Agreement expands Quintiles capabilities to support drug approvals in Japan

Japan is the second largest consumer of pharmaceutical products in the world.  The rapid growth of the pharmaceutical industry in Japanmade it more difficult for pharma companies to enroll clinical trial volunteers in the island nation. But with the adoption of the international Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data, drug approval authorities in Japanmay now accept data from studies involving ethnic Japanese living outside Japan. 

In June 2002, Quintiles signed an agreement with Hawaii Pacific Health, one of Hawaii's largest healthcare providers, to conduct clinical trials including Hawaii's centralized population of ethnic Japanese. In 2003, Quintiles formed an alliance with Newco Trials Pesquisa Cientifica Limitada in Sao Paulo, Brazil, for Phase II-IV clinical trials with adult ethnic Japanese and Phase I trials for ethnic Japanese of all ages. Newco represents hospitals, ambulatory care sites and other healthcare operations in Braziland has a research institute experienced in clinical trials. Newco also operates a Phase I unit within the Kidney and Hypertension Hospital in Sao Paulo.

The Peru alliance is with Asociacion Peruana Japonesa, which operates a hospital in Limathat serves the Japanese community and regularly participates in clinical trials.

"With the addition of Peru, Quintiles now has agreements to conduct clinical trials involving the three largest concentrations of ethnic Japanese living outside Japan," said Anand Tharmaratnam, Senior Vice President, Alliance Management, Quintiles Japan. "We can help pharmaceutical and biotechnology companies in Japanand in the rest of the world speed up the development and launch of safe and effective products for people in Japan."

Carl Trygstad, Vice President, Quintiles Japan-Hawaii, said: "The alliances allow our customers to conduct either small bridging studies or complete, large-scale clinical trials to demonstrate safety and efficacy in ethnic Japanese."

Many Japanese immigrated to South Americain the early 1900s to work on farms and sugar or coffee plantations. Today, an estimated 1.1 million ethnic Japanese reside in Braziland 200,000 in Peru. According to the U.S. Census, about 300,000 ethnic Japanese reside in Hawaii, including a significant number who are first-generation Japanese.

Quintiles 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 ParkNorth Carolina, Quintiles has offices in 50 countries and is the world's leading pharmaceutical services organization. 

For more information visit the company's Web site at www.quintiles.com