Santhera Pharmaceuticals Holding AG / Data from Santhera’s RHODOS Study to Be Presented at the European Neurological Society 2011 Meeting . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
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.
 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.
(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 Staffelbach, Head Public & Investor Relations
(0)61 906 89 47
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.