STA to bring new CDI treatment to A/NZ

Specialised Therapeutics Australia (STA) has secured a deal to launch a new therapy for the colostrum difficile “superbug” in Australia and New Zealand.

The Melbourne biopharma has signed an exclusive distribution and licensing deal with US-based Optimer Pharmaceuticals to develop and commercialise macrolide antibiotic fidaxomicin in the two markets.

Optimer has filed an application with the Therapeutic Goods Administration for the drug. STA will take over the registration, and expects to commercially launch the product by June 2013.

Colostrum difficile infection (CDI) is an infection of the inner lining of the lower colon with c. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, severe diarrhoea and - in very severe cases - death.

CDI is a common problem plaguing hospitals and long-term care facilities. University of Western Australia professor Thomas Riley, a c. difficile authority, said he estimates that infection rates are rising two- to threefold in public hospitals across Australia.

A growing number CDI cases are also being discovered in the general population.

CDI is associated with use of broad spectrum antibiotics, which kills normal bowel bacteria, allowing c. difficile to overgrow.

As a macrolide antibiotic, fidaxomicin is designed to be minimally absorbed by the bloodstream, and leave healthy gut bacteria untouched. It inhibits the bacterial enzyme RNA polymerase, which kills c. difficile bacteria. The drug is administered in tablet form.

Fidaxomicin has been approved by the US FDA to treat colostrum difficile associated diarrhoea (CDAD) in adults, and has marketing authorisation in Europe.

Optimer Pharmaceuticals markets fidaxomicin tablets under the name trade name DIFICID.