UPDATE: Heron Therapeutics Announces Results from Phase 3 MAGIC Study of SUSTOL: Says Primary Endpoint Achieved

Heron Therapeutics, Inc.

today announced positive, top-line results from its recently completed Phase 3 MAGIC study. MAGIC evaluated the efficacy and safety of the Company's 5-HT3 receptor antagonist product candidate SUSTOL® (granisetron injection, extended release) as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of highly emetogenic chemotherapy (HEC) agents. The MAGIC study is the only Phase 3 CINV prophylaxis study in a HEC population performed to-date to use as a comparator the currently recommended, standard-of-care, three-drug regimen: a 5-HT3 receptor antagonist (in this case ondansetron), fosaprepitant and dexamethasone. The study was conducted entirely in the U.S. and enrolled over 900 patients undergoing HEC treatment for various tumor types. The primary endpoint in this study was the proportion of patients who achieved a Complete Response, defined as no emesis and no rescue medications during the delayed-onset phase of CINV, occurring 24-120 hours following administration of HEC agents. The study's major efficacy findings include: The study's primary endpoint was achieved. The percentage of patients who achieved a Complete Response was significantly higher in the SUSTOL group than the comparator group (64.7% vs. 56.6%, p=0.014). The percentage of patients who achieved Complete Control, defined as Complete Response plus no more than mild nausea during the delayed-onset phase, also reached statistical significance in favor of SUSTOL (p = 0.022). The percentage of patients who experienced no nausea or infrequent nausea during the delayed-onset phase was significantly higher in the SUSTOL arm compared with the comparator arm (p = 0.032). Significantly more patients in the SUSTOL arm were satisfied with their therapy based on a quality-of-life questionnaire (p = 0.040). SUSTOL was well tolerated, with no clinically significant differences in the rate or severity of adverse events between the SUSTOL arm and the comparator arm. Injection site reactions observed were consistent with previous trials and generally considered mild, as were the majority of adverse events observed in the study. "The MAGIC study demonstrated that use of SUSTOL with an NK1 receptor antagonist and dexamethasone for patients receiving HEC significantly reduced symptoms of CINV. It is significant that both arms of the study had a three-drug prophylactic regimen, which has not been previously evaluated in prior Phase 3 trials in this high-risk patient group. Symptom management in patients receiving cancer treatment represents a significant unmet medical need, and the results of this study represent another step forward in this important clinical space," stated Ian Schnadig, M.D., Principal Investigator, US Oncology Research, Compass Oncology, Tualatin, Oregon. "The substantial benefit observed with SUSTOL in Complete Response, nausea and overall satisfaction with therapy is all the more impressive given the comparator was a three-drug, standard-of-care regimen. Also, unlike previous CINV studies, all patients in the MAGIC trial came from U.S.-based community oncology centers, so the results are highly representative of what we would expect to see in our patients," stated Jeffrey Vacirca, M.D., Principal Investigator, North Shore Hematology/Oncology Associates. "We are extremely gratified to report that SUSTOL is the first 5-HT3 receptor antagonist to demonstrate a statistically significant improvement in delayed nausea and vomiting in patients receiving HEC. As the first large clinical study to compare two three-drug regimens using the definition for HEC in the 2011 ASCO guidelines, the results reported today further demonstrate the potential for SUSTOL to be the foundation of the new standard-of-care injectable anti-emetic regimen," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "We look forward to presenting additional data from the MAGIC study at an appropriate upcoming scientific conference, but our immediate focus is now the resubmission of our New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), which we expect in mid-2015. In addition, we are planning for the commercial launch of SUSTOL, pending FDA approval."