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A.P. Pharma is a specialty pharmaceutical company developing pharmaceutical products using our proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s primary focus is on its lead product candidate, APF530, which, during 2008, completed a pivotal Phase 3 clinical trial for the prevention of chemotherapy-induced nausea and vomiting (CINV). Results from that trial were announced in the third and fourth quarters of 2008. In July 2009, the U.S. Food and Drug Administration (FDA) accepted the Company's New Drug Application and, under the Prescription Drug User Fee Act (PDUFA), issued an action date of March 18, 2010.
APF530 is designed to prevent CINV for at least five days and contains granisetron, a drug approved for the prevention of CINV. In September 2005, the Company completed a Phase 2 clinical trial of APF530 that achieved all of its primary and secondary endpoints. In May 2006, A.P. Pharma initiated its pivotal Phase 3 clinical trial of APF530. Trial enrollment was completed in June 2008, and top-line results were reported in September 2008. The Company believes that this clinical trial will lead to regulatory approval of APF530 for the prevention of acute onset CINV for patients undergoing both moderately and highly emetogenic chemotherapy, and for delayed onset CINV for patients undergoing moderately emetogenic chemotherapy.
A.P. Pharma’s core Biochronomer technology, on which APF530 and its other products are based, consists of bioerodible polymers designed to release drugs over a defined period of time. The Company has completed over 100 in vivo and in vitro studies demonstrating that its Biochronomer technology is potentially applicable to a range of therapeutic areas, including prevention of nausea and vomiting, pain management, control of inflammation and treatment of ophthalmic diseases. A.P. Pharma has also completed comprehensive animal and human toxicology studies that have established that its Biochronomer polymers are generally well tolerated. Furthermore, the Company’s Biochronomer technology can be designed to deliver drugs over periods varying from days to several months.
In addition to its lead drug candidate, A.P. Pharma has a pipeline of other product candidates that use the Biochronomer technology. Further development of the Company’s pipeline products has been temporarily deferred in order to focus all corporate resources, both managerial and financial, on the APF530 NDA and negotiations of a commercialization partnership for APF530. One of these pipeline products, APF112, incorporates the well-known local anesthetic, mepivacaine. It is designed to provide up to 36 hours of relief from post-surgical pain and to minimize the use of morphine-like drugs, or opiates, which are used extensively in the management of post-surgical pain. Post-surgical pain can be treated with local anesthetics, but the usefulness of these agents is limited by the short duration of their effectiveness. A second pipeline product, APF580, incorporates a presently undisclosed opiate for extended relief of severe pain. An investigational new drug application (IND) for APF580 was successfully filed in the third quarter of 2008.
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