RESEARCH TRIANGLE PARK, N.C. – October 9, 2001 -- Quintiles Transnational Corp. (Nasdaq:QTRN) today announced the opening of its safety pharmacology unit in Kansas City, Missouri. A new guideline on safety pharmacology issued by the International Conference on Harmonization (ICH) has prompted a growing demand for the company's safety pharmacology services worldwide.
Quintiles will continue to offer safety pharmacology services at its site in Edinburgh, Scotland, which is a leading provider of safety pharmacology services. Safety pharmacology studies assist in predicting potential adverse reactions to new chemical entities and biotechnology-derived products prior to administration to man, as well as in supporting clinical studies during the drug development process.
"Quintiles has been a major player in safety pharmacology since we opened our Edinburgh unit six years ago," said Leslie Patmore, Executive Director of Preclinical Safety and Efficacy, at Quintiles. "Our new unit in Kansas City allows us to provide our full service safety pharmacology package to pharmaceutical customers in the United States while at the same time further strengthening our global leadership in safety pharmacology."
The ICH guideline on safety pharmacology (ICHS7A) was recommended for adoption by regulatory bodies in the European Union, United States and Japan in November 2000. The guidance came into effect in Europe and Japan in June 2001 and has been effective in the United States since August. The guideline calls for tests on the effects of compounds on vital functions of the human body, such as the cardiovascular, respiratory and central nervous system before first administration to man. The data provide specific information on the safety profile of a new potential therapeutic agent and are used by clinicians designing clinical studies and by regulatory agencies in their assessment of the safety of a new product.
Patmore added: "Quintiles has been anticipating the emergence of this new ICH guideline and has developed new tests to align our services with the new regulatory guideline in the United States, Europe and Japan. The opening of our U.S.-based Safety Pharmacology unit reflects our pro-active approach of providing the required safety pharmacology services globally and staying ahead of the needs of our customers."
Quintiles Transnational Corp. is the world's leading provider of information, technology and services to bring new medicines to patients faster and improve health care. Headquartered near Research Triangle Park, North Carolina, Quintiles employs a global workforce and is a member of the S&P 500 and Fortune 1000. For more information, visit the company's Web site at www.quintiles.com.
Information in this press release contains "forward-looking statements." These statements involve risks and uncertainties that could cause actual results to differ materially, including without limitation, actual operating performance and the ability to maintain large client contracts or to enter into new contracts. Additional factors that could cause actual results to differ materially are discussed in the company's recent filings with the Securities and Exchange Commission, including but not limited to its S-3 and S-4 Registration Statements, its Annual Report on Form 10-K, its Form 8-Ks, and its other periodic reports, including Form 10-Qs.