<SEC-DOCUMENT>0001299933-15-001118.txt : 20150721
<SEC-HEADER>0001299933-15-001118.hdr.sgml : 20150721
<ACCEPTANCE-DATETIME>20150721134122
ACCESSION NUMBER:		0001299933-15-001118
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20150717
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150721
DATE AS OF CHANGE:		20150721

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			HERON THERAPEUTICS, INC. /DE/
		CENTRAL INDEX KEY:			0000818033
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				942875566
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33221
		FILM NUMBER:		15997478

	BUSINESS ADDRESS:	
		STREET 1:		123 SAGINAW DRIVE
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94063
		BUSINESS PHONE:		6503662626

	MAIL ADDRESS:	
		STREET 1:		123 SAGINAW DRIVE
		STREET 2:		123 SAGINAW DRIVE
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94063

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AP PHARMA INC /DE/
		DATE OF NAME CHANGE:	20010511

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ADVANCED POLYMER SYSTEMS INC /DE/
		DATE OF NAME CHANGE:	19920703
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<TYPE>8-K
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<DESCRIPTION>LIVE FILING
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<TITLE> Heron Therapeutics, Inc. (Form: 8-K) </TITLE>
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		UNITED STATES<BR>
	SECURITIES AND EXCHANGE COMMISSION
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	WASHINGTON, D.C. 20549
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	FORM 8-K
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	CURRENT REPORT
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	Pursuant to Section&nbsp;13 or 15(d) of the Securities Exchange Act of 1934
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	Date of Report (Date of Earliest Event Reported):
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	July 17, 2015
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	Heron Therapeutics, Inc.
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	(Exact name of registrant as specified in its charter)
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	Delaware
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	001-33221
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	94-2875566
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_____________________<BR>
	(State or other jurisdiction
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	of incorporation)
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	File Number)
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	Identification No.)
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	123 Saginaw Drive, Redwood City, California
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	94063
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_________________________________<BR>
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___________<BR>
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	650-366-2626
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	Not Applicable
<BR>______________________________________________<BR>
	Former name or former address, if changed since last report
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	&nbsp;
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Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:</FONT>
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[&nbsp;&nbsp;]&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<br>
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	Item 8.01 Other Events.
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On July 20, 2015, Heron Therapeutics, Inc. (the "Company") issued a press release announcing that it has resubmitted its New Drug Application for SUSTOL&#174; (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting, to the U.S. Food and Drug Administration, as described in the press release furnished herewith as Exhibit 99.1.
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	Item 9.01 Financial Statements and Exhibits.
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(d) Exhibits. <br> <br>		<br>Exhibit No./ Description<br>	<br>99.1 Press Release, dated July 20, 2015<br>
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	SIGNATURES
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	Pursuant to the requirements of the Securities Exchange Act of 1934, the
	registrant has duly caused this report to be signed on its behalf by the
	undersigned hereunto duly authorized.
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	Heron Therapeutics, Inc.
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<I>
	July 21, 2015
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	By:
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<I>
	/s/ Esme C. Smith
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	Name: Esme C. Smith
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	Title: VP, General Counsel & Secretary
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	Exhibit&nbsp;Index
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	99.1
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Press Release dated July 20, 2015
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 12pt"><B>EXHIBIT 99.1</B>
</FONT>

<P align="center" style="font-size: 12pt"><FONT style="font-size: 14pt">Heron Therapeutics Resubmits SUSTOL</FONT><FONT style="font-size: 12pt"><sup>&#174;</FONT><FONT style="font-size: 14pt"></sup> New Drug Application to FDA</FONT>



<P align="center" style="font-size: 14pt"><I>-SUSTOL has potential to be the first 5-HT</I><sub><I>3</sub> antagonist approved for delayed nausea and<BR>
vomiting associated with highly emetogenic chemotherapy</I>



<P align="left" style="font-size: 14pt"><FONT style="font-size: 12pt">REDWOOD CITY, Calif. &#150; July&nbsp;20, 2015 &#150; Heron Therapeutics, Inc. (NASDAQ: HRTX), a
biotechnology company focused on improving the lives of patients by developing best-in-class
medicines that address major unmet medical needs, today announced that it has resubmitted its New
Drug Application (NDA)&nbsp;for SUSTOL<sup>&#174;</sup> (granisetron)&nbsp;Injection, extended release, for the
prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV)&nbsp;associated with
moderately emetogenic chemotherapy (MEC)&nbsp;or highly emetogenic chemotherapy (HEC)&nbsp;regimens, to the
U.S. Food and Drug Administration (FDA). Heron expects confirmation of acceptance from the FDA and
a Prescription Drug User Fee Act (PDUFA)&nbsp;goal date within the next few weeks. The Company
anticipates a six-month review by the FDA.
</FONT>

