Chief executive John Raff said: "There are currently no approved products for the prevention of HIV infection. The FDA recognises the potential of Vivagel to address this unmet medical need. Vivagel's new drug application will now receive priority review, which has a shorter assessment time.
"The early review is expected to shorten FDA's approval time significantly."
Starpharma chief operating officer Jackie Fairley said the FDA's move to expedite the approval process is a significant development for the company.
"The review for the approval of Vivagel could take half the time.
"It would now take about six months instead of 13 for the new drug application to be approved and sold in the market. This means that the drug could get to the market far more quickly."
Vivagel is a preventive agent to women to prevent becoming infected with sexually transmitted diseases.
It is a vaginal gel which works as a chemical barrier to protect women from contracting HIV and genital herpes during sexual intercourse.
"Vivagel is not a treatment for HIV.
"The gel is used topically prior to sexual intercourse to prevent the women from becoming infected with HIV, genital herpes and other sexually transmitted diseases," Dr Fairley said.
HIV, which leads to AIDS, is a major health burden. Forty million people worldwide are infected with the virus.
In Australia about 15,000 have been diagnosed with HIV/AIDS.
About 50 million people in the US are infected with genital herpes. In Australia there are about 3.4 million people with genital herpes. About 16 per cent of sexually active women and 8per cent of men are infected with the disease. Dr Fairley said people with genital herpes were five to seven times more likely to contract HIV.
She said a Phase One safety study of Vivagel was completed recently. The drug is expected to be approved for sale in the US, Europe and Australia by late 2008.
Starpharma, listed on the stock exchange in 2000, has a market capitalisation of $70 million.
Its chairman is Peter Bartels, former chief executive of Coles Myer. Recently the company signed a $US20 million ($26 million) contract with the US National Institute of Allergy and Infectious Diseases, part of the National Institute of Health.
