<SEC-DOCUMENT>0001299933-15-001414.txt : 20150929
<SEC-HEADER>0001299933-15-001414.hdr.sgml : 20150929
<ACCEPTANCE-DATETIME>20150928182626
ACCESSION NUMBER:		0001299933-15-001414
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20150928
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150929
DATE AS OF CHANGE:		20150928

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:		151128532

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>htm_52466.htm
<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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	September 28, 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>
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	of incorporation)
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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>
	(Address of principal executive offices)
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___________<BR>
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	650-366-2626
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	Not Applicable
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	Former name or former address, if changed since last report
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Check the appropriate box below if the Form 8-K filing is intended to
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[&nbsp;&nbsp;]&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<br>
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[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<br>
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	Item 8.01 Other Events.
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On September 28, 2015, Heron Therapeutics, Inc. (the "Company") issued a press release announcing that data from the recently completed Phase 3 MAGIC study of SUSTOL&#174; (granisetron) Injection, extended release, were presented by Ian Schnadig, M.D., Principal Investigator for the MAGIC trial, US Oncology Research, Compass Oncology, at the American Society of Clinical Oncology 2015 Breast Cancer Symposium in San Francisco, CA, 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 September 28, 2015<br>
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	SIGNATURES
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	Pursuant to the requirements of the Securities Exchange Act of 1934, the
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	Heron Therapeutics, Inc.
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	September 29, 2015
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	By:
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	/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 September 28, 2015
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 14pt">EXHIBIT 99.1
</FONT>

<P align="center" style="font-size: 14pt">Heron Therapeutics Announces Oral Presentation of Data from Completed Phase 3 MAGIC Study for<BR>
SUSTOL</FONT><FONT style="font-size: 12pt"><sup>&#174;</FONT><FONT style="font-size: 14pt"></sup> at the ASCO Breast Cancer Symposium</FONT>



<P align="left" style="font-size: 14pt"><FONT style="font-size: 12pt">REDWOOD CITY, Calif. &#150; September&nbsp;28, 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 data from the recently
completed Phase 3 MAGIC study of SUSTOL<sup>&#174;</sup> (granisetron)&nbsp;Injection, extended release, were
presented by Ian Schnadig, M.D., Principal Investigator for the MAGIC trial, US Oncology Research,
Compass Oncology, at the American Society of Clinical Oncology (ASCO)&nbsp;2015 Breast Cancer Symposium
in San Francisco, CA. These data were presented in an oral presentation and poster titled &#147;Phase
III Study of APF530 versus Ondansetron with a Neurokinin 1 Antagonist &#043; Corticosteroid in
Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: MAGIC Trial.&#148; SUSTOL is
Heron&#146;s lead product candidate for the prevention of chemotherapy-induced nausea and vomiting
(CINV)&nbsp;associated with moderately emetogenic chemotherapy (MEC)&nbsp;or highly emetogenic chemotherapy
(HEC). SUSTOL has not been approved by the U.S. Food and Drug Administration (FDA)&nbsp;or any other
regulatory authority. Heron Therapeutics resubmitted its New Drug Application (NDA)&nbsp;for SUSTOL
with the FDA in July&nbsp;2015.
</FONT>

<P align="left" style="font-size: 12pt">Highlights include:


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

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    <TD width="2%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>The MAGIC trial represents the first registrational Phase 3 efficacy trial in patients
receiving HEC using a consensus guideline&#150;recommended three-drug regimen in both arms.</TD>
</TR>

</TABLE>


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<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="2%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>For the primary endpoint, the proportion of patients with delayed-phase complete
response (CR)&nbsp;was significantly greater with the SUSTOL (64.7%) versus ondansetron regimen
(56.6%), an absolute treatment difference of 8.0% (95% CI 1.7-14.4; p = 0.014), equating
to a relative 14.2% CR rate improvement.</TD>
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</TABLE>


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<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="2%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Within the cisplatin stratum (=50 mg/m<sup>2</sup>), delayed-phase CR was greater with
the SUSTOL<sup> </sup>(65.3%) versus ondansetron regimen (54.7%), an absolute treatment
difference of 10.6% (95% CI -1.4-22.7), equating to a relative 19.4% CR rate improvement.</TD>
</TR>

</TABLE>


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<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="2%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>A significantly greater proportion of patients did not require rescue medication in the
delayed phase with the SUSTOL<sup> </sup>versus ondansetron regimen (p = 0.013).</TD>
</TR>

</TABLE>


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<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="2%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Patient-reported satisfaction with nausea and vomiting control was significantly
greater with the SUSTOL<sup> </sup>versus ondansetron regimen in the delayed phase (p =
0.040).</TD>
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</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="2%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Rates of no nausea were numerically higher in the SUSTOL<sup> </sup>versus ondansetron
regimen in the delayed and overall phases and a post hoc analysis indicated SUSTOL<sup>
</sup>was associated with significantly less frequent nausea in the delayed (p = 0.032)
and overall phases (p = 0.048).</TD>
</TR>

</TABLE>


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<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="2%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>SUSTOL<sup> </sup>was generally well tolerated with no new safety signals identified.</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">&#147;The prevention of nausea and vomiting associated with highly emetogenic chemotherapy remains a
significant unmet medical need for patients battling cancer,&#148; stated Dr.&nbsp;Ian Schnadig, M.D.,
Principal Investigator, US Oncology Research, Compass Oncology, &#147;SUSTOL, as part of a three-drug
anti-emetic regimen, is the first and only 5-HT<sub>3</sub> antagonist to demonstrate superiority
over current standard-of-care for preventing delayed CINV following HEC. I am encouraged by the
results of the MAGIC trial and feel that SUSTOL represents a potentially best-in-class agent for
the prevention of CINV.&#148;


<P align="left" style="font-size: 12pt">&#147;We believe that SUSTOL, due to its novel extended-release formulation, has the potential to be the
new standard in the prevention of both acute and delayed nausea and vomiting in patients undergoing
cancer chemotherapy,&#148; commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron
Therapeutics. &#147;The data presented at the ASCO Breast Cancer Symposium further demonstrate the
potential utility of SUSTOL. With a PDUFA goal date of January&nbsp;17, 2016 assigned from the U.S. Food
and Drug Administration following the resubmission of our New Drug Application (NDA), we are
looking ahead to the potential approval and commercial launch of this very important medication.&#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<sup>&#174;</sup> 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 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). Adverse events reported in the study were generally mild to moderate in severity and of
short duration, with the most common being injection site reactions (ISRs). In July&nbsp;2015, Heron
resubmitted its New Drug Application (NDA)&nbsp;for SUSTOL to the U.S. Food and Drug Administration
(FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA)&nbsp;goal date of January&nbsp;17,
2016. SUSTOL has not been 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 or pain. SUSTOL<sup>&#174;</sup> (granisetron)&nbsp;Injection, extended release 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. In July&nbsp;2015, Heron resubmitted its New Drug Application (NDA)&nbsp;for
SUSTOL to the U.S. Food and Drug Administration (FDA), and the FDA has assigned a Prescription Drug
User Fee Act (PDUFA)&nbsp;goal date of January&nbsp;17, 2016. 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
is Heron&#146;s long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination
with the anti-inflammatory meloxicam. In September&nbsp;2015, Heron reported positive top-line results
from a Phase 2 study of HTX-011 in patients undergoing bunionectomy. Heron is also reviewing other
potential indications for the HTX-011 pain management development program. HTX-011 is currently
being evaluated in a Phase 2 clinical trial in patients undergoing inguinal hernia repair. Heron
expects to report results 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: 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, Associate Director, 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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