Otonomy Holds Investor and Analyst Day and Provides Corporate Update
October 07 2015 - 8:00AM
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics for diseases and disorders of the ear,
today held an investor and analyst day which included a review of
the commercialization plans for OTIPRIO™ (formerly known as
AuriPro™) in patients undergoing ear tube surgery, the Phase 3
clinical trial program for OTO-104 in Ménière's disease, an
introduction to the OTO-311 program for tinnitus that has been
cleared for Phase 1 testing, other pipeline activities as well as a
general corporate update. A replay of the event webcast is
available online at www.Otonomy.com in the events and presentations
section under the investors tab.
Key Takeaways from the Investor and Analyst
Day
- Preparations for OTIPRIO's launch in the U.S. are progressing
well. Otonomy expects to launch OTIPRIO in the U.S. in the first
quarter of 2016 assuming FDA approval on or before the December 25,
2015 PDUFA action date.
- Otonomy will pursue a paced plan for OTIPRIO's label expansion
indications including the ongoing Phase 2 clinical trial in
patients with acute otitis externa and initiation of a second Phase
2 trial in patients with acute otitis media and tubes (AOMT)
expected in the first quarter of 2016.
- Design of the OTO-104 Phase 3 clinical trials in Ménière's
disease has been finalized based on learnings from the Phase 2b
study and discussions with the FDA held during an End-of-Phase 2
meeting. The U.S. Phase 3 trial is expected to begin in the fourth
quarter of 2015 with the EU Phase 3 trial to start in the first
quarter of 2016. Results from both trials are expected in the
second half of 2017.
- FDA clearance has been received for the OTO-311 Investigational
New Drug Application (IND), and initiation of a Phase 1 clinical
safety trial is expected to begin before the end of 2015. OTO-311
is a single-dose treatment in development for tinnitus.
- Through corporate development activities, the company has
secured rights to multiple potential product candidates for a
fourth program targeting sensorineural hearing loss, the largest
market opportunity within the otology field, and evaluations are
ongoing regarding ex-U.S. partnering opportunities for Otonomy's
current products.
- Otonomy expects that its strong cash position, together with
OTIPRIO revenues, will fund planned operations into 2018.
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on
the development and commercialization of innovative therapeutics
for diseases and disorders of the ear. Otonomy's proprietary
technology provides sustained exposure of drugs to the ear
following a single administration. Otonomy has three product
candidates in development. OTIPRIO™ is an antibiotic that has
completed Phase 3 clinical trials in pediatric patients with middle
ear effusion at the time of tympanostomy tube placement surgery,
and the FDA has assigned a PDUFA action date of December 25, 2015
for Otonomy's New Drug Application. OTO-104 is a steroid that has
completed a Phase 2b clinical trial in 154 patients with Ménière's
disease. Based on these results, Otonomy intends to initiate two
parallel Phase 3 trials for OTO-104 in Ménière's disease patients
with at least one trial initiated by the end of 2015. OTO-311 is an
NMDA receptor antagonist in development as a treatment for
tinnitus. A Phase 1 clinical safety trial for OTO-311 is expected
to begin before the end of 2015. 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 future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the timing of
commercial launch, the timing of its Phase 2 clinical trials for
OTIPRIO for the treatment of acute otitis media with tympanostomy
tubes (AOMT) and otitis externa, the timing, duration, design and
expectations regarding the two Phase 3 clinical trials for OTO-104,
the timing of the initiation of the Phase 2 clinical trials for
OTO-311, the market for sensorineural hearing loss, and Otonomy's
estimated cash position through 2017. 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: Otonomy's limited
operating history and its expectation that it will incur
significant losses for the foreseeable future; Otonomy's ability to
obtain substantial additional financing; Otonomy's dependence on
the regulatory and commercial success of OTIPRIO and OTO-104 and
advancing additional product candidates, such as OTO-311; 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
preclinical and clinical results for its product candidates, which
may not support further development of product candidates, and
challenges related to patient enrollment in clinical trials;
Otonomy's ability to obtain regulatory approval for its product
candidates; side effects or adverse events associated with
Otonomy's product candidates; competition in the biopharmaceutical
industry; Otonomy's dependence on third parties to conduct
preclinical studies and clinical trials; Otonomy's dependence on
third parties for the manufacture of products; Otonomy's dependence
on a small number of suppliers for raw materials; Otonomy's ability
to protect its intellectual property related to product candidates
in the United States and throughout the world; expectations
regarding potential market size, opportunity and growth; Otonomy's
ability to manage operating expenses; implementation of Otonomy's
business model and strategic plans for its business, products and
technology; and other risks. Information regarding the foregoing
and additional risks may be found in the section entitled "Risk
Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (the "SEC") on August 12, 2015,
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.
CONTACT: Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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