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Note 1 - Organization and Business
12 Months Ended
Dec. 31, 2018
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]
1.
       
Organization and Business
 
Heron Therapeutics, Inc. (“Company”, “Heron”, or “we”) 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. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain.
 
On
August 9, 2016,
our
first
commercial product, SUSTOL, was approved by the U.S. Food and Drug Administration (“FDA”). 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
-hydroxytryptamine type
3
(
“5
-
HT3”
) receptor antagonist that utilizes Heron’s Biochronomer Technology to maintain therapeutic levels of granisetron for
≥5
days. We commenced commercial sales of SUSTOL in the U.S. in
October 2016.
 
On
November 9, 2017,
our
second
commercial product, CINVANTI, was approved by the FDA. 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 (“IV”) formulation of aprepitant, a substance P/neurokinin-
1
(
“NK1”
) receptor antagonist. 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. We commenced commercial sales of CINVANTI in the U.S. in
January 2018.
 
HTX-
011,
which utilizes Heron’s proprietary Biochronomer 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 postoperative pain management. 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 alone 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.
The FDA recently accepted our New Drug Application NDA for HTX-
011,
and has granted it a Priority Review designation. The FDA set a Prescription Drug User Fee Act goal date of
April 30, 2019
and indicated that it is
not
currently planning an advisory committee meeting to discuss this application.
 
HTX-
034,
our next-generation product candidate for postoperative pain management, is in development for postoperative pain via local application. Based on the positive results of preclinical studies in which HTX-
034
demonstrated significant pain reduction for
seven
days, we have initiated formal development of this next-generation postoperative pain management product candidate.
 
As of
December 31, 2018,
we had
$332.4
million in cash, cash equivalents and short-term investments. We have incurred significant operating losses and negative cash flows from operations. Management believes that cash, cash equivalents and short-term investments as of
December 31, 2018
will be sufficient to fund operations for at least
one
year from the date this Annual Report on Form
10
-K is filed with the U.S. Securities and Exchange Commission (“SEC”).