For Immediate Release

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, President and CEO
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Noriaki Ishida, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com

Daiichi Sankyo Submits Supplemental Application for Additional Indication of Anticancer Agent Topotecin® Intravenous Drip Infusion 40mg, 100mg

Tokyo, Japan (May 31, 2013) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental new drug application to Japan’s Ministry of Health, Labor and Welfare (hereafter, MHLW) for an additional indication and dosage for Topotecin® intravenous drip infusion 40 mg and 100 mg (irinotecan hydrochloride hydrate) for treatment of pancreatic cancer.

 

The MHLW officially requested that Daiichi Sankyo develop Topotecin® intravenous drip infusion as a result of discussions by the Review Committee for Unapproved or Off-label Use of Drugs with High Medical Needs (*1) on March 23, 2012.

 

As a part of its corporate social responsibility efforts, Daiichi Sankyo is committed to making unapproved or off-label use of drugs with high medical needs available to the patients who need them.

 

*1 Working group held by the MHLW that aims to promote the development of drugs and indications not yet approved in Japan, but which are available in Europe and the U.S.