REDWOOD CITY, Calif.--(BUSINESS WIRE)--Dec. 18, 2008--A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical
company, today provided an update on the timing for the submission of
the New Drug Application (NDA) for APF530, the company's lead product,
which is being developed for the treatment of chemotherapy-induced
nausea and vomiting (CINV).
Together with its regulatory consultants, the company recently completed
a comprehensive review of the APF530 NDA, which is currently under
development. Among the results from this assessment was a recommendation
that the company conduct and include in the NDA additional sterility
testing and analyses of the transfer and delivery system used in
administering the product to patients. The company accepted this
recommendation. The additional testing is being completed with the
objective of submitting a comprehensive sterility assurance package to
FDA and does not reflect any particular issues with either the transfer
system or any specific concerns regarding the sterility of the product.
The company has determined that with the incorporation of this
additional work, the target NDA filing date would need to be adjusted
from late December 2008 to the end of February 2009.
The company does not expect this delay to significantly impact the
timeline for approval, which is still projected for the first quarter of
Commenting on the NDA submission, Ronald Prentki, A.P., Pharma's
President and Chief Executive Officer stated, "Despite this modest
deferral in the targeted filing date, I am pleased with the status of
the work on the NDA submission package. Given the strength of the Phase
3 data and the additions we have made to key sections of the NDA, we
believe the result will be a more complete and high quality filing,
which we are confident will have a clear path forward to submission and
approval. Completing and filing the APF530 NDA remains our highest
priority, closely followed by establishing a commercialization
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 anti-emetic, typically administered just prior to
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 anti-emetic. 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 significant because the distress caused by
CINV can severely disrupt patient quality of life and can lead some
patients to delay or discontinue chemotherapy.
About APF530 and the Phase 3 Trial
A.P. Pharma's lead product, APF530, is being developed for the
prevention of both acute and delayed onset CINV. APF530 is delivered by
a single subcutaneous injection and contains the 5HT3
antagonist granisetron. Injections and oral tablets containing
granisetron are approved for the prevention of acute onset CINV, but not
for delayed onset CINV. Granisetron was selected because it is a potent
drug and the applicable granisetron U.S. patent expired on December 29,
The pivotal Phase 3 clinical trial, initiated in May 2006, was a
multi-center, randomized, observer-blind, actively-controlled,
double-dummy, parallel group study that compared the efficacy of APF530
with Aloxi. In the trial patients were stratified in two groups, one
receiving moderately and the other receiving highly emetogenic
chemotherapeutic agents. In each group, the patients were randomized to
receive in the first chemotherapy treatment cycle either APF530 high
dose (10mg), APF530 low dose (5mg) or the currently approved dose of
Aloxi. Standardized doses of a corticosteroid were employed in this
trial, the doses used depended on the emetogenic level of chemotherapy
calculated according to the Hesketh algorithm. In subsequent treatment
cycles (up to three additional cycles), the patients were re-randomized
to either of the two APF530 doses. In June of 2008 the company completed
full enrollment and treatment of 1,395 patients in the trial.
Preliminary top-line data from the trial was announced in September 2008.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company focused on the
development of ethical (prescription) pharmaceuticals utilizing its
proprietary polymer-based drug delivery systems. The company's primary
focus is the development and commercialization of its bioerodible
injectable and implantable systems under the trade name Biochronomer(TM).
Initial target areas of application for the company's drug delivery
technology include anti-nausea, where its lead product APF530 is being
developed to prevent CINV, pain management, anti-inflammation and
DNA/RNAI applications. For further information visit the company's web
site at www.appharma.com.
This news release contains "forward-looking statements" as defined by
the Private Securities Reform Act of 1995. These forward-looking
statements involve risks and uncertainties, including uncertainties
associated with timely development, approval, launch and acceptance of
new products, establishment of new corporate alliances, 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.
CONTACT: Investor Relations Contacts:
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
A.P. Pharma, Inc.
Ronald Prentki, President and Chief Executive Officer
Source: A.P. Pharma, Inc.