Santhera Enrolls Last Patient in European Phase III Trial Evaluating SNT-MC17/Idebenone in Friedreich's Ataxia

The European Phase III trial named MICONOS (Mitochondrial Protection with Idebenone In Cardiac Or Neurological Outcome Study) is a double-blind, randomized, placebo-controlled study of 12 months duration investigating the efficacy of three doses of SNT- MC17/idebenone compared to placebo. The primary endpoint is the change in the International Cooperative Ataxia Rating Scale (ICARS), a neurological scale, where the difference between baseline and end of treatment for each of the dosing groups will be compared with the change in the placebo group. The MICONOS study also investigates cardiac outcomes and additional neurological endpoints as well as activities of daily living parameters. As of today, more than 100 patients have completed the trial and have been enrolled into an open label extension study at the highest dose level.

"In Canada, the same drug, known by the brand name CATENA®, was made commercially available in October and initial demand has exceeded our expectations. The strong demand underlines the high unmet medical need in Friedreich's Ataxia and patients' rapid adoption of the first approved therapy for this disease," said Klaus Schollmeier, Chief Executive Officer of Santhera. "By completing enrollment of the European Phase III trial, we have achieved another important milestone in the development of SNT- MC17/idebenone for Friedreich's Ataxia. With a mostly adult population, this trial will help us to understand how these patients can derive the maximum benefit from the drug."

The MICONOS trial is Santhera's second Phase III trial in Friedreich's Ataxia which is now fully enrolled. Recently the Company announced that it's IONIA (Idebenone effects On Neurological ICARS Assessments), trial has enrolled 70 patients in the United States. Whilst the MICONOS study investigates the efficacy of SNT-MC17/idebenone primarily in adult patients for a 12-month treatment period, the IONIA study assesses the efficacy and safety of the drug in 8 to 17 year old patients for six months. Santhera expects that the IONIA data will provide the basis of a New Drug Application filing in the United States and a Marketing Authorization Application filing in the European Union before the end of 2009. The MICONOS study is expected to provide supplementary data to support additional labeling in 2010.