FDA Grants Auris Medical Fast Track Designation for Keyzilen in Acute Peripheral Tinnitus

  • Fast Track designation highlights potential of KeyzilenTM to address unmet medical need
  • Top-line results from Phase 3 TACTT2 trial expected next month

ZUG, Switzerland, July 18, 2016 (GLOBE NEWSWIRE) -- Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that the US Food and Drug Administration (FDA) has granted fast track designation for KeyzilenTM (AM-101) in acute peripheral (inner ear) tinnitus following cochlear injury or otitis media in adults.

"We are very pleased to have received Fast Track designation for Keyzilen from the FDA," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "Acute peripheral tinnitus is a serious condition that negatively impacts the quality of life for those suffering from it, yet there is no clinically proven pharmacological treatment or other effective therapy available."

The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation is granted more frequent access to the FDA to review the drug's development plan and may become eligible for priority review if relevant criteria are met. Additionally, Fast Track designation allows the sponsor to submit parts of the New Drug Application (NDA) for review on a rolling basis as data become available.

"We very much appreciate the FDA's support in the development of Keyzilen and look forward to working with the Agency to advance this potential first-in-class treatment," added Andrea Braun, Auris Medical's Head of Regulatory and Quality Affairs.

About the KeyzilenTM Phase 3 Clinical Development Program

KeyzilenTM (AM-101) is a NMDA receptor antagonist intended for the treatment of acute peripheral (inner ear) tinnitus. The Phase 3 clinical development program includes the TACTT2 and TACTT3 trials. The TACTT2 trial has enrolled approximately 330 patients and is being conducted primarily in North America under a Special Protocol Assessment (SPA) with the FDA. The TACTT3 trial has enrolled approximately 630 patients and is being conducted in Europe. Top-line results from the TACTT2 and TACTT3 trials are expected in August 2016 and in the fourth quarter of 2016, respectively.

About Acute Inner Ear Tinnitus

Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. Tinnitus may be transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Inner ear tinnitus often has a serious impact on the ability to sleep, relax, or concentrate, and it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, neither a universal standard of care for acute inner ear tinnitus, nor a truly proven and effective treatment method is available.

About Auris Medical

Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."

Forward-looking Statements

This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, investors@aurismedical.com


Source:Auris Medical AG