October 17, 2013

Kissei and Kyorin announce the initiation of a Phase I clinical trial of KEA-0447/KRP-EPA605 for the treatment of overactive bladder

Kissei Pharmaceutical Co., Ltd.

KYORIN Holdings, Inc

Kissei Pharmaceutical Co., Ltd. (President & CEO: Mutsuo Kanzawa; hereafter, "Kissei") and KYORIN Pharmaceutical Co., Ltd. (President & CEO: Mitsutomo Miyashita; hereafter, "Kyorin"), a subsidiary of the KYORIN Holdings, Inc. (President & CEO: Masahiro Yamashita), initiated a Phase I clinical trial of "KEA-0447/KRP-EPA605" which has been promoted under a joint development agreement for the treatment of overactive bladder.

Urology is a priority area for research and development of Kissei and Kyorin. From the point of view that it should be possible to make use of know-how and strengths of both companies, and promote the research and development of the new compounds speedy and efficiency in cooperation with each other, Kissei and Kyorin entered into a joint research agreement on the new treatment of overactive bladder in 2009, and had been conducting collaborative research with a view to global expansion in the future. Subsequently, Kissei and Kyorin entered into a joint development agreement in 2012, and has led to the initiation of a Phase I clinical trial of this drug.

This drug is a novel selective prostaglandin EP1 receptor antagonist found in the joint research of Kissei and Kyorin, and expected to improve urinary frequency by suppressing detrusor overactivity of the bladder. Although β3 agonists and anticholinergic drugs are mostly used for the treatment of overactive bladder, this drug, with a different mechanism of action from existing therapies, is expected to become a new approach to overactive bladder improving the QOL of patients suffering from urinary frequency and urgency, symptoms of overactive bladder.

Hereafter, Kissei and Kyorin aim to early approval of this drug by the joint development.


-About Overactive Bladder-
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.

-About Prostaglandin EP1 receptor-
Prostaglandin EP1 receptor (hereafter, "EP1") is a receptor for prostaglandin E2 (hereafter, "PGE2"), a physiologically active substance involved in delivery and fever which act mainly on smooth muscle contraction. It is known that PGE2 is produced in the bladder smooth muscle, and increase in various pathological conditions, which is thought to be related with abnormal contraction through the EP1 existing in the bladder smooth muscle.