Approval
May 13, 2021
Forward-Looking Statements
This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this presentation, and involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, those associated with: risks associated with achieving the full-year 2021 net product sales guidance for the CINV franchise; the timing of the commercial launch of ZYNRELEF in the U.S.; the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunity for ZYNRELEF in the US and Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the timing and results of studies for HTX- 011, the HTX-034 development program, and the HTX-019 development program; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations; the extent of the impact of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic on our business; 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 we take no obligation to update or revise these statements except as may be required by law.
Heron Pipeline
PRECLINICAL | CLINICAL | NDA | APPROVED | |||
Oncology Care
SUSTOL®
(granisetron) extended-release injection
CINVANTI®
(aprepitant) injectable emulsion
US FDA Approved for CINV Prevention*
US FDA Approved for CINV Prevention*
Acute Care
ZYNRELEF™
(bupivacaine and meloxicam) | US FDA Approved for postsurgical analgesia for up to 72 hours* |
extended-release solution |
HTX-019 | IND active for PONV | |
(aprepitant) | NDA planned for 4Q2021 | |
BE Demonstrated to Oral Aprepitant | ||
injectable emulsion | ||
HTX-034 | Under Investigation for |
(bupivacaine/meloxicam/ | |
Postoperative Pain | |
aprepitant) | |
CINV: Chemotherapy-induced nausea and vomiting. SUSTOL® (granisetron) extended-release injection 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. CINVANTI® (aprepitant) injectable emulsion, in combination with other antiemetic agentsis 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 has not been studied for treatment of established nausea and vomiting. ZYRNELEF (bupivacaine and meloxicam) extended-release solution is indicated 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. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel
- spinal, and head and neck procedures.
HTX-034 and HTX-019 are investigational new drugs and are not approved by the FDA
Why Approval of ZYNRELEF is so Important Postoperative Opioids Can Be a Doorway to Addiction
More than 50 million
surgical procedures happen
in the United States.1
> 2 million | were linked to more than |
In 2020, drug overdoses | |
Americans | 90,000 deaths |
67% of patients | users annually after surgery. 1 | recorded in a single year.3 |
may become persistent opioid | the highest number ever | |
filled an opioid prescription between 30 days | ||
before through 14 days after surgery.2* |
In addition, most patients take fewer opioids than the amount prescribed after
surgery, resulting in excess opioid pills that are accessible to others.4
80% | Up to 77% | 51% |
of patients report | of opioid pills remain | of nonmedical users of |
unused opioid tablets4 | inside the home in | opioids received them |
unsecured locations4 | from friends and family5 |
More than
$23.4 billion
in annual healthcare costs associated
with persistent opioid users can be attributed to postoperative pain management.1,6
* This was determined using a 20% national sample of Medicare claims among beneficiaries aged 65 and older with Medicare Part D claims who underwent a major or minor surgical procedure between January 1, 2009 and June 30, 2015.
References: 1. Brummett CM, Waljee JF, Goesling J, et al. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults [published correction appears in JAMA Surg. 2019 Mar 1;154(3):272]. JAMA Surg. 2017;152(6):e170504.
doi:10.1001/jamasurg.2017.0504. 2. Santosa KB, Hu HM, Brummett CM, et al. New persistent opioid use among older patients following surgery: A Medicare claims analysis. Surgery. 2020;167(4):732-742. doi:10.1016/j.surg.2019.04.016. 3. NCHS, National
Vital Statistics System. Estimates for 2020 are based on provisional data. Estimates for 2015-2019 are based on final data (available from: https://www.cdc.gov/nchs/nvss/mortality_public_use_data.htm). 4. Bicket MC, Long JJ, Pronovost PJ, Alexander GC,
Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017;152(11):1066-1071. doi:10.1001/jamasurg.2017.0831. 5. Substance Abuse and Mental Health Services Administration . Center for Behavioral
Health Statistics and Quality, Substance Abuse and Mental Health Services Administration; Rockville, MD: 2019. Key Substance Use and Mental Health Indicators in the United States: Results from the 2018 National Survey on Drug Use and Health (HHS Publication No. PEP19-5068, NSDUH Series H-54).https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf. Accessed April 19, 2021. 6. Brummett CM, Evans-Shields J, England C, Kong AM, Lew CR, Henriques C, Zimmerman NM, Sun EC. Increased health care costs associated with new persistent opioid use after major surgery in opioid-naive patients. J Manag Care Spec Pharm. 2021 Feb 24:1-12. doi:
10.18553/jmcp.2021.20507. Epub ahead of print. PMID: 33624534.
ZYNRELEF Approved Indications and Limitations of Use
Indication
- ZYNRELEF is indicated 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.
Limitations of Use
- Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.
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Heron Therapeutics Inc. published this content on 13 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 May 2021 12:33:05 UTC.