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Cosmo’s CB-03-01 phase II pilot study in acne demonstrates superiority over Retin A®

Lainate, Italy – 11 December 2009 – Cosmo Pharmaceuticals S.p.A. (“Cosmoâ€) (SIX: COPN) announced today positive results in a phase II pilot study of its novel topical anti-androgen 1% cream, CB-03-01. The preliminary data of the trial showed that CB-03-01 met all clinical end points and was clinically superior to placebo and to Retin-A® in the treatment of facial acne vulgaris after 8 weeks of drug application. The detailed clinical report will be available in a few weeks.

CB-03-01 is a new steroid proprietary to Cosmo with anti-androgenic and anti-inflammatory properties; the compound is intended to be indicated for the topical treatment of skin disorders influenced by androgens including acne and potentially, hirsutism or androgenetic alopecia.

This phase II pilot study was designed as a three arm, randomized, double-blind, parallel-groups, controlled study versus placebo and versus Retin-A® 0.05% cream, in facial acne vulgaris.

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