Launch of MINIRIN MELT® OD tablet 25µg and 50µg for the Treatment of Nocturia due to Nocturnal Polyuria in Males

Ferring Pharmaceuticals Co., Ltd.
Kissei Pharmaceutical Co., Ltd.

Ferring Pharmaceuticals Co., Ltd. (headquater: Minato, Tokyo; CEO and Representative Director: Mark Noggle; "Ferring") and Kissei Pharmaceutical Co., Ltd. (head office; Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa; "Kissei") jointly announce that MINIRIN MELT^® OD tablet 25µg and MINIRIN MELT^® OD tablet 50µg (generic name: desmopressin acetate aqueous agent; "Product") will be launched by Ferring on September 20, 2019.

Ferring obtained marketing authorization for the Product in this June as the first drug in Japan to treat nocturia due to nocturnal polyuria in males. At the same time, Ferring and Kissei executed the agreement to co-promote the Product in Japan; since then, both companies have jointly started to promote the Product to healthcare professionals. In this collaboration, Ferring handles the production, marketing, and distribution of the Product.

The Product acts on the vasopressin V2 receptors in the renal collecting tubules and exerts an antidiuretic effect by promoting the re-absorption of water. It was first approved in Canada in 2012; since then, it has been approved in more than 30 countries for the indication of nocturia due to nocturnal polyuria.

Ferring and Kissei have positioned the field of urology as one of their respective strategic areas. Through co-promotion activity in the field, both companies will contribute to the improvement of QOL in patients with related diseases.

<Product Summary of MINIRIN MELT^® OD tablet>
Brand Name:
MINIRIN MELT^® OD tablet 25µg, MINIRIN MELT^® OD tablet 50µg

Generic Name:
Desmopressin acetate aqueous agent

Indications:
Nocturia due to nocturnal polyuria in males

Dosage and Administration:
The usual oral dosage for male adults is 50µg of desmopressin once daily before bedtime.

NHI price:
MINIRIN MELT^® OD tablet 25µg: 59.50 JPY/tab
MINIRIN MELT^® OD tablet 50µg: 100.00 JPY/tab

Package:
MINIRIN MELT^® OD tablet 25µg: 100 tab/box (10 tab/sheet × 10 sheets)
MINIRIN MELT^® OD tablet 50µg: 100 tab/box (10 tab/sheet × 10 sheets)

NHI price listing:
September 4, 2019

Launch:
September 20, 2019

MAH:
Ferring Pharmaceuticals Co., Ltd.

Partnering:
Kissei Pharmaceutical Co., Ltd.

<About Nocturnal Polyuria and Nocturia>
The Japanese Continence Society's definition of nocturnal polyuria states that, out of the total urination over a period of 24 hours, a substantial amount takes place during night-time. Nocturia is defined as a condition in which a person has to wake up once or more than once every night for urination and is bothered by it. If night-time urination occurs more than once, it may impact the patient's QOL and, therefore, becomes a clinical issue that requires treatment.