were
effectively protected from further vision loss. "The clinical significance of
this finding is that patients with discordant visual acuity may represent the
patients with greatest potential reserve and therefore the patients that have
the most clinical benefit in regards to preventing further visual loss,"
concluded the authors.
Thomas Meier, Santhera's Chief Scientific Officer, commenting on the BRAIN
publication said: "We are excited that data from our study are now available to
a wider audience of ophthalmologists, neuro-ophthalmologists and neurologists.
The reported effects of idebenone on patients with the G11778A or G3460A
mutations are of particular interest to us as we specifically applied for
marketing approval based on the significant treatment effect seen in these
patients. Data from the RHODOS study are part of our MAA file currently under
review at the EMA."
References
[1] Thomas Klopstock, Patrick Yu-Wai-Man, Konstantinos Dimitriadis, Jacinthe
Rouleau, Suzette Heck, Maura Bailie, Alaa Atawan, Sandip Chattopadhyay, Marion
Schubert, Aylin Garip, Marcus Kernt, Diana Petraki, Christian Rummey, Mika
Leinonen, Günther Metz, Philip G Griffiths, Thomas Meier and Patrick F Chinnery:
A randomized placebo-controlled trial of idebenone in Leber's hereditary optic
neuropathy. DOI: 10,1093/brain/awr170. * * *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 severe neuromuscular and neurodegenerative
diseases, an area of high unmet medical need which includes many orphan and
niche indications with no current therapy. Santhera's first product, Catena® to
treat Friedreich's Ataxia is marketed in Canada. For further information, please
visitwww.santhera.com.Catena® is a trademark of Santhera Pharmaceuticals.For further information, contact
Thomas Meier
Phone: +41 (0)61 906 89 64
thomas.meier@santhera.comThomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.comDisclaimer/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.
--- Ende der Mitteilung --- Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal SchweizISIN: CH0027148649;New release BRAIN publication:
http://hugin.info/137261/R/1533676/467246.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.

Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE[HUG#1533676]