BRACKNELL, U.K. and FUKUOKA, JAPAN - September 13, 2001 - To help pharmaceutical companies more efficiently conduct "two sites, one protocol" Phase I trials in Japan and at other sites in the United States and Europe, Quintiles Transnational Corp. (Nasdaq: QTRN) and Medical Corporation LTA today announced a scientific alliance.
Demand for Phase I trials involving Japanese and non-Japanese volunteers is expected to be a key element in collecting "bridging data" in the early stages of global clinical development. If they meet Japanese regulatory requirements, bridging data may allow a drug to be registered in Japan based on data collected from trials conducted outside Japan.
The alliance will allow Quintiles, the world's leading supplier of pharmaceutical services, and LTA, a medical corporation and the leading Japanese provider of Phase I trials, to efficiently conduct "two sites, one protocol" studies involving LTA's two Phase I facilities in Japan and Quintiles' four Phase I facilities in the United States and Europe.
"This alliance brings together two organizations with outstanding experience and resources in conducting Phase I trials, a key early step in drug development," said Senior Vice President Jean-Pierre Isal, who leads Quintiles' Phase I activities in Europe. "Through this alliance, Quintiles and LTA can provide pharma companies a more efficient way to conduct studies with the same protocol inside and outside Japan. We believe this will allow our customers to make better-informed decisions sooner on the global potential of new drugs, which is critical to enhancing product pipeline value."
LTA President Akinori Urae said: "In addition to offering 'two sites, one protocol' study services through this scientific alliance, Quintiles and LTA's Phase I experts will evaluate scientific differences between our standard operating procedures, dietary standards for our volunteers, procedure of dose escalation and other factors within a year. We will present outcomes of this research at international conferences and meetings. We believe that this will provide a better understanding of 'two sites, one protocol' studies, and help our customers in dealing with investigators and sites within their global drug development strategy."
Industry analysts forecast an increasing number of potential medicines entering Phase I studies in both Japan and the rest of the world. Phase I trials are designed to help determine a drug's basic safety and pharmacological data, and usually involve a limited number of healthy individuals, typically 20 to 80 people.
"This alliance is further evidence of Quintiles' commitment to provide our customers with a full range of services both locally and abroad," said Derek Winstanly, M.D., President of Quintiles Japan and Asia-Pacific. "The harmonized procedures called for in this alliance are designed to help our customers quickly get high quality Phase I data from Japan and the United States and Europe in a single step. This is vital in choosing the most promising potential drugs as early as possible in the development process."
About Quintiles Transnational Corp.
Quintiles Transnational Corp. is the world's leading provider of information, technology and services to bring new medicines to patients faster and improve healthcare. Headquartered near Research Triangle Park, North Carolina, Quintiles Transnational is a member of the S&P 500 and Fortune 1000. For more information visit the company's web site at www.quintiles.com.
About Medical Corporation LTA
Medical Corporation LTA, a privately held Japanese medical company, has two core businesses: medical care and clinical pharmacology research. LTA's two medical care sites are Miyata Hospital and Hakataeki Higashi Clinic, both in Fukuoka. Its two clinical pharmacology research sites are Kyushu Clinical Pharmacology Research Clinical in Fukuoka and Osaki Clinic in Tokyo. For more information on clinical pharmacology research, visit LTA's clinical research center web site at www.rinsho.or.jp.