MELBOURNE, Australia, Oct. 3 /PRNewswire-FirstCall/ -- * Development of VivaGel(TM)
significantly accelerated * Development costs externally funded through to the
start of large-scale efficacy trials * No loss of product ownership or dilution
of equity for Starpharma * Significant commercial opportunity exists for VivaGel(TM)
in North American and European markets
Starpharma's VivaGel(TM), a vaginal microbicide
against sexually transmitted infections (STIs), received
a major boost today with the award of $US20.3m development
funding by the US-based National Institute of Allergy
and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH).
This is one of the largest awards ever made in Australia
by the NIAID.
Under this award, the development will be led by
Starpharma's Vice President of Drug Development,
Tom McCarthy. Starpharma is a leader in the application
of nanotechnology to pharmaceutical applications.
"We feel that this significant financial support
from the NIH demonstrates that the product rationale
and data for VivaGel(TM) to date is of the highest
quality and that VivaGel(TM) provides a very promising
approach to HIV prevention," said Dr John Raff, CEO
of Starpharma.
"In
addition to funding the development of VivaGel(TM),
we believe that the relationship with the NIH will
also provide access to key investigators and opinion
leaders who will play a significant role in ensuring
the successful development and commercialisation
of VivaGel(TM)."
VivaGel(TM): externally funded through to the start
of large-scale efficacy trials VivaGel(TM) has already
been successfully tested in a number of studies including
a Phase I human safety trial. This new funding is
significant because it accelerates the progress of
VivaGel(TM) to market, and means that VivaGel(TM)
now has fully-external, non-shareholder funding through
to the start of large-scale efficacy trials.
Significant commercial opportunity exists in North
American and European markets along with great need
in the developing world. Microbicides are expected
to be of major importance in the fight against HIV
and other STIs given the limited success of vaccine-based
approaches to date, and the relatively low rates
of condom use. VivaGel(TM) is a vaginal topical microbicide
designed to prevent the transmission of STIs during
intercourse, including HIV and genital herpes.
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. Recent prevalence
studies of HSV-2, which causes genital herpes, indicate
that approximately 45 million Americans (26% of women
and 18% of men) are infected with the virus. With
no cure currently available and the limited success
of existing prevention strategies, infection rates
in the US and elsewhere are expected to continue
to rise sharply. Moreover, infection with HSV-2 has
been shown to increase the probability of subsequent
infection by HIV.
The funding was awarded by the NIAID after an independent,
external review of the proposal to advance VivaGel(TM)
through the clinical pipeline, by an international
panel of experts in this field.
VivaGel(TM)'s value enhanced without sacrificing
Starpharma equity or product ownership.
Peter
Bartels, chairman of Starpharma added: "This
NIH support significantly reduces the financial and
development risk for VivaGel(TM) and provides a high
degree of leverage for investors thus reducing the
burden on their funding of the product. The support
is particularly attractive as it secures development
funding without the company being required to give
away any commercial rights to the product."
In
connection with the award Australian Federal Government
Minister for Industry, Tourism and Resources, Ian
Macfarlane commented: "The Australian Government,
through its $A100 million Pharmaceuticals Partnerships
Program, is an active supporter of R&D in the
pharmaceutical and biotechnology industries, particularly
companies like Starpharma that take a research lead
on such vital global health issues.
"Starpharma was recently awarded $A5.5m under P3
and previously received several R&D grants including
a $A2.7m grant for VivaGel(TM) in recognition of
the significant commercial potential of the product
and of the importance of the prevention of sexually
transmitted infections."
The NIAID/NIH funding is provided under a contract
with Starpharma and development activities will be
conducted under a collaborative research agreement
with a team of internationally recognised leaders
in the development of new HIV treatment and prevention
measures including the Burnet Institute (Melbourne,
Australia), The National Centre for HIV Epidemiology
and Clinical Research at the University of New South
Wales (Sydney, Australia) and the Thai Red Cross
AIDS Research Centre (Bangkok, Thailand).
About Starpharma:
Starpharma Holdings Limited leads the world in the
application of nanotechnology to pharmaceuticals.
The Company's lead development product is VivaGel(TM),
a vaginal microbicide designed to prevent the transmission
of STIs, including HIV and genital herpes.
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-signaling 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, USA; and * 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"). 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 rwilson@bcg.com.au Starpharma
- www.starpharma.com Dr John Raff Chief Executive Officer +61 3 8532 2701 john.raff@starpharma.com Ben
Rogers Company Secretary +61 3 8532 2702 ben.rogers@starpharma.com
Source: Starpharma CONTACT: Rebecca Wilson of Buchan, +61-2-9237-2800,
Cell: +61-417-382-391, rwilson@bcg.com.au ;
or Dr John Raff, Chief Executive
Officer, +61-3-8532-2701, john.raff@starpharma.com ,
or Ben Rogers, Company
Secretary, +61-3-8532-2702, ben.rogers@starpharma.com ,
both of Starpharma
Web site: http://www.starpharma.com/
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