BOSTON, Nov. 6 /PRNewswire-FirstCall/ -- PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, today announced that the Company is among the first to conduct a Chinese bridging study outside of China. PAREXEL is a leader in providing Asian bridging studies, which are conducted in early clinical development to help biopharmaceutical companies prepare strategic global plans, gather relevant ethnic data in the U.S., and save time and development costs for programs in Asia. PAREXEL's California Clinical Trials (CCT) pioneered the ethnobridging study, which is a pharmacokinetic study designed to determine safety and tolerability as well as possible pharmacokinetic differences in a target ethnic population.
The Chinese bridging study was conducted at PAREXEL's dedicated research unit in Los Angeles, California, which provides access to large first generation Asian populations, including 500,000 Chinese, as well as 600,000 Korean and 40,000 Japanese people. This type of study supports biopharmaceutical companies that currently face challenges in conducting early phase studies in certain countries within the Asia/Pacific region, such as China. Phase I clinical data that are gathered in the U.S. can be used for subsequent global trials that include China, or for China registration. PAREXEL's Asian bridging studies also provide clients with options for parallel development in Western and Asia/Pacific geographies. In addition to the Chinese bridging study, PAREXEL has completed Korean and Japanese bridging studies.
"With Japan projected to maintain its position as the second largest pharmaceutical market globally, and China positioned to become the sixth largest market by 2010, the Asia/Pacific region includes important end markets for our clients. To meet increasing client demand for global development programs that include the Asia/Pacific region, we are expanding our ethnobridging study capabilities to expedite early phase approval of compounds in Asia and the Western hemisphere," said Michelle Middle, MB, ChB, Corporate Vice President and Worldwide Head of Clinical Pharmacology at PAREXEL. "PAREXEL's Asian bridging study expertise is focused on helping clients make earlier informed decisions and maximize the return on their product development investment, while rapidly bringing safe, effective treatments to patients in the Asia/Pacific region."
Through the acquisition of CCT in 2006, PAREXEL expanded its capabilities in International Conference on Harmonization (ICH) bridging and ethnic sensitivity study development, including Japanese bridging studies. Japan's regulatory authority has collaborated with PAREXEL's clinical pharmacology experts to establish a high standard for conducting Japanese pharmacology studies outside of Japan. PAREXEL has completed more than 40 Japanese bridging studies, and has the largest number of qualified volunteers outside of Japan in its database.
PAREXEL's ethnobridging study work has been widely published in peer- reviewed journals and books. The recently published book Accelerating Global Drug Development: The Science and Practice of Ethnobridging was authored by several PAREXEL experts, including Stanford S. Jhee, Pharm.D., Senior Director of Research, Clinical Pharmacology, PAREXEL, a renowned authority on ethnobridging studies.
PAREXEL's clinical pharmacology services support numerous therapeutic areas including highly specialized areas such as pain modeling, sleep polysmnography, glucose clamp, and respiratory challenge research. For more information about PAREXEL's early phase development capabilities visit: http://www.parexel.com/early_phase.html.
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 52 countries around the world, and has over 9,180 employees. For more information about PAREXEL International visit http://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; 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 Annual Report on Form 10-K for the Fiscal Year ended June 30, 2008 as filed with the SEC on August 28, 2008, 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.
Jennifer Baird, Senior Director of Public Relations
|SOURCE PAREXEL International Corporation|
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