‒ First program moving into development is a long-acting
anesthetic for post-surgical pain ‒
‒ Planned post marketing study for Sustol with goal of label
expansion in delayed onset CINV in patients receiving HEC regimens ‒
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Nov. 12, 2013--
A.P.
Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company,
today reported it has initiated a program to expand its pipeline of
sustained release products, including a new program targeting the relief
of post-surgical pain. The company also announced it will pursue a
post-approval expansion of its leading drug program for the treatment of
chemotherapy-induced nausea and vomiting (CINV) with the goal of
demonstrating the utility of its lead agent, Sustol™(formerly known as
APF530) in the treatment of delayed onset CINV in patients receiving
highly emetogenic chemotherapy (HEC) agents. Currently there is no
approved 5-HT3 receptor antagonist for the treatment of delayed HEC.
“AP Pharma continues to make significant progress toward resubmission of
the NDA for Sustol targeted for the end of the first quarter 2014,” said
Dr. Barry Quart, CEO of A.P. Pharma. “Our plan to initiate a new
clinical trial to further expand the potential label is an indicator of
our high level of confidence in this product and is part of a broader
plan to build a CINV franchise. With the anticipated FDA approval of our
lead product, it will be much more efficient to develop and register
other drugs utilizing the same proprietary, Biochronomer™,
sustained-release technology. We are very excited to move our most
advanced program for post-surgical pain relief into full-scale
development. This product candidate has the potential to significantly
reduce the need for opiates post-surgery and reduce the length of
hospital stay post-surgery.”
Post-surgical Pain Program
A.P. Pharma’s pain relief program utilizes the company’s polymer-based
Biochronomer drug delivery platform to continuously release anesthetic
agents directly at the source of pain over a period of several days. The
company is targeting a prolonged period of anesthetic release such that
therapeutic concentrations of active drug are achieved rapidly and
maintained for at least 72 hours. The potential benefit of A.P. Pharma’s
prolonged release profile is to achieve rapid pain relief, maintaining
higher levels of active drug at the site of the pain over time to
potentially provide greater relief from pain, and to maintain pain
relief for up to 5 days following surgery. The current market leader,
Exparel®, reduced mean pain intensity only during the first 24 hours
following study drug administration; between 24 and 72 hours after study
drug administration, there was minimal to no difference between EXPAREL
and placebo treatments.
In animal models, the company has demonstrated continuous release of the
pain-relieving agent bupivacaine for more than seven days and release of
the agent ropivacaine for greater than five days. Bupivacaine and
ropivacaine are well established anesthetic agents that provide short
term pain relief. Based on the superior profile of ropivacaine, the
company is focusing its development efforts on this anesthetic agent.
A.P. Pharma expects to move its pain program into human clinical trials
in 2014. The Company will pursue approval utilizing the Food and Drug
Administration’s 505(b)(2) approval process, which provides for much
faster and less costly development than traditional drug approval. In
2012 approximately 24.8 million procedures were performed that were
associated with post-operative pain.
Expansion of CINV Opportunity
A.P. Pharma is currently pursuing the approval of Sustol for the
treatment of acute and delayed CINV in patients administered moderately
emetogenic chemotherapy (MEC) agents and for the treatment of acute CINV
in HEC. Currently, there is no long-acting 5-HT3 receptor antagonist
approved for the treatment of delayed HEC. However, published results of
large clinical trials shows that approximately 35 percent of patients
receiving HEC agents experience breakthrough CINV in the delayed phase
with the currently available standard three-drug regimen, leaving a
significant unmet medical need for better therapy.
With the goal of addressing this significant unmet medical need and to
further differentiate Sustol from all other 5-HT3 antagonists, A.P.
Pharma plans to initiate a clinical study in 2014 designed to establish
the utility of Sustol in the treatment of delayed onset CINV in patients
receiving HEC regimens. The randomized two-arm study will compare
approximately 500 HEC administered patients receiving Sustol plus the
NK-1 inhibitor fosaprepitant to a similar number of HEC administered
patients receiving ondansetron plus fosaprepitant. The company expects
this study to complete following the resubmission and resulting PDUFA
date for Sustol. If the study is successful, the company will seek to
expand the Sustol label (if approved) to incorporate delayed HEC
treatment on a post-approval basis.
In another example of the utility of the company’s Biochronomer
platform, the company has demonstrated in animal models the simultaneous
and prolonged release of three drugs commonly administered individually
for the treatment of CINV. In this study, the company combined
granisetron, dexamethasone and an NK-1 inhibitor to achieve desired
pharmacokinetic levels of these drugs over a period of five days. The
company is evaluating this three-drug combination as a potential
lifecycle extension to its lead program for the treatment of CINV.
About Sustol (formerly known as APF530)
A.P. Pharma's lead product candidate, Sustol, is being developed for the
prevention of both acute- and delayed-onset chemotherapy-induced nausea
and vomiting (CINV). One of the most debilitating side effects of cancer
chemotherapy, CINV is a leading cause of premature discontinuation of
treatment. There is only one injectable 5-HT3 antagonist approved for
the prevention of delayed-onset CINV in patients receiving MEC; none are
approved for delayed-onset CINV in patients receiving HEC. Sustol
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. Currently available intravenous and oral formulations of
granisetron are approved only for the prevention of acute-onset CINV.
Granisetron was selected for Sustol because it is widely prescribed by
physicians based on a well-established record of safety and efficacy.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products
using its proprietary Biochronomer™ polymer-based drug delivery
platform. This drug delivery platform is designed to improve the
therapeutic profile of injectable pharmaceuticals by converting them
from products that must be injected once or twice per day to products
that need to be injected only once every one or two weeks. The Company's
lead product, Sustol, is being developed for the prevention of both
acute- and delayed-onset chemotherapy-induced nausea and vomiting. 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 the potential approval of APF530 and the
potential timing for such approval, if approved at all, as well as risks
relating to qualifying for listing on the NASDAQ Capital Market, capital
resources and liquidity, satisfactory completion of clinical studies,
progress in research and development programs, launch and acceptance of
new products 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.
Investor Relations Contact:
for A.P. Pharma, Inc.
Michael
Rice, 646-597-6979
mrice@lifesciadvisors.com
and
Corporate
Contact:
A.P. Pharma, Inc.
Stephen R. Davis, 650-366-2626
Executive
Vice President and Chief Operating Officer
