PAREXEL Consulting Releases Annual Analysis of FDA New Drug Review Trends

Provides Insights on the 'New Normal' for Innovation, Approval, and Market Access

BOSTON, Oct. 26 /PRNewswire/ -- 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 a new white paper entitled Drug Innovation, Approval, Market Access, and the "New Normal": Emerging FDA Review Outcome Trends for New Drugs.  Exploring trends in the review of new molecular entities (NMEs), as well as first-cycle approval and priority designation rates, PAREXEL Consulting's analysis indicates that there is a "new normal" emerging in the drug review and approval process.

PAREXEL Consulting's analysis identified notable declines in both first-cycle approval rates for priority drug applications and priority designation rates for new drugs at the time when the U.S. Food and Drug Administration (FDA) settled into its FDA Amendments Act (FDAAA)-related responsibilities and the 21st Century Review Process.  Between 2008 and 2009, for example, PAREXEL Consulting found that there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications (NDAs).

"First-cycle approval rates are a key indicator of the biopharmaceutical industry's success in securing FDA approval for new therapies early in the review process.  While there is often some fluctuation in first-cycle approval rates year-to-year, our analysis of the latest FDA metrics leads us to ask whether there is a 'new normal' emerging, which has significant implications for the drug-review process," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting.  "The notable decline in first-cycle approvals for priority-rated drugs comes at a time when the FDA is implementing FDAAA requirements, in particular for Risk Evaluation and Mitigation Strategies, or REMS, which are particularly relevant for priority-rated therapies."

PAREXEL Consulting's analysis reveals that there are other factors pointing to a "new normal."  "The FDA's 13 percent priority designation rate for 2009 new drug applications mirrors the low rate at which some health care plans and other payers are finding value in newly approved drugs.  This illustrates the need for companies to take into account market-based clinical concerns in the product development process," according to Charles A. Stevens, Vice President and General Manager, Reimbursement and Market Access, PAREXEL Consulting.

Despite these trends, PAREXEL Consulting's analysis indicates that there are significant rewards for innovation in the context of the FDA review process.  For instance, despite the decrease in first-cycle approval rates for the class, the analysis shows that priority drugs continue to be approved more often and more quickly in the initial FDA review cycle.  According to the white paper, there is continuing evidence of a widening post-submission advantage for priority drugs.

"Our latest analysis provides strong evidence to further support what PAREXEL Consulting calls 'The Innovation Imperative,' which is the concept that the most innovative new drugs can reap advantages in critical regulatory and reimbursement reviews. These advantages include shorter, more predictable review times for drugs with priority ratings," said Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy Services, PAREXEL Consulting.  "We believe that over time new drugs will be expected to clear a progressively higher bar of innovation, and actually deliver a more significant benefit than previously approved drugs in the same therapeutic class.  As a result, true innovation is becoming part of the 'new normal.'"

The white paper, part of PAREXEL Consulting's Intelligent Development Series, which provides data and insights in support of successful biopharmaceutical and medical device product development, is available at: http://www.PAREXEL.com/services-and-capabilities/consulting/our-thinking/whitepapers.

About PAREXEL International

PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications 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 54 countries around the world, and has approximately 9,720 employees. For more information about PAREXEL International visit www.PAREXEL.com.

This release contains "forward-looking" statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand.   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," "will," "would," "could," "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 and anticipated 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 Annual Report on Form 10-K for the year ended June 30, 2010 as filed with the SEC on August 27, 2010, which "Risk Factors" discussion is incorporated by reference in this press 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.

SOURCE PAREXEL International Corporation