Santhera Pharmaceuticals Holding AG /
Data from Santhera's RHODOS Study to Be Presented at the European Neurological
Society 2011 Meeting
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Liestal, Switzerland, May 27, 2011 - Santhera Pharmaceuticals (SIX: SANN) today
announced that results from the RHODOS study evaluating the efficacy of Catena®
in Leber Hereditary Optic Neuropathy (LHON) will be presented at the 21st
Meeting of the European Neurological Society in Lisbon, Portugal. The
presentation entitled A Randomised, Placebo-Controlled Trial of Idebenone in
Leber's Hereditary Optic Neuropathy will be given on May 30, 2011 at 16:00 CET
[1]. Data will be presented by the co-principal investigator, Professor Thomas
Klopstock from the Friedrich-Baur-Institut at the Department of Neurology,
University of Munich, Germany.The results from the RHODOS study show that Catena® can protect the vision of
patients, who are at highest risk of vision loss, and enhance the recovery of
visual acuity in severely affected patients. These data are supported by
secondary, clinically meaningful efficacy variables such as color contrast
sensitivity, changes in retinal nerve fiber layer thickness and clinical
benefit. In the study, Catena® showed consistent clinically relevant superiority
over placebo. Santhera will file a Marketing Authorization Application with the
European Medicines Agency in the first half of 2011.References
[1] T. Klopstock, P. Yu-Wai-Man, K. Dimitriadis, J. Rouleau, S. Heck, M. Bailie,
A. Atawan, S. Chattopadhyay, M. Schubert, A. Garip, M. Kernt, D. Petraki, C.
Rummey, M. Leinonen, G. Metz, P. Griffiths, T. Meier, P. Chinnery: A randomised,
placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy.
Oral presentation given at the 21st Meeting of the European Neurological Society
in Lisbon, Portugal from May 28 to 31 2011.About Leber Hereditary Optic Neuropathy
Leber Hereditary Optic Neuropathy (LHON) is an inherited atrophy of certain
cells in the retina and optic nerves that leads to rapid loss of central vision
and ultimately to blindness. Blurring of central vision and color desaturation
usually mark the beginning of the symptomatic phase of this neuro-
ophthalmological disorder. The effects of LHON are rapid and severe, typically
leading to blindness within a few months of the onset. While symptoms initially
develop in one eye, the second eye is usually involved within a few months.
Patients are predominantly young adult males who typically have one of three
different point mutations of the mitochondrial genome. These mutations lead to
the reduction in cellular energy production, which in turn results in cell
damage and death of certain optic nerve cells.Catena® is the first drug that has ever been clinically investigated in a
randomized, placebo-controlled intervention study in LHON. Given the drug's
principal mode of action, Catena® may protect the retinal and optic nerve cells
and thereby delay, lessen or prevent vision loss. LHON is found in all ethnic
groups; an estimated 20,000 patients live in Europe and in the United States. * * *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
visit 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 64
thomas.meier@santhera.comThomas 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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