Date: 2012-10-15
Type of information: Licensing agreement
Compound: anamorelin
Company: Helsinn (Switzerland) Specialised Therapeutics Australia (Australia)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
distribution
commercialisation
Action mechanism: Anamorelin is a ghrelin receptor agonist.
Disease: cachexia-anorexia related to non-small cell lung cancer
Details: Helsinn Healthcare has granted Specialised Therapeutics Australia (STA) exclusive commercialisation rights to anamorelin, a new drug for the treatment of non-small cell lung cancer cachexia-anorexia. 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. Under the terms of the 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 (Helsinn data on file). The phase III anamorelin registration trial is ongoing.
The anamorelin phase III clinical trial program (ROMANA 1, 2 & 3) began in Q4 2011 and will complete enrolment in the second half of 2013. It is anticipated that a New Drug Application will be filed with the FDA in mid-2014. Immediately thereafter, a submission for Australian regulatory approval will be lodged with the Therapeutic Goods Administration (TGA).
Financial terms:
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