Key Developments For A.P. Pharma, Inc.
A.P. Pharma, Inc. (APPA.O) (Consolidated Issue listed on NASDAQ Capital Market)
A.P. Pharma, Inc. Announces Private Equity Placement
A.P. Pharma, Inc. announced that it has entered into a definitive securities purchase agreement with certain existing accredited investors providing for a private placement of up to $13.1 million in two tranches, the first consisting of common stock and warrants with aggregate proceeds of approximately $8.1 million, and a second tranche of common stock with proceeds of approximately $5 million. A.P. Pharma expects to complete the first tranche of the private placement on October 22, 2009. Pursuant to the terms of the securities purchase agreement, the Company will sell approximately 8.0 million shares of common stock at $0.88 per share, the closing price on the date of signing the securities purchase agreement, October 19, 2009. The purchasers of the common stock at the first closing will also receive warrants to purchase approximately 4.0 million shares of common stock, exercisable through January 7, 2015 for an exercise price of $0.88 per share. The purchasers will pay $0.125 per underlying share for the warrants at the first closing. The securities purchase agreement also provides, under certain conditions, for the purchasers in the first closing to have the right to purchase up to 5.2 million shares of common stock at $0.97 per share prior to May 14, 2010. At the closing of the first tranche, the purchasers will pay $0.125 per underlying share for the right to purchase shares in the second tranche.
A.P. Pharma, Inc. And Merial Enter Into Worldwide Agreement
A.P. Pharma, Inc. announced that it has entered into a license and development agreement with Merial for a long-acting pain management product . The product, which contains an undisclosed analgesic, uses A.P. Pharma`s Biochronomer technology to provide sustained drug levels and pain relief over several days following a single administration. Under the terms of the new agreement, A.P. Pharma grants Merial a worldwide, exclusive license to the product for use in treating companion animals (cats and dogs). A.P. Pharma will receive an undisclosed upfront payment, development funding and potential future milestones that are in addition to royalties following commercialization.
A.P. Pharma, Inc. Announces FDA Acceptance Of APF530 New Drug Application For Chemotherapy-Induced Nausea And Vomiting
A.P. Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV). APF530 is a long-acting formulation of granisetron that utilizes the Company`s proprietary Biochronomer drug delivery system. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has issued an action date of March 18, 2010.
AP Pharma Inc. Presents APF530 Phase 3 Data At Annual Meeting Of American Society Of Clinical Oncology
AP Pharma Inc. announced additional findings from the Company's Phase 3 study of APF530 for the prevention of chemotherapy-induced nausea and vomiting (CINV). Below is a summary of the additional data presented in June 1, 2009 session: CR rates for APF530 10 mg dose were generally higher in treatment experienced patients when compared to treatment naïve patients. Additionally, in all instances, CR rates for APF530 in treatment experienced patients were numerically higher than those observed for palonosetron. Based on previous clinical studies, many physicians believe that the risk of CINV increases with each additional cycle of chemotherapy. These new data may suggest potential utility for APF530 in treating patients who have received prior chemotherapy; Of the highly emetogenic chemotherapy regimens, those containing cisplatin are considered to be the most troublesome due to their ability to cause significant delayed CINV. The CR rates for patients receiving cisplatin based regimens were numerically higher for APF530 10 mg when compared to palonosetron in both acute and delayed CINV. Specifically, in acute CINV, APF530 had an 81.1% CR rate versus 75.5% for palonosetron, and 66.0% versus 60.4%, respectively, in delayed CINV; A pharmacokinetic analysis, conducted in a sub-group of patients, confirmed that a single APF530 10 mg dose successfully maintained blood levels of granisetron for the entire five day period.
AP Pharma Inc. Announces Additional Restructuring Effort
AP Pharma Inc. announced that it has implemented a reduction of its staff representing approximately 34% of its work force. The actions are being taken to allow the Company to provide the resources needed to continue advancing its lead program, APF530, towards regulatory approval and commercialization. APF530 is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. The New Drug Application (NDA) for APF530 was submitted earlier this month for the prevention of chemotherapy-induced nausea and vomiting (CINV). The Company expects one time costs associated with this headcount reduction to be approximately $350,000, which will be recorded in the second quarter of 2009. The headcount reduction included 11 employees and is a continuation of the organization's commitment to cash preservation, initiated last fall.
