Otonomy Announces Exclusive License Agreement with Kyorin for Novel Compound in OTO-6XX Hearing Loss Program
August 03 2020 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced an exclusive license agreement with
KYORIN Pharmaceutical Co., Ltd. (“Kyorin”) that provides Otonomy
with exclusive worldwide rights to develop, manufacture and
commercialize a novel compound for the treatment of sensorineural
hearing loss. Under the terms of the agreement, Otonomy will make
an upfront payment to Kyorin as well as success-based milestone
payments and royalties on worldwide net sales of a product
containing the patent-protected compound. Otonomy is formulating
the compound utilizing the company’s proprietary technology to
provide sustained drug exposure in the inner ear following a single
local administration.
“We are pleased to complete this license agreement that stems
from a successful research collaboration with Kyorin focused on
identifying a novel treatment for hearing loss,” said David A.
Weber, Ph.D., president and CEO of Otonomy. “We have demonstrated
that this compound is active in preclinical models of cochlear hair
cell regeneration, and has potential for the treatment of severe
hearing loss. The OTO-6XX hair cell regeneration program is
complementary to our OTO-413 hearing loss program that repairs
damaged connections between hair cells and auditory nerve fibers,
giving us the opportunity to address a broad population of hearing
loss patients. We look forward to advancing the OTO-6XX program
while also working to complete the ongoing Phase 1/2 trial of
OTO-413 in patients with speech-in-noise hearing difficulty, with
results from this trial expected in the fourth quarter of
2020.”
About Otonomy Otonomy is a biopharmaceutical
company dedicated to the development of innovative therapeutics for
neurotology. The company pioneered the application 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 is being utilized
to develop a pipeline of products addressing important unmet
medical needs including Ménière’s disease, hearing loss, and
tinnitus. For additional information please visit
www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, expectations regarding the potential benefits and
opportunities of, and activities under the license agreement
between Kyorin and Otonomy; expectations regarding
preclinical programs, including potential benefits, development
activity, and advancement; expectations regarding potential
benefits of, and timing of results for ongoing clinical trials; and
statements by Otonomy’s president and CEO. Otonomy’s expectations
regarding these matters may not materialize, and actual results in
future periods are subject to risks and uncertainties. Actual
results may differ materially from those indicated by these
forward-looking statements as a result of these risks and
uncertainties, including but not limited to: delays and disruption
resulting from the COVID-19 pandemic and governmental
responses to the pandemic, including current and future impacts to
Otonomy’s operations, the manufacturing of its product candidates,
the progression of its current clinical trials, enrollment in its
current and future clinical trials and patient conduct and
compliance; the risks of the occurrence of any event, change or
other circumstance that could give rise to the termination of the
license agreement between Kyorin and Otonomy; Otonomy’s ability to
obtain additional financing; Otonomy’s dependence on the regulatory
success and advancement of its product candidates; the
uncertainties inherent in the clinical drug development process,
including, without limitation, Otonomy’s ability to adequately
demonstrate the safety and efficacy of its product candidates, the
nonclinical and clinical results for its product candidates, which
may not support further development, and challenges related to
patient enrollment in clinical trials; side effects or adverse
events associated with Otonomy’s product candidates; Otonomy’s
dependence on third parties to conduct nonclinical studies and
clinical trials; expectations regarding potential therapy benefits;
general economic and market conditions; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled "Risk Factors" attached as Exhibit
99.2 to Otonomy’s 8-K filed with the Securities and Exchange
Commission (the "SEC") on July 9, 2020, and Otonomy’s future
reports to be filed with the SEC. The forward-looking statements in
this press release are based on information available to Otonomy as
of the date hereof. Otonomy disclaims any obligation to update any
forward-looking statements, except as required by law.
Contacts:
Media InquiriesSpectrum ScienceChloé-Anne RamseyVice
President404.865.3601 cramsey@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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