REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jul. 20, 2009--
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the New Drug Application (NDA) 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.
“The acceptance of the APF530 NDA represents another important step
towards providing physicians and patients with a potential new
long-acting therapeutic agent to combat chemotherapy-induced nausea and
vomiting,” said Ronald J. Prentki, A.P. Pharma’s President and Chief
Executive Officer. “Our team recognizes the important role APF530 could
play in cancer care, and we are dedicated to working with the FDA as it
reviews our NDA submission.”
The NDA was submitted under section 505(b)(2) of the Federal Food, Drug
and Cosmetic Act, whereby the Company can rely upon the FDA’s prior
safety and efficacy findings for APF530's active ingredient, granisetron.
A.P. Pharma's lead product candidate, APF530, is being developed for the
prevention of both acute and delayed onset chemotherapy-induced nausea
and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron,
formulated in our proprietary Biochronomer™ drug delivery system, which
allows therapeutic drug levels to be maintained for five days with a
single subcutaneous injection. 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 widely
prescribed by physicians based on a well-established record of safety
and efficacy. In September 2008, A.P. Pharma reported positive top-line
results from its pivotal Phase 3 study. In this multi-center, randomized
trial that enrolled 1,395 cancer patients, APF530 was shown to be
equally as effective as (statistically non-inferior to) palonosetron
(Aloxi®) in the prevention of both acute onset and delayed onset CINV.
The NDA for APF530 was submitted in May 2009 and the FDA set a
Prescription Drug User Fee Act (PDUFA) date of March 18, 2010.
Palonosetron is the only injectable 5-HT3antagonist
FDA-approved for the prevention of delayed onset CINV. APF530 was also
generally well-tolerated in this study.
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 important because the distress caused by
CINV can severely disrupt patient quality of life and can lead some
patients to delay or discontinue chemotherapy.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products
using its proprietary Biochronomer™ polymer-based drug delivery
technology. The Company’s primary focus is on its lead product
candidate, APF530, which has completed a pivotal Phase 3 clinical trial
for the prevention of CINV. The NDA for APF530 was submitted in May 2009
and the FDA set a Prescription Drug User Fee Act (PDUFA) date of March
18, 2010. The Company has additional clinical- and preclinical-stage
programs in the area of pain management, all of which utilize its
bioerodible injectable and implantable delivery systems. 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 timely development, approval, launch and
acceptance of new products, satisfactory completion of clinical studies,
establishment of new corporate alliances, progress in research and
development programs 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.
A.P. Pharma, Inc.
John B. Whelan, 650-366-2626
Finance and Chief Financial Officer
Investor and Media
Corporate Communications Alliance, LLC