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Heron Therapeutics Highlights Progress in CINV and Pain Management Franchises - SUSTOL Fourth-Quarter 2017 Net Sales of Approximately $10 Million, Up 16% from Third-Quarter 2017 Net Sales of $8.6 Million; Full-Year 2017

Key Takeaway: Heron Therapeutics Highlights Progress in CINV and Pain Management Franchises - SUSTOL Fourth-Quarter 2017 Net Sales of Approximately $10 Million, Up 16% from Third-Quarter 2017 Net Sales of $8.6 Million; Full-Year 2017 Net Sales of Approximately $31 Million, versus Guidance of

Full Press Release Details

Heron Therapeutics Highlights Progress in CINV and Pain Management Franchises
- SUSTOL Fourth-Quarter 2017 Net Sales of Approximately $10 Million, Up 16% from
Third-Quarter 2017 Net Sales of $8.6 Million; Full-Year 2017 Net Sales of Approximately $31 Million, versus Guidance of $25 Million to $30 Million -
- 2018 Net Sales Guidance for CINV Franchise of $60 Million to $70 Million
- Enrollment Complete in Both Pivotal Phase 3 Studies for HTX-011;
Top-line Results Expected in First Half of 2018 -
SAN DIEGO, Calif. (BUSINESS WIRE) January 8, 2018
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the
most important unmet patient needs, today highlighted progress in the Company s pain management and CINV franchises.
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 FDA in the second half of 2018.
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 FDA in the second half of 2018.
(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. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.
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).
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 American Society of Clinical Oncology (ASCO) have categorized chemotherapy regimens based on the degree to which they cause nausea and
vomiting: low emetogenic chemotherapy (LEC); moderately emetogenic chemotherapy (MEC); and highly emetogenic chemotherapy (HEC).
About Heron Therapeutics, Inc.
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 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.
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Last updated: Jan 8, 2018