Full Press Release Details
A.P. Pharma Receives FDA Complete Response Letter for APF530
Projected Launch Timing from 2H 2013 to 1H 2014 -
- Conference Call to Be Held at 8:30 a.m. Eastern Time -
REDWOOD CITY, Calif. March 28, 2013 A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today
announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and
vomiting (CINV). The CRL describes the following issues that must be addressed.
We appreciate the FDA s thorough review of the APF530 NDA, stated John B. Whelan, A.P. Pharma s president and chief executive
officer. While disappointed in today s notification, we believe that the issues raised in the CRL are addressable, and we remain firmly committed to the successful development of APF530, which we believe will fulfill an important unmet
need and improve the lives of patients suffering from CINV. In order to allow us time to carefully address the issues raised in the CRL, we are now projecting product launch for the first half of 2014, versus our prior guidance of the second half of
Conference Call Details
A.P. Pharma will host a conference call on Thursday, March 28, 2013 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Interested investors may participate in the conference call by dialing
(877) 856-1964 (domestic) or (719) 386-0001 (international) and use participant code 135738. In addition, the live conference call is being webcast and can be accessed on the Calendar of Events page of the Investors
section of the Company s website at www.appharma.com. A replay of the webcast will be posted to this same section of the website available approximately two hours after the call.
A.P. Pharma s lead product, APF530, is being developed for the
prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one
injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV, so this indication represents an area of particular unmet medical need. 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. Currently available intravenous and oral formulations of granisetron are approved only for the
prevention of acute-onset CINV. Granisetron was selected for APF530 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. A.P.
Pharma resubmitted its New Drug Application (NDA) for APF530 to the U.S. Food and Drug Administration (FDA) in September 2012 and received a Complete Response Letter in March 2013. For further information, please visit the Company s web site at
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, the projected timing for the commercial launch of APF530, if approved, as well as risks relating to capital
resources and liquidity, satisfactory completion of clinical studies, progress in research and development programs, successful 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 required by law.
Investor Relations Contact:
Email: mrice@lifesciadvisors.com
John B. Whelan, President and Chief Executive Officer
Office Phone: 650-366-2626