Launch of CANAGLU® Tablets 100mg

Mitsubishi Tanabe Pharma Corporation (hereafter, Mitsubishi Tanabe Pharma; Head Office: Chuo-ku, Osaka; President & Representative Director, CEO: Masayuki Mitsuka) and Daiichi Sankyo Co., Ltd., (hereafter, Daiichi Sankyo; Head Office: Chuo-ku, Tokyo; Representative Director, President & CEO: Joji Nakayama) announced today that both companies would launch CANAGLU^® 100mg tablets (generic name: canagliflozin hydrate, hereafter, CANAGLU^®), for a treatment for type 2 diabetes mellitus, in Japan on September 3, 2014, following today’s inclusion of CANAGLU^® in the National Health Insurance drug price list.

CANAGLU^® inhibits SGLT2 (sodium glucose co-transporter 2), a transporter involved in the reabsorption of glucose in the proximal renal tubules of the kidneys, suppresses the reabsorption of glucose, promotes the excretion of excessive glucose into the urine, and as a result, lowers HbA1c. CANAGLU^® exhibits a HbA1c- lowering effect for 52 weeks through the administration of only one dose.

In other countries, licensee Janssen Pharmaceuticals, Inc. (Head Office: Raritan, NJ, US) has received approval of canagliflozin hydrate under the brand name INVOKANA^® for the treatment of adult patients with type 2 diabetes mellitus in the US and, as of August 2014, has obtained approvals in 48 countries worldwide, including the US, Europe, Canada, and Australia. More than 11,000 patients with type 2 diabetes mellitus were enrolled in global Phase 3 programs, including in Japan, which assessed the efficacy and safety of canagliflozin hydrate. The development program included a mono-therapy, dual and triple combination therapies with other anti-hyperglycemic agents, and also involved type 2 diabetes mellitus patients with impaired renal function, patients who are at high risk of developing cardiovascular diseases and elderly patients. The global clinical data from the development program is utilized to provide medical personnel with efficacy and safety information and promote the appropriate usage of CANAGLU^®.

Mitsubishi Tanabe Pharma will manufacture and market CANAGLU^®, and then co-promote it with Daiichi Sankyo based on “common policy” and “common strategy”. This collaboration, which includes the DPP-4 inhibitor, TENELIA^® , will enable the companies to achieve a No.1 presence in the field of diabetes. Mitsubishi Tanabe Pharma and Daiichi Sankyo aim to contribute to the treatment of individual patients by providing this new treatment option for type 2 diabetes mellitus and promoting the appropriate usage of CANAGLU^®.