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WILMINGTON, N.C. (April 27, 2010) - PPD, Inc. (Nasdaq: PPDI) today announced its contract research facility in Athlone, Ireland, has been awarded manufacturer licenses by the Irish Medicines Board (IMB). The licenses support investigational medicinal products and marketed products and provide laboratory certifications for quality control of medicinal products.
PPD opened its contract research facility in Athlone, Ireland, last month, in response to growing client demand from clients in Europe, Middle East and Africa for cGMP analytical testing services. The facility includes an 18,000-square-foot cGMP analytical testing laboratory and clinical supplies business.
"Achieving IMB licensing one month after opening our Athlone facility is a result of our scientific expertise, state-of-the-art laboratories and instrumentation, and commitment to excellence and regulatory compliance," said Magdalena Mejillano, Ph.D., vice president of laboratory services at PPD. "From our lab in Athlone, we will provide a full range of small- and large-molecule testing capabilities, including inhaled products, allowing us to meet the changing needs of our clients more efficiently and effectively."
The new facility will offer fully integrated product and analytical development services, including method development; validation; stability, release and quality control testing; and global clinical supplies services, including secondary packing, labeling and storage. The facility will also provide regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms.
The cGMP analytical testing laboratory conducts testing for clinical programs and marketed products spanning all phases of drug development and builds upon more than 20 years of PPD laboratory expertise.
The licensing of the new facility in Ireland supports the growth of PPD's contract research operations in Ireland, which already operates a medical communications safety call center from Athlone.
PPD is a leading global contract research organization, celebrating 25 years of providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 41 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release, including expectations and assumptions about PPD's facility in Athlone, Ireland, 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: maintaining necessary licenses and certifications to operate the new laboratory; the ability to attract and retain key personnel; success in sales growth for the new laboratory; loss of contracts; high cancellation rates; economic conditions and outsourcing trends in the pharmaceutical, biotechnology, medical device, academic and government industry segments; competition within the outsourcing industry; rapid technological advances that make our products and services less competitive; risks associated with and dependence on collaborative relationships; risks associated with acquisitions and investments, such as impairments; 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.
Contacts
Media:
Sue Ann Pentecost
+1 919 456 5890
sueann.pentecost@ppdi.com
Analysts/Investors:
Luke Heagle
+1 910 558 7585
luke.heagle@ppdi.com
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