Helsinn Group Announces First Patient Enrolled in Phase 3b Study of NEPA IV Versus NEPA Oral

Helsinn recently announced that the first patient has been enrolled in a Phase 3b study to assess the safety and tolerability of IV NEPA fixed combination of fosnetupitant/palonosetron (235 mg/0.25 mg) compared to oral NEPA for the prevention of CINV in women with breast cancer receiving multiple cycles of anthracycline-cyclophosphamide (AC) chemotherapy. This multiregional, Phase 3b study will enroll 400 patients in the US and Europe.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, said “We are pleased that NEPA IV is moving into a Phase 3b trial. The purpose of this study is to add important safety information at the disposal of the physicians to potentially assist them to prescribe antiemetics appropriately in patients receiving AC chemotherapy.”

The IV formulation of NEPA in highly emetogenic chemotherapy in non-AC patients is currently under FDA evaluation for bioequivalence with oral NEPA, with an anticipated PDUFA date of April 20, 2018. The development program included a repeated dose safety study to further establish the safety of the intravenous formulation and potentially uncover adverse drug reactions that may appear during subsequent clinical practice. The safety profile of IV NEPA was generally similar to that seen with oral NEPA, no anaphylactic and injection site reactions were reported in this study.

Fosnetupitant, a component of NEPA IV was developed without the need for surfactant emulsifier or solubility enhancer to result in a clear injectable solution, thereby reducing the number of excipients and potential related toxicities (Abrantes et al 2016). NEPA IV has not been approved for commercial use by any regulatory authority in any part of the world.

Akynzeo (netupitant 300 mg/palonosetron 0.5 mg) capsules for oral use was approved in October 2014 in the United States 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 is an oral fixed combination of palonosetron and netupitant. Palonosetron, a 5HT3 inhibitor, prevents nausea and vomiting during the acute phase and netupitant, an NK-1 inhibitor, prevents nausea and vomiting during both the acute and delayed phases after cancer chemotherapy.

Akynzeo (netupitant 300 mg/palonosetron 0.5 mg) capsules for oral use was approved in May 2015 in the EU. Akynzeo oral is indicated in the EU for adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.

Oral NEPA has been recommended by various antiemetic guidelines: the National Comprehensive Cancer Network (NCCN) antiemetic guidelines, both in Highly Emetogenic Chemotherapy (HEC; inclusive of AC and carboplatin AUC >=4)) and Moderately Emetogenic Chemotherapy (MEC); the American Society for Clinical Oncology (ASCO) guideline for antiemetics in oncology, in HEC AC and carboplatin (AUC >=4) regimens and the MASCC/ESMO Guidelines in HEC, AC and carboplatin based chemotherapy. Helsinn currently has 20 licensing partners for Akynzeo in 167 countries.

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. Formore information, visit www.helsinn.com.