SAN DIEGO, May 25, 2011 /PRNewswire/ --Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced the appointment of Gerald Wroblewski as the company's chief operations officer. Mr. Wroblewski brings the company broad operational expertise in the areas of manufacturing, product supply chain management, packaging and quality assurance. At Otonomy, he will be responsible for overseeing activities in these areas to support the advancement of the company's product candidates through clinical development and into commercialization. The company recently announced plans to initiate a Phase 2 study for its lead drug candidate, OTO-104, in patients with Meniere's disease and is also positioned to begin clinical trials of a second product candidate, OTO-201, by the end of 2011.
Prior to joining Otonomy, Mr. Wroblewski served as vice president of operations at MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions. In this role, he managed manufacturing and product supply chain activities to support clinical advancement of the company's sustained release, injectable drug candidate. Before his work with MacuSight, he was chief operating officer at iScience Interventional Inc., a start-up medical device company in the ophthalmology space, and executive vice president of operations at Oculex Pharmaceuticals, a developer of novel biodegradable therapeutics for diseases of the eye. While at Oculex, Mr. Wroblewski was responsible for developing and implementing GMP manufacturing systems designed to support the production of multiple product components related to the company's sustained release steroid formulation. These innovative manufacturing platforms supported the advancement of the product into late-stage clinical trials and ultimately contributed to Allergan's successful acquisition of Oculex for $230 million. During his career, Mr. Wroblewski has also held senior management positions in large-scale commercial manufacturing operations at The Gillette Company, Oral-B Laboratories and McGaw Laboratories.
"The positive clinical results we recently announced for OTO-104 in Meniere's disease, combined with our rapid progress advancing OTO-201 through IND enabling studies, signals an important transition for the company that requires additional operational expertise and focus," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. "I welcome the opportunity to work with Jerry again and know that his depth and breadth of manufacturing expertise will successfully support the company through clinical development. Furthermore, his experience in commercial manufacturing operations will be essential to achieving our long range business objectives of bringing our products to market."
Otonomy is a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear. There are currently no FDA-approved drug treatments for the nearly 30 million Americans that are affected by debilitating hearing and balance diseases and disorders such as Meniere's disease, sudden sensorineural hearing loss, noise-induced hearing loss, age-related hearing impairment and tinnitus. Otonomy's core technology is a sustained release formulation developed for optimal delivery of drugs to the middle and inner ear with a single intratympanic (IT) injection. This technology has broad applicability across a range of therapeutic classes and two products based on this platform are in active development.
Otonomy's lead product candidate, OTO-104, is a sustained release formulation of the steroid dexamethasone. A Phase 1b clinical trial in Meniere's disease patients has recently been completed, and future studies are being planned in Meniere's disease and other inner ear disorders. OTO-201, the company's second product candidate, is a novel sustained release antibiotic being developed for the treatment of chronic otitis media. OTO-201 clinical trials are expected to begin in 2011. Additional product candidates are expected to target acute and chronic forms of hearing loss, balance disorders, and tinnitus.
For more information visit: www.otonomy.com.
SOURCE Otonomy, Inc.