September 21, 2018
NEWS RELEASEKYORIN Holdings, Inc.
(Securities Code: 4569, TSE 1st Sec.)
Kissei Pharmaceutical Co., Ltd.
(Securities Code: 4547, TSE 1st Sec.)Kyorin Receives Marketing Approval in Japan for"Beova® Tablets 50mg" for the Treatment of Overactive Bladder
KYORIN Holdings, Inc. (Head office: Chiyoda-ku, Tokyo, President & CEO: Minoru Hogawa )andKissei Pharmaceutical Co., Ltd. (Head office: Matsumoto-city, Nagano, Chairman and CEO: Mutsuo
Kanzawa, "Kissei") jointly announced today that KYORIN Pharmaceutical Co., Ltd. (Head office:Chiyoda-ku, Tokyo, President & CEO: Minoru Hogawa, " KYORIN Pharmaceutical"), a wholly owned
subsidiary of KYORIN Holdings, Inc., received approval from the Ministry of Health, Labour andWelfare as of September 21, 2018 to market "Beova® Tablets 50mg" ("Beova® Tablets") for the treatmentof overactive bladder.
KYORIN Pharmaceutical signed a license agreement with Merck & Co., Kenilworth, N.J., U.S.A. (Headoffice: New Jersey, U.S.A., CEO: Kenneth C. Frazier) in July 2014 concerning the grant of an exclusive
license to develop, manufacture and market this agent in Japan. The product has been jointly developedby KYORIN Pharmaceutical and Kissei under a co-development and co-marketing agreement enteredinto as of March 2016. KYORIN Pharmaceutical subsequently filed a marketing approval applicationfor Beova® Tablets with the Ministry of Health, Labour and Welfare in September 2017. With
successful receipt of marketing approval, Beova® Tablets will be co-marketed by KYORIN
Pharmaceutical and Kissei.
Vibegron, an active ingredient of Beova® Tablets, was discovered by Merck & Co., Kenilworth, N.J.,
U.S.A. and developed by KYORIN Pharmaceutical and Kissei locally in Japan as a novel once-daily
oral treatment for overactive bladder (OAB). Beova® Tablets act selectively on the bladder's
β3-adrenergic receptor, relax the bladder and enhance the urine collection, and consequently improve thesymptoms of urgency, urinary frequency and urge urinary incontinence associated with OAB.
Having the effects to improve various symptoms associated with OAB, anti-cholinergic agents have beencommonly prescribed in the OAB medication in Japan, but the long-term therapeutic compliance is notsufficient because the treatment with anti-cholinergic agents sometimes discontinues due to thedevelopment of adverse reactions such as dry mouth as well as the insufficient therapeutic effects. In
these circumstances, β3-adrenergic receptor agonists were developed as new OAB therapeutics.
While β3-adrenergic receptor agonists have a potential to avoid the adverse reactions of anti-cholinergic
drugs, cardiovascular effects such as the increased pulse rate and the change in the blood pressure arepublicly known as the adverse reactions of β3-adrenergic receptor agonists, and elderly patients withmultiple medications need to be careful about drug-drug interactions. With the recognition that it isimportant to develop an easy-to-use OAB treatment with less cardiovascular effects and drug-druginteractions, KYORIN Pharmaceutical decided to develop this product.
Both KYORIN Pharmaceutical and Kissei have positioned the urology field as one of their respective
strategic areas and been engaged in the expansion of product lineup and presences in that filed. The
companies will continuously work on the contribution to the OAB treatments by offering a newtherapeutic option to the OAB patients with smooth penetration of this product into the market.
###About Beova®
Product Name:
INN:
Indications:
Dosage andAdministration:

Beova® Tablets 50mg
Vibegron
Urinary urgency, urinary frequency and urge urinary incontinence associated withoveractive bladder
The usual oral dosage for adults is 50mg of vibegron once daily after meal.

About Overactive Bladder (OAB)
Overactive bladder (OAB) is a condition with the symptoms such as "urinary urgency (sudden,
desire to pass urine that is difficult to defer)", "urinary frequency (the condition where urination is more
often than usual)" and "nocturia" resulting from aging, neurological disorder etc.
Symptom prevalence of OAB tends to increase with advancing age, and OAB patients in Japan are
estimated to be 10.4 million from the population structures in 2012*. In step with the aging of thepopulation, OAB patients is expected to further increase, and the contribution of OAB medication to theimprovement of the health including QOL is considered meaningful.
*Clinical Guidelines for Overactive Bladder Syndrome 2nd Edition, The Japanese Continence Society