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BASILEA ANNOUNCES POSITIVE RESULTS FROM HAND DERMATITIS TRIAL

February 20, 2007

Basilea Pharmaceutica announced that its placebo-controlled, pivotal, Phase III BACH trial successfully met its primary objective. Alitretinoin was effective in patients suffering from severe and refractory chronic hand dermatitis, as determined by the stringent endpoint of clear and almost clear hands. Currently, no approved treatment exists for this disease, according to the company. These positive data will form the basis of regulatory submissions later this year.

This randomized, double-blind, Phase III study was the largest therapeutic trial ever performed in chronic hand dermatitis, according to the company. In the study, 1,032 patients whose severe chronic disease was unresponsive to potent topical steroids were randomized either to a once-daily dose of 30 or 10 mg of alitretinoin or placebo for a treatment duration of up to 24 weeks. The primary endpoint of the study was the proportion of patients whose hands were rated as clear or almost clear by the Physicians Global Assessment.

Alitretinoin's efficacy was significantly superior to placebo in both the high- and low-dose regimen. The difference between the active groups and placebo were highly statistically significant. Forty-eight percent of patients in the 30-mg group and 28 percent of patients in the 10-mg group reached the primary endpoint. The response in the placebo group was 17 percent.

The drug was generally well tolerated with a safety profile consistent with that reported in the Phase II clinical study. The most frequent adverse events were headache and blood lipid elevations. These were dose-dependent and reversible.