Helsinn Group, a privately owned pharmaceutical group based in Switzerland, has granted Especificos Stendhal, a Latin American specialty company, exclusive commercialization rights for Mexico, Venezuela, Colombia, Perú, Ecuador and most of Central American countries, to this novel ghrelin receptor agonist.
Helsinn will retain all development activities (CMC, preclinical and clinical) and supply of anamorelin for commercial use. Stendhal will be responsible for regulatory/clinical development and commercial activities within their territory.
"This is the first step towards what we believe it will be a long and fruitful relationship between two companies sharing the same values," said Dr. Riccardo Braglia, CEO of Helsinn Group. "With this new partnership we are further expanding our anamorelin franchise in America and we are achieving this through Stendhal and its really top quality team."
Anamorelin is a new first-in-class, once daily drug being developed for the treatment of cachexia-anorexia in non-small cell lung cancer (NSCLC), a serious multifactorial disorder which involves muscle wasting, metabolic impairment and loss of appetite and commonly affects people with advanced cancer.
In phase II trials, anamorelin demonstrated to improve appetite, increase lean body mass and improve quality of life in people affected by cancer-related anorexia-cachexia. The phase II trials also showed a good safety and tolerability profile. The anamorelin phase III clinical trial program (ROMANA 1, 2 & 3) began in Q3 2011 and it is proceeding according to plans.