Pharmaust generic drug wins TGA approval

Nedlands-based pharmaceutical company PharmAust Ltd has secured approval from Australia's Therapeutic Goods Administration for its generic version of the cholesterol lowering drug Simavastatin.

The full text of a company announcement is pasted below

PharmAust Ltd is pleased to announce that it has gained approval from the Australian Therapeutic Goods Administration for its generic version of the cholesterol lowering drug Simvastatin.

The prescription medicine - to be branded "PharmAust Simvastatin" - will compete for a share of Australia's $360 million Simvastatin market. Simvastatin is among the top five highest selling prescription medicines in Australia and is the second largest Pharmaceutical Benefits Scheme-reimbursed drug in the country.

PharmAust Simvastatin is expected to be available for distribution and sale during the second half of 2007.

The patent for the branded Simvastatin innovator expired in July 2005, allowing lower cost generic versions to be made available in Australia. Simvastatin accounts for over 5.8 million prescriptions a year.

PharmAust Managing Director Paul D'Sylva said: "The approval of PharmAust Simvastatin is a key element of PharmAust's strategy to bring a range of price competitive generic PBS prescription and over-the-counter medicines to the Australian market.

"This medicine is the first of a number of patent-expired pharmaceuticals that PharmAust will bring to market in 2007 and 2008. PharmAust expects generic versions of the painkillers paracetamol and ibuprofen to be TGA approved during the 3rd Quarter 2007, enabling the Company to compete in the $200 million Over the Counter analgesics market.

"These approvals will also provide entry into the retail grocery sector as well as further building our ties with retail pharmacies," Dr D'Sylva said.