BOSTON, Sept. 23 /PRNewswire-FirstCall/ -- PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released its second annual study on the state of the U.S. Food and Drug Administration (FDA) drug review process. The PAREXEL Consulting analysis, contained in the new white paper entitled "The Innovation Imperative in the Safety First Era," provides insight into how regulatory changes and marketplace dynamics are impacting new drug review times and review outcomes.
"The implications of FDAAA and CDER's* implementation of the law have been widely discussed, and there is considerable conjecture in the biopharmaceutical industry regarding how FDA review timelines and the approval process are being impacted by new requirements, such as REMS--Risk Evaluation and Mitigation Strategies. What our research provides is a real-world, metrics-based assessment to help inform expectations of new drug review outcomes in the Safety First Era," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting and the study's lead author.
The study findings link the implementation of the Food and Drug Administration Amendments Act (FDAAA), as well as FDA's workload and staffing-related challenges, to user-fee review time targets, which were not met for 17% of the Fiscal Year 2008 New Drug Applications** (NDAs), and 36% of the priority-rated NDAs. PAREXEL Consulting's analysis also indicates that although priority-rated NDAs continue to gain first-cycle approval at a higher rate than standard submissions, they dipped to 50% for the Fiscal Year 2008 cohort,** down from a record 70% in 2007. Furthermore, data indicate that FDA granted priority status to 20% of NDAs submitted from fiscal 2006 to 2008, down from 30% in 2005, suggesting that this designation is increasingly difficult to obtain.
"Despite the recent decrease in first-cycle approval rates and increase in overdue reviews for priority NDAs, we believe that there remains powerful evidence in our study to support what PAREXEL Consulting calls the "The Innovation Imperative"--the concept that the most innovative new drugs stand to receive greater regulatory attention and more rapid marketing approval," said Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy Services, PAREXEL Consulting. "Our analysis shows that pursuing priority review status and submitting quality NDAs that can be approved on the first review cycle should continue to be carefully considered by pharmaceutical companies when seeking FDA approval for new drugs and earlier launch dates."
Further supporting "The Innovation Imperative" are PAREXEL's findings in regard to New Molecular Entity (NME) approvals. The PAREXEL Consulting study shows that among the NMEs approved by FDA in the first five months of 2009, priority-rated NMEs were cleared 13.3 months faster than standard-rated NMEs.
The white paper "The Innovation Imperative in the Safety First Era" is part of PAREXEL Consulting's Intelligent Development Series, which provides data and insights in support of successful biopharmaceutical and medical device product development. The white paper is available at: www.ParexelConsulting.com/innovation-imperative.
* Center for Drug Evaluation and Research (CDER), a division of FDA
** Data as of April 1, 2009
About PAREXEL Consulting
PAREXEL Consulting, a division of PAREXEL International, provides integrated product development services with the goal of helping biopharmaceutical and medical device companies get their products to the market, and keep them on the market. Through a unique fusion of scientific, regulatory, and business expertise PAREXEL Consulting helps clients worldwide manage risk and maximize product and portfolio value at every milestone and during each phase of development.
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 over 9,275 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 Annual Report on Form 10-K for the year ended June 30, 2009 as filed with the SEC on August 28, 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.
Contacts: Jennifer Baird, Senior Director of Public Relations PAREXEL International Tel: +781-434-4409 Email: Jennifer.Baird@PAREXEL.com Kim Baker/Gene Carozza PAN Communications Tel: + 978-474-1900 Email: PAREXEL@pancomm.com
|SOURCE PAREXEL International Corporation|
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