PAREXEL ANNOUNCES COLLABORATIVE AGREEMENT WITH PCTI
BOSTON, MA, January 20, 2000 — PAREXEL International Corporation (Nasdaq: PRXL) announced today that it has entered into a collaborative agreement with Pediatric Clinical Trials International, Inc. (PCTI), a wholly-owned corporation of Columbus Children's Hospital, to offer pediatric clinical research services to pharmaceutical and biotechnology companies worldwide.
Under the agreement, PAREXEL will work with PCTI to offer pediatric clinical research for national and international projects. PAREXEL will support joint research initiatives through its knowledge of worldwide drug development, specifically its expertise and capabilities in the design and management of clinical trials, biostatistical services, regulatory affairs, patient recruitment, contract medical marketing, and other drug development services.
The agreement underscores PAREXEL's commitment to increasing its clinical research capabilities by forging relationships with academic and community-based pediatric centers to serve as clinical resources. In a separate release today, PAREXEL appointed Ronald E. Keeney, M.D. as Head of Pediatric Academic Alliances, to develop and oversee collaborative relationships with children's academic research centers. Dr. Keeney is responsible for providing medical leadership to Pediatrics clinical projects and will develop and oversee collaborative relationships with children's academic research centers.
Columbus Children's Hospital has emerged as a leading institution in the area of pediatric drug research and testing. Founded on the principle of "children helping children through research", PCTI, which is housed on the main campus of Columbus Children's Hospital, was incorporated in October 1998, coinciding with the introduction of new regulations announced by the Food and Drug Administration (FDA) as part of the FDA Modernization Act (FDAMA). FDAMA provides the pharmaceutical industry with incentives, in the form of extensions of marketing exclusivity periods, for performing pediatric studies with certain new and marketed drugs. Furthermore, the FDA Final (Mandatory) Rule, which became effective April 1, 1999, requires pediatric studies for all new drugs and biologic agents starting December 2000. Both of these regulatory initiatives address the lack of pediatric use information for many products. The agreement will enhance both organizations' ability to attract and conduct worldwide clinical research projects.
"We look forward to working with PCTI and to utilizing their experience in pediatric clinical research to increase the effectiveness and efficiency of pediatric research and drug development on behalf of our clients worldwide," said Ronald Keeney, M.D., Head of Pediatric Academic Alliances at PAREXEL.
"Both PCTI and PAREXEL initiatives are focused on improving the health of infants and children. This initiative will offer expanded access to some of the best clinical research in the world," said John Niles, CEO, PCTI.
This release contains "forward-looking" statements regarding future results and events, including statements regarding expected future growth and customer demand. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Factors that might cause such a difference include, but are not limited to, risks associated with: loss or delay of large contracts; PAREXEL's dependence on certain industries and clients; the Company's ability to manage growth and its ability to attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses; government regulation of certain industries and clients; competition and consolidation within the 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. These 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 quarter ended September 30, 1999.
PAREXEL is a leading contract research, medical marketing, consulting services organization providing a broad range of knowledge-based outsourcing to the worldwide pharmaceutical, biotechnology, and medical device industries and to the academic community. Over the past fifteen years, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training, publishing and other drug development consulting services. PAREXEL is the first major CRO to develop a pediatric clinical research initiative to respond to the recently enacted FDA Modernization Act and the Final Pediatric Rule. Headquartered near Boston, MA, PAREXEL has approximately 4,400 employees in 46 locations throughout 29 countries around the world. Columbus Children's Hospital has a lengthy history participating in pharmaceutical industry and federally sponsored clinical trials through its Clinical Study Center (now part of PCTI) and since 1982 has participated in over 400 studies involving in excess of 4,000 patients in such areas as diabetes, growth disorders, ulcers, constipation, bacterial and viral infections, vaccines, skin disorders, seizures, asthma, pneumonia, pain and sedation, hyperactivity, psychological disorders, fever, otitis media, and hypertension.