Otonomy Holds Investor and Analyst Day and Provides Corporate Update
October 07 2016 - 8:00AM
Otonomy, Inc. (Nasdaq:OTIC), a 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 an update on the commercial launch of
OTIPRIO
® (ciprofloxacin otic suspension) for use
during ear tube surgery, OTIPRIO label expansion activities,
OTO-104 clinical program for Ménière's disease and
cisplatin-induced hearing loss prevention, OTO-311 clinical program
for tinnitus, as well as providing an introduction to Otonomy's
Program 4 for the treatment of sensorineural hearing loss and 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
- Commercial launch highlights through September include:
- Otonomy has made one or more OTIPRIO presentations to >90%
of the top 100 target physicians, >85% of the top 500, and
>80% of the 2,000 physicians in its target audience.
- Approximately 500 physicians affiliated with 700 facilities
have received OTIPRIO for use during ear tube surgery through
Otonomy's product sample program.
- A survey of 180 physicians participating in the sample
distribution program demonstrates favorable user experience with
the product. More than 90% of respondents indicated a positive
overall impression of OTIPRIO after using the samples and >90%
indicated a likelihood to use OTIPRIO in the future.
- OTIPRIO has received formulary approval in 197 hospitals
compared to 112 at the end of July (including 81 target and 116
non-target hospitals) and reviews are in process in more than 300
additional hospitals (213 target and 97 non-target hospitals).
Otonomy's success rate for formulary approval is 89% in target
hospitals, demonstrating the importance of Otonomy's methodical,
multiple stakeholder approach.
- 121 facilities have purchased OTIPRIO (compared to 74 through
July) and 49% of these accounts have placed multiple orders.
- End-user demand totaled 877 vials in the third quarter compared
to 323 in the second quarter and 56 in March, the first month of
commercial launch.
- Collectively, the facilities that have purchased OTIPRIO, have
formulary approvals or reviews in process, or are affiliated with
physicians who have received product samples, account for
approximately 40% of total annual ear tube surgeries in the United
States.
- The C code assigned to OTIPRIO by the Centers for Medicare and
Medicaid Services (CMS) became effective July 1, 2016. To increase
the level of reimbursement support services available for
facilities, Otonomy has established Otonomy Answers™, which
includes a third party reimbursement resource to provide billing
and coding information, claim review and appeals support, and
national tracking of claim status.
- Otonomy has had discussions with commercial payors that
represent over 125 million covered lives, and has had initial
contact with all state Medicaid programs. Based on these
discussions, the company believes that there will be limited
restrictions placed by payors on the use of OTIPRIO during ear tube
surgery and there will be an opportunity for many facilities to
receive reimbursement for OTIPRIO in addition to the ear tube
procedure payment.
- An update on the OTIPRIO clinical program was provided
including:
- Results from a recently completed Phase 3b trial support the
utility of OTIPRIO in a broader population of patients undergoing
ear tube surgery, and demonstrate similar outcomes for patients
covered by commercial insurance and Medicaid.
- The single Phase 3 registration trial for OTIPRIO in acute
otitis externa is ongoing with topline results expected by the end
of 2016.
- A recently completed Phase 2 trial in acute otitis media with
tympanostomy tubes (AOMT) supports advancement of OTIPRIO to Phase
3. The proportion of patients achieving clinical cure through Day
15 following a single administration of 12 mg (0.2 mL) OTIPRIO
totaled 74% compared to 15% for sham (no treatment). This
difference was statistically significant (p value = 0.017).
- An update on the OTO-104 clinical program was provided
including:
- Two identical Phase 3 trials for OTO-104 in Ménière's disease
are ongoing with results of both trials expected in the second half
of 2017.
- The lead investigator for the OTO-104 one-year, multiple-dose
clinical safety trial conducted in the United Kingdom reviewed the
results that were announced in August 2016. This trial demonstrated
that quarterly dosing of OTO-104 was well tolerated.
- A Phase 2 trial for OTO-104 in pediatric patients undergoing
cisplatin chemotherapy is expected to be initiated by the end of
2016. Patients will receive an administration of OTO-104 in one ear
prior to each of the first three cisplatin treatment cycles.
- A Phase 1 clinical safety trial for OTO-311 in normal healthy
volunteers is ongoing. Several dose cohorts have been completed
without concerns of patient tolerability. Timing for initiating a
Phase 2 trial for OTO-311 in patients with tinnitus has not been
determined.
- Preclinical development is underway with multiple product
candidates for the treatment of sensorineural hearing loss
including age-related hearing loss. Otonomy believes that this
represents the largest market opportunity in the otology field.
Several approaches are being pursued by the company with
preclinical proof-of-concept data provided on several molecules
that act through repair of the ribbon synapse.
- Otonomy believes that there is an attractive market opportunity
for its product pipeline outside the U.S. and is actively
developing a plan for registration and commercialization. This plan
is expected to include strategic partnering, at least for certain
regions of the world.
- Otonomy reiterated its financial guidance that Non-GAAP
operating expenses for 2016 would total $100-$105 million and that
Non-GAAP operating expenses for 2017 would not exceed 2016. The
cash burn for 2017 is expected to decline from 2016 as a result of
the flat operating expense level combined with expected increases
in OTIPRIO revenue.
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, Otonomy’s expectations regarding potential coverage
and reimbursement relating to OTIPRIO, the timing of the completion
of a Phase 3 clinical trial for OTIPRIO in acute otitis externa,
the timing of results for the two OTO-104 Phase 3 clinical trials
in Ménière's disease, the timing of the initiation of the Phase 2
clinical trial for OTO-104 in cisplatin-induced hearing loss, the
size of the market for sensorineural hearing loss, Otonomy’s
ex-U.S. commercialization plans, and the estimated non-GAAP
operating expenses for 2016 and 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 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
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