-APF530 to Become the 2nd Injectable CINV Product-
-Core Marketing and Sales Team to be in Place-
Report is Available for Download at: www.lifesciadvisors.com/clients/ap
On Friday, A.P. Pharma (OTC BB: APPA) announced that the Company has resubmitted its New Drug Application (NDA) to the FDA for APF530. APF530 is the Company’s lead product candidate for the prevention of acute and delayed-onset chemotherapy induced nausea and vomiting (CINV). We are pleased to see that the Company has successful executed on previous guidance as the NDA was resubmitted within the month of September.
Sixth Month Review for APF530 is Expected. We expect the FDA to accept the NDA and notify the Company of the review type (Class I or Class II) and PDUFA date soon. We anticipate that the FDA will consider the resubmission as a Class II resubmission, which allows for a sixth month review. If this is the case, we expect an APF530 approvable decision from the FDA within the first half of 2013 and a subsequent product launch in the second half of the year.
A.P. Pharma is Starting Pre-marketing and Pre-commercialization Activities. A.P. Pharma wholly-owns worldwide rights to APF530 and has no milestone or royalty obligations. The Company’s plan is to build a core sales and marketing team ahead of APF530 launch. This will be a two-stage hiring process to limit cash burn. A.P. Pharma has announced that by the end of the year, they intend to hire core sales and marketing leadership, which will consist of approximately 10 people. Upon APF530 approval in 1H13, a field team consisting of 40 sales representatives will be hired. We believe this sales force will be sufficient to reach the 3,000 oncology practices in the US where 50% of the market ($450MM) is represented by several hundred practices.