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COMPANY WEBSITE
http://www.starpharma.com/framemaster.htm
COMPANY PROFILE
Welcome to Starpharma Holdings Limited
Starpharma is creating value from dendrimer-based nanotechnology through:
* the development of high-value dendrimer nanodrugs to address unmet market needs;
* partnering with pharmaceutical companies to create new opportunities and solutions to problems with the application of dendrimer nanotechnology;
* extending our core skills and know-how through licensing and partnering with others;
* parallel investment in non-pharmaceutical applications of dendrimer nanotechnology.
Company Overview
Starpharma is an ASX listed company established in 1996 to develop a polyvalent technology based on large molecules called dendrimers. Commencing in 1992, the Biomolecular Research Institute (BRI) in Melbourne, Australia, first investigated dendrimers as protein mimics for pharmaceutical applications, before licensing the technology to Starpharma.
Dendrimer nanotechnology...
Dendrimers are synthetic, nanoscale compounds with unique features and benefits making them useful for development as pharmaceuticals, and for incorporation in new and existing products. Starpharma creates dendrimers to achieve polyvalent (i.e. multiple) interaction with biological targets across a wide range of diseases. Dendrimers can be designed to achieve novel pharmaceutical properties. Our dendrimer technologies are also enabling technologies that offer defined nanostructures capable of being developed and modified to offer solutions for problems in a broad range of industries, including medical (e.g. pharmaceutical), material, chemical and electronic.
Creating value...
The company aims to create value for investors 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;
* extend our IP position through partnerships and licensing;
* partner with pharmaceutical and other companies to provide new opportunities and solve problems.
Development Opportunities
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 and Tropical Diseases (toxins, exotic viruses)
The company has a very active program to explore the potential of dendrimers in a wide range of other diseases.
Product Opportunities ...
Starpharma is seeking strategic alliances and license arrangements with pharmaceutical companies for the development of its dendrimers that have demonstrated activity against a wide range of diseases.
Platform Opportunities ...
Starpharma also is keen to work with companies to enable the incorporation of this platform technology into new and existing pharmaceutical products.
PRODUCTS
Dendrimer / Medicinal Chemistry
Starpharma’s team of dendrimer chemists is a core asset of the company. The team works to generate novel intellectual property, optimise dendrimer pharmaceuticals, and provide a pipeline of new dendrimer nanodrug opportunities for commercialisation. The team’s dendrimer chemistry knowledge has been generated through over 90 man-years of experience and is an important factor in the successful commercialisation of dendrimer nanotechnology. The chemistry team has set up its own state of the art, 990m2 laboratory facilities in the Baker Heart Research Building in Melbourne, Australia.
Analytical Chemistry
Starpharma’s analytical chemistry team has developed critical analytical and bioanalytical techniques for supporting dendrimer nanotechnology development, using the latest analytical equipment including high performance liquid chromatography (HPLC), capillary electrophoresis (CE), mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectrometry.
For Starpharma and other companies developing new compounds as drugs, one of the most critical aspects of pharmaceutical product development is the ability to analyse active drug substances, formulated drug products and biological samples, such as plasma obtained during preclinical animal studies and human clinical studies, in compliance with regulatory guidelines. Starpharma’s analytical and bioanalytical chemistry team addresses this aspect of pharmaceutical development and operates in compliance with US Food and Drug Administration (FDA) regulations including 21 CFR Part 58 (Good Laboratory Practice (GLP)).
Our analytical team is developing validated techniques for the analysis of dendrimers as active pharmaceutical ingredients (APIs) in formulated drug products, animal plasma samples for pharmacology and toxicology studies, and human plasma samples to support Phase I clinical trials.
Biology
Starpharma’s biology team supports drug discovery and product development activities through the establishment of animal and cell based assays to screen dendrimer nanodrugs for biological activity and safety. Individualised, flexible and timely testing is vital to the discovery and development of new compounds as drugs. In addition to the dedicated biology laboratory at Starpharma’s facility in Melbourne, the company also has a laboratory at the University of New South Wales, Centre for Entomological Research and Insecticide Technology (CERIT).
