Heron Therapeutics Highlights Progress in CINV and Pain Management Franchises
01/08/2018
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- SUSTOL® Fourth-Quarter 2017 Net Sales of
Approximately
- 2018 Net Sales Guidance for CINV Franchise of
- Enrollment Complete in Both Pivotal Phase 3 Studies for HTX-011; Top-line Results Expected in First Half of 2018 -
CINV Franchise
- SUSTOL® Sales. SUSTOL
(granisetron) extended-release injection fourth-quarter 2017 net
product sales were approximately
$10 million , up 16% from third-quarter 2017 net product sales of$8.6 million . SUSTOL full-year 2017 net product sales were approximately$31 million , versus guidance of$25 million to $30 million . - 2018 CINV Sales Guidance. Net product sales guidance for
full-year 2018 for the CINV franchise is
$60 million to $70 million . - Permanent J-Code Now Effective. On
January 1, 2018 ,a product-specific billing code, or permanent J-code, for SUSTOL became available. The new J-code was assigned by theCenters for Medicare and Medicaid Services (CMS) and will help simplify the billing and reimbursement process for prescribers of SUSTOL. - CINVANTI™ Now Available. In
November 2017 , theU.S. Food and Drug Administration (FDA ) approved the Company’s New Drug Application (NDA) for CINVANTI (aprepitant) injectable emulsion, the first and only polysorbate 80-free intravenous (IV) formulation of a neurokinin-1 (NK1) receptor antagonist indicated for the prevention of acute and delayed CINV. CINVANTI became commercially available inthe United States onJanuary 4, 2018 .
Pain Management Franchise
Enrollment Complete in Phase 3 Pivotal Trials for HTX-011 in
Postoperative Pain. Heron completed enrollment in its two pivotal
Phase 3 efficacy studies in bunionectomy and hernia repair. Heron
anticipates reporting top-line results in the first half of 2018 and
expects to file an NDA with the
“Heron had a strong year in 2017, led by the advancement of the HTX-011 program toward an NDA filing, the success of our commercial team with SUSTOL and the expansion of our CINV franchise with the approval of CINVANTI,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We expect to build on our momentum in 2018 by reporting top-line pivotal Phase 3 results for HTX-011, filing an NDA for HTX-011 and growing our CINV franchise, which now includes two innovative products.”
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer®
drug delivery technology, is an investigational, long-acting,
extended-release formulation of the local anesthetic bupivacaine in a
fixed-dose combination with the anti-inflammatory meloxicam for the
prevention of postoperative pain. By delivering sustained levels of both
a potent anesthetic and a local anti-inflammatory agent directly to the
site of tissue injury, HTX-011 was designed to deliver superior pain
relief while reducing the need for systemically administered pain
medications such as opioids, which carry the risk of harmful side
effects, abuse and addiction. The Phase 2 development program for
HTX-011 was designed to target the many patients undergoing a wide range
of surgeries who experience significant postoperative pain. Heron
completed enrollment in its two pivotal Phase 3 efficacy studies in
bunionectomy and hernia repair and anticipates reporting top-line
results in the first half of 2018 and expects to file an NDA with the
About CINVANTI (aprepitant) injectable emulsion
CINVANTI is indicated in adults, in combination with other antiemetic
agents, for the prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses of highly emetogenic cancer
chemotherapy (HEC), including high-dose cisplatin and nausea and
vomiting associated with initial and repeat courses of moderately
emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous
formulation of aprepitant, a substance P/neurokinin-1 (NK1)
receptor antagonist. CINVANTI is the first intravenous (IV) formulation
to directly deliver aprepitant, the active ingredient in EMEND®
capsules. Aprepitant (including its prodrug, fosaprepitant) is the only
single-agent NK1 receptor antagonist to significantly reduce
CINV in both the acute phase (0 – 24 hours after chemotherapy) and the
delayed phase (24 – 120 hours after chemotherapy). CINVANTI does not
contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical
formulations containing polysorbate 80 have been linked to
hypersensitivity reactions, including anaphylaxis and irritation of
blood vessels resulting in infusion-site pain.
Please see Full Prescribing Information at www.CINVANTI.com.
About SUSTOL (granisetron) extended-release injection
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer® polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).
Please see Full Prescribing Information at www.SUSTOL.com.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
While chemotherapy is one of the most effective and commonly used
therapies to help patients fight cancer, it is accompanied by
debilitating side effects, including varying degrees of nausea and
vomiting, often attributed as a leading cause of premature
discontinuation of cancer treatment. The goal of antiemetic therapy is
to prevent CINV in both the acute phase (0 – 24 hours after
chemotherapy) and delayed phase (24 – 120 hours after chemotherapy). The
National Comprehensive Cancer Network (NCCN) and the
About
Heron is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments that address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain. 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, including, but not limited to, those
associated with: the potential market opportunities for SUSTOL and
CINVANTI; the timing of completion and results of the Phase 3 studies
for HTX-011; the timing of the NDA filing for HTX-011; and other risks
and uncertainties identified in the Company's filings with the
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Source:
Investor Relations and Media Contact:
Heron Therapeutics,
Inc.
David L. Szekeres, 858-251-4447
Senior VP, General
Counsel, Business Development and Corporate Secretary
dszekeres@herontx.com