IRVINE, Calif. and REHOVOT, Israel, Nov. 2, 2015 /PRNewswire/ -- OticPharma, Inc., a privately held specialty pharmaceutical company focused on acquiring and developing innovative therapies for ear, nose, and throat (ENT) disorders, today announced that it has entered into a license agreement with Morristown, New Jersey based drug developer Otodyne, Inc., providing OticPharma with exclusive worldwide rights to develop and commercialize the company's investigational drug products for the treatment of otitis media and other conditions.
"We are extremely pleased to enter into this agreement with Otodyne, a company that has developed a truly novel approach to treating otitis media," said Gregory J. Flesher, chief executive officer for OticPharma, Inc. "The innovative approach focuses on restoring Eustachian tube function as a means to treat the underlying cause of otitis media. If successful, the approach could have broad reaching utility in children and adults."
Under the terms of the agreement, OticPharma will have responsibility for all development and commercialization activities. Otodyne will be eligible to receive a tiered royalty plus milestone payments based on successful development and commercialization of products worldwide.
"We are happy to partner with a company like OticPharma that has expertise in the development of novel products for the ear," said Alan Mautone, Ph.D., president of Otodyne, Inc. and authority on therapeutic surfactants. "We look forward to working with the company to continue the development of our investigational drug product and hope to someday bring this much needed product to patients."
"Otitis media is often painful and burdensome for patients and in chronic and severe cases frequently results in permanent hearing loss," said Sujana S. Chandrasekhar, M.D, chief medical officer of Otodyne, Inc., and leading otologist/neurotologist. "There are no FDA approved products that treat the underlying cause of otitis media, only resulting infections. More importantly, no FDA approved products can rapidly address the pain and pressure which is the primary reason patients seek medical attention. A safe and effective product that is fast-acting and free of antibiotics or steroids would be a significant improvement to the standard of care."
OticPharma, established in 2008, is a clinical-stage company active in the field of ear, nose, and throat disorders. The company's current product candidates are based on FoamOtic, a proprietary foam-based drug delivery system that provides sustained exposure of drugs.
Otic's lead product, FoamOtic Externa, is an investigational proprietary, foam-based, extended-release formulation of ciprofloxacin antibiotic, which has been designated for self-administration, once-daily to potentially treat acute otitis externa in minor and adult patients. The company recently completed a successful Phase 2 clinical trial with FoamOtic Externa in minor and adult patients with acute otitis externa and is currently planning the Phase 3 program.
About Acute Otitis Externa
Acute otitis externa (AOE) or "swimmer's ear" is a generalized inflammation of the epithelium of the external ear canal which may also involve the pinna and/or the tympanic membrane (eardrum). It is variably characterized by erythema, edema, increased sebum or exudates, and desquamation of the epithelium. AOE is a common, worldwide otologic problem occurring in humans mainly during hot and humid weather. The vast majority of the cases of AOE are due to bacterial infections. The common treatment of AOE consists of topical antibiotics, with or without steroids, analgesia and water avoidance. Otic preparations are generally supplied in the form of liquid ear drops which are administered multiple times per day.
About Otitis Media
Otitis media is a generalized inflammation of the middle ear space behind the tympanic membrane (eardrum), which can occur with or without infection. When infection occurs, the initial condition is referred to as acute otitis media (AOM) and when the fluid persists it becomes otitis media with effusion (OME). Recurrent and persistent cases of otitis media are referred to as chronic otitis media (COM). Otitis media is typically characterized by pain, pressure, and hearing impairment. In children, it can cause language and learning delays. If not adequately treated, COM can result in damage to the tympanic membrane and other structures of the middle ear and can lead to permanent hearing loss and other complications.
Gregory J. Flesher
Chief Executive Officer
19900 MacArthur Blvd., Suite 550
Irvine, California 92612
Tel: +1 (949) 238-8090
SOURCE OticPharma, Inc.