<P align="left" style="font-size: 12pt">The NDA filing includes data from the MAGIC study, Heron&#146;s recently completed, multi-center,
placebo-controlled, Phase 3 study in patients receiving HEC agents. The MAGIC study evaluated the
efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV)
neurokinin-1 (NK<sub>1</sub>) receptor antagonist fosaprepitant and the IV/oral corticosteroid
dexamethasone for the prevention of delayed nausea and vomiting in patients receiving HEC. The
MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO guidelines for
classification of emetogenic potential, is the only Phase 3 CINV study to-date to use the currently
recommended, standard-of-care, three-drug regimen for CINV prophylaxis in a HEC population as the
comparator: a 5-HT<sub>3</sub> receptor antagonist, fosaprepitant and dexamethasone.


<P align="left" style="font-size: 12pt">The MAGIC study&#146;s primary endpoint was achieved. Specifically, the percentage of patients who
achieved a Complete Response was significantly higher in the SUSTOL arm compared with the
comparator arm (p=0.014). Significant benefit was also observed in the reduction in episodes of
nausea, which has the greatest impact on patient quality of life. Data from a previous Phase 3
study of more than 1,300 patients, which was previously submitted to the FDA, demonstrated SUSTOL&#146;s
efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV
associated with HEC regimens.


<P align="left" style="font-size: 12pt">&#147;The rapid resubmission of the NDA for SUSTOL, the first and only 5-HT<sub>3</sub> receptor
antagonist with extended-release technology and 5-day CINV prevention in both MEC and HEC, is a
major milestone for Heron Therapeutics,&#148; commented Barry D. Quart, Pharm.D., Chief Executive
Officer of Heron. &#147;We look forward to working closely with the FDA during the SUSTOL NDA review
period, as we believe SUSTOL has the potential to improve the lives of patients suffering from CINV
by significantly reducing both nausea and vomiting associated with MEC or HEC regimens.&#148;


<P align="left" style="font-size: 12pt"><B>About SUSTOL</B><sup><B>&#174; </B></sup><B>for Chemotherapy-Induced Nausea and Vomiting</B>


<P align="left" style="font-size: 12pt">SUSTOL<sup>&#174;</sup> (granisetron)&nbsp;Injection, extended release, which utilizes Heron&#146;s proprietary
Biochronomer&#174; drug delivery technology, is Heron&#146;s novel, long-acting formulation of granisetron
for the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron, an
FDA-approved 5-hydroxytryptamine type 3 (5-HT<sub>3</sub>) receptor antagonist was selected due to
its broad use by physicians based on a well-established record of safety and efficacy. SUSTOL has
been shown to maintain therapeutic drug levels of granisetron for five days with a single
subcutaneous injection. SUSTOL is being developed for the prevention of both acute (day 1
following the administration of chemotherapy agents) and delayed (days 2-5 following the
administration of chemotherapy agents) CINV associated with moderately emetogenic chemotherapy
(MEC)&nbsp;or highly emetogenic chemotherapy (HEC). While other 5-HT<sub>3</sub> antagonists are
approved for the prevention of CINV, SUSTOL is the first agent in the class to demonstrate efficacy
in reducing the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in
a randomized Phase 3 study.


<P align="left" style="font-size: 12pt">Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side
effects of such treatments, often attributed as a leading cause of premature discontinuation of
cancer treatment. 5-HT<sub>3</sub> receptor antagonists have been shown to be among the most
effective and preferred treatments for CINV. However, an unmet medical need exists for patients
suffering from CINV during the delayed phase, which occurs on days 2-5 following the administration
of chemotherapy agents. Only one 5-HT<sub>3</sub> receptor antagonist is approved for the
prevention of delayed CINV associated with MEC, and no 5-HT<sub>3</sub> receptor antagonists are
approved for prevention of delayed CINV associated with HEC.


