Otonomy Announces OTIPRIO® Data Presentation and Symposium at American Academy of Otolaryngology - Head and Neck Surgery Fou...
September 13 2016 - 7:30AM
Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics for diseases and disorders of the ear, today
announced the upcoming presentation of results from an
OTIPRIO® (ciprofloxacin otic suspension) Phase 2 trial in
acute otitis externa (AOE), a potential label expansion indication,
as well as the company’s sponsorship of a symposium related to
OTIPRIO during the annual meeting of the American Academy of
Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) to be
held September 18-21, 2016 in San Diego.
Eric Mair, M.D., Charlotte Eye Ear Nose and Throat Associates,
will present the OTIPRIO (development name OTO-201) Phase 2 trial
results in AOE on Monday, September 19, in a presentation titled,
“OTO-201 for the Treatment of Otitis Externa: Phase 2 Clinical
Trial.” Preliminary results from this trial which enrolled a total
of 75 pediatric and adult patients with unilateral AOE, also known
as swimmer's ear, were announced in December 2015. This trial
demonstrated the feasibility of administering OTIPRIO into the
external ear canal of a patient in the physician office setting,
and a clinical cure rate at both Day 8 and Day 15 of 80% or greater
for patients treated with a 0.2 mL dose. These results served as
the basis for a successful End-of-Phase 2 review by the U.S. Food
and Drug Administration (FDA) which supported Otonomy's initiation
of a single Phase 3 registration trial for OTIPRIO in patients with
AOE that is expected to be completed by the end of 2016.
Otonomy Medical Affairs will be sponsoring a symposium and
reception on September 20 titled, “Practice - and Payer -
Perspectives on a Thermosensitive, Single-Dose, Ciprofloxacin Otic
Suspension in Pediatric Patients Undergoing Tube Placement.” The
symposium will review the burden of illness in pediatric patients
undergoing tube placement, and discuss the clinical evidence from
both registration and real-world clinical trials conducted with
OTIPRIO.
“The AAO-HNSF annual meeting is the largest gathering of
otolaryngologists during the year and therefore provides an
excellent opportunity for continuing our efforts to establish
physician awareness and advocacy to support the ongoing OTIPRIO
commercial launch,” said David A. Weber, Ph.D., president and CEO
of Otonomy. "We are particularly fortunate that the location of
this year's meeting is in our hometown of San Diego which will
facilitate our efforts to have a broad presence and high visibility
to conference attendees."
About OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone
antibacterial indicated for the treatment of pediatric patients
with bilateral otitis media with effusion undergoing tympanostomy
tube placement. OTIPRIO is administered by a physician as a single
0.1 mL (6 mg) intratympanic administration into each affected ear,
following suctioning of the middle ear effusion. The
thermosensitive suspension exists as a liquid at or below room
temperature and gels when warmed. In two Phase 3 trials, a single
intraoperative administration of OTIPRIO demonstrated a
statistically significant reduction in the cumulative proportion of
study treatment failures compared to tubes alone (p-value
<0.001).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated
in patients with a history of hypersensitivity to ciprofloxacin, to
other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions - Potential
for Microbial Overgrowth: OTIPRIO may result in overgrowth
of nonsusceptible bacteria and fungi. If such infections occur,
institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence
at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs
sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and
rhinorrhea (3% vs 2%).
Use in Specific Populations - Pediatric Use:
The safety and effectiveness of OTIPRIO in infants below six months
of age have not been established.
Full prescribing information can be found at
www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics for
diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic
suspension) is approved in the United States for use
during tympanostomy tube placement surgery in pediatric patients,
and commercial launch commenced in March 2016. OTO-104 is a steroid
in development for the treatment of Ménière's disease and other
severe balance and hearing disorders. Two Phase 3 trials in
Ménière's disease patients are underway, with results expected
during the second half of 2017. OTO-311 is an NMDA receptor
antagonist for the treatment of tinnitus that is in a Phase 1
clinical safety trial. Otonomy’s proprietary formulation technology
utilizes a thermosensitive gel and drug microparticles to enable
single dose treatment by a physician. 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, the timing of results for the two OTO-104 Phase 3
clinical trials in Ménière's disease. 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 additional financing; Otonomy's dependence on the commercial
success of OTIPRIO and the regulatory success and advancement of
additional product candidates, such as OTO-104 and OTO-311, and
label expansion indications for OTIPRIO; 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, 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; the timing and
outcome of hospital pharmacy and therapeutics reviews and other
facility reviews; the impact of coverage and reimbursement
decisions by third-party payors on the pricing and market
acceptance of OTIPRIO; Otonomy's dependence on third parties for
the manufacture of OTIPRIO and product candidates; Otonomy's
dependence on a small number of suppliers for raw materials;
Otonomy's ability to protect its intellectual property related to
OTIPRIO and its 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 4, 2016, 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 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
Otonomy (NASDAQ:OTIC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Otonomy (NASDAQ:OTIC)
Historical Stock Chart
From Apr 2023 to Apr 2024