RESEARCH TRIANGLE PARK, N.C. - November 12, 1999 - Quintiles Transnational Corp. (Nasdaq: QTRN) today signed an agreement with Shanghai Xingling Scientific and Technology Pharmaceutical Co., Ltd., to conduct clinical studies of Shanghai Xingling's product, a traditional Chinese medicine derived from the gingko tree, to determine its effectiveness as a treatment for stable angina.
Under terms of the agreement signed in Shanghai, China, Quintiles will provide a wide range of clinical trials services to Shanghai Xingling to help it obtain U.S. Food and Drug Administration approval of its product, Gingkonin. Those services include preparing the Investigational New Drug application, protocol design, regulatory consulting, clinical trial management, data management, data collection and analysis, report drafting and submission of a New Drug Application to the FDA.
"We are very pleased to help Shanghai Xingling conduct scientific studies of this product, which is one of many herbal medicines used in China for generations," Dennis Gillings, Chairman and Chief Executive Officer of Quintiles Transnational Corp., said at today's signing ceremony. "This agreement is one of several we've signed with Chinese companies to help them bring effective traditional Chinese botanical medicines to patients in the United States and other Western countries."
Xie Delong, the General Manager of Shanghai Xingling, said at today's ceremony: "While gingko has long been used as a medicine in China, we recognize the need to scientifically demonstrate its safety and efficacy in accordance with international standards accepted in the U.S., Europe and elsewhere in the world. We are extremely pleased to have a company with Quintiles' global experience and resources helping bring Xingling Pharmaceutical's herbal products to the world."
The Chinese State Drug Administration has approved Gingkonin for a similar indication to that which Shanghai Xingling will be seeking in the United States.
Shanghai Xingling Scientific and Technology Pharmaceutical Co. researches and develops a wide range of herbal products. It currently markets its products in China and Southeast Asia.
Quintiles' employees in China, operating from offices in Beijing, Shanghai and Hong Kong, provide product development and commercialization services to help companies accelerate the regulatory approval and market success of their healthcare products.
Quintiles Transnational Corp. is the market leader in providing a full range of integrated product development and commercialization solutions to the pharmaceutical, biotechnology and medical device industries. Quintiles also is a leader in electronic transactions processing and informatics for the healthcare sector and provides healthcare policy consulting to governments and other organizations worldwide.
Headquartered near Research Triangle Park, North Carolina, Quintiles is a member of the Fortune 1000 and the Nasdaq-100 Index. With more than 20,000 employees worldwide and offices in 31 countries, Quintiles operates through specialized work groups dedicated to meeting customers' individual needs. Visit the Quintiles Transnational 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, the ability of the recently combined businesses to be integrated with Quintiles' current operations, actual operating performance, the ability to operate successfully in new lines of business, the ability to maintain large client contracts or to enter into new contracts, and the actual costs of combining the businesses. 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.