News Release Details

Heron Therapeutics Announces Data on SUSTOL™ Program to be Presented at 2014 ASCO Annual Meeting

05/19/2014 |

REDWOOD CITY, Calif.--(BUSINESS WIRE)--May 19, 2014-- Heron Therapeutics, Inc. (NASDAQ:HRTX), a specialty pharmaceutical company, announced today that data from a completed Phase 3 clinical trial of SUSTOL™ (granisetron), the Company’s lead product candidate for the prevention of acute-onset chemotherapy-induced nausea and vomiting (CINV), will be presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, June 1, 2014 in Chicago, IL.

Presentation details are as follows:

Poster Title:     Phase 3 trial of APF530 versus palonosetron (PALO) in preventing chemotherapy-induced nausea and vomiting (CINV): Efficacy in breast cancer patients (pts) receiving moderately (MEC) or highly (HEC) emetogenic chemotherapy (Abstract #9645)
Session Title: Patient and Survivor Care – General Poster Session
Author/Presenter: Ralph V. Boccia, MD, FACP, Founder, Center for Cancer and Blood Disorders, Bethesda, MD
Poster Number: 295
Date/Time: Sunday, June 1, 2014 from 8:00 a.m. – 11:45 a.m. CDT
 
Poster Title: A prospective, randomized, double-blind phase 3 trial of extended-release granisetron (APF530) vs palonosetron (PALO) for preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately (MEC) or highly (HEC) emetogenic chemotherapy: does a reanalysis using newer ASCO emetogenicity criteria affect study conclusions? (Abstract #9648)
Session Title: Patient and Survivor Care – General Poster Session
Author/Presenter: Harry Raftopoulos, MD, Associate Professor, Hofstra North Shore-LIJ School of Medicine
Poster Number:

298

Date/Time: Sunday, June 1, 2014 from 8:00 a.m. – 11:45 a.m. CDT

About SUSTOL

Heron's lead product candidate, SUSTOL (granisetron), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV in patients receiving moderately emetogenic chemotherapy (MEC); none are approved for delayed-onset CINV in patients receiving highly emetogenic chemotherapy (HEC). SUSTOL contains the 5-HT3 receptor antagonist granisetron formulated in the Company's proprietary Biochronomer polymer-based drug delivery platform, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for SUSTOL because it is widely prescribed by physicians based on a well-established record of safety and efficacy.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.) is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks. The Company's lead product, SUSTOL™ (granisetron), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). Heron is also utilizing its Biochronomer technology to develop an extended release formulation of an established local anesthetic for the treatment of post-surgical pain. In recently completed, post-surgical animal models of pain, the Company's drug candidates demonstrated statistically significant pain relief for five days, representing the potential to significantly reduce the need for opiates post-surgery and the length of post-surgical hospital stays. Heron’s lead product candidate in this program, HTX-011, is a unique combination of local analgesic agent bupivacaine and the NSAID meloxicam utilizing its Biochronomer extended release technology.

Forward Looking Statements

This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the potential approval of SUSTOL and the potential timing for such approval, if approved at all; risks relating to progress in research and development of HTX-011, including the timing of planned toxicology and clinical studies; risks related to other programs; risks related to the launch and acceptance of new products and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.

Source: Heron Therapeutics, Inc.

Heron Therapeutics, Inc
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
jcapuzelo@herontx.com
and
Corporate Contact:
Stephen R. Davis, 650-366-2626
Executive Vice President and Chief Operating Officer

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