SAN
DIEGO, Jan. 7, 2024 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology
company, today announced that it has entered into a five-year
distributor partnership with CrossLink Life Sciences, LLC to expand
the sales network supporting ZYNRELEF® (bupivacaine and
meloxicam) extended-release solution.
The partnership will launch in several phases, initially at a
regional level, followed by an expanded national rollout. In total,
approximately 650 representatives will be added to Heron's sales
network over the next year. CrossLink will be the lead partner in
the United States to expand
ZYNRELEF promotion for orthopedic indications. Under the terms of
the agreement, CrossLink is compensated on a fixed-fee per vial
basis, based on growth over a pre-determined baseline period.
"This partnership will allow Heron to expand access to this
pain-reducing product for orthopedic surgery patients, allowing
more accounts to adopt ZYNRELEF as an essential part of their
surgical procedures," said Craig
Collard, Chief Executive Officer of Heron. "CrossLink has a
proven track record of success in building relationships, providing
superior service to healthcare providers and improving patient
outcomes. We look forward to kicking off a successful collaboration
and further positioning Heron to deliver substantial value and
impact patient lives in the coming years."
"We are excited about the partnership with Heron and its
upcoming potential expansion of the ZYNRELEF label and the
vial-access needle (VAN) which will streamline the product
preparation. We have seen first-hand the impact that ZYNRELEF can
have on post-operative pain, and our team is excited to deliver
ZYNRELEF to more patients across the country," said Thomas Fleetwood, Chief Executive Officer of
CrossLink.
CrossLink is the largest private orthopedic, spine and sports
medicine device distributorship in the
United States, consisting of experienced sales, operations
and logistics teams driven by the foundational goal of improving
patient outcomes. Over the past 45 years, its world class specialty
sales organization and national network of distributors have become
the market leaders in each of the regional markets they serve.
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 U.S. Food and Drug Administration (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 December
2021, the FDA approved an expansion of ZYNRELEF's
indication. In December 2022, we
submitted an sNDA to support the proposed indication for greatly
expanded use of ZYNRELEF in soft tissue and orthopedic surgical
procedures. On July 31, 2023, the FDA
notified Heron of an extension of the PDUFA approval goal date by
three months to provide for a full review of the submission. The
FDA has set a new extended PDUFA approval goal date of January 23, 2024. ZYNRELEF is now indicated in
the U.S. 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. Safety and efficacy have
not been established in highly vascular surgeries, such as
intrathoracic, large multilevel spinal, and head and neck
procedures. ZYNRELEF was granted a marketing authorization by the
European Commission in September 2020
and by the United Kingdom Regulatory Authority in January 2021. In August
2023, we cancelled the ZYNRELEF U.K. marketing authorization
and, in October 2023, we cancelled
the ZYNRELEF European Union (EU) marketing authorization, as we do
not plan to commercially launch ZYNRELEF in the U.K. or the EU.
About Heron Therapeutics, Inc.
Heron Therapeutics,
Inc. is a commercial-stage biotechnology company focused on
improving the lives of patients by developing and commercializing
therapeutic innovations that improve medical care. 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.
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, uncertainties
related to market conditions; the potential market opportunities
for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; the net product sales
guidance for the oncology care franchise and the acute care
franchise; the EBITDA guidance provided by the Company; the results
of the commercial launch of APONVIE; the timing of the FDA's review
process and whether the FDA approves the sNDA for ZYNRELEF to
further expand the U.S. label; the potential additional market
opportunity for the expanded U.S. label for ZYNRELEF, if approved;
the timing of the Company's development of the VAN program; the
timing of the Company's submission of the PAS to the FDA for the
VAN; the timing of the FDA's review process and whether the FDA
approves the PAS for the VAN; the outcome of the Company's pending
ANDA litigation related to CINVANTI; whether the Company is
required to write-off any additional inventory in the future; 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 and the risk that future equity financings may
be needed; any inability or delay in achieving profitability; 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.
Please see full prescribing information, including Boxed
Warning, at www.ZYNRELEF.com.
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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SOURCE Heron Therapeutics, Inc.