×

Otonomy Submits New Drug Application to the FDA for AuriPro(TM)

SAN DIEGO, Feb. 26, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of AuriProTM as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. The NDA submission is supported by data from two identical randomized, prospective, double-blind, sham-controlled Phase 3 clinical trials with a combined total of 532 pediatric patients. In both trials, AuriPro achieved the primary efficacy endpoint of reducing the incidence of treatment failures with statistical significance (p<0.001) and was well tolerated.

"The AuriPro NDA submission represents an important milestone for Otonomy in establishing a leading position in the emerging otology market," said David A. Weber, Ph.D., chief executive officer and president of Otonomy. "If approved by the FDA, we expect that AuriPro will be the first product marketed for the treatment of middle ear effusion during TTP surgery of which there are approximately one million procedures performed each year in the United States. Furthermore, we believe that AuriPro's single-use, physician administered profile has significant advantages over off-label use of antibiotic ear drops by avoiding patient compliance challenges inherent with multi-dose, multi-day treatment regimens in young children."

If approved within the standard review period, Otonomy anticipates product introduction in the United States during the first half of 2016. Initiation of a clinical trial for AuriPro in one or more additional indications is expected to begin in the first half of 2015.

About AuriPro

AuriPro is a sustained-exposure formulation of the antibiotic ciprofloxacin in development for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery. AuriPro has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment. There are approximately one million TTP surgeries performed each year in the United States, and antibiotic ear drops are used in nearly all cases. Despite their routine use, no antibiotic ear drop has received FDA approval for this indication. Moreover, current ear drop products require multi-dose, multi-day regimens for efficacy. Full compliance with these regimens can be challenging, and missed antibiotic doses can compromise efficacy and increase the potential for bacterial resistance.

Otonomy has completed two randomized, prospective, double-blind, sham-controlled Phase 3 clinical trials with identical protocols that enrolled a combined total of 532 pediatric patients. Results of these trials demonstrate that AuriPro achieved the primary efficacy endpoint, reduction in the incidence of treatment failures, with statistical significance (p<0.001) and that AuriPro was well tolerated. In these trials, AuriPro reduced the risk of treatment failure, as measured by the occurrence of post-operative otorrhea (drainage) or any use of rescue antibiotics, by an average of 49% in all randomized patients across the two trials, and the rate of post-operative otorrhea or use of rescue antibiotics for documented otorrhea or otitis media by an average of 62% in all randomized patients across the two trials (p≤ 0.004), in each case as compared to sham. Based on these results, together with feedback received from a pre-NDA meeting and communications with the FDA, Otonomy submitted an NDA for AuriPro to the FDA on February 25, 2015. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first half of 2016. Initiation of a clinical trial for AuriPro in one or more additional indications is expected to begin in the first half of 2015.

About Otonomy

Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the middle and inner ear following a single intratympanic injection. Otonomy has three product candidates in development. AuriPro™ is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. A New Drug Application for AuriPro has been submitted to the FDA. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Ménière's disease. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. 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 Otonomy's future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, Otonomy's expectations that AuriPro™ will be the first product marketed for the treatment of middle ear effusion during TTP surgery and Otonomy's expectations regarding the timing of commercialization of, and additional clinical trials for, AuriPro. 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: expectations regarding clinical trial results for existing product candidates, future development of product candidates for additional indications, and future development of other product candidates; timing and likelihood of regulatory filings and approvals; expectations regarding adoption and use of product candidates by physicians; 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 and developments related to competitors and the industry; Otonomy's ability to manage operating expenses, capital requirements and additional financing needs; implementation of Otonomy's business model and strategic plans for its business, products and technology; Otonomy's dependence on third parties for development, manufacture and distribution of products; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's final prospectus dated January 22, 2015 and filed with the Securities and Exchange Commission (the SEC) on January 23, 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.

CONTACT: Media Inquiries Canale Communications Heidi Chokeir, Ph.D. Vice President 619.849.5377 heidi@canalecomm.com Investor Inquiries Westwicke Partners Robert H. Uhl Managing Director 858.356.5932 robert.uhl@westwicke.com

Source:Otonomy, Inc.