Genepharm cheers regulatory approval

Generic medicines company Genepharm Australasia's (ASX:GAA) brand of Simvastatin has been listed in the Australian Register of Therapeutic Goods, the final stage of TGA approval and registration process for its cholesterol-reducing drug.

Simvastatin is the second largest PBS drug, accounting for more than 5.8 million prescriptions in Australia in the 12 months to June 2005 at a dispensed value of AUD$390 million.

Genepharm has confirmed pre-launch sales orders and sales revenues will begin in April. The company will also launch two other licensed drugs, an antibiotic and an anti-diabetic with total dispensed sales of more than $50 million in 2005 at the same time.

According to Genepharm, a number of other large market size drugs are expected to be approved by TGA in 2006, and are slated for Genepharm's major round of product launches in the next PBS release in August 2006, with further products to also be launched in December 2006.

Genepharm listed on the ASX in June 2004 and aims to make 40-50 generic drug submissions to the TGA in its first three years of operation to the end of 2007. Genepharm's share's rose almost 14 per cent on the announcement made yesterday and at press time shares were trading up 2.5 cents at $1.29.