|Melbourne, Australia: Monday 9 January 2006: Starpharma (ASX:SPL, USOTC:SPHRY) today announced
that the US Food & Drug Administration (FDA) has granted Fast Track status to VivaGel, an
Investigational New Drug (IND) for the prevention of HIV.
"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," commented John Raff, CEO of Starpharma.
"VivaGel's New Drug Application (NDA) will receive Priority Review which has a shorter review time.
Fast Track status also provides more opportunity for Starpharma to communicate with the FDA to ensure
the success of the VivaGel development program. This is excellent news for VivaGel and for Starpharma."
Under the FDA Modernization Act of 1997, the Fast Track drug development program facilitates and
expedites the development of products that serve unmet medical needs of serious or life threatening
conditions. This program provides formal mechanisms for sponsors to communicate with the FDA on
product development issues, including clinical trial design. Under the Fast Track program, portions of the
NDA can be submitted to the FDA before the application is completed. This early review is expected to
shorten FDA approval times significantly.
|VivaGel is currently being developed as a vaginal microbicide gel to prevent the transmission of genital
herpes and HIV. VivaGel was also recently awarded US$20 million by the US-based NIAID, a division of
the National Institutes of Health (NIH) to accelerate its development.
The commercial opportunity for VivaGel is very significant, both in industrialized nations and the developing
world. In the USA, AIDS (a result of HIV infection) is now the number one cause of death among
African-American women between the ages of 25 and 34 and genital herpes affects approximately 50
million Americans. With no cure currently available for HIV or genital herpes, and the limited success of
existing prevention strategies, infection rates in the US and elsewhere are expected to continue to rise
sharply. Microbicides such as VivaGel are now recognised as a key element in this fight against genital
herpes and HIV.
Starpharma Holdings Limited (ASX:SPL, USOTC:SPHRY) leads the world in the application of
nanotechnology to pharmaceuticals. The Company's lead development product is VivaGel (SPL7013 Gel), a
vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
VivaGel is the first example of a product to come from Starpharma's dendrimer-based discovery pipeline,
which also includes specific programs in the fields of ADME Engineering (using dendrimers to control
where and when drugs go when introduced to the body), Polyvalency (using the fact that dendrimers can
activate multiple receptors simultaneously) and Targeted Diagnostics (using dendrimers as a scaffold to
which both location-signalling and targeting groups are added to allow location of specific cell type, such as
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|Microbicide Vivagel Receives Fast Track Status