Nov 12 2013
Swiss Pharma Group Helsinn seals an alliance with Japanese company Chugai by granting exclusive distribution & licensing rights to commercialize its innovative phase III ghrelin receptor agonist in Germany, France, Benelux, UK and Ireland
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.
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 & 3) that started in Q3 2011 is proceeding as expected.
"We are extremely pleased of this new, important collaboration with Chugai and we are 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", said
Riccardo Braglia, Helsinn Group CEO. "We are confident that our product can improve the quality of life of cancer patients in these European countries", he concluded.
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.
"This alliance is a result of our shared vision with Helsinn to introduce an important new treatment to reduce the burden of anorexia-cachexia syndrome in cancer patients. Anamorelin will give physicians a totally new option that could potentially change the way they treat patients with advanced cancer in the future. It is Chugai's commitment and dedication to bring innovative medicines to patients, and we are confident that Anamorelin's novel mechanism of action and strong supporting data will lead to a successful introduction of this medicine to patients and physicians." said John Halls, Managing Director of Chugai Pharma Marketing.