REDWOOD CITY, Calif.--(BUSINESS WIRE)--May. 18, 2009--
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company,
today announced that it has submitted a New Drug Application (NDA) for
its lead product, APF530, to the U.S. Food and Drug Administration
(FDA). APF530 is being developed for the prevention of
chemotherapy-induced nausea and vomiting (CINV) and is a long-acting
formulation of granisetron that utilizes the Company’s proprietary
Biochronomer™ drug delivery system.
“The submission of this NDA marks a significant milestone for the APF530
program, our Biochronomer™ drug delivery technology and A.P. Pharma as a
company,” said Ronald J. Prentki, A.P. Pharma’s president and chief
executive officer. “Our number-one priority has been to assemble and
submit a complete and high-quality NDA. We thank our regulatory, CMC,
clinical and e-filing experts for their tireless efforts and look
forward to a timely review by the FDA.”
“The favorable efficacy and safety demonstrated in the APF530 Phase 3
clinical program provides a strong foundation for our submission,”
stated Mr. Prentki. “We believe APF530, which maintains therapeutic drug
levels for five days, will be a ’long acting’ agent offering important
advantages over anti-emetics currently used in the prevention of CINV,
and would provide a particular benefit to those many patients suffering
with delayed onset nausea and vomiting.”
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. The FDA is expected to determine whether to accept the NDA
for filing within 60 days, and to notify the Company of its
determination within fourteen days thereafter. If the NDA is accepted
for filing, under the Prescription Drug User Fee Act guidelines, it is
expected that the FDA will complete its review and provide an action
letter with respect to the NDA within 10 months following NDA submission.
About APF530
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.
Palonosetron is the only injectable 5-HT3 antagonist FDA-approved for
the prevention of delayed onset CINV. APF530 was also generally
well-tolerated in this study.
About CINV
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.
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 our proprietary Biochronomer™ polymer-based drug delivery
technology. Our primary focus is on our lead product candidate, APF530,
which has completed a pivotal Phase 3 clinical trial for the prevention
of CINV. An NDA for APF530 was submitted in May 2009. 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.
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 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
Vice President,
Finance and Chief Financial Officer
or
Corporate
Communications Alliance, LLC
Edie DeVine, 209-814-9564 (Investor
and Media Relations)
