U.S. Commercial Launch Expected in the First Quarter of 2016
SAN DIEGO, Dec. 11, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the U.S. Food and Drug Administration (FDA) has approved OTIPRIO (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is a single-dose, physician-administered antibacterial and the first product approved by the FDA for this indication.
"The approval of OTIPRIO, our first product, is a landmark moment in the history of Otonomy, and provides important validation for our proprietary drug delivery technology that combines a thermosensitive gel with drug microparticles to enable single dose treatment by a physician," said David A. Weber, Ph.D., president and CEO of Otonomy. "We have an experienced commercialization team in place, are building out our 40 person sales force, and look forward to launching OTIPRIO in the first quarter of 2016."
"As someone who routinely sees young children suffering with persistent ear infections and performs hundreds of tube surgeries each year, I welcome the approval of OTIPRIO as the first FDA approved product for this indication," said Eric Mair, M.D., Charlotte Eye Ear Nose and Throat Associates. "Being able to administer a single dose of OTIPRIO during the procedure gives me the assurance of antibiotic dosing which the Phase 3 trials demonstrate reduces the rate of treatment failure following surgery."
In addition, Otonomy updated its financial guidance for 2015. GAAP and Non-GAAP operating expenses are expected to be below the previous guidance of $70-$75 million and $65-$70 million, respectively, as a result of program cost savings and expense timing differences. The total of cash, cash equivalents, and short-term investments as of December 31, 2015 is expected to be in the range of $180-$185 million versus previous guidance of $165-$170 million. The company maintained its expectation for 2016 non-GAAP operating expenses in the range of $90-$95 million.
Otonomy management will host a webcast and conference call regarding this announcement at 8:30 a.m. EST/5:30 a.m. PST today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 4512695. A live webcast and archive of the call will be available in the investor relations section of the company website at www.otonomy.com. A telephone replay of the call will be available by dialing (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and entering the conference code number: 4512695.
About Tympanostomy Tube Placement Surgery
According to the American Academy of Otolaryngology -- Head and Neck Surgery Foundation (AAO-HNSF), tympanostomy tube placement (TTP) surgery is the most common ambulatory surgery performed on children. Overall, there are approximately one million TTP procedures performed each year in the United States of which 85% are in pediatric patients, who typically have middle ear effusion and receive tubes in both ears (bilateral). The tubes are placed for the treatment of persistent or recurrent otitis media (infection and/or inflammation of the middle ear). Placement of the tube helps to ventilate the middle ear and enables the administration of topical antibiotics to treat the infection.
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. 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).
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: Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).
Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery and commercial launch is expected in the first quarter of 2016. OTO-104 is a steroid in development for the treatment of Meniere's disease and other balance and hearing disorders. A Phase 3 trial in Meniere's disease patients has been initiated in the United States with a second trial expected to begin in the EU during the first quarter of 2016. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy's proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.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 future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, Otonomy's expectations regarding the timing of commercial launch, the timing regarding the Phase 3 clinical trials for OTO-104, estimated cash, cash equivalents, and short-term investments as of December 31, 2015, and estimated operating expenses for 2015 and 2016. 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to obtain substantial additional financing; Otonomy's dependence on the regulatory and commercial success of OTIPRIO and OTO-104 and advancing additional product candidates, such as OTO-311; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development of product candidates, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct preclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of products; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to 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 November 10, 2015, 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.