PAREXEL CONSULTING TO VALIDATE FIRST CGMP BIOPHARMACEUTICAL CONTRACT MANUFACTURING FACILITY IN SOUTH KOREA
BOSTON, MA, November 19, 2004 — PAREXEL International Corporation (Nasdaq: PRXL), one of the world’s largest bio/pharmaceutical services companies, today announced that it has entered into a strategic collaboration with the Korea Institute of Industrial Technology (KITECH). KITECH plans to operate South Korea’s first multi-purpose, current Good Manufacturing Practice (cGMP) contract manufacturing facility, the Korea Biotechnology Commercialization Center (KBCC), designed to be in compliance with United States (U.S.) Food and Drug Administration and European cGMP guidelines. PAREXEL Consulting will provide KBCC with a core team of on-site validation engineering consultants located in South Korea as well as U.S.-based engineering and regulatory experts to train KBCC personnel and validate the manufacturing facility, its utilities, and process equipment. Terms of the agreement were not disclosed.
Headquartered in Incheon, South Korea, KBCC’s full range of services span cell banking, process and analytical method development and scale-up, regulatory support and manufacturing. Founded in 1998 by the Korean Ministry of Commerce, Industry, and Energy, KBCC provides contract manufacturing services for the production of biopharmaceuticals including genetically engineered protein and monoclonal antibody therapeutics.
PAREXEL’s BioPharm Alliance partner, Sartorius AG, a leading laboratory and process technology supplier, maintains a local presence in Seoul, South Korea, and will provide critical bioprocess equipment to be validated by PAREXEL Consulting at KBCC. The BioPharm Alliance was established to help clients achieve business advantage by optimizing manufacturing performance through new technologies that integrate Sartorius AG’s equipment design and PAREXEL Consulting’s process validation expertise, helping to accelerate the regulatory approval process.
“PAREXEL Consulting’s experts will collaborate with KITECH management to position the KBCC manufacturing facility to meet or exceed current FDA and cGMP standards, thus providing a regulatory compliant foundation for future therapies to achieve regulatory approval,” noted Kurt A. Brykman, President of PAREXEL Consulting.
“PAREXEL is proud to support the Korean biotechnology industry through our alliance with KITECH,” stated Josef von Rickenbach, PAREXEL Chairman and Chief Executive Officer. “This is not PAREXEL’s first venture into Korea. Last year, PAREXEL assisted a client in the noteworthy achievement of obtaining approval for the first Korean originated New Molecular Entity (NME) by the U.S. FDA.”
PAREXEL is one of the largest biopharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that expedite time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. Its information technology subsidiary, Perceptive Informatics, Inc., develops and offers a portfolio of innovative technology-based products and services that facilitate clinical drug development and are designed to decrease time to peak sales. The technology portfolio includes web-based portal solutions and tracking tools, Interactive Voice Response Systems (IVRS), Clinical Trial Management Systems (CTMS), electronic diary and investigator database solutions. Perceptive also offers advanced medical diagnostics services to assess rapidly and objectively the safety and efficacy of new drugs, biologics, and medical devices in clinical trials. PAREXEL’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 52 locations throughout 35 countries around the world, and had 4,885 employees as of September 30, 2004.
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" and similar expressions are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. PAREXEL'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; PAREXEL's dependence on certain industries and clients; PAREXEL's ability to win new business, manage growth, and attract and retain employees; PAREXEL's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry; 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 PAREXEL’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 as filed with the SEC on November 8, 2004, which "Risk Factors" discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent PAREXEL’s estimates as of the date of this release. PAREXEL specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing PAREXEL’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.