Otonomy Provides Corporate and Product Pipeline Update
January 09 2017 - 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 provided
an update on its product pipeline, commercial activities, and
financial guidance.
Product Pipeline, Commercial, and Financial
Update
- Positive Top-Line Results from Phase 3 Clinical Trial
of OTIPRIO in Patients with Acute Otitis Externa: Otonomy
announced last week positive results from its pivotal Phase 3
clinical trial of OTIPRIO in 262 pediatric and adult patients with
acute otitis externa (AOE), also known as swimmer's ear. This
single administration trial of OTIPRIO met the primary endpoint by
showing a statistically significant increase in clinical cure rate
compared to sham (no treatment) at Day 8 (p<0.001). OTIPRIO also
demonstrated a statistically significant superiority to sham in
clinical cure rate at all other time points assessed including Day
4 (p<0.021), Day 15 (p<0.001) and Day 29 (p<0.001), and
was well-tolerated. Based on these positive results, Otonomy
expects to submit a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) in the first half of
2017.
- OTIPRIO® Launch Update:
In March 2016, Otonomy announced the commercial availability of
OTIPRIO (ciprofloxacin otic suspension) in the United States for
the treatment of pediatric patients with bilateral otitis media
with effusion undergoing tympanostomy tube placement (TTP). During
2016, Otonomy's commercial efforts focused on establishing patient
"access" to OTIPRIO by building awareness and advocacy with
physicians, gaining formulary approval in target facilities, and
establishing reimbursement. These efforts require contact and
coordination with multiple stakeholders including physicians,
hospital pharmacists, facility administrators, and payors. In 2017,
Otonomy's commercial priority is "pull-through" which the company
defines as the purchase and utilization of OTIPRIO in facilities
where the product has received formulary approval.
Commercial
launch highlights through December
include:
- More than 600 physicians affiliated with over 800 facilities
received OTIPRIO for use during ear tube surgery
through Otonomy's product sample program.
- OTIPRIO received formulary approval or was purchased by 326
facilities, and reviews were in process at approximately 250
additional hospitals. Otonomy's success rate for
formulary approval was 89%, demonstrating the importance
of our methodical, multiple stakeholder approach.
- 173 facilities purchased OTIPRIO and 55% of these accounts
placed multiple orders. An increasing number of facilities placed
regular stocking orders.
- End-user demand totaled 1,172 vials in the fourth quarter
compared to 877 in the third quarter.
- Collectively, the facilities that purchased OTIPRIO, had
formulary approvals or reviews in process, or are affiliated with
physicians who received product samples, account for over 40% of
total annual ear tube surgeries in the United States.
- The J code assigned to OTIPRIO by the Centers for Medicare
and Medicaid Services (CMS) became effective on January
1, 2017. This code is the permanent billing code for OTIPRIO,
replacing the previously assigned C code while retaining
transitional pass-through payment status. Assignment of the J code
will support patient access for use of OTIPRIO during ear tube
surgery and for office-based expansion indications when
approved.
- Ongoing tracking of reimbursement claims by Otonomy's third
party vendor has confirmed payment for OTIPRIO in addition to the
TTP procedure itself by multiple payors for both Medicaid and
commercially-insured patients.
- Preparing for End-of-Phase 2 Discussion with the FDA
Related to Second Label Expansion Indication for OTIPRIO:
In October 2016, Otonomy announced the successful completion of a
Phase 2 clinical trial that evaluated a single administration of
OTIPRIO for the treatment of pediatric patients with acute otitis
media with tympanostomy tubes (AOMT). The trial demonstrated that
both OTIPRIO doses, 6 mg (0.1 mL) and 12 mg (0.2 mL), were
well-tolerated and achieved higher and statistically significant
(p<0.05) clinical cure rates over sham (no treatment). Otonomy
believes this trial supports the advancement of OTIPRIO into Phase
3 in AOMT and intends to discuss the requirements for such a
program with the FDA in the first half of 2017.
- Enrollment in AVERTS-1 and AVERTS-2 Phase 3 Clinical
Trials for OTO-104 in Ménière’s Disease Remains Ongoing:
Otonomy is conducting two identical, parallel Phase 3 trials for
OTO-104 in patients with Ménière’s disease, AVERTS-1 in the United
States and AVERTS-2 in Europe. Each trial is a 16-week,
prospective, randomized, double-blind, placebo-controlled trial
that is expected to enroll approximately 160 patients with
unilateral Ménière’s disease. Results from the Phase 3 trials are
expected in the second half of 2017.
- Initiated Phase 2 Clinical Trial of OTO-104 in Hearing
Loss Indication: In December, Otonomy initiated patient
screening for a Phase 2 clinical trial evaluating OTO-104 for the
prevention of hearing loss in cancer patients undergoing
chemotherapy with platinum-based agents. This multicenter,
randomized trial is designed to assess the feasibility, safety and
efficacy of OTO-104 given by intratympanic administration in
subjects at risk for ototoxicity from cisplatin chemotherapy.
Approximately 60 subjects will receive an administration of OTO-104
in one ear prior to each of the first three cisplatin treatment
cycles with hearing assessed throughout the trial and following the
last chemotherapy treatment cycle.
- Phase 1 Clinical Safety Trial of OTO-311 Remains
Ongoing: OTO-311 is a single-dose, sustained-exposure
formulation of the potent and selective N-Methyl-D-Aspartate (NMDA)
receptor antagonist gacyclidine that is in development for the
treatment of tinnitus. Several dose cohorts in the Phase 1 clinical
safety trial have been completed and there have been no patient
tolerability concerns. The trial remains open pending the potential
evaluation of additional dose levels in order to establish a
maximum tolerated dose. During 2017, Otonomy expects to complete
the Phase 1 trial and define a plan for Phase 2.
- Financial Update and Operating Expense Guidance for
2017: Otonomy had cash, cash equivalents and short-term
investments totaling approximately $196 million on December 31,
2016. Based on preliminary estimates, Otonomy expects that Non-GAAP
operating expenses for 2016 were at the low end of the $100-$105
million guidance range previously provided. In addition, Otonomy
expects Non-GAAP operating expenses for 2017 in the range of
$85-$90 million. The decrease in expenses from 2016 to 2017 is
primarily related to a reduction in the clinical trial activity
expected this year.
“Our
strong momentum continued into 2017 with the positive Phase 3 AOE
results announced last week. We expect to build on this success
throughout the year by focusing on driving OTIPRIO commercial
adoption for ear tube surgery and by delivering top-line results
for the OTO-104 AVERTS-1 and AVERTS-2 trials in Ménière’s disease,”
said David A. Weber, Ph.D., president and CEO of Otonomy. “In
addition, we continue to advance our earlier stage programs for
tinnitus and age-related hearing loss which represent large market
opportunities with high unmet medical needs."
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 has achieved positive pivotal trial results
in patients with acute otitis externa. 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 sNDA
submission for OTIPRIO in patients with acute otitis externa, the
advancement of OTIPRIO to Phase 3 in AOMT and related discussions
with the FDA, the timing of results for the two OTO-104 Phase 3
clinical trials in Ménière's disease, the number of patients
expected to participate in the two OTO-104 Phase 3 clinical trials
in Ménière's disease, the number of patients expected to
participate in the Phase 2 clinical trial for OTO-104 in
cisplatin-induced hearing loss, the statements of Otonomy’s
president and CEO, 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 November 3, 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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