MAHWAH, N.J., May 2, 2019 /PRNewswire/ -- Glenmark Therapeutics
Inc., USA, a wholly-owned
subsidiary of Glenmark Holding SA., today announced a co-promotion
agreement with Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical
company dedicated to the development of innovative therapeutics for
neurotology. Glenmark Therapeutics is dedicated to developing and
commercializing a franchise of branded products for Glenmark
Pharmaceuticals and is focused in the areas of respiratory and
dermatology. Ryaltris™ (olopatadine hydrochloride [665 mcg] and
mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, is the
company's leading respiratory pipeline asset and currently under
review with the U.S. Food and Drug Administration (FDA) as a
treatment for seasonal allergic rhinitis in patients 12 years and
older. "Ryaltris" has been conditionally accepted by the FDA as the
brand name.
This agreement provides Glenmark Therapeutics with an exclusive
right to promote OTIPRIO (ciprofloxacin otic suspension) for the
treatment of acute otitis externa (AOE) in patients 6 months of age
and older due to Pseudomonas aeruginosa and
Staphylococcus aureus in ear, nose and throat specialist
offices in the United States and
its territories. Financial terms for the multi-year agreement were
not disclosed; however, Glenmark Therapeutics will provide Otonomy
an annual co-promotion fee and provide reimbursement of a
proportion of product support expenses. In addition, Otonomy will
retain a share of the adjusted gross profits from the sale of
OTIPRIO to Glenmark's accounts. Commercial rights for use of
OTIPRIO in other indications, including treatment of bilateral
otitis media with effusion in patients 6 months and older who need
ear tubes, will remain with Otonomy.
"We are pleased to collaborate
with Otonomy on this agreement which represents an excellent
opportunity to fit within our respiratory franchise and supports
our strategy of maintaining commercial emphasis on specialists,"
said Robert Matsuk, President North
America for Glenmark Therapeutics. "With FDA review of our first
New Drug Application for Ryaltris well underway, we remain focused
on developing new partnerships that bolster our specialty portfolio
and commercial footprint in the U.S. This agreement is a clear
example of Glenmark Therapeutics' efforts to maximize and grow our
presence by pursuing opportunities both through external
partnerships and our internal R&D pipeline."
About Glenmark Therapeutics' Respiratory Pipeline
Glenmark's respiratory pipeline is specifically aimed at addressing
the global public health burden of allergic rhinitis, asthma and
chronic obstructive pulmonary disease (COPD), and includes
investigational treatments across the disease spectrum. This
includes Ryaltris (GSP 301 Nasal Spray), an investigational
combination antihistamine plus steroid nasal spray for the
treatment of seasonal allergic rhinitis currently under review by
the FDA. It also includes GBR 310 (omalizumab), a proposed
biosimilar candidate intended for the treatment of allergic asthma
and chronic idiopathic urticaria; and GSP 304, which is being
investigated for the treatment of COPD.
About Glenmark Therapeutics
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.
About Otonomy
Otonomy 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 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.
SOURCE Glenmark Therapeutics Inc., USA