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A.P. Pharma Resubmits New Drug Application for APF530, a Product Candidate for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Key Takeaway: A.P. Pharma Resubmits New Drug Application for APF530, a Product Candidate for the Prevention of Chemotherapy-Induced Nausea and Vomiting REDWOOD CITY, Calif. September 28, 2012 A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, today announced that it has resu

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A.P. Pharma Resubmits New Drug Application for APF530, a Product Candidate for the Prevention of Chemotherapy-Induced Nausea and Vomiting
REDWOOD CITY, Calif. September 28, 2012 A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for its lead product candidate, APF530, for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). A.P. Pharma expects confirmation of acceptance from the FDA and a
Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company anticipates a six-month review by FDA.
resubmission of the APF530 NDA is a pivotal milestone for A.P. Pharma and brings this important therapeutic option one step closer to cancer patients suffering from CINV, said John B. Whelan, A.P. Pharma s president and chief executive
officer. Now that we have resubmitted the NDA, our focus will shift to pre-marketing and pre-commercialization activities in anticipation of potential FDA approval of APF530.
Prevention and control of nausea and vomiting, or emesis, are very important in
the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an antiemetic, typically administered just prior to chemotherapy.
Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning
that more than 90% of patients experience CINV, if they do not receive an antiemetic. Acute-onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed-onset CINV occurs more than 24 hours after treatment and may persist
for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy.
product, APF530, is in development for the prevention of both acute-onset and delayed-onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated in the Company s proprietary
Biochronomer drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Intravenous and oral formulations containing granisetron are approved for the prevention of
acute-onset CINV, but not delayed-onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer polymer-based drug delivery platform. This drug delivery platform is designed to improve the
therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks. The Company s lead product, APF530, is being
developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting. For further information, please visit the Company s web site at www.appharma.com.
Forward-looking Statements
This news release contains forward-looking
statements as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the potential approval of APF530 and the potential timing
for such approval, if approved at all, as well as risks relating to capital resources and liquidity, satisfactory completion of clinical studies, progress in research and development programs, launch and acceptance of new products and other risks
and uncertainties identified in the Company s filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as
Investor Relations Contact:
Office Phone: (646) 597-6979
Whelan, President and Chief Executive Officer
Office Phone: 650-366-2626
Last updated: Sep 28, 2012