Wyeth Clinical Trials in Japan: the real story

A few weeks ago, we reported some cryptic news we'd seen floating around the Internet, originating from the financial news wire, Trading Markets, indicating that Wyeth was planning to increase three-fold the number of clinical trials it conducts in Japan this year. Turns out the report was somewhat inaccurate. Fortunately, today, Gerald Burr, the company's vice president for scientific communications, set the record straight. The company has significantly increased the number of clinical trials that it initiates in Japan, and is running them simultaneously with trials in the U.S. and Europe, breaking with past tradition, where trials were first launched in the U.S. and Europe.  Currently, Wyeth has: 12 compounds in Phase I trials 7 compounds in Phase II and 6 compounds in Phase III (including some products that had been approved in the U.S. and Europe). Compounds undergoing trials run the gamut of Wyeth's therapies, and include treatments for:
  • cardiovascular disease
  • cancer
  • Alzheimer's disease (2)
  • rheumatoid arthritis
  • muscular dystrophy
  • endometriosis
As well as a vaccine and an antibiotic.  Despite the fact that Japan is opening up some of its regulatory practices, and officially allows alternatives to clinical trials with Japanese subjects in Japan (approving new drug applications with foreign data, or allowing the use of "bridging studies") , international companies say that progress has been uneven, with some officials still demanding that all trial data come from Japan.  Clearly, Wyeth is taking a conservative and long-term view toward the Japanese market. Read June's issue of Pharmaceutical Manufacturing and check PharmaManufacturing.com for more on this issue, and on Japanese pharma. -AMS