Advertisement
The estimate, which appears in a new PAREXEL Consulting white paperentitled Getting to Approval: Emerging FDA Review Outcome Trends for NewDrugs, is based on the NMEs approved in 2007 and during the first half of2008. The analysis tracks the differences in review times between the newdrugs that obtained first-cycle approval and those that did not. PAREXELConsulting has analyzed the average review time gap between approved NMEs thatthe U.S. Food and Drug Administration (FDA) cleared in the first review cycleand those that took multiple review cycles to gain approval. The dollar valueof the approval time gap is based on using five-year post-launch salesprojections for recently approved NMEs from EvaluatePharma(R), which tracksand forecasts the performance of biopharmaceutical companies and theirproducts, from early-stage R&D through post-marketing.
Advertisement
"Obtaining new product approvals is an important measure of the industry'sperformance, and this first-cycle approval metric helps companies calculateappropriate investments in initial new drug application submissions," saidGadi Saarony, Corporate Vice President and Worldwide Head, PAREXEL Consulting."More than ever, biopharmaceutical companies should focus on reaping thegreatest return on their R&D investments, maximizing product value at everystage of the lifecycle, and gaining the most efficiency from the developmentprocess. Crucial decisions must be made early in development planning,including which regulatory approaches to apply to achieve first-cycleapproval."
"With continuing focus on first-cycle approvals for new drugs, especiallyunder FDA Good Review Management Practices, our goal was to providebiopharmaceutical companies with a real-world metric on the value offirst-cycle approvals," said Mark Mathieu, Director of Strategic Research atPAREXEL Consulting. "Our data show that priority designations are now closelylinked to first-cycle approvals for both NMEs and NDAs. As a result, thismetric can help biopharmaceutical companies assess the value of the newpriority review vouchers available under the FDA Amendments Act."
The Getting to Approval white paper is part of PAREXEL Consulting'sIntelligent Development Series, which provides data and insights in support ofsuccessful biopharmaceutical and medical device product development. Thewhite paper is available athttp://www.PAREXELConsulting.com/firstcycleapproval.
About PAREXEL Consulting
PAREXEL Consulting is a leading life sciences consultancy that helpscompanies design and execute their biopharmaceutical and medical deviceproduct strategies through our unique fusion of scientific, regulatory, andbusiness expertise. Our approach helps clients manage risk, and drivessuperior quality and performance for clients worldwide. The firm has more than270 experts, and serves clients on a global basis. For further informationvisit: http://www.PAREXELConsulting.com. PAREXEL Consulting is a division ofPAREXEL International.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceuticalservices organization, providing a broad range of knowledge-based contractresearch, medical communications and consulting services to the worldwidepharmaceutical, biotechnology and medical device industries. Committed toproviding solutions that expedite time-to-market and peak-market penetration,PAREXEL has developed significant expertise across the development andcommercialization continuum, from drug development and regulatory consultingto clinical pharmacology, clinical trials management, medical education andreimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, providesadvanced technology solutions, including medical imaging, to facilitate theclinical development process. Headquartered near Boston, Massachusetts,PAREXEL operates in 69 locations throughout 52 countries around the world, andhas approximately 8,800 employees. For more information about PAREXELInternational visit http://www.PAREXEL.com.
This release contains "forward-looking" statements regarding futureresults and events. For this purpose, any statements contained herein that arenot 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," andsimilar expressions are also intended to identify forward-looking statements.The forward-looking statements in this release involve a number of risks anduncertainties. The Company's actual future results may differ significantlyfrom the results discussed in the forward-looking statements contained in thisrelease. Important factors that might cause such a difference include, but arenot limited to, risks associated with: actual operating performance; actualexpense savings and other operating improvements resulting from recentrestructurings; the loss, modification, or delay of contracts which would,among other things, adversely impact the Company's recognition of revenueincluded in backlog; the Company's dependence on certain industries andclients; the Company's ability to win new business, manage growth and costs,and attract and retain employees; the Company's ability to complete additionalacquisitions and to integrate newly acquired businesses or enter into newlines of business, including ClinPhone; the impact on the Company's businessof government regulation of the drug, medical device and biotechnologyindustry; consolidation within the pharmaceutical industry and competitionwithin the biopharmaceutical services industry; the potential for significantliability to clients and third parties; the potential adverse impact of healthcare reform; and the effects of exchange rate fluctuations and otherinternational economic, political, and other risks. Such factors and othersare discussed more fully in the section entitled "Risk Factors" of theCompany's Annual Report on Form 10-K for the Fiscal Year ended June 30, 2008as filed with the SEC on August 28, 2008, which "Risk Factors" discussion isincorporated by reference in this press release. The forward-lookingstatements included in this press release represent the Company's estimates asof the date of this release. The Company specifically disclaims any obligationto update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company'sestimates or views as of any date subsequent to the date of this pressrelease.
PAREXEL is a registered trademark of PAREXEL International Corporation,and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. Allother names or marks may be registered trademarks or trademarks of theirrespective business and are hereby acknowledgedContacts: Jennifer Baird, Senior Director of Public Relations PAREXEL International Tel: +781-434-4409 Email: [email protected] Rebecca Passo SHIFT Communications Tel: +617-779-1817 Email: [email protected]
SOURCE PAREXEL International
