REDWOOD CITY, Calif.--(BUSINESS WIRE)--Sep. 22, 2015--
Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused
on improving the lives of patients by developing best-in-class medicines
that address major unmet medical needs, today announced that data from
Heron’s recently completed MAGIC Study of SUSTOL®
(granisetron) Injection, extended release, for the prevention of
chemotherapy-induced nausea and vomiting (CINV) in patients receiving
highly emetogenic chemotherapy (HEC), will be presented at the American
Society of Clinical Oncology (ASCO) 2015 Breast Cancer Symposium on
Saturday, September 26, 2015 in San Francisco, CA.
Heron will present a poster and give an oral presentation for the
abstract titled “Phase III Study of APF530 versus Ondansetron with a
Neurokinin 1 Antagonist + Corticosteroid in Preventing Highly Emetogenic
Chemotherapy-Induced Nausea and Vomiting: MAGIC Trial.”
Presentation details are as follows:
Session Title:
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Oral Abstract Session B
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Author/Presenter:
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Ian D. Schnadig, MD, Chair, Pharmacy and Therapeutics, Compass
Oncology
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Abstract Number:
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68
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Date/Time:
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Saturday, September 26, 2015 from 1:15 PM – 2:45 PM PT
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Location:
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Yerba Buena Ballroom, Salon 9
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Session Title:
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Poster Session B
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Author/Presenter:
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Ian D. Schnadig, MD, Chair, Pharmacy and Therapeutics, Compass
Oncology
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Poster Number:
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Board #A5
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Date/Time:
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Saturday, September 26, 2015 from 11:50 AM – 1:15 PM PT and 4:45 PM
– 5:45 PM PT
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Location:
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Yerba Buena Ballroom, Salon 8
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About SUSTOL® for Chemotherapy-Induced
Nausea and Vomiting
SUSTOL® (granisetron) Injection, extended release, which
utilizes Heron’s proprietary Biochronomer® drug delivery
technology, is Heron’s novel, long-acting formulation of granisetron for
the prevention of chemotherapy-induced nausea and vomiting (CINV).
Granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3)
receptor antagonist was selected due to its broad use by physicians
based on a well-established record of safety and efficacy. SUSTOL has
been shown to maintain therapeutic drug levels of granisetron for five
days with a single subcutaneous injection. SUSTOL is being developed for
the prevention of both acute (day 1 following the administration of
chemotherapy agents) and delayed (days 2-5 following the administration
of chemotherapy agents) CINV associated with moderately emetogenic
chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). While other
5-HT3 antagonists are approved for the prevention of CINV,
SUSTOL is the first agent in the class to demonstrate efficacy in
reducing the incidence of delayed CINV in patients receiving HEC, a
major unmet medical need, in a randomized Phase 3 study.
Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the
most debilitating side effects of such treatments, often attributed as a
leading cause of premature discontinuation of cancer treatment. 5-HT3
receptor antagonists have been shown to be among the most effective and
preferred treatments for CINV. However, an unmet medical need exists for
patients suffering from CINV during the delayed phase, which occurs on
days 2-5 following the administration of chemotherapy agents. Only one
5-HT3 receptor antagonist is approved for the prevention of
delayed CINV associated with MEC, and no 5-HT3 receptor
antagonists are approved for prevention of delayed CINV associated with
HEC.
SUSTOL was the subject of a recently completed, multi-center,
placebo-controlled, Phase 3 clinical study in patients receiving HEC
regimens known as MAGIC. The MAGIC study evaluated the efficacy and
safety of SUSTOL as part of a three-drug regimen with the intravenous
(IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and
the corticosteroid dexamethasone. The MAGIC study, which was conducted
entirely in the U.S. using the 2011 ASCO guidelines for classification
of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a
HEC population performed to date to use the currently recommended,
standard-of-care, three-drug regimen as a comparator: a 5-HT3
receptor antagonist, fosaprepitant, and dexamethasone. The study's
primary endpoint was achieved. Specifically, the percentage of patients
who achieved a Complete Response in the delayed phase was significantly
higher in the SUSTOL arm compared with the comparator arm (p=0.014).
Adverse events reported in the study were generally mild to moderate in
severity and of short duration, with the most common being injection
site reactions (ISRs). In July 2015, Heron resubmitted its New Drug
Application (NDA) for SUSTOL to the U.S. Food and Drug Administration
(FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA)
goal date of January 17, 2016. SUSTOL is not approved by the FDA or any
other regulatory authority.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a biotechnology company focused on improving
the lives of patients by developing best-in-class medicines that address
major unmet medical needs. Heron is developing novel, patient-focused
solutions that apply its innovative science and technologies to
already-approved pharmacological agents. Heron’s goal is to build on
therapeutics with well-known pharmacology by improving their
tolerability and efficacy as well as broadening their potential field of
use. Heron is currently developing four pharmaceutical products for
patients suffering from cancer or pain. SUSTOL® (granisetron)
Injection, extended release is being developed for the prevention of
both acute and delayed chemotherapy-induced nausea and vomiting (CINV)
associated with moderately emetogenic chemotherapy (MEC) or highly
emetogenic chemotherapy (HEC). CINV is one of the most debilitating side
effects of chemotherapy and is a leading cause of premature
discontinuation of cancer treatment. Heron recently reported positive,
top-line results from its Phase 3 MAGIC study. In July 2015, Heron
resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food
and Drug Administration (FDA), and the FDA has assigned a Prescription
Drug User Fee Act (PDUFA) goal date of January 17, 2016. HTX-019, also
being developed for the prevention of CINV, has the potential to become
the first polysorbate 80-free, intravenous formulation of aprepitant, a
neurokinin-1 (NK1) receptor antagonist. Heron intends to file
an NDA for HTX-019 using the 505(b)(2) regulatory pathway in the second
half of 2016. HTX-011, Heron’s long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam, is currently being evaluated in two Phase 2
clinical trials for the prevention of post-operative pain. Heron expects
to report results from both of these trials in the second half of 2015.
HTX-003, a long-acting formulation of buprenorphine, is being developed
for the potential management of chronic pain and opioid addiction. All
of Heron’s product candidates utilize Heron’s innovative science and
technology platforms, including its proprietary Biochronomer®
drug delivery technology, which can deliver therapeutic levels of a wide
range of otherwise short-acting pharmacological agents over a period of
days to weeks with a single injection.
For more information, visit www.herontx.com.
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 based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially. These risks and uncertainties include, but
are not limited to, those associated with: whether the U.S. Food and
Drug Administration (FDA) approves the SUSTOL NDA as submitted or
supports as broad of a labeled indication for SUSTOL as requested, the
progress in the research and development of HTX-019, HTX-011, HTX-003
and our other programs, including the timing of preclinical, clinical,
and manufacturing activities, safety and efficacy results from our
studies that may not justify the pursuit of further development of our
product candidates, the launch and acceptance of SUSTOL and new products
generally, our financial position and our ability to raise additional
capital to fund operations, if necessary, or to pursue additional
business opportunities, strategic business alliances we may pursue or
the potential acquisition of products or technologies, and our ability
to grow our organization to sustain the commercial launch for SUSTOL,
and other risks and uncertainties identified in the Company's filings
with the Securities and Exchange Commission. Forward-looking statements
reflect our analysis only on their stated date, and Heron takes no
obligation to update or revise these statements except as may be
required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150922005534/en/
Source: Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
Associate Director, Investor Relations
jcapuzelo@herontx.com
Corporate
Contact:
Barry D. Quart, Pharm D., 650-366-2626
Chief
Executive Officer