SAN DIEGO, Feb. 5, 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 announced that Robert Rosen, President, will be retiring. Mr.
Rosen's responsibilities will be transitioned to Barry Quart,
Pharm.D., Chief Executive Officer of Heron, who will take on the
additional role of President.
"Rob has been instrumental in building a world-class commercial
organization at Heron. The commercial success of our recent launch
of CINVANTI® is a testament to the quality of that
organization," said Barry Quart, Pharm.D., Chief Executive Officer
and President of Heron. "We thank Rob for staying with Heron
through several health issues, which enabled Heron to build a
premier commercial team led by two executives that he brought into
the Company: Jesse Hollingsworth,
Senior Vice President, Oncology Franchise, who has led Oncology
sales for the past 6 years, and Michael
Mathews, Senior Vice President, Pain Franchise, who has
built our pain franchise commercial organization over the past 2
years. We wish Rob well in his retirement."
Under Mr. Rosen's leadership, Heron has grown from a late-stage,
clinical company with one program in development into a
revenue-generating, commercial organization with fast-growing
chemotherapy-induced nausea and vomiting (CINV) and postoperative
pain management franchises. Mr. Rosen was instrumental in building
the commercial teams and infrastructure needed to execute on some
of Heron's most important goals, including the launches of
SUSTOL® and CINVANTI and the advancement of HTX-011 to a
Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2019 with the U.S. Food and Drug
Administration (FDA).
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 a New Drug Application
(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: whether the FDA approves
the HTX-011 NDA as submitted; the timing of the FDA's review
process for HTX-011; the anticipated commercial launch of HTX-011;
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
Senior VP, General Counsel, Business Development and Corporate
Secretary
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.