APP Hires Reg Consultant for Review, CEO Departs

A.P. Pharma, Inc. has hired a consulting practice in regulatory affairs to lead the FDA Review Process for its lead product candidate, APF530 for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that uses the company’s Biochronomer drug delivery system. In March 2010, the company received a Complete Response Letter from the FDA regarding its NDA, which outlined several issues to be addressed prior to FDA approval of APF530.

Ronald J. Prentki, president, chief executive officer and director, has resigned due to differences of opinion in the company’s regulatory strategy. Mr. Prentki will assist in the transition of management responsibilities. John B. Whelan, who has served as vice president, finance and chief financial officer since February 2009, has been appointed acting chief executive officer.

“In going forward, we have one goal in mind: to thoughtfully and thoroughly address FDA’s remaining concerns as outlined in the March 2010 Complete Response Letter so that we may best facilitate the approval of our lead product,” stated Paul Goddard, Ph.D., APP’s chairman. “We remain fully committed to APF530, as we believe that this product could improve the lives of many patients suffering from cancer by treating one of the major morbidities associated with its treatment, namely chemotherapy-induced nausea and vomiting. As potentially the first product that could address both acute-onset and delayed-onset nausea and vomiting with a single, subcutaneous injection at the time of chemotherapy administration, APF530 would represent an important treatment alternative for patients and physicians.”