Heron Therapeutics Announces U.S. FDA Approval of CINVANTI™ (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV)

- CINVANTI Is the First and Only Polysorbate 80-Free, Intravenous Formulation of an NK1 Receptor Antagonist Indicated for the Prevention of Acute and Delayed CINV -

- Heron’s CINV Franchise Is the Only Franchise to Include Approved Injectable Therapies That Address Both Mechanisms of CINV -

- U.S. Commercial Launch of CINVANTI Is Planned for January 2018 -

SAN DIEGO, CA, USA I November 9, 2017 I Heron Therapeutics, Inc. (Nasdaq: HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved CINVANTI™ (aprepitant) injectable emulsion, for intravenous infusion. CINVANTI is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). With this approval, Heron now is the only company with approved injectable therapies that address the two primary mechanisms of CINV: SUSTOL®, a serotonin-3 (5-HT3) receptor antagonist, and CINVANTI, an NK1 receptor antagonist.

CINVANTI is the first and only polysorbate 80-free, intravenous formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed CINV. CINVANTI is the first intravenous formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce CINV in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy).i, ii CINVANTI does not contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain.ii, iii, iv

CINVANTI was approved based on data demonstrating the bioequivalence of CINVANTI to EMEND IV® (fosaprepitant), supporting its efficacy for the prevention of acute and delayed CINV following HEC and MEC.

Results from 2 pivotal randomized, cross-over bioequivalence studies of CINVANTI and EMEND IV showed subjects receiving CINVANTI reported fewer adverse events than those receiving EMEND IV, including substantially fewer infusion-site reactions.v

“CINV remains a high unmet medical need in the oncology community, and 5 full days of CINV coverage continues to be our goal. NK1 receptor antagonists are recommended for routine use with HEC and are a recommended option with MEC. Despite this, NK1 receptor antagonists are underutilized in CINV. This provides a large opportunity for CINVANTI to help more patients avoid CINV and adhere to their chemotherapy regimens,” said Jeffrey F. Patton, M.D., Chief Executive Officer of Tennessee Oncology.

“Aprepitant has long been the standard in the NK1 class and it remains the only single-agent NK1 with proven efficacy in preventing CINV in both the acute and delayed phases in HEC and MEC. Because CINVANTI is a novel, polysorbate 80-free IV formulation of aprepitant, it enables physicians to provide patients with standard-of-care efficacy without the potential risk of polysorbate 80-related adverse events, such as infusion-site reactions,” said Rudolph M. Navari, M.D., Ph.D., University of Alabama, Birmingham School of Medicine, Director, Cancer Care Program, Division of Hematology Oncology.

“Since both CINVANTI and SUSTOL have been shown to significantly reduce CINV in both the acute and delayed phase, by complementary mechanisms, they are an excellent strategic and operational fit for the Heron commercial team. The commercial team is ready to launch CINVANTI in January of next year,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “To obtain FDA approval for a second product in just over a year is a significant achievement for Heron, and we remain on-track with our third important product, HTX-011, which we expect to file for FDA review in 2018.”

Conference Call and Webcast

Heron will host a conference call and webcast on November 9, 2017 at 4:30 PM EST. The conference call can be accessed by dialing 877-311-5906 for domestic callers and 281-241-6150 for international callers. Please provide the operator with the passcode 3496939 to join the conference call. A slide presentation accompanying today’s press release and conference call may also be found on Heron’s website at www.herontx.com under the investor relations section. The conference call will also be available via webcast under the investor relations section of Heron's website. Please connect to Heron's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archive of today’s teleconference and webcast will be available on Heron’s website for 60 days following the call.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI is an intravenous formulation of aprepitant, an NK1 receptor antagonist for the prevention of CINV. CINVANTI is used in combination with a 5-HT3 receptor antagonist and dexamethasone. Heron developed CINVANTI, a proprietary novel lipid emulsion formulation of aprepitant, to overcome the low water solubility of aprepitant without polysorbate 80 or other synthetic surfactants, with the goal to reduce the risk for infusion-site reactions and hypersensitivity reactions that are reported with EMEND IV.

Please see Full Prescribing Information at www.CINVANTI.com.

About Chemotherapy-Induced Nausea and Vomiting (CINV)

While chemotherapy is one of the most effective and commonly used therapies to help patients fight cancer, it is accompanied by debilitating side effects, including varying degrees of nausea and vomiting, often attributed as a leading cause of premature discontinuation of cancer treatment. The goal of antiemetic therapy is to prevent CINV in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy). The National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) have categorized chemotherapy regimens based on the degree to which they cause nausea and vomiting: low emetogenic chemotherapy (LEC); moderately emetogenic chemotherapy (MEC); and highly emetogenic chemotherapy (HEC).

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. The Phase 2 development program for HTX-011 was designed to target the many patients undergoing a wide range of surgeries who experience significant postoperative pain. Heron has recently initiated the HTX-011 Phase 3 program and expects to file an NDA in 2018.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments that address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain. For more information, visit www.herontx.com.

i EMEND [aprepitant] capsules [US package insert] (Rev. May 2017).

ii EMEND [fosaprepitant dimeglumine] for injection [US package insert] (Rev. August 2017).

iii Joerger, M. (2012). “Prevention and handling of acute allergic and infusion reactions in oncology.” Ann Oncol 23 Suppl 10: x313-319.

iv Leal, A. D., K. C. Kadakia, S. Looker, C. Hilger, K. Sorgatz, K. Anderson, A. Jacobson, D. Grendahl, D. Seisler, T. Hobday and C. L. Loprinzi (2014). “Fosaprepitant-induced phlebitis: a focus on patients receiving doxorubicin/cyclophosphamide therapy.” Support Care Cancer 22(5): 1313-1317.

v Ottoboni, T., G. Boccia, M.R. Keller, M. Cravets, N. Clendeninn, B. Quart. “Bioequivalence of HTX-019 (aprepitant IV) and fosaprepitant in healthy subjects.” Presented at Hematology/Oncology Pharmacy Association Annual Conference, March 29-April 1, 2017, Anaheim, CA.

SOURCE: Heron Therapeutics

La Merie Biologics

FREE Weekly News Bulletin

2016 Sales ofAntibodies & Proteins

New Product Alert

For La Merie Publishing

Top