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Agreements

Date: 2014-07-17

Type of information: Commercialisation agreement

Compound: oral fixed-dose combination capsule of netupitant 300 mg + palonosetron 0.50 mg (NEPA)

Company: Helsinn (Switzerland) Chugai Pharmaceutical (Japan)

Therapeutic area: Cancer - Oncology - CNS diseases

Type agreement:

commercialisation

Action mechanism:

NEPA is an investigational single-day, fixed-dose combination of a selective NK1 receptor antagonist, netupitant, and a 5-HT3 receptor antagonist, palonosetron, designed to target two critical pathways thought to be associated with chemotherapy-induced nausea and vomiting (CINV).

Disease: prevention of chemotherapy-induced nausea and vomiting (CINV)

Details:

* On July 17, 2014,  Helsinn, the Swiss Group focused on building quality cancer care, and Chugai Pharmaceutical announced that exclusive rights to NEPA, an investigational oral fixed-dose combination of netupitant and palonosetron being evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV), has been granted to Chugai Pharma Marketing Ltd., a wholly owned subsidiary of Chugai, in the UK and Ireland. Chugai has also been granted the exclusive right to market the palonosetron monotherapy, Aloxi®, in the UK as from January 1st, 2015. In the phase 2 and phase 3 clinical trials NEPA demonstrated that it provides a significant improvement in the prevention of acute and delayed CINV when compared to oral palonosetron. Clinical data have been published in peer reviewed medical journals and presented in several international congresses such as the American Society of Clinical Oncology (ASCO) and the Multinational Association of Supportive Care in Cancer (MASCC).

Chugai is already one of Helsinn’s partners for anamorelin, a new first-in-class, once daily ghrelin receptor agonist, currently in phase 3 trials for the treatment of Cancer Anorexia Cachexia Syndrome (CACS) in non-small cell lung cancer, in seven EU countries including Germany, France, Belgium, Netherlands, Luxemburg, the UK and Ireland. Under the terms of the new agreement, Helsinn retains all development activities and the supply of both NEPA and palonosetron for commercial use, as well as regulatory and clinical development. Chugai will be responsible for all marketing activities in the designated territories.

Financial terms:

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