It takes an average of 3.5 years longer for a drug to reach the market in Japan than in the US and Europe and the new deal between the UK firm's Japanese subsidiary and Tokyo-based Keio University School of Medicine is aimed at helping to close this gap. "The agreement has been signed against a background of the recent severe environment for clinical trials in Japan," said AstraZeneca in a statement. Some of Japan's drug lag has to do with the fact that the country is very sensitive to have pharmacokinetics (PK) and pharmacodynamics (PD) study data (generated from at least single-dose safety and PK study) on its own population first before any other studies in the country can begin. In addition, clinical development in the country has been held back by the high cost of trials and the reluctance of patients to participate in them. As a result, despite being the world's second largest drug market, Japan represents only 15 per cent of the total global spend on clinical development. Meanwhile, regulatory hurdles are another major cause of the drug lag although they are now starting to be lowered by the Japanese regulators and it is expected that in the next year or two sponsors will begin more regularly involving Japan in global studies from the start. AstraZeneca's move could be the proof that the efforts made by the Japanese government to face up the issue - it is about half way through an extended six-year plan aimed at addressing the problems - are starting to pay off. Furthermore, a recent report from PriceWaterhouseCoopers (PWC) said that a deregulatory trend in the country, resulting in efforts to accelerate new drug approvals and the removal of compulsory local manufacturing had all made investment opportunities in the sector more attractive. Keio University is itself taking steps to build up its clinical research capability, and said it will have discussions with AstraZeneca as part of this effort under the agreement. The university will also conduct early clinical trials of drug candidate discovered by AstraZeneca. "At the same time, it is the university's intention to reduce the time required to undertake and conclude clinical trial contracts to contribute to earlier commencement and enhanced efficiency of clinical developments in Japan," said the company. The country has suffered several setbacks this year, as a number of big pharma players recently pulled out the country. In March, GlaxoSmithKline said it would close its only research facility in Japan in a bid to accelerate its clinical trials and the commercialisation of new products - just two months after Pfizer made a similar announcement.
