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Basilea Reports Positive Re-treatment Results from a Second Phase,III Trial of Alitretinoin for Patients with Severe Chronic Hand,Eczema

BASEL, Switzerland, April 25, 2007 - Basilea Pharmaceutica Ltd. (SWX:BSLN) reported today phase III study results showing that patients with severe chronic hand eczema can benefit from re-treatment with alitretinoin. In two previous randomized clinical trials, alitretinoin was found to be effective in treating severe chronic hand eczema in patients refractory to topical treatments. This pivotal trial demonstrated that patients responsive to initial treatment with alitretinoin can also benefit from additional treatment courses after eventual disease recurrence. The safety profile of alitretinoin observed in this study was consistent with that seen in previous trials. These positive data will be integrated into regulatory submissions planned for later this year.

Severe refractory Chronic Hand Eczema (CHE) is a relapsing disorder for which no approved treatment currently exists. This debilitating disease prevents patients from using their hands normally and requires frequent treatment interventions over time.

The objective of this re-treatment study was to describe the safety and efficacy of a second treatment course of alitretinoin in patients who achieved clear or almost clear hands after a previous initial treatment course. This study included 117 patients who eventually had disease recurrence, and 243 patients who had incomplete response after the initial treatment trial.

Patients who had disease recurrence were randomized in double blind manner to receive another 12 to 24 weeks treatment with either placebo or their previous dose of alitretinoin. Response rates were 80% for the alitretinoin 30mg group (Placebo 8.3%) and 48% for the 10mg group (Placebo 10%). These results indicate that alitretinoin is effective in treating severe refractory CHE in subsequent treatment courses.

Those patients who had either no or an incomplete response in the previous study received 30mg alitretinoin
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