15 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Melbourne-based biopharmaceutical company Specialised Therapeutics Australia (STA) has been granted exclusive commercialization rights to a new drug for the treatment of NSCLC cachexia-anorexia. This condition is a serious multifactorial disorder that involves muscle wasting and metabolic impairment and commonly affects patients with advanced cancer. STA has reached agreement with Swiss pharmaceutical company Helsinn Healthcare to in-license the novel ghrelin receptor agonist anamorelin for both Australia and New Zealand.
This further collaboration follows on from STA's successful Australian commercialization of Helsinn's second-generation 5-HT3 antagonist, Aloxi (palonosetron), as well as STA in-licensing Helsinn's new fixed dose combination compound, netupitant-palonosetron, for the prevention of chemotherapy-induced nausea and vomiting. Under the terms of the latest agreement, Helsinn will retain all development activities (CMC, preclinical and clinical) and supply of anamorelin for commercial use. STA will be responsible for regulatory/clinical development and commercial activities within Australia and New Zealand.
Anamorelin is a first-in-class therapy being developed for the treatment of cachexia-anorexia in NSCLC, suitable for once daily oral administration. Previous phase II trials have demonstrated an improvement in appetite, an increase in lean body mass and improved quality of life in patients with cancer cachexia-anorexia. These trials have also demonstrated a good safety and tolerability profile.
There are currently no approved treatments for cancer-related cachexia-anorexia in Australia, the EU or in the US. Regional Director of Palliative Care for Barwon Health in Victoria, and a principal investigator for the phase III anamorelin registration trial, Associate Professor Peter Martin, described cachexia-anorexia as "a massive issue of concern" for clinicians, cancer patients and their families. He said it was not uncommon for patients to lose five-to-10 percent of their body weight, and in extreme cases it can be significantly higher. "Cachexia-anorexia is an issue right from diagnosis," said Mr Martin said. "Anamorelin has produced some very encouraging data in placebo-controlled phase II studies, and we look forward to seeing a compound that is capable of successfully treating this serious condition."
STA CEO Mr Carlo Montagner said anamorelin was an important addition to the company's expanding oncology portfolio, and specifically the company's supportive care business. "Our mission is to expand our portfolio to include treatment options which not only treat cancer, but address concerns related to this disease and improve the quality of life for all cancer patients," said Mr Montagner.
"There are currently no approved or effective drugs to treat muscle wasting and more generally cachexia-anorexia in cancer patients. This condition affects a significant number of Australian and New Zealand patients with advanced cancers and severely diminishes their quality of life, and potentially compromises treatment."