MELBOURNE, Australia, Oct. 3 /PRNewswire-FirstCall/ --
* Development of VivaGel(TM) significantly accelerated
* Development costs externally funded through to the start of large-scale
* 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 (ASX: SPL, USOTC: SPHRY) 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
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).
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), 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,
* 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:
Tel: +61 2 9237 2800
Mob: +61 417 382 391
Starpharma - www.starpharma.com
Dr John Raff
Chief Executive Officer
+61 3 8532 2701
+61 3 8532 2702