BOSTON, Oct. 16 /PRNewswire-FirstCall/ -- Gaining a first-cycle approval for a new molecular entity (NME) is worth an estimated $640 million in incremental revenue on average, according to a new analysis from PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and leading global life sciences consultancy serving the biopharmaceutical and medical device industries. According to the PAREXEL Consulting analysis, 60 percent of sales for newly-approved drugs and biologics each year are derived from the top five-selling products. Therefore, first-cycle approval can potentially produce up to approximately $2 billion in additional revenue for each of these top-selling products.
The estimate, which appears in a new PAREXEL Consulting white paper entitled Getting to Approval: Emerging FDA Review Outcome Trends for New Drugs, is based on the NMEs approved in 2007 and during the first half of 2008. The analysis tracks the differences in review times between the new drugs that obtained first-cycle approval and those that did not. PAREXEL Consulting has analyzed the average review time gap between approved NMEs that the U.S. Food and Drug Administration (FDA) cleared in the first review cycle and those that took multiple review cycles to gain approval. The dollar value of the approval time gap is based on using five-year post-launch sales projections for recently approved NMEs from EvaluatePharma(R), which tracks and forecasts the performance of biopharmaceutical companies and their products, from early-stage R&D through post-marketing.
"Obtaining new product approvals is an important measure of the industry's performance, and this first-cycle approval metric helps companies calculate appropriate investments in initial new drug application submissions," said Gadi Saarony, Corporate Vice President and Worldwide Head, PAREXEL Consulting. "More than ever, biopharmaceutical companies should focus on reaping the greatest return on their R&D investments, maximizing product value at every stage of the lifecycle, and gaining the most efficiency from the development process. Crucial decisions must be made early in development planning, including which regulatory approaches to apply to achieve first-cycle approval."
"With continuing focus on first-cycle approvals for new drugs, especially under FDA Good Review Management Practices, our goal was to provide biopharmaceutical companies with a real-world metric on the value of first-cycle approvals," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting. "Our data show that priority designations are now closely linked to first-cycle approvals for both NMEs and NDAs. As a result, this metric can help biopharmaceutical companies assess the value of the new priority review vouchers available under the FDA Amendments Act."
The Getting to Approval white paper 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 http://www.PAREXELConsulting.com/firstcycleapproval.
About PAREXEL Consulting
PAREXEL Consulting is a leading life sciences consultancy that helps companies design and execute their biopharmaceutical and medical device product strategies through our unique fusion of scientific, regulatory, and business expertise. Our approach helps clients manage risk, and drives superior quality and performance for clients worldwide. The firm has more than 270 experts, and serves clients on a global basis. For further information visit: http://www.PAREXELConsulting.com. PAREXEL Consulting is a division of PAREXEL International.
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 approximately 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, including ClinPhone; 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
their respective business and are hereby acknowledged
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|SOURCE PAREXEL International|
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