SAN DIEGO, Aug. 06, 2018 (GLOBE NEWSWIRE) — 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.”
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.
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.
Heidi Chokeir, Ph.D.
Senior Vice President
Robert H. Uhl