Announcement of Co-promotion Agreement and Marketing Authorization Approval in Japan for MINIRIN MELT® OD Tablet 25µg and 50µg for 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") have jointly announced that they have entered into a co-promotion agreement for MINIRIN MELT^® OD tablet 25µg and MINIRIN MELT^® OD tablet 50µg (generic name: desmopressin acetate aqueous agent; "Product") in Japan.

Ferring has developed the Product and received Marketing Authorization approval for nocturia due to nocturnal polyuria in males in Japan today. The Product is the first drug in Japan to have acquired the indication. It works on the renal collecting tubule, vasopressin V2 receptor, and expresses antidiuretic action by promoting the re-absorption of water. Canada first approved the Product in 2012, and since then it has been approved in more than 30 countries globally for the indication of nocturia due to nocturnal polyuria.

Ferring will handle the production, marketing, and distribution of the Product while Ferring and Kissei collaboratively promote it to medical institutions in the field in accordance with the agreement.

Ferring and Kissei have positioned the urology field as one of their respective strategic areas. Through the co-promotion activity in the field, both companies will contribute to improve the QOL of patients who suffer from the relevant disease.

<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

Date of Marketing Approval:
June 18, 2019

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 sleeping.

<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 where a person has to wake up once or more than once every night for urination. If night time urination occurs more than once, it might further affect the QOL and becomes a clinical issue, and therefore comes within the scope of treatment.

<About Ferring Pharmaceuticals Co., Ltd>
The Ferring Group, founded in 1950, is a research-driven, specialty biopharmaceutical company headquartered in Switzerland. It is the worldwide leader in peptide-based and hormone-based medicines and is committed to the research, development, and marketing of innovative products in areas such as reproduction, women's health, urology, gastroenterology, endocrinology, and orthopedics. It has operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Ferring Pharmaceuticals Co., Ltd., established in 2001, is its 100% subsidiary.
For more details of Ferring Pharmaceuticals, please visit http://www.ferring.com/.

<About Kissei Pharmaceutical Co., Ltd>
Kissei is a Japanese pharmaceutical company based on the management philosophy "contributing to society through high-quality, innovative pharmaceutical products" and "serving society through our employees." As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide. Kissei is engaged in bringing new drugs into the world through drug discovery and licensing activities in the field of urology, nephrology/dialysis, and rare diseases, which are its focus fields.