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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): August 12, 2004
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A.P. PHARMA, INC.
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(Exact name of Registrant as specified in its charter)
DELAWARE 1-16109 94-2875566
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
123 SAGINAW DRIVE, REDWOOD CITY, CALIFORNIA 94063
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(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code:
(650) 366-2626
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N/A
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(Former Name or Former Address, if Changed Since Last Report)
INFORMATION TO BE INCLUDED IN THE REPORT
ITEM 5.
On August 12, 2004, the Registrant issued a press release
announcing its preliminary clinical data results from the second
part of the Phase 2 trial using APF112 for the treatment of pain
following inguinal hernia procedures and initial Phase 1 data for
APF530 that is designed to provide relief from chemotherapy-
induced nausea and vomiting following a single subcutaneous
injection. The press release is attached hereto as Exhibit 99.1
and incorporated herein by reference.
ITEM 7. Financial Statements and Exhibits.
(c) Exhibits
99.1 Press release dated August 12, 2004.
SIGNATURE
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.
A.P. PHARMA, INC.
Date: August 12, 2004 By: /S/ Michael O'Connell
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Michael P. J. O'Connell,
President and Chief
Executive Officer
EXHIBIT INDEX
99.1 Press release dated August 12, 2004.
(continued from previous page)
Exhibit 99.1
A.P. Pharma Logo
News Release
A.P. PHARMA REPORTS PRELIMINARY CLINICAL DATA RESULTS
FROM STUDIES USING APF112 AND APF530
Conference call to begin today at 12:00 noon ET/9:00 a.m. PT
REDWOOD CITY, Calif. (August 12, 2004) - A.P. Pharma, Inc.
(NASDAQ NM: APPA), a specialty pharmaceutical company, today
reported preliminary top-line results from the second part of the
Phase 2 trial using APF112, and also reported initial Phase 1
data for APF530. APF112 is being tested for the treatment of
pain following surgical inguinal hernia repair, and APF530 is
being tested for the treatment of chemotherapy-induced nausea and
vomiting.
APF112
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* Safety and tolerability of APF112 as evaluated in both parts
of this study (Part 1 reported March 12, 2004) were very
good.
* Initial open-label study (Part 1) included a pharmacokinetic
evaluation that showed measurable blood levels of
mepivacaine over a three-day period.
* Blinded study (Part 2) with two doses of APF112 (150 mg and
300 mg of mepivacaine) compared with standard of care
(infiltration with bupivacaine) was completed in 90
patients; top-line data was analyzed in 79 patients.
* No significant difference was shown between the two doses of
APF112 and standard of care (bupivacaine) in terms of pain
scores as well as amount of rescue pain medication used.
* Mean Visual Analog Scale (VAS) pain scores in the standard
of care group (bupivacaine) were unusually low at
approximately 3, compared with historical published data of
approximately 5, within the first 24 hours post surgery.
APF530
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* First dosing in six healthy human volunteers showed
sustained blood levels over four days following
administration.
* APF530 was well tolerated in all subjects with no
unanticipated side effects.
* Further dosing with higher levels in two cohorts of six
volunteers each should begin following approval by U.K.
regulatory authorities in the near term. The Company notes
that a change in procedures for clinical trial authorization
implemented mid 2004 has led to an unexpected regulatory
review delay.
* U.S. regulatory submission still planned for end of the year
to allow the start of Phase 2 clinical studies.
"APF112 preliminary Phase 2 clinical results came as a surprise
and a disappointment, and we intend to further analyze and
evaluate the data to determine potential alternatives and next
steps with that program," said Paul Goddard, Ph.D., A.P. Pharma
Chairman. "We are, however, encouraged by some of the
preliminary results and also by the initial data from the APF530
study, and we remain committed to the development and
commercialization of bioerodible injectable and implantable
delivery systems utilizing our Biochronomer(TM) polymer-based
drug delivery technologies."
Preliminary Results - APF112
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APF112 contains the local anesthetic mepivacaine and is designed
to provide pain relief for a sustained period of time following
surgery. The APF112 Phase 2 study for the treatment of pain
following inguinal hernia procedures was designed in two parts.
Part one of the Phase 2 study was a 10-patient open-label study
completed in early 2004. In that study mepivacaine was sustained
in blood levels for up to 72 hours, wound healing in all patients
was observed to be normal and no adverse events were reported.
In addition, both patients and physicians reported good to very
good quality of pain control. Based on these results, the second
part of the study was initiated.
