PPD has licensed the development rights for dapoxetine to Alza, a Janssen-Cilag affiliate. Under terms of the agreement, PPD will receive a $2.5 million milestone payment for each of the first two national approvals.
These approvals follow the positive outcome of a decentralized regulatory procedure in seven EU countries, which was finalized in December 2008 with Finland and Sweden being the first two countries worldwide to grant a marketing authorization for this compound.
Fred Eshelman, CEO of PPD, said: “We are pleased that Janssen-Cilag has received regulatory approvals of dapoxetine in Finland and Sweden. As the first approved oral medication for the treatment of premature ejaculation, it represents a significant, innovative advancement in treating this condition. Our partnership with Janssen-Cilag demonstrates our ability to effectively apply our drug development expertise to bring new therapies to market.”