Starpharma

section heading graphic   Overview

Starpharma Pooled Development Ltd is an ASX listed company established in 1996 to develop polyvalent nanoscale molecules called dendrimers, which had been under development by the Biomolecular Research Institute (BRI) in Melbourne, Australia, since 1992. The BRI first investigated dendrimers as protein mimics for pharmaceutical applications, before licensing the technology to Starpharma Pooled Development Ltd’s subsidiary company, Starpharma Ltd (“Starpharma”). Today, Starpharma Pooled Development Ltd has parallel investments to develop both pharmaceutical and non-pharmaceutical applications of dendrimer nanotechnology.

As a registered pooled development fund (PDF), shareholders of Starpharma Pooled Development Ltd are entitled to significant taxation benefits. Investee companies include Starpharma Ltd, which manages the group’s activities associated with the development and commercialisation of dendrimers for pharmaceutical applications, and Dendritic Nanotechnologies, Inc. (DNT) based in Michigan, USA, which carries out the development and commercialisation of dendrimers for other applications.

Starpharma’s team of highly skilled dendrimer chemists is a core asset of the company. The team’s dendrimer and medicinal chemistry knowledge has been generated through years of experience and is an important factor in the successful commercialisation of dendrimer nanotechnology.

The company aims to create value for shareholders from dendrimer nanotechnology by growing and utilising our team’s core skills in dendrimer and medicinal chemistry, and associated development, commercialisation and regulatory compliance activities to -

  • advance selected pharmaceutical products through early stage development;
  • leverage our IP position through partnerships and licensing;
  • partner with pharmaceutical and other companies to provide new opportunities and solve problems.

section heading graphic   Technology

Starpharma’s leading product in late stage preclinical development is a vaginal microbicide, VivaGel™, for the prevention of HIV and other sexually transmitted diseases (i.e. hepatitis B, herpes simplex and Chlamydia). In recent primate studies, VivaGel™ was 100% effective in the control of HIV infection. Starpharma is submitting an IND application to the US FDA for human trials of the microbicide in June 2003. This is the first dendrimer based product to go through the US regulatory system.

Nanotechnology is the manipulation of matter, molecule by molecule, to create new materials with novel, tailored properties. Dendrimers (dendri – tree, mer – branch) are synthetic, nanoscale structures that can be tailored for various applications. Specialised chemistry techniques allow for precise control over the physical and chemical properties of the dendrimers. They are constructed generation by generation in a series of controlled steps that increase the number of small branching molecules around a central core molecule. The final generation of molecules added to the growing structure makes up the polyvalent surface of the dendrimer and can be chosen to give desired properties and functions.

Dendrimers are nanoscale compositions of matter with a wide range of applications in diverse industries including medical, electronics, chemicals and materials. Dendrimers also provide a unique system to design and synthesise nanotechnology components.

Dendrimers are polyvalent, meaning that a single dendrimer can have multiple, simultaneous attachments to biological targets (e.g. cell surface). Polyvalent interactions are significant in the development of novel pharmaceuticals. Many natural biological structures possess multiple binding, or therapeutic, targets. Polyvalent molecules can effectively and efficiently interact with these multiple binding targets, resulting in enhanced or novel pharmaceutical activity compared with small molecules.

Dendrimers can be similar in size to biological structures, such as proteins. Dendrimers are suitable for the development of polyvalent, highly defined pharmaceuticals with unique activities and applications, or for creating new and improved presentations of existing pharmaceuticals. Some benefits of dendrimers as drugs include their activity against a wide range of diseases, stability as solids and in a variety of pharmaceutical formulations, favourable toxicity profile, reproducible and defined structures and cost effective cGMP manufacture.

By altering the surface composition, dendrimers can be targeted to specific diseases, tissues or organs, and important properties such as bioavailability can be altered.

section heading graphic   Competitive Advantages

Starpharma has established a leading IP position in dendrimer pharmaceuticals. Starpharma’s technology is protected by a number of patents covering a wide range of applications of dendrimers and polyvalent compounds. Three of these patents are broad-based patents granted in the US.

