STA cleared to market C. difficile treatment


By Dylan Bushell-Embling
Friday, 26 April, 2013


STA cleared to market <em>C. difficile</em> treatment

Specialised Therapeutics Australia (STA) has secured TGA approval for fidaxomicin, its licensed treatment for hospital superbug Clostridium difficile (C. difficile).

Melbourne-based STA has been given the all-clear to market fidaxomicin - trade name DIFICID - for C. difficile infections.

Fidaxomicin is a macrocyclic antibiotic therapy administered in tablet form. It is designed to be minimally absorbed into the bloodstream and to fight C. difficile infections while leaving healthy gut flora alone.

STA last year signed a licensing deal with US-based Optimer Pharmaceuticals to become the exclusive distributor of fidaxomicin in Australia and New Zealand.

C. difficile is a common infection plaguing hospitals and aged-care facilities. Symptoms include moderate to life-threatening diarrhoea. Older patients are particularly vulnerable. Infection recurs in roughly 30% of patients.

STA CEO Carlo Montagner said fidaxomicin “is a potentially life-saving drug for this extremely serious infection plaguing public hospitals and the wider community”.

Immuron (ASX:IMC), another Melbourne biotech company, has been working with Monash University to develop their own treatments for C. difficile infections. Lab tests of a candidate conducted last year showed a 100% survival rate in animal models.

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