The second part of the Phase 2 trial was a 90-patient blinded
study comparing two doses of APF112 with bupivacaine, the current
standard of treatment for post-surgical pain. Although the
primary endpoints for the study were the evaluation of safety and
tolerability, additional efficacy endpoints included a visual
analog score (VAS) of pain intensity, the standard means of
measuring pain, and reduction in use of opioid-type rescue pain
medication such as Vicodin. Analysis of preliminary top-line
clinical data from the second part of the study indicates that
safety, tolerability and wound healing aspects of APF112 were
very good in these patients. However, there was no meaningful
trend or significant difference in clinical efficacy data between
the two selected formulations of APF112 and bupivacaine. The
pain scores following bupivacaine infiltration, as assessed by
the VAS scale, appear to be significantly lower in this study
when compared with other previously published studies in similar
hernia trials for reasons that we do not yet understand. Based
on published data, VAS scores for the standard of care in similar
inguinal hernia studies ranged from 4.5 to 6.7, whereas in this
study the mean score for the bupivacaine arm was 2.9 within the
first 24 hours post surgery.
The Company and its consultants are continuing to analyze and
evaluate the results of the trial, and are currently considering
a variety of alternatives regarding the future of the APF112
clinical program including higher dosing levels, alternative
surgical procedures and variations in current polymeric
formulations.
Preliminary Results - APF530
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APF530 contains the anti-emetic granisetron and is designed to
provide three to five days of continuous relief from
chemotherapy-induced nausea and vomiting (CINV) following a
single subcutaneous injection. The polymer formulation in APF530
is the same as that included in the APF112 Phase 2 studies, which
demonstrated a very good safety profile. A Phase 1 open-label
clinical study with APF530 was initiated in the U.K. and analysis
of preliminary data from the first arm (lowest dose) of the study
indicates that pharmacokinetic measurements demonstrated
measurable blood levels of granisetron over a four-day period.
These preliminary data are consistent with pre-clinical dose
ranging studies and the Company therefore anticipates achieving
potentially therapeutic blood levels as the remaining human dose
ranging studies are completed. These initial clinical data,
together with other pre-clinical and safety data, have been
submitted to the U.K. regulatory authorities (MHRA) in compliance
with new regulatory procedures initiated in mid 2004 in order to
complete the study. These new regulatory procedures have led to
an unexpected delay but the Company still plans to make a
regulatory submission to the U.S. Food and Drug Administration
(FDA) around the end of the year seeking permission to allow the
start of Phase 2 clinical studies with APF530.
Current treatment for CINV involves the intravenous injection of
the drug prior to chemotherapy to treat nausea and vomiting over
24 hours. Additionally, oral drug treatment is generally taken
twice a day for three to four days in an attempt to treat delayed
nausea and vomiting. It is the Company's goal to treat both the
acute and delayed nausea and vomiting associated with
chemotherapy following a single, small-volume subcutaneous
administration of APF530.
Conference Call
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Management will be hosting an investment community conference
call beginning at 12:00 noon Eastern Time/9:00 a.m. Pacific Time
today to discuss this announcement as well as 2004 second quarter
financial results and to answer questions.
To participate in the live call by telephone, please dial (888)
803-8275 from the U.S., or (706) 634-1287 from outside the U.S.
A telephone replay will be available for 48 hours by dialing
(800) 642-1687 from the U.S., or (706) 645-9291 from outside the
U.S., and entering reservation number 9289034.
Individuals interested in listening to the conference call via
the Internet may do so by visiting www.appharma.com. A replay
will be available on the Company's web site for 30 days.
Please note: In light of today's conference call A.P. Pharma will
not be holding its previously scheduled conference call to
discuss 2004 second quarter results. That call was to be held
Monday, August 16 at 11:00 a.m. Eastern Time/8:00 a.m. Pacific
Time.
About A.P. Pharma
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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 pain
management, anti-nausea, inflammation, oncology and ophthalmology
applications. The Company's product development programs are
funded by the sale of common stock, royalties from topical
products currently marketed by pharmaceutical partners, proceeds
from the divestitures of its cosmeceutical and analytical
standards product lines and by fees it receives from
collaborative partners. For further information visit the
Company's web site at www.appharma.com.
Forward-looking Statements
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Except for historical information, this news release contains
certain forward-looking statements that involve risks and
uncertainties including, among others, uncertainty associated
with timely development, approval, launch and acceptance of new
products, establishment of new corporate alliances and progress
in research and development programs. Other risks and
uncertainties associated with the Company's business and
prospects are identified in the Company's filings with the
Securities and Exchange Commission. The Company does not
undertake to revise these forward-looking statements to reflect
events or circumstances occurring in the future.
Investor Relations Contacts: Company Contact:
Lippert/Heilshorn & Associates Gordon Sangster
Zachary Bryant (zbryant@lhai.com) Chief Financial Officer
Jody Cain (jcain@lhai.com (650) 366-2626
Bruce Voss (bvoss@lhai.com)
(310) 691-7100