FDA worries about the dosing system and manufacture of a drug candidate for chemotherapy-induced nausea has led to disagreement about regulatory strategy between the drugmaker's CEO and board of directors. And as such business matters often go, the CEO is no longer with the company.
AP Pharma president and chief executive Ronald J. Prentki tendered his resignation after the hiring of a consulting team and creation of a board committee to lead regulatory affairs. The action follows a mid-March complete response letter, in which the FDA expressed manufacturing concerns. Those concerns, affecting the specialty pharma's lead product candidate now in late-stage development, include manufacturing facility deficiencies. And before it will approve the drug, the agency wants the company to switch to a terminal sterilization process.
AP Pharma has leveraged itself against the product, APF530, a potential competitor to Eisai's Aloxi. It has cut early-stage development programs and a third of its staff to minimize costs, reports Dow Jones.
- here's AP's release on Prentki's resignation
- see the article