Helsinn group, a Swiss-based privately owned pharmaceutical 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 per cent 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 programme (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.

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.

Cancer anorexia-cachexia is a multifactorial syndrome that cannot be fully reversed by conventional nutritional support, and in which systemic inflammation, reduced food intake and altered metabolism contribute to loss of muscle mass and reduction in body weight.

Helsinn is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas.

Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products.