SAN DIEGO, Jan. 13, 2020 /PRNewswire/ -- 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
- 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 FDA set 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's Priority Review status provides an accelerated 6-month review target for the NDS. A decision by Health Canada is 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 million for CINVANTI® (aprepitant) injectable emulsion and approximately $0.4 million for 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 million and up 88% year-over-year. This included net product sales of approximately $132.0 million for CINVANTI and approximately $13.7 million for SUSTOL.
- December 31, 2019 Cash, Cash Equivalents and Short-Term Investments: As of December 31, 2019, Heron had approximately $391.0 million in 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 $391.0 million, which will support the anticipated launch of HTX-011 in the second quarter of 2020, pending FDA approval."