PAREXEL Data Indicate U.S. Marketing Applications for New Molecular Entities Bounce Back
BOSTON, August 25, 2008 /PRNewswire-FirstCall/ -- New data from PAREXEL International Corporation , a leading global biopharmaceutical services organization, reveal that U.S. marketing applications for new molecular entities (NMEs) surged 33 percent in 2007. While NME approvals reached a many-year low of 16 in the U.S., and global new active substance (NAS) launches declined 19 percent to 25, during 2007, marketing applications for NMEs increased to 28 in 2007, up from 21 filed in 2006, according to PAREXEL's newly-released The US Drug Approval Trends and Yearbook 2008/2009.
Mark Mathieu, Director of Publications at PAREXEL and Editor of The US Drug Approval Trends and Yearbook 2008/2009, said: "NME and NAS approvals are key measures of new drug productivity in the biopharmaceutical industry, and these measures tend to improve based on the volume of new drug submissions. The recent increase in the number of NME submissions is an encouraging sign. NMEs are a closely watched category because they are medicines that have never before been approved for any use."
"Our analysis also shows that record percentages of drug marketing applications that the FDA has designated as priority submissions are going straight to approval in the first review cycle," added Mr. Mathieu.
The US Drug Approval Trends and Yearbook 2008/2009 provides a comprehensive overview of the current state of the U.S. Food and Drug Administration (FDA) drug review and approval process, as well as a broad range of in-depth analyses and benchmarks, supported by hundreds of data tables, graphs, and exhibits, including:
-- New Drug Application (NDA) and NME first-cycle success rates and trends
-- Complete approval profiles for each NME and NDA
-- Analysis of drug review times, performance trends, and success rates by therapeutic category, as well as standard versus priority classification
-- The impact of accelerated approval, orphan drug status, and related programs on review times and outcomes
-- Data regarding other key new drug submissions, including NDA resubmissions, efficacy supplements, and manufacturing supplements
PAREXEL's newly-released The US Drug Approval Trends and Yearbook 2008/2009 is the largest compendium of drug approval trends and metrics ever compiled.
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 69 locations throughout 52 countries around the world, and has more than 8,800 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; 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 period ended March 31, 2008 as filed with the SEC on May 9, 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, Perceptive Informatics is a trademark of Perceptive Informatics, Inc., and ClinPhone is a registered trademark of ClinPhone Limited. All other names or marks may be registered trademarks or trademarks of their respective business and are hereby acknowledged.
Posted: August 2008
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