Liestal, Switzerland, July 15, 2010 - Santhera Pharmaceuticals (SIX: SANN) announced today the presentation of the positive results from its RHODOS study with Catena® in Leber's Hereditary Optic Neuropathy (LHON) at the mitoNET congress for mitochondrial medicine in Munich, Germany. Data from this study show an improvement in vision in patients suffering from LHON. The results also show that Catena® can significantly protect patients with residual vision from further disease progression.
Professor Thomas Klopstock, University of Munich, and investigator of the RHODOS study will present the data to an international audience of experts in mitochondrial medicine. He commented: "Catena® holds the promise to protect LHON patients from deterioration of vision. The RHODOS-data establish the drug as a first treatment option for LHON. The trial also has key importance for the whole field of mitochondrial medicine as it shows that randomized, placebo-controlled studies can be conducted in these rare disorders. The energy defect of mitochondria may be tackled by drugs."
LHON is a rare genetic eye disease that leads to a rapid loss of central vision and ultimately to blindness as a result of nerve cell degeneration in the retina and optic nerve. Catena® supports cellular energy production and has the potential to mitigate the effects of the genetic mutations which lead to blindness in LHON. The RHODOS study (Rescue of Hereditary Optic Disease Outpatient Study) was a randomized, double blind, placebo controlled trial testing the efficacy and safety of Catena® and placebo over a six-month treatment period.
About Leber's Hereditary Optic Neuropathy
Leber's 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 mitoNET
mitoNET is a German network of clinicians and scientists aiming for the improvement, the medical care and research in the field of mitochondrial diseases. Such disorders are rare and variable in severity and characterization. The mitoNET 2010 congress builds a bridge from the rapid scientific advances in this field to the clinically relevant aspects of these devastating diseases.
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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 diseases, an area of high unmet medical need which includes many orphan indications with no current therapy. Santhera's first product, Catena® to treat Friedreich's Ataxia, is marketed in Canada. The drug is also being investigated in a Phase III study in Duchenne Muscular Dystrophy. Commercial rights in Europe for Friedreich's Ataxia and Duchenne Muscular Dystrophy are licensed to Takeda Pharmaceutical. Santhera's second compound fipamezole has demonstrated efficacy in reducing levodopa-induced Dyskinesia in Parkinson's Disease. Phase III development and commercialization rights in the United States and Canada are partnered with Biovail. For further information, please visit the Company's web site 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.com
Thomas 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.
