Heron Therapeutics, Inc.

Heron Therapeutics, Inc.

http://www.herontx.com lclark@herontx.com
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Our mission is to improve the lives of patients by developing novel, best-in-class treatments to address some of the most important unmet patient needs. We aim to develop patient-focused solutions by applying our innovative science and technologies with well-known pharmacology. Our product portfolio includes the following: SUSTOL® (granisetron) extended-release injection is a serotonin-3 (5-HT3) receptor antagonist that is approved by the U.S. Food and Drug Administration (FDA) and 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. See Indication and Important Safety Information Below. CINVANTI® (aprepitant) injectable emulsion, for intravenous use is a substance P/neurokinin-1 (NK1) receptor antagonist that is approved by the FDA and is indicated in adults, in combination with other antiemetic agents, 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. In February 2019, the FDA approved the administration of CINVANTI as a 2-minute IV injection (push), providing an alternative to 30-minute IV infusion. CINVANTI is now the only IV NK1 RA that offers the operational flexibility of a 2-minute IV push. In October 2019, the FDA approved CINVANTI to be administered as a 130-mg, single-dose regimen on Day 1 for MEC as well as HEC. This eliminates the need for patients to take oral aprepitant on Days 2 or 3. The CINVANTI label also includes the 3-day dose MEC regimen that requires oral aprepitant on Days 2 and 3. Limitations of Use: CINVANTI has not been studied for treatment of established nausea and vomiting. See Indication and Important Safety Information Below. In July 2020, we initiated a Phase 2 clinical study evaluating CINVANTI in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). ZYNRELEF® (bupivacaine and meloxicam) extended-release solution is approved in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. ZYNRELEF is the first and only extended-release dual-acting local anesthetic™ (DALA™) and delivers 72 hours of postoperative pain relief via a single needle-free application. It has been clinically proven to better manage pain than standard of care bupivacaine HCl solution over 72 hours and to significantly reduce opioid utilization following surgery. ZYNRELEF utilizes a novel synergistic mechanism of action that combines bupivacaine with a low dose of meloxicam to overcome the challenges of the inflammatory process at the surgical site. ZYNRELEF is formulated in Heron’s proprietary controlled-diffusion Biochronomer® polymer for consistently regulated delivery of bupivacaine and meloxicam. ZYNRELEF was initially approved by the FDA in May 2021 and in December 2021, the FDA approved an expansion of ZYNRELEF’s indication. In April 2021, Heron responded to a list of questions received from Health Canada and we anticipate up to a 300-day review period following screening of the response. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom. See Indication and Important Safety Information. SUSTOL, CINVANTI, ZYNRELEF, and our investigational product candidates utilize our innovative formulation science and technology platforms, including our proprietary Biochronomer® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a longer period of time with a single injection or application.

Company Information

January 31, 2022