Starpharma HIV drug gets on FDA fast track

The US Food and Drug Administration (FDA) has granted 'fast track' status to Melbourne drug developer Starpharma's (ASX:SPL) VivaGel.

VivaGel is a dendrimer-based vaginal anti-microbial gel for the prevention of HIV and genital herpes. The drug has completed clinical trials for safety in humans and is expected to enter further clinical trials in 2006.

"The products eligible for fast-track status are those which meet an unmet medical need and also are used in serious or life-threatening conditions," said Starpharma COO Dr Jackie Fairley. "HIV is obviously both a serious and life-threatening condition and there are no other products available which prevent the spread of HIV."

Under the fast-tack development program, portions of a company's New Drug Application (NDA) can be submitted to the FDA before the application is completed and early review can significantly shorten FDA approval times.

"Having received fast-track status means that the FDA will give the submission priority review," said Fairley. "Importantly, it also provides more opportunity for the company to communicate directly with the FDA."

This increased dialogue means that there is a greater chance that the final submission will contain all the information required by the FDA, which "reduces the risk associated with putting the application together," said Fairley. "It means that the company can liaise directly with the FDA and can get the benefit of the FDA's input into the clinical development program and clinical trial design -- which means you get there faster but it's also a more certain route."

Starpharma hopes VivaGel will be on the market in 2008. "The sooner the product gets on the market, the sooner the opportunity for returns to shareholders through revenues derived from a product," said Fairley.

Starpharma's shares were trading at $0.52 at the time of writing, up $0.055 since the market opened this morning.