UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported) July 17, 2009
A.P.
Pharma, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-33221
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94-2875566
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(I.R.S.
Employer
Identification
No.)
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123
Saginaw Drive
Redwood
City, CA 94063
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(Address
of principal executive offices)
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(650) 366-2626
Registrant’s
telephone number, including area code
N/A
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item 8.01
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Other
Events.
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On July
20, 2009, A.P. Pharma, Inc. announced that the U.S. Food and Drug Administration
(the “FDA”) has accepted for review the New Drug Application for APF530 for the
potential treatment of chemotherapy-induced nausea and
vomiting. Based on the Prescription Drug User Fee Act, the FDA has
issued an action date of March 18, 2010.
The
foregoing description is qualified in its entirety by reference to our press
release dated July 20, 2009, a copy of which is attached hereto as Exhibit 99.1
and incorporated herein by reference.
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ITEM 9.01
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Financial
Statements and Exhibits.
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(d)
Exhibits
Exhibit
No. Document
Description
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99.1
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Press
Release issued on July 20, 2009.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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A.P.
Pharma, Inc.
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Date:
July 20, 2009
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/s/
Ronald J. Prentki
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Ronald
J. Prentki
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President,
Chief Executive Officer and
Director
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Exhibit 99.1
For
Immediate Release
A.P.
Pharma Announces FDA Acceptance of APF530 New Drug Application for
Chemotherapy-Induced Nausea and Vomiting
REDWOOD CITY, Calif. – July
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.
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. 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-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 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.
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.
Contacts
Corporate
Contact:
A.P.
Pharma, Inc.
John B.
Whelan, Vice President, Finance and Chief Financial Officer
650-366-2626
and
Investor
and Media Relations:
Corporate
Communications Alliance, LLC
Edie
DeVine
209-814-9564