PPD Confirms Johnson & Johnson Pharmaceutical Research & Development's Completion of Additional Phase III Studies Providing Expanded Safety and Efficacy Data for Priligy
Priligy now approved in seven European countries, with filings currently under review in four geographic regions
WILMINGTON, N.C. (June 10, 2009) - PPD, Inc. (Nasdaq: PPDI) today confirmed that Johnson & Johnson Pharmaceutical Research & Development announced the completion of three additional Phase III studies using Priligy® (dapoxetine) for the treatment of premature ejaculation. The new studies increase the number of subjects in the Priligy clinical dataset to more than 6,000 patients, providing an expanded safety database and confirmed efficacy. Johnson & Johnson Pharmaceutical Research & Development announced its intention to review the new dataset with the U.S. Food and Drug Administration.
PPD partnered with ALZA Corporation, a Janssen-Cilag affiliate, to develop Priligy, the first and only medication approved for the treatment of premature ejaculation.
The FDA did not approve Priligy in 2005. Priligy has been approved for the treatment of premature ejaculation in Finland, Sweden, Portugal, Austria, Germany, Italy and Spain. Additional regulatory filings are currently under review in the Middle East, Asia Pacific, North America and Latin America.
"Our hope is that these data will provide additional safety and efficacy information in support of the Priligy new drug application," said Fred Eshelman, PPD's chief executive officer. "We are pleased that our partner Janssen-Cilag continues to obtain clinical data for Priligy in pursuit of additional marketing approvals."
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 38 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 safety and efficacy of Priligy® (dapoxetine), additional regulatory approvals and the value of PPD's interest in Priligy, 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: risks associated with the development and commercialization of drugs, including obtaining regulatory approvals; risks associated with and dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; competition in the development and commercialization of drugs to treat premature ejaculation; the ability to attract and retain key personnel; 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; 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.