Therapeutics, Inc. (NASDAQ: HRTX), a specialty pharmaceutical
company, today announced an approximate one-quarter delay to the
Company's timeline for the resubmission of the new drug application
(NDA) for Sustol® to the U.S. Food and Drug Administration (FDA), the
Company's product candidate for chemotherapy-induced nausea and vomiting
The Company received notice last week from the supplier of the syringes
used for Sustol injections that the production order of syringes
manufactured for Heron, and scheduled to be used in the validation of
the commercial manufacturing process for Sustol required for
resubmission of the NDA, will be delayed due to equipment failure of an
in-process quality control check. The equipment failure is not specific
to Sustol or Heron, and remedial efforts are underway.
"The manufacturer of our syringe is a well-established global
manufacturer of medical products and we are confident that the issue
they have identified can and will be rectified within a quarter," said
Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics.
"Although this delay is extremely frustrating for us, we are looking at
every possible alternative to accelerate the timing of resubmission. We
expect the delay in delivery of final syringes, which were planned for
use in our commercial validation of Sustol and the impact on associated
activities to result in an approximate one quarter delay in resubmission
of the NDA for Sustol, which we had previously targeted for end of the
first quarter of 2014."
"While the timing of our resubmission will be impacted by this delay, we
expect it to have minimal impact on our projected timing of the launch
of Sustol," continued Dr. Quart. "Subject to the FDA's review and
approval of the Sustol NDA, we project being in a position to launch
Sustol in early 2015, which presentsmore optimal timing than
potentially launching into the late 2014 holiday season."
Clinical trial supplies of Sustol were produced prior to the delay in
syringe manufacturing; therefore, the Company remains on track to
commence and complete in 2014 a study of Sustol in the treatment of
delayed onset CINV in patients receiving highly emetogenic chemotherapy
(HEC) agents. Currently, there is no 5-HT3 receptor antagonist approved
for the treatment of delayed HEC.
About Heron Therapeutics
Heron Therapeutics (formerly A.P. Pharma, Inc.) 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 (formerly
known as APF530), is being developed for the prevention of both acute-
and delayed-onset chemotherapy-induced nausea and vomiting.
In addition to Sustol, Heron is also utilizing its proprietary,
Biochronomer™, sustained-release technology to develop other drugs
designed to extend the duration of action of known active ingredients to
address important unmet medical needs. In November 2013, the Company
announced movement into full development of the first of these new drug
programs - the Biochronomer extended release of an established local
anesthetic for the treatment of post-surgical pain. In recently
completed post-surgical animal models of pain, the Company's drug
candidates demonstrated statistically significant pain relief for five
days, representing the potential to significantly reduce the need for
opiates post-surgery and the length of post-surgical hospital stays.
Heron expects to move its pain program into human clinical studies in
For further information, please visit the Company's web site at www.herontx.com.
Heron'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 moderately
emetogenic chemotherapy (MEC); none are approved for delayed-onset CINV
in patients receiving highly emetogenic chemotherapy (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.
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 Sustol (formerly
APF530) and the potential timing for such approval, if approved at all,
as well as risks and benefits relating to listing on the NASDAQ Capital
Market, 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.
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