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Note 1 - Business
9 Months Ended
Sep. 30, 2014
Disclosure Text Block [Abstract]  
Business Description and Basis of Presentation [Text Block]

1.     Business


Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.) (the “Company,” “we,” “us” and “our”) is a biotechnology company using its proprietary technology and innovative efforts to develop products to address unmet medical needs. Our proprietary Biochronomer® polymer-based drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by extending the duration of action of known active ingredients. Our product development program also focuses on identifying new delivery methods and formulations utilizing known compounds that may expand or extend the therapeutic effort, or eliminate the drawbacks of current therapies.


Our lead investigational product candidate, APF530, which we intend to market as SUSTOL® (granisetron injection, extended release), subject to regulatory approval, is being developed for the prevention of both acute- and delayed-onset chemotherapy induced nausea and vomiting (“CINV”). In 2014, we initiated a Phase 3 clinical study with APF530 for the prevention of delayed-onset CINV in patients receiving highly emetogenic chemotherapy (“HEC study”). 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 receptor antagonist approved for the prevention of delayed-onset CINV in patients receiving moderately emetogenic chemotherapy; none are approved for delayed-onset CINV in patients receiving highly emetogenic chemotherapy.


SUSTOL contains the 5-HT3 receptor antagonist granisetron formulated in the Company's proprietary Biochronomer polymer-based drug delivery platform, which has been shown in clinical studies to maintain therapeutic drug levels of SUSTOL for up to 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. We own the worldwide rights to SUSTOL.


In May 2009, we filed the original New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval for SUSTOL for the prevention of acute-onset CINV in patients receiving both moderately and highly emetogenic chemotherapy and delayed-onset CINV in patients receiving moderately emetogenic chemotherapy. The FDA issued a Complete Response Letter (“CRL”) for the SUSTOL NDA in March 2010. In September 2012, we resubmitted our NDA for SUSTOL and, in March 2013, we received a second CRL, which identified several remaining issues that need to be addressed prior to approval of the SUSTOL NDA. We believe that we have substantially addressed those issues raised in the March 2013 CRL. We are targeting completing enrollment of our ongoing HEC study in the first quarter of 2015. We intend to include the results of the study in the resubmission of the SUSTOL NDA, which we anticipate filing shortly thereafter. 


Our core Biochronomer technology, on which SUSTOL and our other product candidates are based, consists of bioerodible polymers designed to release drugs over a defined period of time. The results of over 100 in vivo and in vitro studies demonstrate that our Biochronomer technology is potentially applicable to a range of therapeutic areas, including prevention of CINV, pain management and control of inflammation, among others. We have also completed comprehensive animal and human toxicology studies that have established that our Biochronomer polymers are well tolerated. Furthermore, our Biochronomer technology can be designed to deliver drugs over periods varying from days to potentially multiple weeks. We are researching the potential use of our Biochronomer technology with other drugs for the clinical development of other drug candidates.


In November 2013, we initiated a program to expand our pipeline of sustained-release products, including a new program targeting pain management. We selected HTX-011, a combination of local anesthetic bupivacaine and the anti-inflammatory meloxicam in a formulation utilizing our proprietary Biochronomer polymer-based drug delivery platform, as the lead product candidate for our pain management program. We are in the process of commencing a Phase 1 study in Europe to examine the product candidate in human candidates. As of 2012, approximately 25 million1 procedures associated with post-operative pain were conducted in the U.S. In addition, post-operative pain market sales were approximately $3.1 billion2 in 2012.


In November 2014, we announced the initiation of a product development program for HTX-019. The investigational product HTX-019 is a proprietary intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist used in combination with a 5-HT3 for the prevention of CINV. HTX-019 does not contain polysorbate 80. By eliminating the use of surfactant polysorbate 80, HTX-019 may reduce the hypersensitivity reactions observed with fosaprepitant formulations containing this component. At present, there is only one intravenous Nk1 receptor antagonist approved in the U.S. for the prevention of CINV.


In January 2014, we changed our name from A.P. Pharma, Inc. to Heron Therapeutics, Inc. Effective January 13, 2014, we effected a 1 - for - 20 reverse split of our outstanding common stock (“Reverse Stock Split”) (See Note 5). All historical share and per share amounts have been adjusted to reflect the Reverse Stock Split. All stock options, common stock underlying convertible notes and warrants outstanding were adjusted to give effect to the Reverse Stock Split.


Liquidity


We have incurred significant operating losses and negative cash flows from operations and we have an accumulated deficit of $294.6 million as of September 30, 2014. Since 2011, we completed a total of five rounds of equity and/or debt financings, which provided us with cash of approximately $194.3 million, net of issuance costs, to fund operations (see Notes 4 and 5). As of September 30, 2014, we had cash on hand of $86.2 million.


We believe that our current working capital is sufficient to fund operations into 2015, including pursuing regulatory approval to market SUSTOL, and beginning human clinical studies relative to our HTX-011 and HTX-019 development programs. In the event we were to pursue clinical product development in other areas, potentially acquire other strategic assets, or begin to make significant investments in preparing for commercialization of SUSTOL, we would need to raise additional capital. If we are unable to obtain sufficient financing on acceptable terms or otherwise, we may be required to reduce or defer our activities.