STA licenses treatment for cachexia-anorexia

Specialised Therapeutics Australia (STA) has negotiated commercialisation rights for a new drug to treat cachexia-anorexia, a serious condition linked with advanced cancers.

STA has signed a licensing and distribution deal for Anamorelin from its developer, Swiss-based Helsinn.

The deal grants STA exclusive commercialisation rights to the product in Australia and New Zealand.

Helsinn will retain all development activities for Anamorelin, while STA will take charge of regulatory/clinical development and commercial activities within Australia and New Zealand.

The target, cachexia-anorexia, is a multifactorial disorder which involves muscle wasting and metabolic impairment. It is linked with cancers including non-small cell lung cancer. Symptoms include weight loss, anorexia, fatigue and low albumin.

Anamorelin seeks to alleviate these symptoms by employing an agonist against the ghlerin receptor, a hunger-stimulating hormone produced by cells lining the fundus of the human stomach.

Phase II trials of the drug have demonstrated an improvement in appetite and an increase in lean body mass in patients with cancer cachexia-anorexia. A phase III program began in Q4 of 2011, and is scheduled to complete enrolment by the second half of 2013.

There are currently no approved treatments for cacheta-anorexia in Australia, the EU or the US. The companies plan to file for TGA approval straight after submitting a new drug application with the US FDA. This application is expected in mid-2014.

STA and Helsinn are becoming inseparable partners. STA has already commercialised Helsinn's Aloxi - an antiemetic post-chemotherapy drug which received a PBS listing in late 2010 - in Australia and New Zealand.

STA has also in-licensed netupitant-palonosetron, Helsinn's new preventative treatment for chemotherapy-induced nausea and vomiting.