Otonomy Announces OTIPRIO® Co-Promotion Agreement with Glenmark Therapeutics for Acute Otitis Externa Indication
May 02 2019 - 7:30AM
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the signing of a co-promotion
agreement with Glenmark Therapeutics Inc., USA, a wholly-owned
subsidiary of Glenmark Holding SA., which is dedicated to building
and commercializing a franchise of branded products for Glenmark
Pharmaceuticals focused in the areas of respiratory and
dermatology.
This agreement provides Glenmark Therapeutics with an exclusive
right to promote OTIPRIO (ciprofloxacin otic suspension) to ear,
nose and throat (ENT) physician offices in the United States and
its territories for the treatment of acute otitis externa (AOE) in
patients 6 months of age and older due to Pseudomonas aeruginosa
and Staphylococcus aureus. 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, while retaining a share of the adjusted
gross profits from the sale of OTIPRIO to Glenmark's accounts.
Otonomy retains commercial rights for use of OTIPRIO in other
indications including ongoing sales for use during pediatric ear
tube surgery.
“We are excited to expand our promotional support for OTIPRIO in
AOE by initiating this collaboration with Glenmark Therapeutics,
which is part of a global pharmaceutical company with operations in
more than 80 countries, and is committed to establishing a branded
product commercial presence in the U.S.,” said David A. Weber,
Ph.D., president and CEO of Otonomy. “Through this partnership and
the ongoing co-promotion by Mission Pharmacal to pediatricians and
primary care physician offices as well as urgent care clinics, we
have established commercial support for OTIPRIO across all of the
key physician groups involved in treating AOE in time for the peak
2019 season."
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 OtonomyOtonomy is a biopharmaceutical
company dedicated to the development of innovative therapeutics for
neurotology. 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 Glenmark Therapeutics Inc., USA Glenmark
Therapeutics Inc., USA, is a wholly-owned subsidiary of Glenmark
Holding SA. The company is dedicated to building a franchise of
branded products for Glenmark Pharmaceuticals, a global, integrated
pharmaceutical company with operations in more than 80 countries.
Glenmark Therapeutics will initially focus its efforts on launching
and commercializing assets in the therapeutic areas of dermatology
and respiratory. Glenmark Therapeutics has a short- and long-term
pipeline of investigational medicines intended to meet the needs of
patients suffering from a variety of dermatological and respiratory
conditions and is consistently working to expand its product
portfolio.
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 and information relating
to the co-promotion agreement between Otonomy and Glenmark, 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 risks of the
occurrence of any event, change or other circumstance that could
give rise to the termination of the co-promotion agreement between
Otonomy and Glenmark and/or the co-promotion agreement between
Otonomy and Mission Pharmacal; side effects or adverse events
associated with Otonomy’s products or product candidates; Otonomy’s
and its co-promotion partners’ ability to successfully
commercialize OTIPRIO; competition in the biopharmaceutical
industry; Otonomy’s dependence on third parties for the manufacture
of its product 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 its product and
product candidates in the United States and throughout the world;
expectations regarding potential market size, opportunity and
growth; 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-K filed with the Securities and Exchange
Commission (the "SEC") on March 4, 2019, 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 InquiriesSpectrum ScienceLeticia DiazVice President
202.587.2517ldiaz@spectrumscience.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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