Date: 2013-11-12
Type of information: Commercialisation agreement
Compound: anamorelin
Company: Helsinn (Switzerland) Chugai Pharmaceutical (Japan)
Therapeutic area: Cancer - Oncology
Type agreement: distribution
commercialisation
Action mechanism: Anamorelin HCl is a selective, novel, orally active ghrelin receptor agonist and has been previously studied in approximately 500 subjects, including four completed phase II trials dosing 361 patients with cancer. Anamorelin is currently being tested in two phase III studies, ROMANA 1 and ROMANA 2 evaluating anamorelin HCI for the treatment of anorexia-cachexia syndrome in patients with advanced non-small cell lung cancer (NSCLC). The two studies enroll approximately 477 patients each in over 15 countries, with sites in North America, Europe, Russia, Australia and the Middle East. Patients who complete ROMANA 1 or 2 have the option of continuing treatment in the ROMANA 3 safety extension study. Ghrelin, also known as the “hunger hormone”, is a multiacting peptide secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the regulation of body weight, lean body mass, appetite and metabolism.
Disease: anorexia-cachexia
Details: * On November 12, 2013, Swiss-based Helsinn group has granted Chugai Pharma Marketing Ltd., a wholly-owned subsidiary of Chugai Pharmaceutical Co., Ltd., exclusive commercialization rights to their innovative ghrelin receptor agonist, anamorelin, for the three major European pharma markets. Phase II trials have highlighted how anamorelin can improve appetite, increase lean body mass and have a positive impact on the quality of life of patients with cancer suffering from anorexia-cachexia. A good safety and tolerability profile was also shown. Phase II data have recently been presented at the ECCO/ESMO 2013 meeting in Amsterdam while the phase III clinical trial program (ROMANA 1, 2 & 3) that started in Q3 2011 is proceeding as expected.
Under the terms of the agreement, Helsinn will retain all development activities (CMC, preclinical and clinical) and supply of anamorelin for commercial use. In addition, Helsinn will be responsible for the regulatory and clinical development whilst Chugai Pharma Marketing will undertake all the commercial actions within Germany, France, Benelux, UK and Ireland.
Financial terms:
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