Starpharma Holdings Limited
(ASX:SPL) (OCTQX:SPHRY) has received binding agreement from the Food and Drug Administration on the design of its phase three clinical studies of VivaGel, its lead product.
VivaGel is designed to prevent the transmission of sexually transmitted infections like genital herpes and HIV.
Chief executive of Starpharma Jackie Fairley says the rapid agreement gives the company great confidence and will allow it to proceed through the final development stage with a high level of clarity about the approval pathway for the drug.
Starpharma has a licence agreement with Ansell Limited
(ASX:ANN) and Okamoto Industries Inc in Japan to develop VivaGel coated condoms.
Starpharma Holdings Limited reported a loss of $8.93 million for the year to June 2011.
