Helsinn, a privately owned pharmaceutical group focused on building quality cancer care, and Mundipharma, have entered into distribution, license and supply agreements granting exclusive rights to anamorelin in Switzerland and Liechtenstein.

Under the terms of the new agreements, Helsinn retains all international development as well as regulatory and clinical development activities and the supply of anamorelin for commercial use. Mundipharma obtains exclusive rights to registration, marketing, promotion, distribution and sales of anamorelin in Switzerland and Liechtenstein.

Helsinn already has existing partnerships with Mundipharma, for anamorelin, in Brazil, Middle East and North Africa, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, China, Hong Kong and Macao.

Anamorelin is a novel, once-daily, orally active ghrelin receptor agonist in development for the treatment of cancer anorexia-cachexia in patients suffering from non-small cell lung cancer (NSCLC), an area of significant unmet medical need. Also known as the wasting syndrome, cancer anorexia-cachexia characteristics such as reduced appetite/food intake and unintended weight loss (mainly due to muscle loss) are known to lead to early deaths of cancer patients. It is estimated that over 50 per cent of late-stage cancer patients suffer from cancer anorexia-cachexia.

By mimicking ghrelin, the so-called “hunger hormone” secreted by the gastrointestinal tract, anamorelinwas shown to increase lean body mass and improve appetite in patients with non-small cell lung cancer who are suffering from cancer anorexia-cachexia in two pivotal large-scale 12-week phase III studies, ROMANA 1 and ROMANA 2.

Riccardo Braglia, CEO of Helsinn Group, said, “Helsinn has a successful existing collaboration with Mundipharma in a number of territories and we are delighted that they will be our partner in Switzerland. We believe that anamorelin could offer a significant improvement on current treatment options for cancer anorexia-cachexia, increasing lean body mass, and alleviating patient concerns.”

Dr. Athanasios Zikopoulos, general manager of Mundipharma Medical Company Basel said, “We are excited to enter into this collaboration with Helsinn for Switzerland. Improving the quality of patients’ lives through effective therapies is one of our core commitments, and we believe that anamorelin, when approved, will make a significant contribution to help further this goal in cancer supportive care.”

Anamorelin HCl is an investigational selective, novel, orally active ghrelin receptor agonist that is in development for the treatment of Cancer Anorexia-Cachexia in NSCLC patients. Ghrelin is an endogenous peptide secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, lean body mass, appetite and metabolism.

Anamorelin is administered orally at 100mg, once daily. In phase II trials, anamorelin was shown to increase body weight compared with placebo and to improve patient-reported symptoms, including appetite.

Anamorelin recently completed phase III studies (the ROMANA programme) in NSCLC patients with cachexia. In ROMANA 1 and ROMANA 2, anamorelin increased in respect to placebo body weight, lean body mass, improved patient’s symptoms and concerns related to anorexia-cachexia and was generally well tolerated.