Priligy now approved in seven European countries, with filings
currently under review in four geographic regions
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.
PPD, Inc.
Media:
Sue Ann Pentecost, 919-456-5890; sueann.pentecost@ppdi.com
or
Analysts/Investors:
Luke Heagle, 910-558-7585; luke.heagle@ppdi.com
