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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

to leave their jobs and one patient in five takes prolonged sick leave resulting in high socio-economic and individual patient burden.

About Alitretinoin Alitretinoin is an investigational drug being developed in Phase III clinical trials by Basilea as a novel treatment for severe refractory Chronic Hand Eczema (CHE), a complex disease for which no effective treatment options are currently available. Alitretinoin has been shown to be effective in Phase II and Phase III clinical studies in patients with severe refractory CHE.

In a phase II double-blind international multi-center placebo controlled trial of 319 patients with moderate and severe chronic hand eczema refractory to topical treatment, alitretinoin was clinically effective in 29% to 53 % of patients depending on the dose administered. Alitretinoin was generally well tolerated with dose dependent headache observed as the most common side effect.

Basilea's first pivotal phase III international multi-center placebo-controlled BACH trial (Benefit of Alitretinoin in Chronic Hand eczema) showed that alitretinoin was effective in patients suffering from severe refractory CHE, as determined by the endpoint of clear and almost clear hands.

This randomized double-blind phase III pivotal study was the largest therapeutic trial ever performed in chronic hand eczema with 1,032 patients whose severe chronic disease was unresponsive to topical steroids. The patients were randomized either to a once-daily dose of 30mg or 10mg of alitretinoin, or placebo for a treatment duration of up to 24 weeks. Alitretinoin's efficacy was significantly superior to placebo in both the high and the low dose regimen. In the 30mg group 48% of patients and in the 10 mg group 28% of patients reached the primary endpoint. In this study alitretinoin was again generally well tolerated with dose dependent headache and blood lipid elevations as the most commonly observed side effects.

Alitretinoin is a teratogen
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