Helsinn, a Swiss Group focused on building quality cancer care, and Mundipharma, have entered into a distribution and license agreement for the exclusive rights to anamorelin in China, Hong Kong and Macao.

Under the terms of the new agreement, Helsinn retains all international development as well as regulatory and clinical development activities and the supply of anamorelin for commercial use. Mundipharma will obtain the rights to marketing, promotion, distribution and sales of anamorelin in the designated territories.

Anamorelin is a novel, once-daily, orally active ghrelin receptor agonist under investigation for the treatment of Cancer Anorexia-Cachexia in patients suffering from non-small cell lung cancer (NSCLC), an area of significant unmet medical need. Cancer Anorexia-Cachexia is a multifactorial syndrome defined by an ongoing loss of skeletal muscle mass, the inability to be fully reversed by conventional nutritional support and a progressive functional impairment.  In addition to its physical impact, Cancer Anorexia-Cachexia has also a marked psychological implication that contributes to decreased quality of life for both patients and their families. By mimicking ghrelin, the so-called “hunger hormone” secreted by the gastrointestinal tract, anamorelin has been shown to improve lean body mass and appetite in NSCLC patients who are suffering from Cancer Anorexia-Cachexia.

The drug was also commented by the European Society for Medical Oncology (ESMO) in the “ESMO 2014 Wrap-Up: What should be remembered?” as one of the top innovations in oncology of 2014. The Guest Associate Editor mentioned that “The results from the phase III ROMANA 1 and 2 studies in NSCLC (1483O_PR) demonstrated significant benefits with anamorelin in body mass, body weight and patients’ symptoms and concerns about anorexia-cachexia. These findings suggest that anamorelin has the potential to improve the lives of a significant number of cancer patients.”

Riccardo Braglia, CEO of Helsinn Group, said: “This partnership is another step in what we foresee as a long and successful collaboration with Mundipharma. We believe that anamorelin could be established as an important advancement in the management of cancer anorexia-cachexia. Anamorelin offers the potential for a new approach of treating this multifactorial clinical condition which can be devastating for patients and caregivers. Anamorelin has been shown in two large-scale clinical studies to improve lean body mass, potentially enabling patients to tolerate more treatments, and to alleviate their symptoms and concerns, ultimately helping them get more out of every day.”

Raman Singh, president, Mundipharma Asia, Latin America, Middle East and Africa, said: “Improving the quality of patients’ lives has always been one of our core commitments, and the eventual launch of anamorelin in China seeks to provide healthcare professionals and patients with the effective support they need as patients undergo treatment. Our continued partnership with the Helsinn Group helps us further this goal, with their excellence in innovation and cancer supportive care.”

Anamorelin HCl is an investigational selective, novel, orally active ghrelin receptor agonist that is under evaluation 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 trials (the ROMANA program) in NSCLC patients with cachexia. In ROMANA 1 and ROMANA 2, anamorelin increased, in respect to placebo, body weight, lean body mass, improved patients’ symptoms and concerns related to anorexia/cachexia and was generally well tolerated.

Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the USA and a representative office in China.

Mundipharma’s global network of companies are privately owned entities covering the world's pharmaceutical markets. Mundipharma provides patients across 6 continents with a growing portfolio of 19 products in 5 therapeutic areas, which include moderate-to-severe pain, consumer healthcare, oncology, respiratory disease, rheumatoid arthritis, antiseptics and laxatives.