Disclosure Policy of the Astellas Group for Information on Conduct and Results of Clinical Trials

The Astellas Group (*1) (hereinafter collectively Astellas) supports a general concept that significant benefits of public health are acquired from information on the conduct and results of clinical trials widely provided to healthcare professionals and patients. Astellas has a policy of transparency in disclosing this information to the public according to the recommendation by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The policy is as follows:

1. Astellas discloses information on controlled clinical investigations other than phase 1 trials (*2) sponsored and conducted mainly by Astellas, which were started after October 1, 2007, or earlier as required by regulation or industry agreement. Astellas may register other studies as necessary to facilitate publication in peer-reviewed medical journals. All clinical trial information we disclose is posted on the website, Clinicaltrials.gov.
2. Astellas discloses the results of controlled clinical investigations other than phase 1 trials (*2) sponsored and conducted mainly by Astellas which were started after October 1, 2007, or earlier as required by regulation or industry agreement. The results will be registered at an appropriate timing indicated by the Authority's guideline. All results of the studies we disclose will be posted on the website, Clinicalstudyresults.org.
3. Astellas discloses information on the conduct of hypothesis testing clinical trials (*2) sponsored by Astellas in Japan, which is posted on the website of the Japan Pharmaceutical Information Center, clinicaltrials.jp/user/cte_main.jsp (*1) Astellas Pharma Inc. and its group companies worldwide (*2) Control is a standard against which experimental observations may be evaluated. Controlled clinical investigation means clinical studies with targeted patients containing at least one control group so as to provide firm evidence to safety and/or efficacy to support product claims. Phase-1 studies are not included in the controlled clinical investigations.