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).