Otonomy Announces OTIPRIO® Co-Promotion Agreement with Mission Pharmacal for Acute Otitis Externa Indication
August 06 2018 - 7:30AM
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
otology, today announced the signing of a co-promotion agreement
with Mission Pharmacal Company (“Mission”), a well-established
privately held pharmaceutical company, that provides Mission with
an exclusive right to promote OTIPRIO (ciprofloxacin otic
suspension) for acute otitis externa (AOE) in pediatrician and
primary care physician offices as well as urgent care clinics in
the United States. Financial terms for the multi-year agreement
were not disclosed; however, Otonomy will receive an annual
co-promotion fee and reimbursement of a proportion of product
support expenses, and retain a share of gross profits from the sale
of OTIPRIO to Mission's accounts. Otonomy retains all commercial
rights for other customer segments for AOE and use of OTIPRIO in
all other indications including ongoing sales for use during
pediatric ear tube surgery.
“We are excited to begin this collaboration with the team at
Mission, which has a broad set of pharmaceutical commercialization
capabilities developed over its more than 70 years of operation as
a family-owned company,” said David A. Weber, Ph.D., president and
CEO of Otonomy. “Mission will utilize its established promotional
resources to launch OTIPRIO for use by pediatricians and primary
care physicians for the treatment of AOE, with the proceeds from
this partnership helping to support the advancement of our product
pipeline.”
About OTIPRIO
OTIPRIO is a sterile, preservative-free, otic suspension of 6%
ciprofloxacin administered as a single-dose by a healthcare
professional. The thermosensitive suspension exists as a liquid at
or below room temperature and gels when warmed.
For bilateral otitis media with effusion, OTIPRIO is
administered during ear tube surgery as a single 0.1 mL (6 mg)
intratympanic administration into each affected ear, following
suctioning of the middle ear effusion. 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).
For AOE, OTIPRIO is administered as a single 0.2 mL (12 mg)
administration to the external ear canal of each affected ear. In a
single Phase 3 trial, OTIPRIO demonstrated statistically
significant clinical response defined as the complete absence of
signs and symptoms of AOE (i.e., tenderness, erythema, edema, and
otorrhea) compared to sham (p-value < 0.001).
Approved Indications for OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone
antibacterial indicated for
- The treatment of pediatric patients 6 months of age and older
with bilateral otitis media with effusion undergoing tympanostomy
tube placement and
- The treatment of acute otitis externa in patients 6 months of
age and older due to Pseudomonas aeruginosa and Staphylococcus
aureus.
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 - Bilateral otitis media with effusion
clinical trials: Adverse reactions (incidence at least 3%)
with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability
(5% vs 3%), and rhinorrhea (3% vs 2%). Acute otitis externa
clinical trial: Adverse reactions (incidence at least 2%)
with OTIPRIO vs sham were: ear pruritus (2% vs 2%), headache (2% vs
1%), otitis media (2% vs 1%), and ear discomfort (2% vs 0%).
Use in Specific Populations - Pediatric Use:
The safety and effectiveness of OTIPRIO in infants below six months
of age have not been established for the treatment of pediatric
patients with bilateral otitis media with effusion undergoing
tympanostomy tube placement and acute otitis externa.
Full prescribing information can be found at
www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the
development of innovative therapeutics for otology. The company
pioneered the application of drug delivery technology to the ear in
order to develop products that achieve sustained drug exposure from
a single local administration. This approach is covered by a broad
patent estate and is being utilized to develop a pipeline of
products addressing important unmet medical needs including
Ménière’s disease, hearing loss, and tinnitus. For additional
information please visit www.otonomy.com.
About Mission Pharmacal
Mission Pharmacal Company is a privately held pharmaceutical
company based in San Antonio, Texas. For more than seven decades,
the company has been improving the lives of people through every
stage of life by manufacturing and delivering innovative,
high-quality prescription, over-the-counter, and dietary supplement
products in the therapeutic areas of women’s health, urology,
pediatrics, dermatology, and primary care. For additional
information, please visit www.missionpharmacal.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 the future financial or operating performance of
Otonomy. Forward-looking statements in this press release include,
but are not limited to, the potential benefits of the
collaboration, other information relating to the transaction
between Otonomy and Mission, and statements by Otonomy’s president
and CEO. 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: the
risk of the occurrence of any event, change or other circumstance
that could give rise to the termination of the agreement; side
effects or adverse events associated with Otonomy's products or
product candidates; Otonomy's and Mission’s ability to successfully
commercialize OTIPRIO; competition in the biopharmaceutical
industry; Otonomy's dependence on third parties for the manufacture
of its product candidates; Otonomy's dependence on a small number
of suppliers for raw materials; Otonomy's ability to protect its
intellectual property related to 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 May 9, 2018, 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 InquiriesCanale CommunicationsHeidi Chokeir, Ph.D.Senior
Vice President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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