New Data from Santhera's Phase III Trial (DELOS) in Duchenne Muscular Dystrophy (DMD) in Neuromuscular Disorders

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Raxone^® Reduces Bronchopulmonary Complications in Patients with DMD

Liestal, Switzerland, June 1, 2016 - Santhera Pharmaceuticals (SIX: SANN) announces that additional data from the pivotal phase III trial (DELOS) were published online as an article in press in Neuromuscular Disorders, the official journal of the World Muscle Society (http://dx.doi.org/10.1016/j.nmd.2016.05.008). These data show that DMD patients treated with Raxone^® (idebenone) have a reduced risk of bronchopulmonary complications including fewer hospitalizations caused by such complications and a reduced need for systemic antibiotic treatment compared to patients receiving placebo.

These results originate from additional analyses of the phase III DELOS trial which was performed in DMD patients not taking concomitant glucocorticoids and showed that Raxone^® reduced the loss of respiratory function in a statistically significant and clinically relevant manner (Buyse et al., The Lancet 2015 385(9979):1748-57). The data now published in Neuromuscular Disorders demonstrated that Raxone also reduced the proportions of patients falling below clinically relevant thresholds for peak cough flow, relevant for proper airway clearance, and forced vital capacity, an indicator of respiratory failure. Researchers also found that there were fewer bronchopulmonary adverse events (BAEs), including upper and lower airway infections and related complications, in patients on Raxone therapy (6 of 31 patients with 7 BAEs) compared to patients in the placebo group (17 of 33 patients with 28 BAEs). For the patients receiving Raxone, there was a 67% reduction for the risk of experiencing at least one BAE during the 1-year study period (p = 0.0187), and a 72% reduction for the risk of experiencing one or more BAEs (p = 0.0026). Additionally, the overall BAE duration for the Raxone group (82 days) was markedly shorter than for the placebo group (222 days). This result was also supported by a smaller number of hospitalizations due to respiratory complications in the Raxone group compared to the placebo group. The need for systemic antibiotic use was also lower in the Raxone group (7 or 22.6% of patients with 8 episodes of antibiotic treatment) than in the placebo group (13 or 39.4% of patients with 17 episodes).