Healthcare Industry News: PATANASE
News Release - February 3, 2011
Otonomy Adds Key Product and Industry Experience with Appointment of New Vice PresidentsMove Represents Latest Step in Establishment of Otonomy as Leader in Treatment of Ear Disorders
SAN DIEGO, Feb. 3, 2011 -- (Healthcare Sales & Marketing Network) -- Otonomy, Inc., a developer of innovative therapeutics for disorders of the ear, today announced the appointments of G. Michael Wall, Ph.D., as the company's vice president of product development and Cindy Berejikian as the company's vice president of program management. The appointments of Dr. Wall and Mrs. Berejikian, each of whom possesses extensive global pharmaceutical product development and commercialization expertise, further advance Otonomy's efforts to establish the company as the industry's leader in the development of novel treatments for disorders of the ear. Along with the recent appointment of David A. Weber, Ph.D. as chief executive officer, these additions provide the company with key experience to guide the continued development of OTO-104 and OTO-201, Otonomy's lead product candidates.
"Otonomy's ability to attract individuals of the caliber of Cindy and Mike speaks to the tremendous opportunity and potential for success that we are cultivating at the company. Our objective is to establish Otonomy as the global leader in the development of therapeutics for the treatment of disorders of the ear and the additions of Mike and Cindy demonstrate our commitment to attaining that goal," stated David A. Weber, Ph.D., president and chief executive officer of Otonomy. "Their combined experience is clearly impressive, but more importantly, it is incredibly relevant to the work that we are undertaking as we strive to break ground in the virtually untapped otology market. We look forward to the contributions that they will make not only to our ongoing development programs for OTO-104 and OTO-201 but more broadly to the overall success of Otonomy."
Dr. Wall brings to Otonomy extensive pharmaceutical industry leadership experience spanning the entire lifecycle of pharmaceutical development from preclinical research to global regulatory approval and product launch. Having served most recently as senior director of pharmaceutical development at Alcon Research, he contributed to the development, registration, approval and post-approval activities of numerous major ophthalmic drug products. Over the last several years, he led Alcon's otolaryngology research and development program leading to the approval and commercialization of several novel otic and nasal drug products, including Ciprodex®(1) Otic Suspension and PATANASE®(2) Nasal Spray. Ciprodex® Otic Suspension is the only topical combination antibiotic/corticosteroid drug product approved by the United States Food and Drug Administration (FDA) for the treatment of external and middle ear infections and is the most widely prescribed branded eardrop by pediatricians and ear, nose and throat specialists in the U.S. Dr. Wall's education includes the Harvard Business School Advanced Management Program, Ph.D. in medicinal chemistry from the University of Mississippi School of Pharmacy and M.S. in medicinal chemistry from the Auburn University School of Pharmacy.
Mrs. Berejikian possesses more than 20 years of biotechnology and pharmaceutical experience overseeing the critical project management elements associated with advancing a product from the development stage to the commercial market. Throughout her career, she has overseen the filing and approval of four biologic license applications, as well as two global product launches. Mrs. Berejikian most recently served as principal of biopharmaceutical consulting at DrugDevPM where she assisted clients in developing and executing successful strategic programs related to regulatory filings, clinical development programs, product launches, positioning and marketing. Prior to her work with DrugDevPM, she spent over 15 years with Amgen, Inc., most recently as director of global R&D project management. In this position Mrs. Berejikian was responsible for leading the operations of a global cross-functional product team to ensure worldwide filing, approval and launch of the novel cancer treatment Kepivance®(3). While at Amgen, she also led the operations of the product team responsible for securing global approval and launch of the blockbuster Aranesp®(4) in the area of oncology. Mrs. Berejikian earned her Master of Business Administration degree from the Anderson School of Management at the University of California, Los Angeles.
Otonomy is a clinical stage biopharmaceutical company developing novel drug therapies for disorders of the inner and middle ear. The company's core technology is a sustained release formulation developed for optimal delivery of drugs from a single intratympanic (IT) injection. Broad applicability of this delivery and formulation technology has been established 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 is ongoing in Meniere's disease patients, and future studies are being planned for acute onset hearing loss. OTO-201, the company's second product candidate, is a novel sustained release antibiotic being developed for the treatment of recurrent otitis media in patients requiring tympanostomy tube placement. 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.
(1) Ciprodex is a registered trademark of Bayer AG, licensed to Alcon, Inc. by Bayer AG.
(2) PATANASE is a registered trademark of Alcon, Inc.
(3) Kepivance is a registered trademark of Amgen, licensed to Biovitrum, AB. by Amgen.
(4) Aranesp is a registered trademark of Amgen.
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