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Dutton Associates Featured Company: A.P. Pharma, Inc. (APPA)

A.P. Pharma, Inc. (NASDAQ: APPA) is a specialty pharmaceutical company focused on the development and commercialization of innovative medical treatments utilizing their proprietary polymer-based drug delivery systems.

The company’s proprietary Biochronomer™ technology, featuring bioerodible polymers intended to create controlled-release pharmaceuticals that improve treatments for diseases or health-threatening conditions, is their primary focus as they continue to advance the technology. The company’s lead product candidate is APF530, which is currently in a pivotal Phase III clinical trial for the prevention of acute and delayed onset chemotherapy-induced nausea and vomiting, or CINV.

The company has made significant investments in the development of their bioerodible drug delivery technologies, which have produced tangible results. Specifically, A.P. Pharma has developed a broad family of polymers consisting of unique attributes referred to as poly (ortho esters), under the trade name Biochronomer. This technology has been designed for use in drug delivery applications with a number of technical advantages that include ease of manufacturing, flexible delivery times, various physical forms and multiple potential applications due to a neutral pH environment of acid sensitive actives (nucleic acids, proteins, etc.).

An advantage of Biochronomer technology is that it is extremely versatile, as products can be designed to deliver drugs at a variety of implantation sites such as under the skin, at the site of a surgical procedure, in joints, in the eye, or directly in muscle tissue. The company’s Biochronomer technology can provide sustained levels of drugs in systematic circulation for prolonged efficacy.

Having completed over 100 in vivo and in vitro studies, A.P. Pharma believes that their Biochronomer technology demonstrates that it can be used within a wide range of potentially applicable therapeutic areas including pain management, prevention of nausea and vomiting, control of inflammation and treatment of ophthalmic diseases. The company has also completed comprehensive animal and human toxicology studies that have established that their Biochronomer polymers are safe and well tolerated. Furthermore, the Biochronomer technology can be designed to deliver drugs over periods varying from days to several months.

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