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September 24, 2024

Succession of Manufacturing and Marketing Authorization for MARIZEV®, Diabetes Treatment

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa) announced that it has completed the succession of the manufacturing and marketing authorization for the diabetes treatment drug "MARIZEV® Tablets 12.5mg/25mg (generic name: omarigliptin)" from MSD K.K. (Head Office: Chiyoda, Tokyo; President: Kyle Tattle; "MSD") effective September 24, 2024.

MARIZEV® is a once-weekly administered, long-acting selective DPP-4 inhibitor, which was launched by MSD in Japan in November 2015 and its distribution operation was transferred to us in April 20201. Since then, we have been responsible for the sales, marketing, provision of information to medical institutions, and collection of information as the distributor of MARIZEV®.

With this succession of manufacturing and marketing authorization, we take responsibility for the stable supply of MARIZEV® as the manufacturer and marketing authorization holder, and continue to provide information to medical institutions and promote its appropriate use.

The costs associated with this succession have already been incorporated into the consolidated financial results forecast for the fiscal year ending March 31, 2025, announced on May 7, 2024.


Product Overview

Product Name

MARIZEV® Tablets 12.5mg, MARIZEV® Tablets 25mg

Generic Name

Omarigliptin

Pharmacological Classification

Long-Acting Selective DPP-4 Inhibitor / Oral Antidiabetic Agent

Indications

Type 2 Diabetes Mellitus

Dosage and Administration

For adults, the usual dosage is 25mg of omarigliptin taken orally once a week.

Date of Succession of Manufacturing and Marketing Approval

September 24, 2024


1
News Release: February 3, 2020
Transfer of Distribution Operation of MARIZEV® Type-2 Diabetes Treatment