In addition to its own extensive intellectual property portfolio, Starpharma also has license rights to 33 patent families (182 issued patents) and all future IP relevant to pharmaceuticals from Dendritic Nanotechnologies, Inc. (DNT).

Starpharma’s dendrimer nanotechnologies have several competitive advantages over other technologies -

  • dendrimers are polyvalent while most conventional small molecules are not;
  • compared with large linear polymers, dendrimers are rigid structures that enable more predictable placement of surface groups and greater control of surface functionality;
  • dendrimer properties can be easily tailored for a wide range of applications and functions.

section heading graphic   Corporate Alliances / Partnerships

Funding for Starpharma’s development projects has been sought and obtained from government (Australian and US) grants. In this way, shareholder equity is maintained, and even increased, compared with the alternative strategy of raising additional capital through the issue of new shares. A key part of Starpharma’s strategy in reducing development cost is to form relationships and alliances with leading companies and institutions around the world, including universities, contract research organisations and contract manufacturers.

Starpharma’s extensive network of international collaborators significantly expands our capabilities in the full spectrum of drug development activities from discovery research through to GMP manufacture.

Partners

Australia and New Zealand:

  • Industrial Research Limited (Wellington)
  • Institute of Drug Technology (IDT) Australia, Ltd (Melbourne)
  • Monash University (Melbourne)
  • Peter MacCallum Cancer Institute (Melbourne)
  • RMIT University (Melbourne)
  • University of New South Wales, Centre for Entomological Research and Insecticide Technology (Sydney)
  • Victorian College of Pharmacy, Centre for Drug Candidate Optimisation

Europe

  • Institute of Organic Chemistry and Biochemistry (Czech Republic)
  • REGA Institute (Belgium)

USA

  • Cincinnati Children’s Hospital Medical Center (Ohio)
  • Dendritic Nanotechnologies, Inc. (Michigan)
  • Fox Chase Institute for Cancer (Pennsylvania)
  • Georgetown University (Maryland)
  • Institute for Antiviral Research, Utah State University (Utah)
  • National Institutes of Health (NIH), NCI and NIAID (Maryland)
  • US Army Medical Research Institute for Infectious Diseases (Maryland)
  • University of Alabama (Alabama)

Partnering Opportunities

Dendrimers have potential applications such as:

  • new drugs with unique activities;
  • targeted drug delivery or modifying agents for new and existing drugs;
  • diagnostics;
  • many other life and non-life science products.

Starpharma has immediate licensing opportunities and is actively seeking strategic commercialisation partners and licensees for its technologies at all stages of development. Starpharma also seeks to work with companies to enable the incorporation of its platform technologies into new and existing pharmaceutical products.

Starpharma’s current development programs focus on compounds with therapeutic activity in the following specific disease areas -

  • sexually transmitted diseases (e.g. HIV)
  • respiratory viruses (e.g. influenza, RSV)
  • systemic viral diseases (e.g. HBV)
  • cancer (angiogenesis)
  • biodefense (toxins, exotic viruses)

Potential benefits of Starpharma’s technology for licensees and partners include -

  • opportunities for development of new pharmaceuticals with novel activities, optimised properties and significant potential market value;
  • improved pharmaceutical activity of existing drugs;
  • improved bioavailability of existing drugs;
  • improved solubility of existing drugs;
  • improved delivery of existing drugs;
  • specific targeting of organs or diseases by existing drugs;
  • reduced side effects of existing drugs;
  • extended patent life of existing drugs;
  • worldwide exclusive license opportunities.

Partnerships to develop Starpharma’s technologies could include Starpharma’s expertise for the successful development of dendrimer-based products. Starpharma’s established skills and expertise in these areas lower the barrier to entry for commercial partners and licensees in the field of dendrimer nanotechnology.

Contact Person John Raff, PhD Starpharma Logo
Job Title Chief Executive Officer
Address PO Box 6535
City/Suburb St Kilda Rd Central
Victoria 8008 Australia
Email john.raff@starpharma.com
Phone +61 3 8532 2701
Fax +61 3 9510 5955
Website www.starpharma.com

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