A.P. Pharma Announces the Allowance of Three Patents Covering APF530
– APF530 patent protection extended through 2024 –
REDWOOD CITY, Calif. -- July 10, 2012
A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company,
announced today that the United States Patent and Trademark Office (USPTO) has
allowed three new patents covering the Company’s lead product candidate,
APF530, which is being developed for the prevention of both acute- and
delayed-onset chemotherapy-induced nausea and vomiting (CINV). The newly
allowed patents, when issued, will extend the patent life around APF530
“The newly allowed patents are instrumental in bolstering APF530’s overall
patent life and will extend the intellectual property protection surrounding
the product through 2024,” said John B. Whelan, A.P. Pharma’s president and
chief executive officer. “A.P. Pharma continues to make advancements related
to APF530 beyond clinical and regulatory development, and the allowance of
these patents provides added strength to the APF530 patent estate and will
help support the product’s longevity.”
*U.S. Patent application number 13/279,949, entitled “Process for Preparing
a Semi-Solid Delivery Vehicle Comprising Granisetron,” relates to methods
for preparing extended release formulations of granisetron.
*U.S. Patent application number 13/279,938, entitled “Methods of Treating
Emesis Utilizing Semi-Solid Pharmaceutical Compositions Comprising
Granisetron,” relates to methods for the treatment of emesis using
extended release formulations of granisetron.
*U.S. Patent application number 12/564,881, entitled “Semi-Solid Delivery
Vehicle and Pharmaceutical Compositions for Delivery of Granisetron,”
relates to compositions for extended delivery of granisetron.
Additional information regarding these patent applications can be found on the
USPTO website. APF530 is already covered by multiple issued patents on the
polymer technology and formulations that extend into 2021.
A.P. Pharma's lead product, APF530, is in development for the prevention of
both acute-onset 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. Intravenous and oral formulations containing
granisetron are approved for the prevention of acute-onset CINV, but not
delayed-onset CINV. Granisetron was selected 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 technology. The
Company’s primary focus is on its lead product, APF530, for the prevention of
CINV. A.P. Pharma received a Complete Response Letter on the APF530 NDA and is
targeting the resubmission of the NDA in mid-2012. The Company has additional
research and development programs that utilize its bioerodible, injectable and
implantable delivery systems. For further information, please visit the
Company's web site at www.appharma.com.
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 capital resources and liquidity, timely development and regulatory
approval of product candidates, 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.
Investor Relations Contact:
Office Phone: 646-597-6979
A.P. Pharma, Inc.
John B. Whelan, President and Chief Executive Officer
Office Phone: 650-366-2626
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