Heron Therapeutics Highlights Progress in Pain Management and CINV Franchises
Recent Corporate Progress
Pain Management Franchise
- New Drug Application Resubmission for HTX-011: In
September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration( FDA) for HTX-011, an investigational agent for the management of postoperative pain. The FDAset a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020.
- Marketing Authorisation Application for HTX-011: In
March 2019, Heron's Marketing Authorisation Application (MAA) for HTX-011 for the management of postoperative pain was validated by the European Medicines Agency's(EMA) for review under the Centralised Procedure. An opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) is anticipated in the second quarter of 2020.
- New Drug Submission for HTX-011: In
December 2019, Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada. Health Canada'sPriority Review status provides an accelerated 6-month review target for the NDS. A decision by Health Canadais anticipated in the third quarter of 2020.
- Fourth-Quarter 2019 Net Product Sales: Preliminary fourth-quarter 2019 net product sales for the CINV franchise were approximately
$34.8 million, up 21% year-over-year. This included net product sales of approximately $34.4 millionfor CINVANTI® (aprepitant) injectable emulsion and approximately $0.4 millionfor SUSTOL® (granisetron) extended-release injection.
- Full-Year 2019 Net Product Sales: Preliminary full-year 2019 net product sales for the CINV franchise were approximately
$145.7 million, versus guidance of $135.0 millionand up 88% year-over-year. This included net product sales of approximately $132.0 millionfor CINVANTI and approximately $13.7 millionfor SUSTOL.
December 31, 2019Cash, Cash Equivalents and Short-Term Investments: As of December 31, 2019, Heron had approximately $391.0 millionin cash, cash equivalents and short-term investments.
"We have made important advances in 2019 in both our pain management and CINV franchises, highlighted by the submission of three marketing applications for HTX-011 for postoperative pain management and strong net product sales for CINVANTI, even amid the launch of generic fosaprepitant," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "We ended 2019 in a strong cash position of
About HTX-011 for Postoperative Pain
HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the
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 HEC, including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of MEC. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA 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). The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.
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.
For more information, visit www.herontx.com.
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 fourth-quarter 2019 and full-year 2019 net product sales for the CINV franchise; whether the
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