Heron Therapeutics Highlights Progress in Acute Care and Oncology Care Franchises
01/09/2023
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- Preliminary Annual Net Product Sales Across the Company Grew 24% to
- Preliminary Fourth-Quarter 2022 Net Product Sales for ZYNRELEF® Increased 40% to Approximately $3.8 Million -
- Preliminary Full-Year 2022 Net Product Sales for Oncology Care Franchise of Approximately
- Full-Year 2023 Net Product Sales Guidance for Oncology Care Franchise of
Recent Corporate Progress
Acute Care Franchise
- Fourth-Quarter 2022 Net Product Sales: Preliminary fourth-quarter 2022 net product sales for ZYNRELEF were approximately
$3.8 million , a 40% increase compared to$2.7 million for the third quarter of 2022. - Full-Year 2022 Net Product Sales: Preliminary full-year 2022 net product sales for ZYNRELEF were approximately
$10.1 million . - Fourth-Quarter 2022 Demand Unit Sales: ZYNRELEF demand unit sales were 20,765 in the fourth quarter, a 38% increase compared to 15,077 units for the third quarter of 2022.
- Supplemental New Drug Application Submitted for ZYNRELEF: The supplemental New Drug Application (sNDA) for ZYNRELEF, to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures, was submitted in
December 2022 to theU.S. Food and Drug Administration (FDA). The anticipated action date is 10 months after submission of this sNDA. - Approval of Heron's Fourth Drug, APONVIE, in
September 2022 : APONVIE is the first and only IV formulation of aprepitant approved for postoperative nausea and vomiting (PONV). This ready-to-use, easy to administer, innovative IV formulation ensures rapid and consistent exposure of aprepitant, a molecule that has been found to be the most effective agent for prevention of vomiting in patients undergoing surgery. APONVIE will be commercialized by the acute care franchise starting this quarter. - NOPAIN Act Approval Provides Three Years of CMS Reimbursement Outside the Surgical Bundled Payment Beginning
January 2025 : ZYNRELEF currently has pass-through status in the outpatient setting of care throughMarch 31, 2025 and this provision of H.R. 2617 should extend separate reimbursement for ZYNRELEF outside of the packaged surgical payment throughDecember 31, 2027 .
Oncology Care Franchise
- Fourth-Quarter 2022 Net Product Sales: Preliminary fourth-quarter 2022 net product sales for the oncology care franchise were approximately
$25.3 million . This included net product sales of approximately$22.3 million for CINVANTI® (aprepitant) injectable emulsion and approximately$3.0 million for SUSTOL® (granisetron) extended-release injection, compared to$17.3 million and$2.5 million , respectively, for the same periods in 2021. - Full-Year 2022 Net Product Sales: Preliminary full-year 2022 net product sales for the oncology care franchise were approximately
$96.6 million versus guidance of$93 million to$95 million . This included net product sales of approximately$86.4 million for CINVANTI and approximately$10.2 million for SUSTOL, compared to$73.5 million and$9.9 million , respectively, for the same periods in 2021. - Full-Year 2023 Net Product Sales Guidance: Heron expects full-year 2023 net product sales for the oncology care franchise of
$99 million to$103 million .
Corporate Update
- Annual Net Product Sales: Annual net product sales across the Company grew by approximately 24% in 2022 compared to annual net product sales in 2021, based on preliminary fourth-quarter 2022 results.
"We have made important advances in 2022 in both our acute care and oncology care franchises, highlighted by the submission to the FDA of the sNDA for ZYNRELEF to significantly expand ZYNRELEF's indication for use in soft tissue and orthopedic procedures, 40% growth in net product sales of ZYNRELEF in the fourth quarter compared to third quarter, approval of APONVIE in the
About ZYNRELEF for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
About APONVIE for PONV
APONVIE (aprepitant) injectable emulsion is a substance NK1 RA, indicated for the prevention of postoperative nausea and vomiting in adults. Delivered via a 30-second intravenous (IV) injection, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in
Please see full prescribing information at www.APONVIE.com.
About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention
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 as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. 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 U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.
Please see full prescribing information at www.CINVANTI.com.
About SUSTOL for CINV Prevention
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-hydroxytryptamine type 3 RA 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
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: adjustments to the preliminary fourth-quarter 2022 and full-year 2022 net product sales for the acute care and oncology care franchises in connection with completion of financial closing procedures and an audit for the 2022 fiscal year; risks associated with the full-year 2023 net product sales guidance for the oncology care franchise; the timing of the
Investor Relations and Media Contact:
Executive Vice President, Chief Operating Officer
dszekeres@herontx.com
858-251-4447
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