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March 30, 2016

Kissei and Kyorin signed an Agreement for Co-Development and Co-Marketing of KRP-114V

Kissei Pharmaceutical Co., Ltd.
KYORIN Holdings, Inc.



Kissei Pharmaceutical Co., Ltd. (Head office: Matsumoto-city, Nagano, Chairman and CEO: Mutsuo Kanzawa; "Kissei") and KYORIN Pharmaceutical Co., Ltd. (Head office: Chiyoda-ku, Tokyo, President and CEO: Mitsutomo Miyashita; "Kyorin"), a wholly-owned subsidiary of KYORIN Holdings, Inc. (President and CEO: Minoru Hogawa) jointly announced a co-development and co-marketing agreement for an overactive bladder medication of KRP-114V (INN: Vibegron) which is being developed by Kyorin in Japan.

Under the terms of the agreement, Kyorin grants Kissei a right to co-develop and co-market the product containing KRP-114V with Kyorin in Japan. The companies will share the development costs and, after Kyorin receives the marketing approval from the regulatory authority, will jointly market the product. Kyorin will be responsible for supplying Kissei with the finished product, and be eligible to receive royalties on net sales.

Vibegron is a new chemical entity discovered by Merck Sharp & Dohme and is expected to be a once daily OAB medication having selective beta 3 adrenergic receptor agonist activity. Kyorin acquired license to the compound from Merck Sharp & Dohme in July 2014 (for which Phase 2 clinical trials had been completed in and outside Japan) and has been carrying out Phase 3 clinical trials.

Urology is one of the strategic fields for both Kissei and Kyorin, and each of them has been dedicating its efforts to expand the product lineups and increase the presences in that area. This transaction is expected to enable the companies to effectively and efficiently develop a urological treatment of KRP-114V and maximize the promotion of the product.

Kissei and Kyorin strive to contribute to further increasing QOL of the patients with OAB symptoms through rapidly penetrating the product into the market taking advantage of their strengths and know-how.

* Overactive Bladder (OAB) is a disorder with symptoms such as urinary urgency (sudden and unquenchable micturition), frequency (more frequent urination than usual), and nocturia caused by increasing age or neurological disease.