Marketing and manufacturing approval received for TENELIA(R) 20mg tablets

Mitsubishi Tanabe Pharma Corporation (hereafter, Mitsubishi Tanabe; Head Office: Chuo-ku, Osaka; President & CEO: Michihiro Tsuchiya) and Daiichi Sankyo Co., Ltd., (hereafter, Daiichi Sankyo; Head Office: Chuo-ku, Tokyo; President & Representative Director: Joji Nakayama) announced today that Mitsubishi Tanabe has received approval to manufacture and market the selective DPP-4 inhibitor TENELIA® 20mg tablets (generic name: Teneligliptin hydrobromide hydrate) in Japan.

TENELIA® is a DPP-4 inhibitor created by Mitsubishi Tanabe and is the first drug of its kind to originate from Japan. In August 2011, Mitsubishi Tanabe applied for manufacturing and marketing approval in Japan, and approval was subsequently received based on the drug’s efficacy in the treatment of type 2 diabetes mellitus when satisfactory improvement cannot be achieved through diet and exercise, or by a combination of diet and exercise with the use of sulfonylurea- or thiazolidine-class drugs.

TENELIA® suppresses glucagon release and increases insulin release, subsequently lowering blood-glucose levels by inhibiting the activity of dipeptidyl peptidase-4 (DPP-4), an enzyme that selectively inactivates glucagon-like peptide-1 (GLP-1), a hormone excreted from the gastrointestinal tract in response to food ingestion. TENELIA®, with its potent and sustained action, has made it highly effective in lowering each of the blood glucose postprandial levels, as well as fasting blood glucose levels, with once-a-day administration.

Following its inclusion in the NHI drug price list, Daiichi Sankyo and Mitsubishi Tanabe will begin joint marketing under one brand name–TENELIA® 20mg tablets. By providing this new treatment option for type 2 diabetes mellitus, the two companies hope to support patients who are combating this disease.