-SUSTOL has potential to be the first 5-HT3
antagonist approved for delayed nausea and vomiting associated with
highly emetogenic chemotherapy
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jul. 20, 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 it has
resubmitted its New Drug Application (NDA) for SUSTOL®
(granisetron) Injection, extended release, for the prevention of acute
and delayed chemotherapy-induced nausea and vomiting (CINV) associated
with moderately emetogenic chemotherapy (MEC) or highly emetogenic
chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration
(FDA). Heron expects confirmation of acceptance from the FDA and a
Prescription Drug User Fee Act (PDUFA) goal date within the next few
weeks. The Company anticipates a six-month review by the FDA.
The NDA filing includes data from the MAGIC study, Heron’s recently
completed, multi-center, placebo-controlled, Phase 3 study in patients
receiving HEC agents. 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
IV/oral corticosteroid dexamethasone for the prevention of delayed
nausea and vomiting in patients receiving HEC. 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 study
to-date to use the currently recommended, standard-of-care, three-drug
regimen for CINV prophylaxis in a HEC population as the comparator: a
5-HT3 receptor antagonist, fosaprepitant and dexamethasone.
The MAGIC study’s primary endpoint was achieved. Specifically, the
percentage of patients who achieved a Complete Response was
significantly higher in the SUSTOL arm compared with the comparator arm
(p=0.014). Significant benefit was also observed in the reduction in
episodes of nausea, which has the greatest impact on patient quality of
life. Data from a previous Phase 3 study of more than 1,300 patients,
which was previously submitted to the FDA, demonstrated SUSTOL’s
efficacy in the prevention of acute and delayed CINV associated with MEC
regimens and acute CINV associated with HEC regimens.
“The rapid resubmission of the NDA for SUSTOL, the first and only 5-HT3
receptor antagonist with extended-release technology and 5-day CINV
prevention in both MEC and HEC, is a major milestone for Heron
Therapeutics,” commented Barry D. Quart, Pharm.D., Chief Executive
Officer of Heron. “We look forward to working closely with the FDA
during the SUSTOL NDA review period, as we believe SUSTOL has the
potential to improve the lives of patients suffering from CINV by
significantly reducing both nausea and vomiting associated with MEC or
HEC regimens.”
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 IV/oral 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). Heron resubmitted its New Drug Application
(NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA) in July
2015. 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 and pain. SUSTOL® is Heron’s
injectable, extended-release formulation of granisetron that 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 and resubmitted its New Drug Application
(NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA) in July
2015. 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 in a
Phase 2 trial for the prevention of post-operative pain. Heron expects
to report results from this trial 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: the acceptance of the
Company’s resubmission of its New Drug Application (NDA) for SUSTOL®,
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/20150720005349/en/
Source: Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
jcapuzelo@herontx.com
Corporate
Contact:
Barry D. Quart, 650-366-2626
Pharm D., Chief
Executive Officer