Priligy™ (Dapoxetine)

Partnership with Johnson & Johnson

Priligy™ (dapoxetine) is a drug specifically developed for the on-demand treatment of premature ejaculation (PE) and is the first oral medication (tablet) to be approved for this condition. Priligy is marketed by Janssen-Cilag, a division of Johnson & Johnson. Priligy is approved in 25 countries and currently marketed in 14 countries in Europe, Asia and Latin America. Janssen is conducting additional Phase IIIb studies to support a re-filing in the US. Under our drug development collaboration with Janssen-Cilag we have rights to royalties and sales-based milestones from sales of Priligy.

PE is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. A combination of physiological and psychological factors is believed to influence the mechanism of ejaculation. Men with PE appear to go through the same process of ejaculation as other men, but it happens more quickly and with a reduced feeling of control. Research suggests serotonin plays a central role in the timing of ejaculation.

Dapoxetine is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed – one to three hours before sexual intercourse is anticipated – rather than every day. Dapoxetine has been extensively evaluated in five randomized, placebo-controlled Phase III clinical trials involving more than 6,000 men with PE and their partners. This is the largest and most comprehensive clinical trial program to date for a drug therapy to treat PE.

Dapoxetine clinical trials can be accessed at www.clinicaltrials.gov.

Depending on the methodology and criteria used to evaluate the prevalence of PE in studies, the reported proportion of men affected with this condition at some point in their lives has ranged from 4 to 30 percent compared to 10 to 20 percent for erectile dysfunction (ED). The erectile dysfunction market was estimated at $4 billion in 2009.