PAREXEL EXPERTS TO DISCUSS IMPACT OF PHARMACOVIGILANCE TRENDS ON BIOSIMILARS AND GENERICS AT WORLD GENERIC MEDICINES CONGRESS AMERICAS
Boston, MA, November 18, 2009–Experts from PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, will provide insights into evolving pharmacovigilance trends and their impact on biosimilars and generic products at the World Generic Medicines Congress Americas, being held November 17 – 20, 2009 in Washington, DC. PAREXEL is a sponsor of the second annual congress, which will address the health economics, pricing, and competition pressures facing the generics sector in the U.S. as well as issues around building scale and value through globalization.
The congress program features the following sessions on Thursday, November 19, which will be led by Ravi Harapanhalli, Ph.D., Principal Consultant and Practice Lead, Late Stage Development, PAREXEL Consulting:
• Economic Implications of Outsourcing Pharmacovigilance (8:00 a.m. – 8:50 a.m.)
This special breakfast briefing session will identify the key opportunities for biopharmaceutical outsourcing in the area of pharmacovigilance, including a presentation of case study analyses of key processes that can be outsourced with high value to biopharmaceutical companies.
• Pharmacovigilance and Biosimilars: Ensuring Patient Safety (2:30 p.m. – 3:00 p.m.)
Experts from PAREXEL will be available during the congress to discuss a broad range of capabilities including:
Pharmacovigilance: PAREXEL offers a comprehensive portfolio of services for the active management of safety, risk, and patient health during the entire lifecycle of a product from early phase development through the conclusion of the marketing period of a product. For more information about PAREXEL’s pharmacovigilance capabilities visit: http://www.PAREXEL.com/Late-Phase/pharmacovigilance.html.
Biosimilars/Follow-on Biologics: PAREXEL has the expertise and experience needed to help formulate a successful Follow-on Biologics (FOB) program and can bring together regulatory, product development, pharmacology, medical, clinical research, statistical and medical marketing experts to create a tailored, comprehensive, effective and efficient development program for any FOB. For more information about this offering visit: http://www.PAREXEL.com/Consulting/Follow-on-Biologics.html.
Bioequivalence Studies: PAREXEL’s early phase clinical units worldwide with experience in conducting bioequivalence studies provide specialized bioequivalence development services involving patient populations as well as healthy volunteers. PAREXEL’s early phase clinical unit in Bloemfontein, South Africa, a center of excellence in this area with an on-site bioanalytical laboratory, has more than 27 years of experience in the conduct of clinical trials for the generics industry and is strategically located in a fast study-start up environment. For more information about PAREXEL’s early phase bioequivalence services visit: http://www.PAREXEL.com/Early-Phase/Bioequivalence-Services.html.
Information about the World Generic Medicines Congress Americas can be found at: http://www.healthnetworkcommunications.com/2009/genericsusa/index.stm.
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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 70 locations throughout 52 countries around the world, and has more than 9,130 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; 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 September 30, 2009 as filed with the SEC on November 6, 2009, 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.