Published: March 19, 2010
A.P. Pharma Receives FDA Complete Response Letter for APF530
REDWOOD CITY, Calif. - (BUSINESS WIRE) - A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company,
today announced that it received a Complete Response Letter from the
U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug
Application (NDA) for APF530 in the prevention of both acute and delayed
onset chemotherapy-induced nausea and vomiting (CINV). APF530 is a
long-acting formulation of granisetron utilizing the Company's
proprietary Biochronomer drug delivery system. A conference call has
been scheduled for Friday, March 19, 2010 at 9:00 a.m. Eastern Time.
A Complete Response Letter is issued by the FDA's Center for Drug
Evaluation and Research when the review of a file is completed and
questions remain that preclude the approval of the NDA in its current
form. The primary points raised in the FDA Complete Response Letter are
discussed below:
Dosing System
-
The FDA expressed concerns relating to A.P. Pharma's two-syringe
administration system, including potential issues with the transfer of
material from one syringe to the other syringe prior to patient
administration, certain components used in the dosing system and the
potential risk of improper administration of the drug product.
Chemistry, Manufacturing and Control
-
The FDA has completed inspections of A.P. Pharma and several of its
contract manufacturing facilities. The Agency identified certain
deficiencies during these inspections, and satisfactory resolution of
these deficiencies will be required for approval.
-
During the NDA review, the FDA asked that the Company determine if
terminal sterilization with gamma irradiation is a feasible approach
to enhance the assurance of sterility. A.P. Pharma has subsequently
demonstrated that terminal sterilization is feasible, and the FDA has
requested the Company change to terminal sterilization prior to
approval.
-
The FDA requested clarification and revision of certain analytical
specifications proposed in the Company's NDA.
Clinical
-
The FDA did not request additional clinical efficacy studies, although
the Agency has asked for the re-presentation and re-analysis of select
existing Phase 3 clinical trial data.
-
The FDA requested the Company perform two studies relating to
bioavailability and metabolism. A.P. Pharma believes these studies
should be of short duration in normal volunteers.
-
The FDA did not accept the Company's request to waive the requirement
for a thorough QT study. A.P. Pharma believes this study should be of
short duration in normal volunteers. The Company plans to discuss the
design and timing of the study with the FDA.
Some of the FDA's points were addressed in recent NDA amendments by A.P.
Pharma that the Agency did not review prior to issuing the Complete
Response Letter. The Company believes that these amendments may address
some of the issues raised in the Complete Response Letter. The FDA has
indicated that A.P. Pharma may incorporate applicable sections of these
amendments by specific reference in its resubmission. The Company will
be contacting the FDA to request an End-of-Review meeting to discuss the
Complete Response Letter. A.P. Pharma is committed to expeditiously
resolving the remaining issues required for FDA approval; however, based
on the anticipated time needed to prepare a resubmission, the Company
does not anticipate the commercial launch of APF530 in 2010.
Conference Call and Webcast Details
A.P. Pharma's management will host a conference call on Friday, March
19, 2010 at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) and
interested investors may participate in the conference call by dialing
(888) 732-6202 (domestic) or (719) 457-1017 (international) and use
passcode 844199. In addition, the live conference call is being webcast
and can be accessed on the "Calendar of Events" page of the "News &
Events" section of the Company's website at www.appharma.com.
A replay of the webcast will be available approximately two hours after
the call and will be available through April 2, 2010.
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 the Company's 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. A.P. Pharma received a Complete
Response Letter on the APF530 NDA in March 2010 and intends to respond
to the issues in the Complete Response Letter in as timely and
expeditious a manner as possible.
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, for the prevention of chemotherapy-induced nausea and
vomiting (CINV). A.P. Pharma received a Complete Response Letter on the
APF530 NDA in March 2010 and is in the process of preparing a
resubmission responsive to the deficiencies listed in the Complete
Response Letter. 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, visit the Company's web site at www.appharma.com.
A.P. Pharma's 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.
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
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