Otonomy Provides Corporate and Product Pipeline Update
January 08 2015 - 4:55PM
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics for diseases and disorders of the inner and
middle ear, today announced an update on its corporate activities
and product pipeline.
Corporate and Product Pipeline Update
- NDA Submission for AuriPro™
planned for 1Q2015: Preparation of the New Drug
Application (NDA) for AuriPro is in process, and incorporates
feedback received from a Pre-NDA meeting and communications with
the FDA. Otonomy expects to submit the NDA to the FDA during the
first quarter of 2015. If approved within the 12 month standard
review period, Otonomy anticipates product introduction in the
United States during the first half of 2016. The findings from two
identical Phase 3 trials of AuriPro with a combined total of 532
pediatric patients with bilateral middle ear effusion requiring
tympanostomy tube placement (TTP) surgery will form the basis of
the NDA submission. In both trials, AuriPro achieved the primary
efficacy endpoint of reducing the rate of treatment failures with
statistical significance (p<0.001) and was well tolerated.
Results have been accepted for presentation at the American Society
of Pediatric Otolaryngology (ASPO) spring meeting in April 2015.
- Phase 2b results for OTO-104 in Ménière's disease
patients expected in 2Q2015: Otonomy completed enrollment
in its Phase 2b clinical trial in December 2014, exceeding the
target enrollment of 140 patients with a final total of 154
patients. This trial is expected to serve as one of two pivotal,
single-dose efficacy trials required to support U.S. regulatory
approval. The company plans to report results from this clinical
trial during the second quarter of 2015, and if results are
positive, initiate a second pivotal trial of OTO-104 in 2015. A
multiple-dose safety study with OTO-104 in patients with Ménière's
disease was initiated in the United Kingdom in October 2014 and is
on-going. OTO-104 for Ménière's disease has been granted Fast Track
designation by the FDA.
- Initiation of a clinical trial for AuriPro in one or
more additional indications expected to begin in 1H2015:
Potential expansion indications for AuriPro include recurrent
ear infections in patients with tympanostomy tubes, acute otitis
externa, chronic suppurative otitis media (a perforated tympanic
membrane with persistent drainage from the middle ear), and
prophylaxis following middle ear surgeries. Otonomy plans to
initiate clinical trials for AuriPro in one or more of these
indications during the first half of 2015.
- IND filing and start of Phase 1 clinical trial for
OTO-311 expected in 2015: Otonomy plans to file an
Investigational New Drug (IND) application with the FDA for OTO-311
and to initiate a Phase 1 clinical trial in 2015. OTO-311 is a
sustained-exposure formulation of the N-Methyl-D-Aspartate, or
NMDA, receptor antagonist gacyclidine in development for the
treatment of tinnitus. In November 2014, Otonomy announced the
completion of an exclusive license agreement with Ipsen that
enables Otonomy to use clinical and non-clinical gacyclidine data
generated by Ipsen to support worldwide development and regulatory
filings for OTO-311.
- Cash and short-term investments totaled $156.0 million
at year end 2014: Otonomy had cash and short-term
investments totaling $156.0 million on December 31, 2014 compared
to $165.2 million on September 30, 2014.
"We have made significant progress in the short time since our
IPO last August including acceleration of the target NDA submission
date for AuriPro into the first quarter of 2015, and recent
completion of the over-enrollment of the OTO-104 Phase 2b trial in
Ménière's disease patients which will enable us to report results
in the second quarter of 2015," said David A. Weber, Ph.D.,
president and CEO of Otonomy. "In addition to these near-term
milestones, we look forward to initiating market expansion studies
for AuriPro and clinical development for OTO-311 during 2015, and
plan to make significant progress in preparing for the U.S. launch
of AuriPro following the recent hiring of our chief commercial
officer."
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 middle and inner ear following a
single intratympanic injection. Otonomy has three product
candidates in development. AuriPro™ 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.
OTO-104 is a steroid that is in the first of two pivotal clinical
studies for the treatment of patients with Ménière's disease.
OTO-311 is an NMDA receptor antagonist in development as a
treatment for 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 Otonomy's future financial or operating performance.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the timing of its
NDA submission with the FDA for AuriPro, the potential and timing
for commercialization of AuriPro, the timing of the initiation of
clinical trials for AuriPro in other indications, the timing
of the results for Otonomy's single-dose Phase 2b clinical trial of
OTO-104, the timing of the initiation of Otonomy's second pivotal
trial of OTO-104, Otonomy's expectations regarding the OTO-104
Phase 2b clinical trial serving as one of two pivotal trials
required to support U.S. regulatory approval and the timing of the
filing of the IND for OTO-311 and initiation of Otonomy's OTO-311
Phase 1 clinical trial. 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: expectations regarding clinical trial results for
existing product candidates, future development of product
candidates for additional indications, and future development of
other product candidates; timing and likelihood of regulatory
filings and approvals; expectations regarding adoption and use of
product candidates by physicians; 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 and developments related to
competitors and the industry; Otonomy's ability to manage operating
expenses, capital requirements and additional financing needs;
implementation of Otonomy's business model and strategic plans for
its business, products and technology; Otonomy's dependence on
third parties for development, manufacture and distribution of
products; and other risks. Information regarding the foregoing and
additional risks may be found in the section entitled "Risk
Factors" in Otonomy's Form 10-Q filed on November 12, 2014 with the
Securities and Exchange Commission (the SEC) and in Otonomy's
future filings 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.
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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