Switzerland-based Helsinn group has granted Chugai Pharma Marketing, a wholly-owned subsidiary of Chugai Pharmaceutical, exclusive commercialization rights to their ghrelin receptor agonist, anamorelin, for the three major European pharma markets.
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, the UK and Ireland.
Anamorelin is a new first-in-class, oral, once daily drug, currently in phase III for the treatment of anorexia-cachexia in NSCLC, a detrimental multifactorial disorder that affects over 50% of people with cancer and in which systemic inflammation, reduced food intake and altered metabolism contribute to loss of muscle mass and reduction of body weight leading to reduced quality of life, functional impairment and decreased survival.
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 and 3) that started in the third quarter of 2011 is proceeding as expected.
Helsinn Group CEO Riccardo Braglia noted the company is extremely pleased of this new, important collaboration with Chugai and it is very confident it will be significantly fruitful for both parties.
"This milestone is an additional recognition of anamorelin's promising clinical development in the cancer supportive care arena.
"We are confident that our product can improve the quality of life of cancer patients in these European countries," Braglia added.