PAREXEL COMPLETES EARLY PHASE STUDY REQUIRING GENOTYPING OF MORE THAN 10,000 POTENTIAL PARTICIPANTS
Boston, MA, March 17, 2010 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that it has completed a large and complex pharmacogenetics-based early phase study. The study was conducted in a healthy volunteer population of poor metabolizers of Cytochrome P450 2D6 (CYP2D6), an important enzyme involved in the metabolism of drugs. The study monitored the QTc interval following administration of a neurological treatment, which has been shown to have a higher drug exposure in poor metabolizers of CYP2D6.
More than 10,000 potential study participants were genotyped by PAREXEL to identify nearly 400 CYP2D6 poor metabolizers. Of these individuals, nearly 300 were screened for eligibility to achieve the goal of enrolling more than 130 CYP2D6 poor metabolizers for this study. PAREXEL’s rapid recruitment strategies for early phase development enabled management of the large pool for genotyping and contributed to accelerating development timelines and quickly achieving milestone targets.
“All of our early phase units have experience performing studies in genotyped populations. As personalized medicine continues to evolve, biopharmaceutical companies are working with our experts to target specific, well-defined study populations,” said Michelle Middle, MB ChB, Corporate Vice President and Worldwide Head of Early Phase, PAREXEL International. “This study is an example of how we help our clients significantly decrease their timelines by utilizing the strategic capabilities of our early phase unit locations worldwide to accelerate volunteer recruitment.”
Key goals of the study, conducted at PAREXEL’s early phase units in South Africa, were to evaluate a possible drug effect on cardiac repolarization, as defined by QT/QTc prolongation, and to assess safety and tolerability. The low prevalence of CYP2D6 poor metabolizers, complex inclusion criteria and the long duration of the thorough QT/QTc study, with four periods each lasting 15 days, were identified as major recruitment challenges; however, PAREXEL’s early phase experts were able to complete the study in only nine months.
PAREXEL’s early phase services provide fully integrated solutions from First in Man through Proof of Concept and help biopharmaceutical companies generate better and faster go/no-go decisions about their compounds, while striving to return solid, reproducible outcomes, which bode well for success in later-phase trials. PAREXEL’s early phase capabilities include a full scope of early phase studies, specialized trial design, state-of-the-art technologies, hospital-based resources, and scientific expertise as well as vast experience in the oncology, neurology, cardiology, respiratory, and metabolism/endocrine therapeutic areas. For more information about PAREXEL’s early phase capabilities visit: http://www.PAREXEL.com/Early_Phase.
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About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 50 countries around the world, and has approximately 9,200 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings, including the anticipated restructuring charge of approximately $30 million over the second and third quarters of Fiscal Year 2010; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2009 as filed with the SEC on February 5, 2010, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.