UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) March 19, 2015
Heron Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-33221 | 94-2875566 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 123 Saginaw Drive Redwood City CA |
94063 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code (650) 366-2626
N/A
(Former name or former address, if changed since last report)
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 (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| ITEM 8.01 | Other Events. |
On March 19, 2015, Heron Therapeutics, Inc. (the “Company”) issued a press release announcing results from the Company’s Phase 1 single-ascending dose, placebo controlled clinical trial of HTX-011, the Company’s lead product candidate in its pain management program targeting post-operative pain, as described in the press release furnished herewith as Exhibit 99.1.
A copy of presentation materials describing the results of the Phase 1 single-ascending dose, placebo controlled clinical trial of HTX-011, all or a part of which may be used by the Company in investor or scientific presentations from time to time, is furnished as Exhibit 99.2 hereto. The attached materials have also been posted on the Company’s website at www.herontx.com. The Company does not undertake to update this presentation.
| ITEM 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated March 19, 2015 | |
| 99.2 | HTX-011 Presentation, dated March 2015 | |
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SIGNATURE
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.
| Heron Therapeutics, Inc. | ||||||
| Date: March 19, 2015 | /s/ Esme C. Smith | |||||
| Esme C. Smith | ||||||
| Vice President, General Counsel & Secretary | ||||||
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Exhibit 99.1
Heron Therapeutics Reports Positive Results from Phase 1 Study of HTX-011
-Results Support Best-in-Class Potential for Lead Candidate for Post-Operative Pain
REDWOOD CITY, Calif. – March 19, 2015 – Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company, announced today positive results from a Phase 1 clinical study of HTX-011, Heron’s lead product candidate for the prevention of post-operative pain. HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in combination with the anti-inflammatory meloxicam.
This placebo-controlled, Phase 1 study evaluated single doses of 100 mg, 200 mg and 400 mg of HTX-011 in healthy volunteers. The key results from the study are described below:
| • | The desired pharmacokinetic profile for both bupivacaine and meloxicam was achieved. Specifically, therapeutically relevant drug levels of bupivacaine were sustained for 2-3 days. This was achieved in the absence of the large initial peak of bupivacaine that is observed with commercially available formulations of the drug. |
| • | Robust anesthetic activity that closely correlated with plasma bupivacaine concentrations was observed, with anesthetic effects persisting through 96 hours. |
| • | All three doses were well-tolerated with no serious adverse events, clinically relevant ECG or laboratory changes, or premature discontinuations. Mild redness and bruising were seen at some injection sites due to the subcutaneous administration of the product in this healthy volunteer study. |
“The effective management of pain without the use of opioids remains an important area of unmet medical need, and we are excited that HTX-011 could potentially provide a differentiated therapeutic profile with advantages compared to currently available pain management options,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. “We are encouraged by these positive results supporting HTX-011’s best-in-class potential and look forward to moving into Phase 2 clinical development in the second quarter of this year.”
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About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. The effective management of pain without the use of opioids remains an important area of unmet medical need, and HTX-011 could potentially provide a differentiated therapeutic profile with advantages compared to currently available pain management options. In a Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam. Therapeutically relevant plasma bupivacaine levels were sustained for 2-3 days in the absence of the large initial peak that can be observed with commercially available formulations of the drug. The anesthetic effects of HTX-011 persisted through 96 hours, which closely correlated with plasma bupivacaine concentrations, and HTX-011 was well-tolerated with no serious adverse events. Heron plans to move HTX-011 into Phase 2 clinical development in the second quarter of 2015.
About HTX-003 for Chronic Pain and Addiction
HTX-003, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is a long-acting formulation of buprenorphine for the management of chronic pain and opioid addiction. HTX-003 is designed to maintain therapeutic drug levels of buprenorphine for 30 days following a single subcutaneous injection with a low potential for patient abuse.
About SUSTOL® and Chemotherapy Induced Nausea and Vomiting
Heron Therapeutics’ lead investigational product candidate, SUSTOL® (granisetron injection, extended release), is being developed for the prevention of both acute- and delayed-onset chemotherapy induced nausea and vomiting (CINV) following the administration of moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) agents. 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. Injectable 5-hydroxytryptamine type 3 (5-HT3) 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-onset phase, which typically occurs one to five days following administration of chemotherapy agents. Only one injectable 5-HT3 receptor antagonist is approved for use following the administration of MEC agents, and none are approved for use following administration of HEC agents. SUSTOL contains the 5-HT3 receptor antagonist granisetron, selected due to its broad use by physicians based on a well-
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established record of safety and efficacy, and the fact that it is only currently approved for the prevention of CINV during the acute-onset phase. SUSTOL is formulated with the Company’s proprietary Biochronomer® polymer-based drug delivery platform technology and in clinical trials has been shown to maintain therapeutic drug levels of granisetron for up to five days with a single subcutaneous injection.
About HTX-019 for Chemotherapy Induced Nausea and Vomiting
HTX-019 is a proprietary injectable formulation of aprepitant, a neurokinin-1 (NK1) receptor antagonist for the prevention of CINV. NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists. At present, the only injectable NK1 receptor antagonist approved in the U.S. contains polysorbate 80, a surfactant, which may cause hypersensitivity reactions or other adverse reactions in some patients. Heron Therapeutics’ formulation for HTX-019 does not contain polysorbate 80, and may have a lower incidence of infusion-site reactions than reported with the other commercially available injectable NK1 receptor antagonist.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a biotechnology company using its proprietary technology and innovative efforts to develop products to address unmet medical needs. The Company’s proprietary Biochronomer polymer-based drug delivery platform technology is designed to improve the therapeutic profile of injectable pharmaceuticals. The Company’s product development efforts focus on identifying current therapies with the potential to be reformulated to expand or extend therapeutic effect or duration of action, minimize drawbacks or to apply new delivery methods. In addition, we continually evaluate potential development programs, technologies and product candidates that may be complementary to or synergistic with our existing programs and product development goals.
