Helsinn, the Swiss group focused on building quality cancer care, and BIAL - Portela & Ca. S.A. (BIAL), one of the largest Iberian pharmaceutical companies, have entered into an agreement for the exclusive distribution and licence rights to Anamorelin in Spain, Portugal, Angola and Mozambique.

Under the terms of the agreement, Helsinn retains all international regulatory and clinical development activities and the supply of Anamorelin for commercial use. BIAL will be responsible for all distribution and marketing activities in the designated territories.

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. 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 has shown to increase body weight compared with placebo and to improve patient-reported symptoms, including appetite.

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

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 impact that decreases the quality of life of 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 patients with NSCLC who are suffering from cancer anorexia-cachexia.

Riccardo Braglia, CEO of Helsinn Group, said, “This new agreement with BIAL is an important step for Anamorelin as it can bring us into Spain and Portugal, two key markets for Helsinn. We are confident that this first agreement between Helsinn and BIAL will form the foundation of a trusted partnership between our companies. Anamorelin has demonstrated in phase III development trials a clear potential to improve lean body mass and improve the concerns of patients with cancer-anorexia cachexia.”

Commenting on the deal, António Portela, CEO of BIAL, said, “We are delighted to be working with Helsinn Group and to have the opportunity to bring to the market such a potentially promising treatment to improve the quality of life of people suffering from such a devastating disease as cancer. This partnership marks the entering of BIAL in the oncology market. Our excitement is reinforced by the possibility to commercialize Anamorelin not only in Portugal, but also in Spain, Mozambique and Angola. This helps us to achieve our corporate mission to provide innovative and high quality medicines to fulfill the unmet medical needs of the health care professionals, patients and their families.”