Health & Fitness 
Health and Fitness
Health and Fitness 
Tue, February 10, 2009
PPD to Receive Milestone Payments for First Regulatory Approvals of Priligy" (Dapoxetine) in Finland and Sweden for Treatment o
WILMINGTON, N.C.--([ BUSINESS WIRE ])--PPD, Inc. (NASDAQ:PPDI) today announced it will receive milestone payments from Janssen-Cilag in connection with the recently announced regulatory approvals in Finland and Sweden of Priligy™ (dapoxetine) for the "on-demand" treatment of premature ejaculation in men 18-64 years of age.
PPD licensed the development rights for dapoxetine to Alza Corp., 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 European Union 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.
"We are pleased that Janssen-Cilag has received regulatory approvals of dapoxetine in Finland and Sweden," said Fred Eshelman, PPD's chief executive officer. "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."
PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 33 countries and approximately 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at [ http://www.ppdi.com ].
Except for historical information, all of the statements, expectations and assumptions contained in this news release, including expectations and assumptions about the first country approval of Priligy™ (dapoxetine) by Finland and Sweden, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause results to differ materially include the following: obtaining required additional approvals, including national approvals; risks associated with the development and commercialization of drugs; risks associated with and dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; competition from related products; continued success in sales growth; loss of large contracts; increased cancellation rates; economic conditions and outsourcing trends in the pharmaceutical, biotechnology, medical device, academic and government industry segments; competition within the outsourcing industry; the ability to attract and retain key personnel; risks associated with acquisitions and investments, such as impairments; risks that we may not continue our dividend policy; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.