PAREXEL Data Reveal A Record High Number Of Clinical Trials Initiated

According to new data from PAREXEL International Corporation, a leading global biopharmaceutical services organization, the number of new industry-sponsored clinical trial initiations, or starts, surged another 12 percent to a record high in 2007. PAREXEL's analysis shows that the biopharmaceutical industry submitted 662 commercial Investigational New Drug (IND) applications in support of new clinical studies for drugs in 2007, up from the previous record of 593 in 2006.

"The number of commercial IND submissions is a key measure of the number of clinical studies that are initiated by biopharmaceutical companies. IND submissions have been steadily increasing from 2004 to 2007, from 542 to 662 submissions, representing a 22 percent increase over this three year time period," said Mark Mathieu, Director of Publications at PAREXEL and Editor of PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook, 2008/2009.

Mr. Mathieu observed, "There has been a less consistent year-over-year pattern for commercial IND submissions of therapeutic biological products as compared with IND submissions related to drug products. PAREXEL data show that 83 commercial INDs were submitted for therapeutic biological products in 2007, which was down 27 percent from 114 submitted in 2006. The 114 INDs submitted in 2006 however, represented a 67 percent increase over submissions in 2005."

Oncology Studies Represent Largest Percentage of New Clinical Studies

According to PAREXEL data, new clinical studies of oncology drugs, which rose another 13 percent in 2007, comprised the largest percentage among all therapeutic areas for new clinical trial starts in 2007-nearly 15 percent of the total number of clinical trials that were initiated. Clinical trial starts involving neurology compounds spiked 45 percent in 2007, up from eight percent in 2006, and represented almost 11 percent of the total. Clinical trial starts for metabolism and endocrinology compounds represented another 11 percent of the total, although they were down 6 percent in 2007.

Overall Clinical Research Activity Just Below Record High PAREXEL's analysis also includes an assessment of the number of active commercial INDs at the FDA Center for Drug Evaluation and Research (CDER), which is an indicator of overall clinical research activity. At the end of 2007, 5,417 active commercial INDs were being managed by CDER, compared to 5,445 at the end of 2006. "Our analysis shows that following a steady climb in recent years, the total number of active FDA-regulated INDs declined very slightly by a half percent in 2007, which was just below the record high," notes Mr. Mathieu.

About PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook
PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook, 2008/2009 is a leading compendium providing new insights into the trends that are reshaping the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the compendium provides the latest intelligence on every aspect of biopharmaceutical development-from product discovery to R&D performance and productivity to time-to-market trends.

With key analyses and contributions from leading consultancies and experts, the compendium provides real-world data and analyses, including:

• New analysis of the countries in which biopharmaceutical companies are locating clinical studies
• New global R&D spending trends and other international R&D data from key markets
• International statistics on drug development output
• Emerging data on worldwide and company-specific R&D pipelines and product launch trends
• New analyses on drug development costs, development cycle times, and attrition rates
• Drug approval statistics compiled from FDA, EMEA, and other regulatory agencies

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009 (400+ pages) is published by Cambridge Healthtech Institute (CHI), an industry leader offering information to researchers and business experts from top pharmaceutical, biotech, and academic organizations. To order this compendium, which is available in hardcopy ($425 USD) and electronic format ($1,200, includes hardcover), visit the Educational Services section of the CHI website at www.chicorporate.com or email customerservice@barnettinternational.com.

About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical 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 63 locations throughout 52 countries around the world, and has more than 7,600 employees. For more information about PAREXEL International visit www.PAREXEL.com.

SOURCE: PAREXEL International Corporation