Heron Therapeutics Announces 340B Prime Vendor Contract with Apexus for ZYNRELEF™

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Jul 06, 2021, 08:30 ET

SAN DIEGO, July 6, 2021 /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 announced that it has executed a contract for ZYNRELEF with Apexus, LLC (Apexus). Apexus is the designated Prime Vendor for the 340B Drug Pricing Program. ZYNRELEF was approved by the U.S. Food and Drug Administration (FDA) on May 12, 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. ZYNRELEF is the first and only extended-release dual-acting local anesthetic and has been clinically shown to better manage pain, including severe pain, compared to standard-of-care bupivacaine over 72 hours and to significantly reduce or eliminate opioid use in many patients following surgery.

The 340B Drug Pricing Program provides drug discounts to hospitals and clinics serving vulnerable communities. The 340B Drug Pricing Program allows 340B healthcare providers to stretch limited federal resources to reduce the price of outpatient pharmaceuticals for patients and expand health services to the patients and communities they serve.

Under the agreement, Heron and the Prime Vendor Program, managed by Apexus, will collaborate to lower drug pricing for participating covered entities. The two organizations are working together to assure that covered entities have access to safe and effective non-opioid postoperative pain management.

"More than 90,000 Americans died of drug overdoses over the 12-month period that ended in September 2020, surpassing the yearly totals from any year since the opioid epidemic began in the 1990s," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "Ensuring ZYNRELEF is widely available to healthcare providers at an affordable price is a critical next to step to reducing exposure to opioids in the surgical setting and to decreasing the number of unused opioids available for potential misuse."

As the Prime Vendor, Apexus contracts with manufacturers and distributors to help ensure access to discounted medications. Since 2004, the Prime Vendor Program has brought more than 40,000 covered entities lower 340B drug pricing and additional discounts for those who need it most.

"We are pleased to work alongside Heron to improve patient care by increasing access to ZYNRELEF, a non-opioid option that has been clinically shown to manage postoperative pain for up to 72 hours after surgery," said Chris Hatwig, President of Apexus.

Indication

ZYNRELEF is approved for use in adults to reduce pain for up to 3 days after removal of bunions, groin hernia repair, and total knee replacement. ZYNRELEF is applied into the wound at the time of surgery.

Important Safety Information

ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:

can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
cannot be used during heart bypass surgery.
can increase the risk of gastrointestinal bleeding, ulcers, and tears.

ZYNRELEF should also not be used:

if you are allergic to any components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines.
as a paracervical block, during childbirth.

The most common side effects of ZYNRELEF are constipation, vomiting, and headache.

The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia).

Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you.

Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning.

About ZYNRELEF™ for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic (DALA) 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 modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also 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 approved by the FDA on May 12, 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. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission 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. For more information visit ZYNRELEF.com.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

About Apexus

The 340B Prime Vendor Program, managed by Apexus™, is a contract awarded by the Health Resources and Services Administration (HRSA), which is responsible for administering the 340B Drug Pricing Program. As the Prime Vendor, Apexus contracts with manufacturers and distributors to help ensure access to discounted medications, provides 340B education to all stakeholders, and helps support program integrity through technical assistance.

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, the potential market opportunity for ZYNRELEF in the U.S.; the extent of the impact of the ongoing Coronavirus Disease 2019 pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Investor Relations and Media Contact:

David Szekeres
Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
[email protected]
858-251-4447

SOURCE Heron Therapeutics, Inc.