PAREXEL ADVANCES EARLY PHASE CNS RESEARCH CAPABILITIES WITH LEADING MEDICAL IMAGING TECHNOLOGY
Boston, MA, November 22, 2011—PAREXEL International (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that it has enhanced its central nervous system (CNS) capabilities for clinical development through the implementation of functional magnetic resonance imaging (fMRI) technology in its Early Phase units. This advanced imaging scanning measures hemodynamic response, or change in blood flow, related to neural activity in the brain or spinal cord. Through this approach, PAREXEL is able to provide sponsors with improved testing paradigms for cognitive biomarkers and better understand the impact of compounds earlier in disease progression.
PAREXEL is among the first to apply this technology broadly to multicenter trials with centralized imaging review processes to improve the quality, consistency and reproducibility of clinical data. This advancement is part of PAREXEL’s long-standing commitment to the CNS therapeutic area. The Company has focused on bringing extensive expertise and the latest innovations to early phase drug development, making it a premier provider to biopharmaceutical companies worldwide.
“PAREXEL has continued to provide clients with true leadership in early phase CNS drug development—combining the latest technology with our extensive scientific expertise and CNS research tools, including cerebrospinal fluid dynabridging studies,” said Larry Ereshefsky, Pharm. D., F.C.C.P, B.C.P.P., Vice President and Principal Consultant, Early Phase, PAREXEL.
According to Dr. Ereshefsky, “We are helping the biopharmaceutical industry take a major step forward to leverage advanced technologies in the assessment of CNS diseases, such as Alzheimer’s disease, other neurodegenerative disorders, such as Parkinson’s and Multiple Sclerosis, as well as in psychiatric disorders and in pain research. Our goals are to diagnose and treat ahead of significant brain and neurological damage, and open the door for disease course modifying drugs, including primary and secondary prevention strategies.”
The research-enhanced fMRI technology provides greater speed, advanced image detail, and more scanning flexibility. Enabled with 3 Tesla (3T) power—a unit of measurement quantifying the strength of the magnetic field—PAREXEL can conduct scans to evaluate regions of interest with more anatomical detail, and detect smaller drug induced changes in brain function. With this capability, image quality is increased significantly, and image acquisition times are shortened. This technology allows PAREXEL to not only assess regions of activity but also functional connectivity among neurological networks. Additionally, early phase CNS experts can determine which regions are activated or deactivated by certain drug effects. This more sensitive measurement capability supports complex clinical studies focused on disease course modification techniques and improved symptomatic therapies earlier in the progression of an illness. The approach can be a sensitive pharmacodynamic tool to demonstrate proof of mechanism, especially when used in conjunction with other corroborative CNS biomarkers.
With extensive, relevant experience and in-depth expertise, PAREXEL assists clients with ever more complex early-phase trial design and execution, as well as efficient delivery of better, faster go/no-go decisions from First-in-Human (FIH) through Proof-of-Concept. The Company’s hospital-based units in the U.S., Europe, and South Africa, as well as a network of alliance sites, provide clients with excellent patient access specific to key therapeutic areas for early phase development. For more information about PAREXEL's early phase development capabilities visit: http://www.parexel.com/services-and-capabilities/early-phase.
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About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications 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 67 locations throughout 52 countries around the world, and has approximately 10,850 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. 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,” “will,” “would,” “could,” “should,” “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 and anticipated restructurings, including the anticipated additional restructuring charges of approximately $4 million in the second quarter of Fiscal Year 2012; 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; 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 September 30, 2011 as filed with the SEC on November 9, 2011, which “Risk Factors” discussion is incorporated by reference in this press 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