Helsinn Healthcare S.A.

Helsinn Group Announces Upcoming Presentation of Phase 3b data of NEPA (fosnetupitant / palonosetron) IV at ASCO 2019

Helsinn Group Announces Upcoming Presentation of Phase 3b data of NEPA (fosnetupitant / palonosetron) IV at ASCO 2019

Helsinn Group Announces Upcoming Presentation of Phase 3b data of NEPA (fosnetupitant /palonosetron) IV at ASCO 2019

Lugano, Switzerland, May 31, 2019 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that the data on the intravenous (IV) formulation of NEPA (Akynzeo®) will be presented as poster at the American Society of Clinical Oncology (ASCO) Congress in June 2019 on the poster session Symptoms and Survivorship.

NEPA (Akynzeo®) is the first and only 5-HT3 and NK1 receptor combination approved for the prevention of chemotherapy induced acute and delayed nausea and vomiting. A single dose of Akynzeo given with dexamethasone has been shown to prevent chemotherapy induced nausea and vomiting for 5 days.

This randomized, multinational, double-blind, stratified (by age and region) Phase 3b study in chemotherapy-naïve patients, evaluated the safety of a single 30-minute infusion of NEPA IV agent (fosnetupitant 235 mg, a neurokinin 1 receptor antagonist (NK1 RA), and palonosetron 0.25 mg, a serotonin-3 receptor antagonist (5-HT3 RA)) in breast cancer patients receiving anthracycline/cyclophosphamide (AC) chemotherapy. 402 patients received either NEPA IV (200 patients) or NEPA oral (202 patients), in combination with oral dexamethasone on day 1. Safety was assessed primarily by treatment-emergent adverse events (TEAEs).

The AE profiles were similar for the two treatment groups1. No infusion site reactions related to NEPA IV occurred, and no anaphylactic reactions were reported for either formulation. NEPA IV does not require a surfactant, emulsifier, or solubility enhancer, and contains no allergenic excipients.

Lee S. Schwartzberg, Hematology & Oncology, West Cancer Center, Germantown, TN, the author of the study, commented: “These data demonstrate that NEPA IV has a similar safety profile to NEPA administered orally. We are encouraged by the similar profiles, and particularly by the lack of infusion site reactions.

Sergio Cantoreggi, Helsinn Group Chief Scientific Officer and Group Head of R&D, added:At Helsinn, our key focus is on the quality of life and well-being of the patients. Tolerability can be a significant concern for intravenously administered antiemetics especially in AC. We look forward to discussing these new NEPA IV safety data at ASCO.

ASCO 2019 will be held from May 31 to June 4, 2019 in Chicago, US. Further details can be found here: https://www.asco.org/meetings

About Akynzeo® (NEPA)

INDICATION

AKYNZEO® (netupitant 300mg/palonosetron 0.5mg) capsules was approved October 2014 in the United States and is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. 

AKYNZEO® (fosnetupitant 235mg/palonosetron 0.25) for injection was approved April 2018 in the United States and is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. 

Limitations of Use

AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Adverse Reactions

Drug Interactions

Use in Specific Populations

For more information about AKYNZEO® please see the full Prescribing Information or visit www.AKYNZEO.com

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco and China, as well as a product presence in approximately 190 countries globally.

To learn more about Helsinn Group please visit www.helsinn.com

For more information:

Helsinn Group Media Contact

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

[email protected]

For more information, please visit www.helsinn.com and follow us on TwitterLinkedIn and Vimeo




1 The most common treatment-related AEs during the entire study were headache (2.5% IV NEPA, 3.4% oral NEPA), dizziness (2.5% in both groups), fatigue (2.0% in both groups) and constipation (2.5% IV NEPA, 1.0% oral NEPA); all other treatment-related AEs occurred in < 2% of patients.