SAN DIEGO, Jan. 13, 2020 /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
- New Drug Application Resubmission for HTX-011: In
September 2019, Heron resubmitted a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for HTX-011, an investigational agent for the management of
postoperative pain. The FDA set a Prescription Drug User Fee Act
(PDUFA) goal date of March 26,
2020.
- Marketing Authorisation Application for HTX-011: In
March 2019, Heron's Marketing
Authorisation Application (MAA) for HTX-011 for the management of
postoperative pain was validated by the European Medicines Agency's
(EMA) for review under the Centralised Procedure. An opinion from
the EMA Committee for Medicinal Products for Human Use (CHMP) is
anticipated in the second quarter of 2020.
- New Drug Submission for HTX-011: In December 2019, Heron's New Drug Submission (NDS)
for HTX-011 for the management of postoperative pain was granted
Priority Review status and accepted by Health Canada. Health
Canada's Priority Review status
provides an accelerated 6-month review target for the NDS. A
decision by Health Canada is anticipated in the third quarter of
2020.
CINV Franchise
- Fourth-Quarter 2019 Net Product Sales: Preliminary
fourth-quarter 2019 net product sales for the CINV franchise were
approximately $34.8 million, up 21%
year-over-year. This included net product sales of approximately
$34.4 million for
CINVANTI® (aprepitant) injectable emulsion and
approximately $0.4 million for
SUSTOL® (granisetron) extended-release injection.
- Full-Year 2019 Net Product Sales: Preliminary full-year
2019 net product sales for the CINV franchise were approximately
$145.7 million, versus guidance of
$135.0 million and up 88%
year-over-year. This included net product sales of approximately
$132.0 million for CINVANTI and
approximately $13.7 million for
SUSTOL.
Corporate Update
- December 31, 2019 Cash, Cash
Equivalents and Short-Term Investments: As of December 31, 2019, Heron had approximately
$391.0 million in cash, cash
equivalents and short-term investments.
"We have made important advances in 2019 in both our pain
management and CINV franchises, highlighted by the submission of
three marketing applications for HTX-011 for postoperative pain
management and strong net product sales for CINVANTI, even amid the
launch of generic fosaprepitant," said Barry Quart, Pharm.D.,
President and Chief Executive Officer of Heron. "We ended 2019 in a
strong cash position of $391.0
million, which will support the anticipated launch of
HTX-011 in the second quarter of 2020, pending FDA approval."
About HTX-011 for Postoperative Pain
HTX-011, an investigational agent, is a dual-acting, fixed-dose
combination of the local anesthetic bupivacaine with a low dose of
the nonsteroidal anti-inflammatory drug meloxicam. It is the
first and only extended-release local anesthetic to demonstrate in
Phase 3 studies significantly reduced pain and opioid use through
72 hours compared to bupivacaine solution, the current
standard-of-care local anesthetic for postoperative pain control.
HTX-011 was granted Fast Track designation from the U.S. Food and
Drug Administration (FDA) in the fourth quarter of 2017 and
Breakthrough Therapy designation in the second quarter of 2018.
Heron submitted a New Drug Application (NDA) to the FDA for HTX-011
in October of 2018 and received Priority Review designation in
December of 2018. A Complete Response Letter (CRL) was received
from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry,
manufacturing and controls and non-clinical information. No issues
related to clinical efficacy or safety were noted. Heron
resubmitted an NDA to the FDA for HTX-011 in September 2019 and the FDA set a Prescription
Drug User Fee Act (PDUFA) goal date of March
26, 2020. A Marketing Authorisation Application (MAA) for
HTX-011 was validated by the European Medicines Agency (EMA) in
March 2019 for review under the
Centralised Procedure. Heron's New Drug Submission (NDS) for
HTX-011 for the management of postoperative pain was granted
Priority Review status by Health Canada in October 2019 and accepted by Health
Canada in November 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 HEC,
including high-dose cisplatin, and nausea and vomiting associated
with initial and repeat courses of MEC. CINVANTI is an IV
formulation of aprepitant, an NK1 RA. CINVANTI is the first IV
formulation to directly deliver aprepitant, the active ingredient
in EMEND® capsules. Aprepitant (including its prodrug,
fosaprepitant) is the only single-agent NK1 RA 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). The FDA-approved dosing administration
included in the United States prescribing information for
CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.
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 fourth-quarter 2019
and full-year 2019 net product sales for the CINV franchise;
whether the U.S. Food and Drug Administration (FDA) approves
the New Drug Application (NDA) for HTX-011; the timing of the
commercial launch of HTX-011; the timing of the European Medicines
Agency (EMA) Committee for Medicinal Products for Human Use
(CHMP) review process for HTX-011; whether the European
Commission authorizes the Marketing Authorization Application
(MAA) for HTX-011; the timing of Health Canada's New Drug
Submission (NDS) review process for HTX-011; whether Health
Canada issues a Notice of Compliance for the NDS for HTX-011;
the expected 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 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
Chief Legal, Business, and Administrative Officer
dszekeres@herontx.com
858-251-4447
View original
content:http://www.prnewswire.com/news-releases/heron-therapeutics-highlights-progress-in-pain-management-and-cinv-franchises-300985411.html
SOURCE Heron Therapeutics, Inc.