The biology team provides toxicity and activity screening services to Starpharma’s core research and development programs. Our capabilities include in vitro screening assays for angiogenesis inhibition, cancer cell line growth inhibition, antiviral activity and pro- or anti-coagulant activity, and in vivo acute and chronic toxicity testing.
An international network of collaborative research groups and institutions significantly increases Starpharma’s biological capabilities.
Product Development
Starpharma’s Product Development team coordinates Starpharma’s pharmaceutical development activities for new drug opportunities, including preclinical safety and efficacy testing, scale-up manufacturing, regulatory compliance, and liaison with external parties on aspects of specific drug development and funding. Starpharma’s lead product in development is a topical microbicide gel called VivaGel™ for the prevention of sexually transmitted diseases, such as HIV, Herpes and Chlamydia, in women.
The objectives of Starpharma’s product development program are to:
* build value and generate revenue through development of high-value products for licensing to pharmaceutical companies for further development;
* provide illustrative product development examples to demonstrate the potential application and developability of dendrimers and Starpharma’s technology.
Quality Assurance and Regulatory Affairs
The aim of Quality Assurance and Regulatory Affairs is to manage regulatory risk and provide contingencies for regulatory change. Quality systems implemented throughout Starpharma reduce risk for Starpharma’s partners and licensees by ensuring the provision of quality data and maximising the probability of regulatory approval of Starpharma’s products at all stages of development.
Quality management systems are critical to, and underpin, Starpharma’s business strategy of developing dendrimer pharmaceutical products to the proof-of-concept stage in humans and the earlier out-licensing of products in non-core areas.
Starpharma’s quality management systems have been developed in compliance with international standards, including:
* Title 21 of the United States Code of Federal Regulations - Food and Drugs (21 CFR):
* Part 58 - Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies;
* Part 312 - Investigational New Drug Application; and
* Part 11 - Electronic Records; Electronic Signatures.
Starpharma expects its contractors to meet similar quality and regulatory standards, including Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) where relevant, and has implemented programs to assure the quality of input and external service provided to the company.
Commercial Development and Intellectual Property
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.
Starpharma’s strategy is to create value from dendrimer nanotechnology by leveraging IP through licensing and partnerships. Starpharma has immediate licensing opportunities and is actively seeking strategic commercialisation partners and licensees for its technologies at all stages of development. Starpharma has an extensive patent portfolio consisting of intellectual property related to dendrimers as pharmaceuticals.
Starpharma’s commercial development and IP management skills were critical to the successful establishment of Dendritic Nanotechnologies, Inc. (DNT).
ADDRESS
Starpharma Holdings Ltd
Postal Address:
PO Box 6535
St Kilda Road Central VIC 8008
AUSTRALIA
Street Address:
Baker Building
75 Commercial Road
Melbourne VIC 3004
AUSTRALIA
T: +61 3 8532 2700
F: +61 3 9510 5955
E: info@starpharma.com
MANAGEMENT
Board of Directors
Starpharma Holdings Ltd has a board of directors with significant scientific, business, financial and legal experience.
Peter T. Bartels, CHAIRMAN
Non-Executive Director
Peter Bartels was previously CEO and Managing Director of Coles Myer Ltd and before that CEO and Managing Director of Fosters Brewing Company Ltd. He has also had broad based experience in the pharmaceutical industry in previous roles with DHA Pharmaceuticals and Abbott Laboratories. Peter Bartels is currently Chairman of the Australian Sports Commission, the Australian Institute of Sport, the Commonwealth Heads of Government Committee for Sport, and Central City Studios. He is the immediate past Chairman of the Women's and Children's Health Service. He is also a Director of the Australian Grand Prix Corporation and Melbourne Business School (Melbourne University).
