Heron Therapeutics Reports Oral Presentation of Data from Completed Phase 3 MAGIC Study for SUSTOL

Heron Therapeutics, Inc.

, 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® (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 (ASCO) 2015 Breast Cancer Symposium in San Francisco, CA. These data were presented in an oral presentation and poster titled "Phase III Study of APF530 versus Ondansetron with a Neurokinin 1 Antagonist + Corticosteroid in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: MAGIC Trial." SUSTOL is Heron's lead product candidate for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Heron Therapeutics resubmitted its New Drug Application (NDA) for SUSTOL with the FDA in July 2015. Highlights include: The MAGIC trial represents the first registrational Phase 3 efficacy trial in patients receiving HEC using a consensus guideline–recommended three-drug regimen in both arms. For the primary endpoint, the proportion of patients with delayed-phase complete response (CR) 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. Within the cisplatin stratum (≥50 mg/m2), delayed-phase CR was greater with the SUSTOL (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. A significantly greater proportion of patients did not require rescue medication in the delayed phase with the SUSTOL versus ondansetron regimen (p = 0.013). Patient-reported satisfaction with nausea and vomiting control was significantly greater with the SUSTOL versus ondansetron regimen in the delayed phase (p = 0.040). Rates of no nausea were numerically higher in the SUSTOL versus ondansetron regimen in the delayed and overall phases and a post hoc analysis indicated SUSTOL was associated with significantly less frequent nausea in the delayed (p = 0.032) and overall phases (p = 0.048). SUSTOL was generally well tolerated with no new safety signals identified. "The prevention of nausea and vomiting associated with highly emetogenic chemotherapy remains a significant unmet medical need for patients battling cancer," stated Dr. Ian Schnadig, M.D., Principal Investigator, US Oncology Research, Compass Oncology, "SUSTOL, as part of a three-drug anti-emetic regimen, is the first and only 5-HT3 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." "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," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "The data presented at the ASCO Breast Cancer Symposium further demonstrate the potential utility of SUSTOL. With a PDUFA goal date of January 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."