Forward Looking Statements
This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron Therapeutics cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those associated with: the timing of completion of the HEC study, and the results thereof, and the new drug application resubmission for SUSTOL, potential regulatory approval of SUSTOL and the timing for such approval, if approved at all; the progress in research and development of HTX-011, HTX-003, HTX-019 and our other product candidate programs, including the timing of planned toxicology and clinical studies; safety and efficacy data from our clinical studies that may not warrant further development of our product
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candidates; the launch and acceptance of 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 other products or technologies; 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.
Contacts:
Investor Relations Contact:
Jennifer Capuzelo, Sr. Manager, Investor Relations 858-703-6063
jcapuzelo@herontx.com
Corporate Contact:
Barry D. Quart, Pharm D., Chief Executive Officer
650-366-2626
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Exhibit 99.2
Heron Post-Operative Pain Program: HTX-011 Phase 1 Single-Ascending-Dose Study HERON THERAPEUTICS Advancing medicine. Improving Health.
Legal 4Disclaimer This presentation 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 development, regulatory approval, manufacture, launch and acceptance of new products, completion of clinical studies and the results thereof, the ability to establish strategic alliances and/or acquire desirable assets, progress in research and development programs and other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. Actual results may differ materially from the results anticipated in our forward looking statements. 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. 2 HERON THERAPEUTICS Advancing medicine. Improving Health.
Heron Post-Operative Pain Program Objective: Develop a best-in-class therapeutic for post-operative pain 3 HERON THERAPEUTICS Advancing medicine. Improving Health.
Heron Post-Operative Pain Program Target Product Profile: Maximal pain relief that lasts for 2-3 days Maximal reduction of opioid use Maximal reduction of length of hospital stay Elimination of dose-limiting peak of bupivacaine 4 HERON THERAPEUTICS Advancing medicine. Improving Health.
Heron Post-Operative Pain Program Introducing HTX-011: An injectable pain therapeutic that utilizes proprietary Biochronomer® polymer-based drug delivery platform technology Contains both bupivacaine (anesthetic) and meloxicam (anti-inflammatory) Designed to deliver both drugs evenly over 2-3 days without a large initial peak HTX-011 builds on other innovations in the category and has best-in-class potential 5 HERON THERAPEUTICS Advancing medicine. Improving Health.
HTX-011 Phase 1 Single-Ascending-Dose Study Design Randomized, Single-Blind, Placebo-Controlled 3 Single Rising Dose Cohorts 144 hr pharmacokinetic & pharmacodynamic assessments Cohort 3 Min 7-day Observation Safety PK evaluation 400 mg HTX-011 (5 active:1 placebo) Min 7-day Observation Cohort 2 Safety PK evaluation 200 mg HTX-011 (5 active:1 placebo) Cohort 1 100 mg HTX-011 (5 active:1 placebo) 6 HERON THERAPEUTICS Advancing medicine. Improving Health.
Plasma Concentrations of Bupivacaine Observed with HTX-011 600 500 (ng/ml) 400 300 Bupivacaine 200 Plasma 100 0 0 24 48 72 96 120 144 Hours HTX-011 100 mg HTX-011 200 mg HTX-011 400 mg 7 HERON THERAPEUTICS Advancing medicine. Improving Health.
HTX-011 Provides Longer Duration of Bupivacaine Release without a Large Initial Peak 900 800 700 (ng/ml) 600 500 Bupivacaine 400 300 Plasma 200 100 0 0 24 48 72 96 120 144 Hours HTX-011 400 mg Exparel Hemorrhoidectomy 300 mg* * Exparel data extracted from FDA Clin Pharm review 8 HERON THERAPEUTICS Advancing medicine. Improving Health.
Mechanical Detection Threshold Using von Frey Fibers Force where Subject No Longer Feels the Fiber Lost 250 200 Sensation 150 when 100 (mN) Force 50 0 HOURS HTX-011 400 mg (n=5) Placebo (n=3) 9 *Combined placebo data from all cohorts HERON THERAPEUTICS Advancing medicine. Improving Health.
Pharmacodynamic Effects of HTX-011 Correlate with Pharmacokinetic Profile 250 500 Lost 450 200 400 Plasma 350 Sensation 150 300 250 100 200 Bupviacaine 150 when(mN) 50 100 50 (ng/mL) Force 0 0 HOURS HTX-011 400 mg (n=5) Placebo (n=3) Plasma Bupivacaine Observed with HTX-011 10 *Combined placebo data from all cohorts HERON THERAPEUTICS Advancing medicine. Improving Health.
Safety • No serious adverse events or premature discontinuations • No clinically relevant ECG changes • No clinically relevant laboratory changes • Only adverse events considered possibly related to drug were associated with the subcutaneous administration of the product: mild redness and bruising at some injection sites 11 HERON THERAPEUTICS Advancing medicine. Improving Health.
Summary • Initial Phase 1 experience validates target product profile for HTX-011 • Desired pharmacokinetic profile for both bupivacaine and meloxicam achieved • Strong pharmacodynamic activity that correlated with pharmacokinetic profile observed – Rapid on-set of action without a large initial peak – 2-3 days of stable bupivacaine plasma levels correlated to 2-3 days of anesthetic effects • All three doses were well-tolerated • Phase 1 results support immediate advancement into Phase 2 12 HERON THERAPEUTICS Advancing medicine. Improving Health.