Swiss pharma firm Helsinn granted Specialised Therapeutics Australia (STA) exclusive commercialization rights in Australia and New Zealand to its Phase III-stage ghrelin receptor agonist, anamorelin, for the treatment of non-small cell lung cancer cachexia-anorexia.
STA has already successfully commercialized Helsinn’s 5-HT3 antagonist Aloxi® (palonosetron), and holds a license to the firm’s Phase III-stage fixed dose netupitant-palonosetron combination therapy for preventing chemotherapy-induced nausea and vomiting. Under terms of the latest anamorelin deal, STA will be responsible for regulatory/clinical development and commercial activities within Australia and New Zealand.
There are currently no approved therapies for treating muscle wasting and more generally cachexia-anorexia in cancer patients, the firms note. Helsinn’s anamorelin is currently undergoing two Phase III trials, Romana 1 and Romana 2, as at treatment for cachexia-anorexia in patients with NSCLC. The two studies will enroll about 477 patients in over 15 countries, and patients who complete Romana 1 or Romana 2 and opt to continue on anamorelin therapy will be enrolled into an extension safety study, Romana 3. Pending positive trial results, an NDA filing with FDA is anticipated in mid-2014, followed immediately by regulatory filing in Australia.