July 3, 2020
NEWS RELEASE
Company:KYORIN Holdings, Inc.
Representative: Yutaka Ogihara
Representative Director, President(Securities Code: 4569, TSE 1st Sec.)Contact:
Yoshinori Tanifuji
Director, Corporate Planning
Telephone:(0)3-3525-4707

KYORIN and Otonomy Signed License Agreement
for Novel Candidate Compound for Sensorineural Hearing Loss
KYORIN Holdings, Inc. today announced that its wholly owned subsidiary, KYORIN
Pharmaceutical Co., Ltd. (Head office: Chiyoda-ku, Tokyo, President & CEO: Shigeru
Ogihara, "Kyorin") has entered into a license agreement with Otonomy, Inc. (Head office:San Diego, CA, President & CEO: David A. Weber, Ph.D. , "Otonomy") regarding a novel
candidate compound for sensorineural hearing loss (“therapeutic agent”) synthesized byKyorin.
Under the terms of the agreement, Kyorin will grant to Otonomy a global exclusive license
to develop, manufacture and commercialize the therapeutic agent for the treatment of otic
disorders such as hearing loss and receive an upfront payment and success-based
development milestone payments. Following the commercial launch of the therapeutic
agent, Kyorin will be eligible to receive royalties and sales milestone payments based on net
sales of the therapeutic agent. Kyorin reserves a commercialization right of thetherapeutic agent in Japan.
This therapeutic agent is expected to help improve hearing function in patients withsensorineural hearing loss by regenerating cochlear hair cells to replace cells damaged due
to noise exposure or aging. Otonomy will utilize its proprietary otic drug delivery technology
to provide sustained exposure of the agent in the inner ear following a single local
administration.
Kyorin is pursuing contribution to health of people around the world by maximizing value ofthe novel candidate compound discovered in house with rapid global development and by
developing original new drugs which meet the needs of the medical needs.
The impact on business performance for the fiscal year ending March 2021 is to be
negligible.
###About Otonomy, Inc.
Foundation:
2008
President & CEO: David A. Weber, Ph.D.
Employees:
Approx. 49 (as of December 31, 2019)
Overview:
Otonomy is a biopharmaceutical company dedicated to the developmentof innovative therapeutics for neurotology. The company pioneered theapplication of drug delivery technology to the ear in order to develop
products that achieve sustained drug exposure from a single local
administration. This approach is covered by a broad patent estate and isbeing utilized to develop a pipeline of products addressing important
unmet medical needs including Ménière’s disease, hearing loss, andtinnitus.
For
additional
information,please
visit
http://www.otonomy.com/
About KYORIN Pharmaceutical Co., Ltd.
Foundation:
December 1923
President & CEO: Shigeru Ogihara
Annual Sales:
JPY 96.336 billion (Fiscal Year ending on March 31, 2020)
Employees:
1,502 (as of March 31, 2020)
Overview:
Trusted among patients and professionals in the medical industry,
KYORIN Pharmaceutical strives to be the pharmaceutical company
recognized as a one with social significance by improving its presence inthe specific therapeutic areas and through global discovery of novel
drugs. KYORIN Pharmaceutical 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.
About Sensorineural Hearing Loss
Sensorineural hearing loss is a common condition caused by damage to the sensory system
including cochlear hair cells and auditory nerve fibers in the inner ear, which negatively
impacts socialization and has been demonstrated to lead to dementia and depression. It is
expected that various factors such as aging, noise exposure, and treatment with ototoxic
medications cause damage to hair cells and results in hearing loss. According to thestatistics of the World Health Organization (WHO), the number of patients with hearing
loss in the world is around 470 million including 34 million children, and this population isexpected to grow to 900 million in the year 2050. The estimation of the US National
Institutes of Health (NIH) says that about 90% of hearing loss is caused by sensorineural
hearing loss. As of today, there is no cure for sensorineural hearing loss and there are nodrugs approved for its treatment.