Heron Therapeutics Discloses New Proprietary Intravenous Formulation of NK-1 Receptor Antagonist for Prevention of CINV
11/06/2014
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Heron Therapeutics’ new investigational product candidate HTX-019 is a
proprietary intravenous (IV) formulation of aprepitant, an NK1
receptor antagonist. The HTX-019 formulation is distinguishable from the
only IV NK1 receptor antagonist presently approved for the
prevention of CINV in the U.S. in that it does not contain polysorbate
80, which may cause hypersensitivity reactions in some patients.
Registration of HTX-019 is expected to use the 505(b)(2) regulatory
approval pathway for new drug applications filed with the
“The addition of a differentiated IV administrable NK1
receptor antagonist to our growing CINV franchise will help us to build
a potentially dominant position in this segment of the oncology
supportive care market, which is estimated to be greater than
Dr. Quart continued, “In addition, we are close to completing our ongoing Phase 3 clinical study of SUSTOL in combination with EMEND®, designed to expand the potential indications for SUSTOL to include the treatment of delayed-onset CINV after HEC. No presently approved 5-HT3 antagonist is indicated for delayed-onset CINV in HEC. We anticipate completing enrollment in first quarter of 2015, with the resubmission of the new drug application (NDA) for SUSTOL quickly thereafter.”
About HTX-019
HTX-019 is a proprietary intravenous formulation of aprepitant, an NK1 receptor antagonist. HTX-019 does not contain polysorbate 80, which may cause hypersensitivity reactions in some patients. At present, there is only one intravenous NK1 receptor antagonist approved in the U.S. for the prevention of CINV. NK1 receptor antagonists are always used in combination with a 5-HT3 receptor antagonist for the prevention of CINV.
About SUSTOL®
Heron's lead investigational product candidate, SUSTOL® (granisetron injection, extended release), 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 receptor 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 receptor antagonist granisetron formulated in the Company's proprietary Biochronomer® polymer-based drug delivery platform, which has been shown in clinical studies to maintain therapeutic drug levels of SUSTOL for up to 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
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially.
These risks and uncertainties include those associated with the timing
of completion of the HEC study, and the results thereof, and the NDA
resubmission for SUSTOL, potential regulatory approval of SUSTOL and the
timing for such approval, if approved at all; risks relating to progress
in research and development of HTX-019, HTX-011 and our other product
candidate programs, including the timing of planned toxicology and
clinical studies; the risk that safety and efficacy data from our
clinical studies may not warrant further development of our product
candidates, risks related to the launch and acceptance of new products
generally; risks related to our financial position and our ability to
raise additional capital to fund operations if necessary or to pursue
additional business opportunities; risks related to strategic business
alliances we may pursue or the potential acquisition of other products
or technologies and other risks and uncertainties identified in the
Company's filings with the
Source:
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
jcapuzelo@herontx.com
or
Corporate
Contact:
Barry D. Quart, 650-366-2626
Pharm.D., Chief
Executive Officer