REDWOOD CITY, Calif.--(BUSINESS WIRE)--Sep. 28, 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
the recently completed Phase 3 MAGIC study of SUSTOL®
(granisetron) Injection, extended release, were presented by Ian
Schnadig, M.D., Principal Investigator for the MAGIC trial, US Oncology
Research, Compass Oncology, at the American Society of Clinical Oncology
(ASCO) 2015 Breast Cancer Symposium in San Francisco, CA. These data
were presented in an oral presentation and poster 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.” SUSTOL is Heron’s lead product
candidate for the prevention of chemotherapy-induced nausea and vomiting
(CINV) associated with moderately emetogenic chemotherapy (MEC) or
highly emetogenic chemotherapy (HEC). SUSTOL has not been approved by
the U.S. Food and Drug Administration (FDA) or any other regulatory
authority. Heron Therapeutics resubmitted its New Drug Application (NDA)
for SUSTOL with the FDA in July 2015.
Highlights include:
-
The MAGIC trial represents the first registrational Phase 3 efficacy
trial in patients receiving HEC using a consensus
guideline–recommended three-drug regimen in both arms.
-
For the primary endpoint, the proportion of patients with
delayed-phase complete response (CR) was significantly greater with
the SUSTOL (64.7%) versus ondansetron regimen (56.6%), an absolute
treatment difference of 8.0% (95% CI 1.7-14.4; p = 0.014), equating to
a relative 14.2% CR rate improvement.
-
Within the cisplatin stratum (≥50 mg/m2), delayed-phase CR
was greater with the SUSTOL (65.3%) versus ondansetron regimen
(54.7%), an absolute treatment difference of 10.6% (95% CI -1.4-22.7),
equating to a relative 19.4% CR rate improvement.
-
A significantly greater proportion of patients did not require rescue
medication in the delayed phase with the SUSTOLversus
ondansetron regimen (p = 0.013).
-
Patient-reported satisfaction with nausea and vomiting control was
significantly greater with the SUSTOLversus ondansetron
regimen in the delayed phase (p = 0.040).
-
Rates of no nausea were numerically higher in the SUSTOLversus
ondansetron regimen in the delayed and overall phases and a post hoc
analysis indicated SUSTOLwas associated with significantly
less frequent nausea in the delayed (p = 0.032) and overall
phases (p = 0.048).
-
SUSTOL was generally well tolerated with no new safety signals
identified.
“The prevention of nausea and vomiting associated with highly emetogenic
chemotherapy remains a significant unmet medical need for patients
battling cancer,” stated Dr. Ian Schnadig, M.D., Principal Investigator,
US Oncology Research, Compass Oncology, “SUSTOL, as part of a three-drug
anti-emetic regimen, is the first and only 5-HT3 antagonist
to demonstrate superiority over current standard-of-care for preventing
delayed CINV following HEC. I am encouraged by the results of the MAGIC
trial and feel that SUSTOL represents a potentially best-in-class agent
for the prevention of CINV.”
“We believe that SUSTOL, due to its novel extended-release formulation,
has the potential to be the new standard in the prevention of both acute
and delayed nausea and vomiting in patients undergoing cancer
chemotherapy,” commented Barry D. Quart, Pharm.D., Chief Executive
Officer of Heron Therapeutics. “The data presented at the ASCO Breast
Cancer Symposium further demonstrate the potential utility of SUSTOL.
With a PDUFA goal date of January 17, 2016 assigned from the U.S. Food
and Drug Administration following the resubmission of our New Drug
Application (NDA), we are looking ahead to the potential approval and
commercial launch of this very important medication.”
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 has not been 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 is Heron’s long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam. In September 2015, Heron reported positive
top-line results from a Phase 2 study of HTX-011 in patients undergoing
bunionectomy. Heron is also reviewing other potential indications for
the HTX-011 pain management development program. HTX-011 is currently
being evaluated in a Phase 2 clinical trial in patients undergoing
inguinal hernia repair. Heron expects to report results 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/20150928005483/en/
Source: Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
Associate Director, Investor Relations
jcapuzelo@herontx.com
or
Corporate
Contact:
Barry D. Quart, Pharm D., 650-366-2626
Chief
Executive Officer
