SAN DIEGO, Jan. 7, 2019 /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 highlighted progress in its pain
management and chemotherapy-induced nausea and vomiting (CINV)
franchises.
Recent Corporate Progress
Pain Management Franchise
- Acceptance of HTX-011 NDA for Postoperative Pain Management
with Priority Review Designation; PDUFA Date of April 30, 2019: The U.S. Food and Drug
Administration (FDA) recently accepted the new drug application
(NDA) for Heron's investigational agent, HTX-011, and has granted
it a Priority Review designation. The FDA set a Prescription Drug
User Fee Act (PDUFA) goal date of April 30,
2019 and indicated that it is not currently planning an
advisory committee meeting to discuss this application.
- 90% of Patients Treated with HTX-011 Opioid-Free 72 Hours
Post-Surgery in New Multi-center Clinical Study: In this
study, 63 patients undergoing hernia repair surgery received
HTX-011 together with a regimen of generic, over-the-counter (OTC),
oral analgesics (acetaminophen and ibuprofen). Ninety percent (90%)
of patients were opioid-free 72 hours post-surgery, and 81% were
still opioid-free 28 days post-surgery.
- Formal Development Initiated on HTX-034, Our Next-Generation
Product for Postoperative Pain Management: Based on the
positive results of preclinical studies in which HTX-034
demonstrated significant pain reduction for 7 days, Heron has
initiated formal development of this next-generation postoperative
pain product.
CINV Franchise
- Fourth-Quarter 2018 Net Sales: Fourth-quarter 2018 net
sales for the CINV franchise were approximately $28.1 million, up 180% year-over-year and up 42%
from the third quarter of 2018. This included net sales of
approximately $23.0 million for
CINVANTI® (aprepitant) injectable emulsion and
approximately $5.1 million for
SUSTOL® (granisetron) extended-release
injection.
- Full-Year 2018 Net Sales: Full-year 2018 net sales
for the CINV franchise were approximately $76.7 million, versus guidance of $70 million to $72
million. This included net sales of approximately
$55.8 million for CINVANTI and
approximately $20.9 million for
SUSTOL.
- Full-Year 2019 Net Sales Guidance: Heron expects full
year 2019 net sales for the CINV franchise of $115 million to $120
million.
"2018 was a year of significant progress for Heron. On the
commercial front, we are very pleased with the strong sales
performance of our CINV franchise. On the development front,
HTX-011 has now been shown to reduce pain significantly better than
placebo or bupivacaine solution in five diverse surgical models,
including studies that resulted in significantly more patients
receiving HTX-011 who were opioid-free through 72 hours after
surgery," said Barry D. Quart, Pharm.D., Chief Executive Officer of
Heron. "In 2019, we look forward to working with the FDA to bring
an important non-opioid pain management option to patients. We
believe that HTX-011, if approved, could have a considerable impact
on the opioid epidemic by significantly reducing the proportion of
patients who experience severe pain and receive opioids after
surgery."
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron's proprietary
Biochronomer® drug delivery technology, is an
investigational, long-acting, extended-release formulation of the
local anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam for the management of postoperative
pain. By delivering sustained levels of both a potent anesthetic
and a local anti-inflammatory agent directly to the site of tissue
injury, HTX-011 was designed to deliver superior pain relief while
reducing the need for systemically administered pain medications
such as opioids, which carry the risk of harmful side effects,
abuse and addiction. HTX-011 has been shown to reduce pain
significantly better than placebo or bupivacaine solution in five
diverse surgical models: hernia repair, abdominoplasty,
bunionectomy, total knee arthroplasty and breast augmentation.
HTX-011 was granted Fast Track designation from the FDA in the
fourth quarter of 2017 and Breakthrough Therapy designation in the
second quarter of 2018. Heron submitted an NDA to
the FDA for HTX-011 in October of 2018 and received
Priority Review designation in December of 2018. The FDA set a
PDUFA goal date of April 30,
2019.
About CINVANTI (aprepitant) injectable emulsion
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
and nausea and vomiting associated with initial and repeat courses
of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an
intravenous formulation of aprepitant, a substance P/neurokinin-1
(NK1) receptor antagonist. CINVANTI is the first
intravenous (IV) formulation to directly deliver aprepitant, the
active ingredient in EMEND® capsules. Aprepitant
(including its prodrug, fosaprepitant) is the only single-agent
NK1 receptor antagonist 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). CINVANTI is the only IV formulation of an
NK1 receptor antagonist indicated for the
prevention of acute and delayed nausea and vomiting associated with
HEC and nausea and vomiting associated with MEC that is free
of polysorbate 80 or any other synthetic surfactant. Pharmaceutical
formulations containing polysorbate 80 have been linked to
hypersensitivity reactions, including anaphylaxis and irritation of
blood vessels resulting in infusion-site pain. FDA-approved dosing
administration included in the United
States prescribing information for CINVANTI is a 30-minute
infusion.
Please see full prescribing information at www.CINVANTI.com.
About SUSTOL (granisetron) extended-release injection
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-HT3 receptor antagonist 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 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. Heron is developing novel, patient-focused
solutions that apply its innovative science and technologies to
already-approved pharmacological agents for patients suffering from
pain or cancer.
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, those associated with: the full-year 2019 net
sales guidance for the CINV franchise; whether the FDA approves the
HTX-011 NDA as submitted; the timing of the FDA's review process
for HTX-011; whether the FDA will require an advisory committee
meeting for HTX-011 in the future; the anticipated commercial
launch of HTX-011; the timing and results of the studies in the
HTX-034 development program; 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 L. Szekeres
Senior VP, General Counsel, Business Development and Corporate
Secretary
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.