<P align="left" style="font-size: 12pt">SUSTOL was the subject of a recently completed, multi-center, placebo-controlled, Phase 3 clinical
study in patients receiving HEC regimens known as MAGIC. The MAGIC study evaluated the efficacy
and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV)&nbsp;neurokinin-1
(NK<sub>1</sub>) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone.
The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO guidelines for
classification of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a HEC
population performed to date to use the currently recommended, standard-of-care, three-drug regimen
as a comparator: a 5-HT<sub>3</sub> receptor antagonist, fosaprepitant, and dexamethasone. The
study&#146;s primary endpoint was achieved. Specifically, the percentage of patients who achieved a
Complete Response in the delayed phase was significantly higher in the SUSTOL arm compared with the
comparator arm (p=0.014). Heron resubmitted its New Drug Application (NDA)&nbsp;for SUSTOL to the U.S.
Food and Drug Administration (FDA)&nbsp;in July&nbsp;2015. SUSTOL is not approved by the FDA or any other
regulatory authority.


<P align="left" style="font-size: 12pt"><B>About Heron Therapeutics, Inc.</B>


<P align="left" style="font-size: 12pt">Heron Therapeutics, Inc. is a biotechnology company focused on improving the lives of patients by
developing best-in-class medicines that address major unmet medical needs. Heron is developing
novel, patient-focused solutions that apply its innovative science and technologies to
already-approved pharmacological agents. Heron&#146;s goal is to build on therapeutics with well-known
pharmacology by improving their tolerability and efficacy as well as broadening their potential
field of use. Heron is currently developing four pharmaceutical products for patients suffering
from cancer and pain. SUSTOL<sup>&#174;</sup> is Heron&#146;s injectable, extended-release formulation of
granisetron that is being developed for the prevention of both acute and delayed
chemotherapy-induced nausea and vomiting (CINV)&nbsp;associated with moderately emetogenic chemotherapy
(MEC)&nbsp;or highly emetogenic chemotherapy (HEC). CINV is one of the most debilitating side effects
of chemotherapy and is a leading cause of premature discontinuation of cancer treatment. Heron
recently reported positive, top-line results from its Phase 3 MAGIC study and resubmitted its New
Drug Application (NDA)&nbsp;for SUSTOL to the U.S. Food and Drug Administration (FDA)&nbsp;in July&nbsp;2015.
HTX-019, also being developed for the prevention of CINV, has the potential to become the first
polysorbate 80-free, intravenous formulation of aprepitant, a neurokinin-1 (NK<sub>1</sub>)
receptor antagonist. Heron intends to file an NDA for HTX-019 using the 505(b)(2) regulatory
pathway in the second half of 2016. HTX-011, Heron&#146;s long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam, is in a
Phase 2 trial for the prevention of post-operative pain. Heron expects to report results from this
trial in the second half of 2015. HTX-003, a long-acting formulation of buprenorphine, is being
developed for the potential management of chronic pain and opioid addiction. All of Heron&#146;s
product candidates utilize Heron&#146;s innovative science and technology platforms, including its
proprietary Biochronomer<sup>&#174;</sup> drug delivery technology, which can deliver therapeutic levels
of a wide range of otherwise short-acting pharmacological agents over a period of days to weeks
with a single injection.


<P align="left" style="font-size: 12pt">For more information, visit <U>www.herontx.com</U>.


<P align="left" style="font-size: 12pt"><B>Forward Looking Statements</B>


<P align="left" style="font-size: 12pt">This news release contains &#147;forward-looking statements&#148; as defined by the Private Securities
Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on
management&#146;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. These risks
and uncertainties include, but are not limited to, those associated with: the acceptance of the
Company&#146;s resubmission of its New Drug Application (NDA)&nbsp;for SUSTOL<sup>&#174;</sup>, whether the U.S.
Food and Drug Administration (FDA)&nbsp;approves the SUSTOL NDA as submitted or supports as broad of a
labeled indication for SUSTOL as requested, the progress in the research and development of
HTX-019, HTX-011, HTX-003 and our other programs, including the timing of preclinical, clinical,
and manufacturing activities, safety and efficacy results from our studies that may not justify the
pursuit of further development of our product candidates, the launch and acceptance of SUSTOL and
new products generally, our financial position and our ability to raise additional capital to fund
operations, if necessary, or to pursue additional business opportunities, strategic business
alliances we may pursue or the potential acquisition of products or technologies, and our ability
to grow our organization to sustain the commercial launch for SUSTOL, and other risks and
uncertainties identified in the Company&#146;s filings with the 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.


<P align="left" style="font-size: 12pt"><B>Contacts:</B>
<BR>
<B>Investor Relations Contact:</B>
<BR>
Jennifer Capuzelo, Sr. Manager, Investor Relations
<BR>
858-703-6063
<BR>
<U>jcapuzelo@herontx.com</U>


<P align="left" style="font-size: 12pt"><B>Corporate Contact:</B>
<BR>
Barry D. Quart, Pharm D., Chief Executive Officer
<BR>
650-366-2626


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