Otic Pharma Ltd. is developing a line of products that are formulated in its novel proprietary drug delivery system: “Foam-Otic” that addresses inherent limitations of all current ear drops medications. Pleasant foam is applied to the ear via a dedicated device, remains there for a long time and slowly releases and “supplies” the active drug to the external ear. Excellent compliance, once or twice a day use, novelty, safety and efficacy contribute to an attractive product line with a potential to capture a significant market share (estimated in $1 billion worldwide).

The risk and regulatory requirements involved in developing our technology and products is relatively low. At this stage, we completed the development of the formulation and the application device and demonstrated the safety of our first product, Foam Otic Ciprofloxacin, in a 50 patients sensitization/allergenicity Phase I trial. A Phase ll proof of concept clinical trial started in May 2009 and will enroll 100 patients with Otitis Externa in two medical centers in Israel.

A device for foam delivery was designed by Otic Pharma. A prototype of the device was assembled and a provisional patent was filed covering the various features (multi-metered dose and self-cleaning) and the use of the device in multiple fields besides drug delivery.

Patent applications relating to various aspects of the Foam-Otic products have been filed and are in various stages of prosecution. According to the broad patent strategy Foam-Otic products will be protected by intellectual property on three levels: the formulation of the drug product; its dedicated metered dose dispenser and specific features of the applicator; and the intended methods of using foam therapeutics for otic diseases.