Helsinn Group Announces The Launch Of The Iv Formulation Of Akynzeo® İn The United States

Helsinn Group announces the launch of the IV formulation of AKYNZEO® (fosnetupitant/palonosetron) in the United States.

Swiss pharmaceutical group focused on building quality cancer care products, today announces that the intravenous formulation of AKYNZEO® (a fixed antiemetic combination of fosnetupitant, 235mg, and palonosetron, 0.25mg) for injection has been launched in the United States by its U.S. subsidiary, Helsinn Therapeutics (U.S.), Inc.

The FDA, on April 19, 2018, has approved AKYNZEO® IV 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. AKYNZEO® for injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

Oral AKYNZEO® was previously approved by the FDA as a fixed combination oral agent in 2014 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 prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

The bioequivalence of fosnetupitant and netupitant was demonstrated in a Phase 1 study and the safety of IV AKYNZEO® was established through a repeated dose safety study in cancer patients to potentially uncover adverse drug reactions that may appear during subsequent clinical practice. No anaphylactic and injection site reactions related to IV AKYNZEO® were reported in this study.

A repeated dose safety study is ongoing in patients receiving anthracycline plus cyclophosphamide to further establish the safety profile in this setting.

The prevention of CINV has significantly evolved over the past several decades. Currently the combination treatment of antiemetic medicines with different mechanisms of actions is recommended by the main international antiemetic guidelines for the prevention of CINV in most settings.

Giorgio Calderari, Helsinn Group General Manager, commented: "Helsinn's mission is to help people with cancer get the most out of every day. We're delighted that we are now able to make this therapy available in intravenous formulation. This is an important moment for Helsinn, as it allows us to bring an additional option to patients experiencing CINV in highly emetogenic chemotherapy treatment."

Paul Rittman, Chief Executive Officer of Helsinn Therapeutics, added: "We are delighted to launch the intravenous formulation of AKYNZEO® in the U.S market. One of our top priorities is to further expand the presence of Helsinn in the U.S. in order to help even more people who are suffering from the emetogenic side effects of cancer treatment."

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. - Istanbul