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 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).
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,
* 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