AZ tackles Japanese drug lag with Keio University agreement

The UK’s AstraZeneca (AZ) has announced a clinical trials agreement with a Japanese university aimed at tackling the persistent obstacle of ‘drug lag’ between that country and other developed markets.

It is estimated that medicines take nearly two to three times longer to reach the market in Japan than they do in the US and Europe, despite various efforts by the Japanese authorities in recent years to galvanise clinical development and accelerate access to new drugs.

AZ said the Master Clinical Study Agreement between its Osaka-based subsidiary, AstraZeneca K.K., and Keio University School of Medicine, based in Shinjuku-ku, Tokyo, had been signed “against a background of the recent severe environment for clinical trials in Japan”. This had resulted in a “huge time difference” in making new medicines available in Japan compared with the US and Europe, which had “become a social problem”.

The umbrella agreement with Keio University lays the foundations for more specific collaboration with AstraZeneca on clinical development as well as exploratory and transational research. Separate project agreements on future clinical trials will be concluded independently under the master agreement, the UK company noted.

If better medicines are to be made available as quickly as possible in Japan, “it is vital for medical institutions and pharmaceutical companies to select medicines in areas of high unmet need and promptly proceed with clinical development while keeping close communications with each other”, AZ commented.

Growing capacity

Keio University School of Medicine has just started trying to build up its clinical trial and research capacity, and will “have discussions with AstraZeneca as part of this effort under this agreement”, the company explained. One objective is to reduce the time taken to arrange and conclude clinical trial contracts in the Japanese market.

The university will also support the early initiation of clinical trials with drug candidates in AstraZeneca’s pipeline, the company said.

According to a recent report by Sushma Raja, a research associate with Frost & Sullivan’s Asia Pacific Healthcare Practice, the faltering development of Japan’s clinical trial sector has been exacerbated by domestic companies opting to conduct their studies abroad.

And despite government initiatives such as accepting foreign clinical data in drug applications under revisions to the Pharmaceutical Affairs Law, the review time for new drugs in Japan rose to 23 months in 2005 against 15 months in the EU, Raja pointed out.

Late last year a report by PricewaterhouseCoopers (PwC) said the high cost of trials and the reluctance of many patients to take part in them remained a significant damper on clinical development in Japan.

In 2003 the Ministry of Health, Labor and Welfare (MHLW) launched a three-year programme aimed at encouraging more doctors to take part in clinical trials, providing incentives for patient enrolment and increasing the number of centres operating in accordance with Good Clinical Practice.

This initiative had made a palpable impact, with the number of clinical trial applications rising by nearly 40% in 2003-2005, PwC reported. But clinical development was still a sticking point, aggravated by historical factors such as stigmas attached to clinical studies and poor communication between doctors and patients.

Progress to report

More recently, the sixth annual report of the US-Japan Regulatory Reform and Competition Policy Initiative had some progress to report on this front. The MHLW had pledged to ensure that the Pharmaceuticals and Medical Devices Agency (PMDA) achieved its target of hiring 236 more reviewers by 31 March, 2010, funded by the user-fee increases that took effect in April 2007, the report noted.

The MHLW had also published draft guidelines clarifying Japan’s regulations for global clinical trials and had announced a five-year plan to stimulate the domestic sector. It also aimed to cut the pre-application drug lag by 1.5 years and the application review period by one year by the end of fiscal year 2011, thereby reducing the total development-to-approval period in Japan by 2.5 years.