Print（PDF/123KB） Mar. 06, 2023 Licensing

KYORIN and Sumitomo Pharma Enter into License Agreement of Vibegron in Taiwan and Other Asian Countries

KYORIN Pharmaceutical Co., Ltd. (Head office: Chiyoda-ku, Tokyo; President & CEO: Shigeru Ogihara, hereinafter "KYORIN"), a subsidiary of KYORIN Holdings, Inc. (Head office: Chiyoda-ku, Tokyo; President & CEO: Yutaka Ogihara), and Sumitomo Pharma Co., Ltd. (Head office: Chuo-ku, Osaka; President & CEO: Hiroshi Nomura, hereinafter "Sumitomo Pharma") have entered into a license agreement (hereinafter the "Agreement") for development, manufacturing, and commercialization of a therapeutic agent for overactive bladder (OAB) called Vibegron as international nonproprietary name (INN), (hereinafter "Compound"), in Taiwan, Hong Kong, Singapore, Indonesia, and Vietnam.

Based on the Agreement, KYORIN will grant Sumitomo Pharma the exclusive rights to develop, manufacture, and commercialize the Compound in these five countries and regions, and Sumitomo Pharma will develop, manufacture, and commercialize the Compound in these five countries and regions. KYORIN will receive an upfront payment and is eligible to receive development and sales milestone payments from Sumitomo Pharma. Following the launch of the Compound, KYORIN is eligible to receive royalties based on net sales of the Compound by Sumitomo Pharma.

The Compound is a once-daily oral selective β₃-adrenergic receptor agonist. It acts selectively on the bladder's β₃-adrenergic receptor, relaxes the bladder, and enhances the urine collection and consequently improves the symptoms of urgency, urinary frequency, and urge urinary incontinence associated with OAB.

KYORIN will work with Sumitomo Pharma to make the Compound available in the five countries and regions and promote the expansion of its business internationally. In the countries and regions of the Agreement, Sumitomo Pharma will deliver the Compound to patients who need it and will work to maximize profits in East and Southeast Asia, which Sumitomo Pharma is focusing on as a growth market for pharmaceutical products.

1. About KYORIN
Trusted among patients and professionals in the medical industry, KYORIN strives to be a pharmaceutical company recognized as the one with social significance by improving its presence in the specific therapeutic areas and through its global discovery of novel drugs. KYORIN uses franchise customer strategy where its marketing efforts are focused on respiratory medicine, otolaryngology and urology. In drug discovery, it is deploying 'selection and concentration' and promoting activities aimed at first-in-class drug discovery, such as actively searching for and introducing external drug discovery themes as well as multi-tiered program development. For more information, please visit https://www.kyorin-pharm.co.jp/

2.About Sumitomo Pharma
Sumitomo Pharma Co., Ltd., defines its corporate mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." By channeling our efforts into the research and development of new drugs, Sumitomo Pharma aims to realize our mission and provide innovative and effective pharmaceutical solutions not only to people in Japan but also around the world. Sumitomo Pharma's goal is to create innovative pharmaceutical products in the research focus areas with high unmet medical needs of Psychiatry & Neurology, Oncology, and Regenerative Medicine/Cell Therapy. For more information, please visit https://www.sumitomo-pharma.com

3.About Vibegron
The Compound was discovered by Merck & Co., Inc. (Head office: Kenilworth, N.J., USA., known as MSD outside the United States and Canada) as a once-daily oral treatment for overactive bladder (OAB), which acts selectively on the bladder's β₃-adrenergic receptor agonists. It selectively acts on β₃ receptors in the bladder and increases bladder capacity by enhancing the bladder-relaxing effect of noradrenaline during the urinary storage phase, resulting in the improvement of OAB symptoms of urinary urgency, frequent urination, and urge urinary incontinence. KYORIN has the exclusive rights to develop, manufacture, and commercialize the Compound in Japan and Asian countries^*. In Japan, KYORIN and Kissei Pharmaceutical Co., Ltd., have been co-marketing the same product under the brand name of "Beova^® Tablets 50mg" since November 2018. In China, Sumitomo Pharma and its Chinese subsidiary, Sumitomo Pharma (Suzhou) Co., Ltd., has obtained the exclusive rights to develop and commercialize the Compound in May 2021. Sumitomo Pharma's consolidated subsidiary, Urovant Sciences Ltd., has the exclusive rights to develop, manufacture, and commercialize the Compound worldwide, excluding Japan, China, and Asia^*. In the United States, it has been on the market since April 2021 under the brand name of "GEMTESA^® Tablets 75mg".
*Korea, Taiwan, Hong Kong, and ten-member states of ASEAN

4.About Overactive Bladder (OAB)
OAB is characterized by urinary urgency as an essential symptom and often accompanied by frequent urination and nocturia, in some cases by urge urinary incontinence. All of which lead to significant reduction in patient's quality of life, e.g., refraining from going out due to anxiety about using the toilet, not getting enough sleep, etc.