SAN DIEGO, May 02, 2019 (GLOBE NEWSWIRE) -- 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."
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
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.
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 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.
Robert H. Uhl