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Consultancy to lead FDA review process

AP Pharma has hired a leading consulting practice in pharma regulatory affairs to maximise the chance of APF530's approval by the FDA

AP Pharma, a US-based speciality pharmaceutical company, has hired a leading consulting practice in pharmaceutical regulatory affairs to lead the US Food and Drug Administration (FDA) review process and has formed a special committee of the Board to oversee its regulatory affairs. This follows the company receiving a Complete Response Letter from the FDA in March 2010, regarding its New Drug Application submitted in May 2009. The letter outlined several issues that would need to be addressed prior to FDA approval of APF530, the company's lead product candidate for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting.

According to Dr Paul Goddard, chairman of AP Pharma's Board, the company is "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."

The appointment of the consultancy and formation of the Board were undertaken to maximise the probability of APF530's approval by the FDA.

"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," Dr Goddard said.

AP Pharma also announced that Ronald J Prentki, president, chief executive officer and director, has resigned from the company due to differences of opinion in regulatory strategy.

Mr Prentki has agreed to assist in implementing an orderly transition of management responsibilities. John B Whelan, who has served as vice president, finance and chief financial officer since February 2009, has been appointed to the position of acting chief executive officer.

26th May 2010


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