SAN DIEGO, Oct. 07, 2016 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today held an investor and analyst day which included an update on the commercial launch of OTIPRIO® (ciprofloxacin otic suspension) for use during ear tube surgery, OTIPRIO label expansion activities, OTO-104 clinical program for Ménière’s disease and cisplatin-induced hearing loss prevention, OTO-311 clinical program for tinnitus, as well as providing an introduction to Otonomy’s Program 4 for the treatment of sensorineural hearing loss and a general corporate update. A replay of the event webcast is available online at www.Otonomy.com in the events and presentations section under the investors tab.
Key Takeaways from the Investor and Analyst Day
- Commercial launch highlights through September include:
- Otonomy has made one or more OTIPRIO presentations to >90% of the top 100 target physicians, >85% of the top 500, and >80% of the 2,000 physicians in its target audience.
- Approximately 500 physicians affiliated with 700 facilities have received OTIPRIO for use during ear tube surgery through Otonomy’s product sample program.
- A survey of 180 physicians participating in the sample distribution program demonstrates favorable user experience with the product. More than 90% of respondents indicated a positive overall impression of OTIPRIO after using the samples and >90% indicated a likelihood to use OTIPRIO in the future.
- OTIPRIO has received formulary approval in 197 hospitals compared to 112 at the end of July (including 81 target and 116 non-target hospitals) and reviews are in process in more than 300 additional hospitals (213 target and 97 non-target hospitals). Otonomy’s success rate for formulary approval is 89% in target hospitals, demonstrating the importance of Otonomy’s methodical, multiple stakeholder approach.
- 121 facilities have purchased OTIPRIO (compared to 74 through July) and 49% of these accounts have placed multiple orders.
- End-user demand totaled 877 vials in the third quarter compared to 323 in the second quarter and 56 in March, the first month of commercial launch.
- Collectively, the facilities that have purchased OTIPRIO, have formulary approvals or reviews in process, or are affiliated with physicians who have received product samples, account for approximately 40% of total annual ear tube surgeries in the United States.
- The C code assigned to OTIPRIO by the Centers for Medicare and Medicaid Services (CMS) became effective July 1, 2016. To increase the level of reimbursement support services available for facilities, Otonomy has established Otonomy Answers™, which includes a third party reimbursement resource to provide billing and coding information, claim review and appeals support, and national tracking of claim status.
- Otonomy has had discussions with commercial payors that represent over 125 million covered lives, and has had initial contact with all state Medicaid programs. Based on these discussions, the company believes that there will be limited restrictions placed by payors on the use of OTIPRIO during ear tube surgery and there will be an opportunity for many facilities to receive reimbursement for OTIPRIO in addition to the ear tube procedure payment.
- An update on the OTIPRIO clinical program was provided including:
- Results from a recently completed Phase 3b trial support the utility of OTIPRIO in a broader population of patients undergoing ear tube surgery, and demonstrate similar outcomes for patients covered by commercial insurance and Medicaid.
- The single Phase 3 registration trial for OTIPRIO in acute otitis externa is ongoing with topline results expected by the end of 2016.
- A recently completed Phase 2 trial in acute otitis media with tympanostomy tubes (AOMT) supports advancement of OTIPRIO to Phase 3. The proportion of patients achieving clinical cure through Day 15 following a single administration of 12 mg (0.2 mL) OTIPRIO totaled 74% compared to 15% for sham (no treatment). This difference was statistically significant (p value = 0.017).
- An update on the OTO-104 clinical program was provided including:
- Two identical Phase 3 trials for OTO-104 in Ménière’s disease are ongoing with results of both trials expected in the second half of 2017.
- The lead investigator for the OTO-104 one-year, multiple-dose clinical safety trial conducted in the United Kingdom reviewed the results that were announced in August 2016. This trial demonstrated that quarterly dosing of OTO-104 was well tolerated.
- A Phase 2 trial for OTO-104 in pediatric patients undergoing cisplatin chemotherapy is expected to be initiated by the end of 2016. Patients will receive an administration of OTO-104 in one ear prior to each of the first three cisplatin treatment cycles.
- A Phase 1 clinical safety trial for OTO-311 in normal healthy volunteers is ongoing. Several dose cohorts have been completed without concerns of patient tolerability. Timing for initiating a Phase 2 trial for OTO-311 in patients with tinnitus has not been determined.
- Preclinical development is underway with multiple product candidates for the treatment of sensorineural hearing loss including age-related hearing loss. Otonomy believes that this represents the largest market opportunity in the otology field. Several approaches are being pursued by the company with preclinical proof-of-concept data provided on several molecules that act through repair of the ribbon synapse.
- Otonomy believes that there is an attractive market opportunity for its product pipeline outside the U.S. and is actively developing a plan for registration and commercialization. This plan is expected to include strategic partnering, at least for certain regions of the world.
- Otonomy reiterated its financial guidance that Non-GAAP operating expenses for 2016 would total $100-$105 million and that Non-GAAP operating expenses for 2017 would not exceed 2016. The cash burn for 2017 is expected to decline from 2016 as a result of the flat operating expense level combined with expected increases in OTIPRIO revenue.
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%).
Use in Specific Populations – Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.
Full prescribing information can be found at www.OTIPRIO.com.
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 in pediatric patients, and commercial launch commenced in March 2016. OTO-104 is a steroid in development for the treatment of Ménière’s disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière’s disease patients are underway, with results expected during the second half of 2017. 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 potential coverage and reimbursement relating to OTIPRIO, the timing of the completion of a Phase 3 clinical trial for OTIPRIO in acute otitis externa, the timing of results for the two OTO-104 Phase 3 clinical trials in Ménière’s disease, the timing of the initiation of the Phase 2 clinical trial for OTO-104 in cisplatin-induced hearing loss, the size of the market for sensorineural hearing loss, Otonomy’s ex-U.S. commercialization plans, and the estimated non-GAAP operating expenses for 2016 and 2017. 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 additional financing; Otonomy’s dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTO-104 and OTO-311, and label expansion indications for OTIPRIO; 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, 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; the timing and outcome of hospital pharmacy and therapeutics reviews and other facility reviews; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy’s dependence on third parties for the manufacture of OTIPRIO 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 OTIPRIO and 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 August 4, 2016, 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.
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