MELBOURNE, Australia, Jan. 9 /PRNewswire-FirstCall/ -- Starpharma
(ASX: SPL, USOTC: SPHRY) today announced that the US Food & Drug
Administration (FDA) has granted Fast Track status to VivaGel(TM), 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(TM) to address this
unmet medical need," commented John Raff, CEO of Starpharma. "VivaGel's(TM)
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(TM)
development program. This is excellent news for VivaGel(TM) and for
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(TM) is currently being developed as a vaginal microbicide gel to
prevent the transmission of genital herpes and HIV. VivaGel(TM) 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(TM) 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(TM) 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(TM) (SPL7013 Gel), a vaginal microbicide
designed to prevent the transmission of STIs, including HIV and genital
VivaGel(TM) 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(TM) (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 cancer cells).
Starpharma also has equity interests in two companies:
-- Dendritic NanoTechnologies, Inc. (DNT) -- established with the pioneer
of dendrimer nanotechnology Dr Donald A. Tomalia and based in Michigan,
-- Dimerix Bioscience Pty Ltd -- a specialist drug development company
established to commercialise unique technology developed at the Western
Australian Institute for Medical Research in the new field of receptor
coupling, specifically G-Protein coupled receptors ("GPCRs").
Dendrimers: A type of precisely-defined, branched nanoparticle.
Dendrimers have applications in the medical, electronics, chemicals and
Microbicides: A microbicide inactivates, kills or destroys microbes such
as viruses and bacteria. Microbicides may be formulated as gels, creams,
sponges, suppositories or films with the purpose of reducing significantly the
incidence of STIs. They are intended for vaginal or rectal use to afford
protection for varying periods, from several hours up to days. Microbicides
may also be designed to have a contraceptive function.
American Depositary Receipts (ADRs): Starpharma's ADRs trade under the
code SPHRY (CUSIP number 855563102). Each Starpharma ADR is equivalent to 10
ordinary shares of Starpharma as traded on the Australian Stock Exchange. The
Bank of New York is the depositary bank.
For further information:
Media: Rebecca Wilson - Buchan
Tel: +61 2 9237 2800 -- Mob: +61 417 382 391 -- firstname.lastname@example.org
Dr Jackie Fairley -- Chief Operating Officer
+61 3 8532 2715 -- email@example.com
Ben Rogers -- Company Secretary
+61 3 8532 2702 -- firstname.lastname@example.org