John Raff, Dip. Ag. Sc., B.Sc., Ph.D. DEPUTY CHAIRMAN
Non-Executive Director
John Raff is the Chief Executive Officer of Starpharma Holdings Ltd. Previously, he was General Manager of the Biomolecular Research Institute from 1990 to 1997. John Raff received a Ph.D. from Melbourne University in 1982 for molecular biology studies on cell recognition systems, under the supervision of Professor Adrienne Clarke. He is the co-founder, director and major shareholder of a technology-based agricultural seed company with subsidiary operations in India. John Raff is also founder and investor in a number of start-up technology companies.
Jackie Fairley, B.Sc., B.V.Sc. (Hons), MBA.
Chief Executive Officer, Executive Director
Dr Jackie Fairley was appointed Chief Executive Officer of Starpharma in July 2006 having joined the company as Chief Operating Officer (COO) in July 2005. Jackie has over sixteen years experience in the pharmaceutical and biotechnology industries working in business development and senior management roles with companies including CSL and Faulding (now Mayne Pharma). Prior to joining Starpharma she was Chief Executive Officer of a private biotech, Cerylid Biosciences. During her time as CEO the company generated revenues of over $20 million from pharmaceutical partners including Aventis, Chugai and Chiron, raised more than $10 million equity and completed the acquisition of a private kinase company. From 1995 to 2000 Jackie was Vice President - International Business Development for Faulding’s injectable division where she was responsible for the group’s global business development and injectable product development programs, supporting product sales in excess of $200M into 70 countries, including the US and Europe. Jackie holds first class honours degrees in Science (pharmacology/pathology) and Veterinary Science, and has an MBA from the Melbourne Business School where she was the recipient of the prestigious Clemenger Medal. She is a member of Federal Government’s Pharmaceutical Industry Working Group and the Australian Biotechnology Advisory Council.
Professor Peter Colman, B.Sc., Ph.D., FAA, FTSE
Non-Executive Director
Peter Colman was formerly executive director of the Biomolecular Research Institute. Peter was educated at the University of Adelaide, South Australia, and has worked at the University of Oregon, USA, the Max Planck Institute for Biochemistry, Munich, Germany, the University of Sydney and the CSIRO. He is published widely in the field of structural biology, and in 1983, Peter Colman’s laboratory determined the structure of the surface proteins of influenza virus, leading to the discovery of the influenza drug, Relenza. Peter Colman was a founding director of Biota Holdings Ltd.
Ross Dobinson, B.Bus. (Acc), ACA
Non-Executive Director
Ross Dobinson has a background in investment banking and stockbroking. He has acted as corporate director for two leading stockbrokers, was an executive director of the National Australia Bank’s corporate advisory subsidiary, and later headed the corporate advisory division of Dresdner Australia Ltd. Ross Dobinson is currently managing director of TSL Group Ltd, a corporate advisory company specialising in establishing and advising life science companies. He is also a director of Acrux Ltd, Nutrihealth Pty Ltd, Plantic Technologies Ltd and Roc Oil Company Ltd, chairman of Micronix Pty Ltd, director of PharmaQest Pty Ltd, Diagnotech Pty Ltd and Cardanal Pty Ltd.
Leon Gorr, B. Juris, LLB, M Admin
Non-Executive Director
Leon Gorr is a senior partner of Herbert, Geer & Rundle. As a solicitor, he has had extensive experience in a broad range of commercial transactions, providing advice on the negotiation and interpretation of technology licensing agreements. Clients include investors in, and advisors to the biotechnology industry.
Peter Jenkins, MB, BS, FRACP
Non-Executive Director
Peter Jenkins is a consultant physician and gastroenterologist. He holds a number of clinical and research positions at the Alfred Hospital, and has held a number of clinical positions with the Baker Medical Research Institute. He has served on the Victorian State Committee of the Royal Australasian College of Physicians and held the position of Clinical Dean for the Monash University Faculty of Medicine. Peter Jenkins is a foundation director of Anadis Ltd, a listed bio-pharmaceutical company.
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