LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of A.P. Pharma, Inc. (OTCQB:APPA), a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s lead product candidate, APF530, is a long-acting antiemetic drug for the prevention chemotherapy-induced nausea and vomiting (CINV). APF530 has already achieved primary efficacy endpoints in both acute-onset and delayed-onset CINV in one of the largest Phase III studies ever undertaken in CINV. A planned NDA resubmission to FDA is targeted for the first half of 2012.
“A.P. Pharma’s APF530 is a well-differentiated product that is positioned for success in the $850 Million U.S. CINV market, driven by multiple factors including long-acting efficacy, convenience and favorable reimbursement dynamics,” said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “APF530’s proprietary subcutaneous delivery system confers both rapid onset of action and extended 5-day exposure, thereby helping to prevent the nausea and vomiting cancer patients typically experience following chemotherapy. APF530 will be welcomed at busy infusion centers and by patients themselves because of its ability to decrease total infusion time in patients receiving standard intravenous chemotherapy. In addition, the drug is suitable for patients undergoing oral chemotherapy, in patients who have difficulty swallowing, and in patients that have failed to achieve a complete response in prior treatment with another antiemetic drug.”
A.P. Pharma has a strong cash position following recent financing activity, and they now have sufficient cash on hand for activities into 2013. The Company is currently focused on resubmitting the APF530 NDA in response to a Complete Response Letter (CRL) for APF530 received from FDA in March 2010, for which the Company has laid out a detailed plan addressing all points raised by the agency.
In a 43-page Initiation Report by LifeSci Advisors, the clinical achievements of APF530 to date are presented, as is a thorough analysis of the CINV market that highlights the positioning of APF530, and an overview of key aspects of the Company’s response to the CRL. APF530 is long-acting formulation of granisetron, a well-known 5-HT3 antagonist widely used for CINV prophylaxis that is now generic. As such, A.P. Pharma is using the streamlined 505(b)(2) regulatory path in seeking approval from FDA.