Besipirdine is a potential novel first-in-class oral treatment for OAB currently in Phase II development, with a mechanism of action clearly different from that of antimuscarinics.

Besipirdine was developed in a CNS indication up to phase III when it was abandoned for lack of efficacy. Based on its pharmacological properties, it was identified as a promising candidate for treating Lower Urinary Tract Dysfunctions.

UroGene was granted an exclusive worldwide license from sanofi-aventis on besipirdine, with the right to develop, register and commercialize besipirdine for the treatment of urological disorders.

Disease-oriented in vivo models have provided preclinical evidence of efficacy :

1. Besipirdine dose-dependently increases:

· Bladder capacity

· Micturition volume

· Intercontraction intervals without increasing bladder weight and bladder contraction amplitude

2. Besipirdine also dose-dependently increases striated sphincter activity, without affecting micturition.

Besipirdine is covered by an array of international patents both licensed from sanofi-aventis and filed separately by Urogene.

Besipirdine's clinical track record (1559 subjects included in Phase I, Phase II and Phase III studies) provides an extensive knowledge of its pharmacodynamic and safety profile.

Besipirdine is currently in the final stages of a double blind Phase II study powered by 210 patients at 46 sites and expected to be completed in December, 2006.

Besipirdine pharmacological profile makes it an interesting candidate for additional indications such as Interstitial Cystitis (IC) and Stress-related Urinary Incontinence (SUI).