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Heron Therapeutics Highlights Progress in Pain Management and CINV Franchises - Acceptance of HTX-011 NDA for Postoperative Pain Management with Priority Review Designation; PDUFA Date of

Key Takeaway: Heron Therapeutics Highlights Progress in Pain Management and CINV Franchises - Acceptance of HTX-011 NDA for Postoperative Pain Management with Priority Review Designation; PDUFA Date of April 30, 2019 - - 90% of Patients Treated with HTX-011 Opioid-Free 72 Hours Post-Surger

Full Press Release Details

Heron Therapeutics Highlights Progress in Pain Management and CINV Franchises
- Acceptance of HTX-011 NDA for Postoperative Pain Management with Priority Review Designation;
PDUFA Date of April 30, 2019 -
- 90% of Patients Treated with HTX-011 Opioid-Free 72
Hours Post-Surgery in New Multi-center Clinical Study -
- Formal Development Initiated on
HTX-034, Our Next-Generation Product for Postoperative Pain Management, Following Positive Preclinical Results -
- Fourth-Quarter 2018 Net Sales for CINV Franchise of Approximately $28.1 Million, Up 180% Year-over-Year and Up 42% from the Third-Quarter
- Full-Year 2018 Net Sales for CINV Franchise of Approximately $76.7 Million, versus Guidance of $70 Million to $72
- Full-Year 2019 Net Sales Guidance for CINV Franchise of $115 Million to $120 Million -
SAN DIEGO, Calif. (PR NEWSWIRE) January 7, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on
improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today highlighted progress in its pain
management and chemotherapy-induced nausea and vomiting (CINV) franchises.
Recent Corporate Progress
Pain Management Franchise
2018 was a year of significant progress for Heron. On the commercial front, we are very
pleased with the strong sales performance of our CINV franchise. On the development front, HTX-011 has now been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse
surgical models, including studies that resulted in significantly more patients receiving HTX-011 who were opioid-free through 72 hours after surgery, said Barry D. Quart, Pharm.D., Chief Executive
Officer of Heron. In 2019, we look forward to working with the FDA to bring an important non-opioid pain management option to patients. We believe that HTX-011, if
approved, could have a considerable impact on the opioid epidemic by significantly reducing the proportion of patients who experience severe pain and receive opioids after surgery.
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 management 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. HTX-011 has been shown to reduce pain significantly better than placebo or
bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA
in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review
designation in December of 2018. The FDA set a PDUFA goal date of April 30, 2019.
About CINVANTI (aprepitant) injectable emulsion
CINVANTI, in combination with other antiemetic agents, is indicated in adults 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 nausea and vomiting in both the acute phase (0 24 hours after chemotherapy) and the delayed phase (24 120 hours after
chemotherapy). CINVANTI is the only IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and
vomiting associated with MEC that is free of 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 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 Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to 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 pain or cancer.
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 full-year 2019 net sales guidance for the CINV franchise; whether the FDA approves the HTX-011 NDA as submitted; the timing of the FDA s review process for HTX-011; whether the FDA will require an advisory committee meeting for HTX-011 in the future; the anticipated commercial launch of
HTX-011; the timing and results of the studies in the HTX-034 development program; and other risks and uncertainties identified in the Company s filings with the
U.S. 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.
Investor Relations and Media Contact:
Senior VP, General Counsel, Business Development and Corporate Secretary
Last updated: Jan 7, 2019