- Company Revises Projected Launch Timing from 2H 2013 to 1H 2014 -
- Conference Call to Be Held at 8:30 a.m. Eastern Time -
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar. 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.
With respect to chemistry, manufacturing and controls (CMC), the FDA
has requested the refinement of one product quality analytical test
method, and that certain deficiencies identified during facility
pre-approval inspections be addressed.
The FDA has requested that a human factors validation study evaluating
the usability of the APF530 syringe system together with its proposed
product labeling and instructions for use be conducted with product
assembled using a validated, commercial process.
With respect to clinical, the FDA has requested a re-analysis of the
existing Phase 3 clinical data that reclassifies patients into those
receiving moderately emetogenic chemotherapy (MEC) and highly
emetogenic chemotherapy (HEC) according to the recently modified ASCO
2011 Guideline. The FDA did not request any new clinical studies.
“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 2013.”
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.
About A.P. Pharma
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 www.appharma.com.
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.
Source: A.P. Pharma, Inc.
Investor Relations Contact:
John B. Whelan, President and Chief Executive Officer