RESEARCH TRIANGLE PARK, N.C. and HONOLULU - June 6, 2002 - Quintiles Transnational Corp. (Nasdaq: QTRN) and Hawaii Pacific Health today announced an exclusive collaborative agreement to support new drug applications in Japan by conducting clinical trials in Hawaii involving the state's large population of ethnic Japanese.
Japanese drug approval authorities recently announced that they would accept data from trials involving ethnic Japanese living outside Japan if those trials are conducted using International Conference on Harmonization Good Clinical Practice (ICH GCP) standards and meet other specific requirements.
The alliance between Quintiles, the world's leading provider of pharmaceutical services, and Hawaii Pacific Health, the largest health organization in the Hawaii/Pacific region, is designed to facilitate fast, efficient start-up and management of Phase II-IV trials that meet ICH GCP standards and Japanese regulatory requirements.
"The opening of Japan's pharmaceutical market has created greater demand for clinical trials acceptable for drug registration in Japan than can be easily met by GCP-compliant sites in Japan alone," said Quintiles Transnational Chief Executive Officer Pam Kirby, Ph.D. "Access to Hawaii's large population of ethnic Japanese offers a solution to this challenge."
The agreement gives Quintiles exclusive access to Hawaii Pacific Health's Research Institute, a Phase II-IV clinical research center in Honolulu, and its hospitals and ambulatory care sites, for trials primarily involving ethnic Japanese and designed for regulatory approval in Japan. Hawaii Pacific Health serves a substantial portion of the state's 1.2 million residents, of which about one-fifth are ethnic Japanese. The Research Institute has experience in trials involving adult, pediatric, inpatient and outpatient volunteers.
Hawaii Pacific Health President and Chief Executive Officer Roger Drue said: "This partnership goes well beyond the agreement between Quintiles and Hawaii Pacific Health. Those of us in healthcare truly understand the significant impact pharmaceuticals have had on medicine. We routinely save patients now whom we couldn't before, and millions of people lead perfectly normal lives thanks to maintenance drugs. We look forward to helping develop medicines that will bring more of these same benefits to the people of Japan."
Under the agreement, Quintiles will provide study start-up support and help Hawaii Pacific Health expand its clinical research infrastructure, and Hawaii Pacific Health will provide site management organization services for trials conducted under the alliance. The agreement also calls for Quintiles and Hawaii Pacific Health to cooperate in marketing their services to pharmaceutical and biotech companies seeking to introduce new medicines in Japan.
About Hawaii Pacific Health
Hawaii Pacific Health is a non-profit healthcare organization formed with the merger of three longtime Hawaii health systems: Wilcox Health, Kapi'olani Health and Straub Clinic and Hospital. Hawaii Pacific Health is one of the state's largest healthcare systems, with a network of four hospitals, 24 outpatient centers and 1,100 physicians on four islands. In addition to providing care on Oahu, Kauai, Lanai and the Big Island, Hawaii Pacific Health's services also are extended to care for patients and visitors throughout the state and the Pacific Region.
About Quintiles Transnational Corp.
Quintiles Transnational helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Headquartered near Research Triangle Park, North Carolina, Quintiles is a member of the S&P 500 and Fortune 1000. For more information visit the company's Web site at www.quintiles.com.