Development of Starpharma's VivaGel(TM) Accelerated with $US20m Funding from NIH

Oct 03, 2005, 01:00 ET from Starpharma

    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 (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
 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 (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,
       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:
      Rebecca Wilson
      Tel: +61 2 9237 2800
      Mob: +61 417 382 391
      Starpharma -
      Dr John Raff
      Chief Executive Officer
      +61 3 8532 2701
      Ben Rogers
      Company Secretary
      +61 3 8532 2702

SOURCE Starpharma