Otonomy Announces Commercial Availability of OTIPRIO™
March 09 2016 - 7:46PM
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
commercial launch of OTIPRIO (ciprofloxacin otic suspension) in the
United States. OTIPRIO was approved by the U.S. Food and Drug
Administration (FDA) in December 2015 for the treatment of
pediatric patients with bilateral otitis media with effusion
undergoing tympanostomy tube placement (TTP). OTIPRIO is a
single-dose, physician-administered antibacterial and the first
product approved by the FDA for this indication.
“We have moved quickly following the approval of OTIPRIO in
mid-December to hire, train and field an experienced sales force
totaling 40 representatives who are already calling on target
physicians and facilities,” said David A. Weber, Ph.D., president
and CEO of Otonomy. “Interest in joining our team was tremendous
with approximately 1,900 resumes received, and we were extremely
pleased with the quality of candidates who have an average of 15
years of experience including hospital-based selling which we
expect to leverage in gaining access for OTIPRIO.”
Otonomy is commercializing OTIPRIO using an internal sales force
of 40 representatives that will cover approximately
2,000 physicians and 800 facilities that account for nearly
70% of the one million TTP procedures performed each year in the
U.S., 85% of which are in pediatric patients. The company has also
hired a team of field-based medical science liaisons (MSLs) and
expects that they will play an important role in providing medical
information about OTIPRIO to clinicians and other health care
professionals. As of March 1, 2016, Otonomy has shipped OTIPRIO
product to a network of specialty distributors who will fulfill
orders received from hospital and ambulatory surgery center
customers.
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 Tympanostomy Tube Placement Surgery
According to the American Academy of Otolaryngology – Head and
Neck Surgery Foundation (AAO-HNSF), tympanostomy tube placement
(TTP) surgery is the most common ambulatory surgery performed on
children. Overall, there are approximately one million TTP
procedures performed each year in the United States of which 85%
are in pediatric patients, who typically have middle ear effusion
and receive tubes in both ears (bilateral). The tubes are placed
for the treatment of persistent or recurrent otitis media
(infection and/or inflammation of the middle ear). Placement of the
tube helps to ventilate the middle ear and enables the
administration of topical antibiotics to treat the infection.
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. A Phase 3 trial in Ménière's disease
patients is underway in the United States with a second trial
expected to be initiated in the EU during the first quarter of
2016. 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 the timing of the
OTO-104 Phase 3 clinical trial for Ménière's disease in the EU.
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-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, 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 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 Current Report on Form 8-K filed with the
Securities and Exchange Commission (the "SEC") on January 5, 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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