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Protemix Named Company Of The Year

Protemix Corporation has been named Biotech Company of the Year at the annual Hi-Tech Awards, held in Auckland last night (Saturday November 15).

The five year-old biopharmaceutical company is a world leader in the discovery, development and commercialisation of pharmaceutical treatments for diabetes. The Protemix approach is to link the best in NZ; from academic, commercial, and medical expertise with Government and financial investment institutions, and in turn couple this with international expertise. The outcome is an innovative company structure able to move drug therapies from development to market rapidly; making Protemix a ‘turbo-hybrid biopharmaceutical corporation’. Protemix’s combination of a drug discovery programme and its own clinical drug trial expertise is receiving international recognition for the development of a number of new diabetes therapies. It has received FDA confirmation that on application, approval to enter Phase 111 clinical trials would be granted with ‘fast-track’ status for Protemix’s lead compound ‘Laszarin’™.

The company has a deliberate philosophy of using NZ expertise in drug discovery and through its association with the University of Auckland, integrates academic student research into focused discovery programmes, leading to employment opportunities. This unique relationship sees the University of Auckland as a share-holder in Protemix, providing access to the University laboratories and infrastructure such as technical, security, physical plant, and administrative support. Recent figures released from the International Diabetes Foundation recognise that just under 200 million people are affected by diabetes, which is expected to rise by 50% over the next 15 years. Protemix CEO, Professor Garth Cooper says “It is one of the leading causes of death and disability globally, and whilst we expect the market for diabetes medications to exceed $US20bn pa by 2006, the delivery of new drugs to market is a long and difficult path and remains high risk to the end,”. The fledgling status of the biopharmaceutical industry in NZ has presented an opportunity for Protemix to ‘write the book’ as a model of an innovative biotechnology company, specifically tailored to resources within NZ. The company has an innovative business strategy linking NZ academic, medical and financial expertise with to international experts and companies. Its three-division structure and cross-disciplinary approach gives scientists in the laboratory direct access to medical/clinical input in their experimental design. “It ensures that Protemix is a science-driven biotech company firmly focused on the clinical development endpoints - even at the level of basic research and day-to-day management decisions,” says Professor Cooper. While Protemix is a relatively young company, the “after-guard” has a wealth of experience. Key management individuals are the CEO/ CSO, Professor Garth Cooper and the CMO, Dr John Baker, both highly qualified through achieving success in both business and medicine. Professor Cooper made previous breakthroughs in diabetes research, discovering the peptide hormone, amylin (soon to be marketed as SymlinTM, for diabetes therapy) and co-founded Amylin Pharmaceuticals in the US, (NASDAQ: AMLN) with a current market capitalization of US$2.4B. Dr Baker, a diabetologist, invented a biochemical assay, now licensed to Roche, which became one of the standard measures for monitoring patients’ diabetic control. Recent changes to the Board have brought in business expertise in the combination of David Pool (CFO), Bill Birnie (investor capital) and QC, Dr Tony Molloy (tax law). The most recent endorsement for the potential of Protemix is the recruitment of the international expertise of Professor Keith Mansford (UK), former Chairman of R&D at SmithKline Beecham, as the Chairman of the new Protemix Board. Two years ago, Protemix received the Hi-Tech ‘Start-up of the Year” award.

Notes for editors: PROTEMIX BACKGROUND INFORMATION Protemix is a biopharmaceutical company that develops novel therapies for cardiovascular disease, diabetes mellitus and other metabolic disorders. Protemix was founded in 1999 to commercialise the research of Professor Garth Cooper and Dr John Baker, both internationally recognized researchers with proven records of commercial success. Professor Cooper, Protemix’s Chief Executive Officer and Chief Scientific Officer of Protemix, discovered the peptide hormone amylin and invented amylin replacement therapy for diabetics. In 1987, Professor Cooper initiated commercialisation of his discovery by co-founding Amylin Pharmaceuticals, a NASDAQ-listed diabetes biopharmaceutical company currently capitalized at over US$2.4 billion. Protemix has developed an extensive pipeline of diabetes-related drug candidates. The Company’s lead compound, GC811007, is a potential blockbuster treatment for diabetic heart disease, a generally fatal complication associated with Type 2 diabetes for which current treatment options are relatively ineffective. The FDA has also agreed to Protemix’s request that upon application GC811007 be granted “fast track” Phase III trial status. This is thought to be the first time a drug being developed in the southern hemisphere has received fast track status. Fast track status is granted to drugs where the FDA believes the benefits of the drug to the target patient population are unique and significant.

Diabetes is one of the most common and serious diseases affecting mankind, with over 194 million people with Type 2 diabetes worldwide. This number is expected to rise to almost 330 million by the year 2025. Much of this increase will be due to population aging, unhealthy diets, obesity and a sedentary lifestyle. By 2025, most people with diabetes in developed countries will be aged 65 years or more. However, most people with diabetes in developing countries will be in the 45 – 64 year age range and affected in their most productive years. It is believed that only 30% of diabetes sufferers are diagnosed globally. The economic costs of diabetes are massive. Direct healthcares costs for treating diabetes in the United States alone, amounted to US$92 billion in 2002 with the costs of disability and death arising from complications amounting to a further US$40 billion. In New Zealand the estimated direct cost of treating diabetes in 1999 was $270 million with the indirect costs estimated to be at least that amount again. Diabetes is associated with long-term complications that affect almost every part of the body. The disease can lead to blindness, heart and blood vessel disease, strokes, kidney failure, amputations and nerve damage. Whilst there have been numerous attempts to target the underlying mechanism of diabetes complications, there are no FDA approved therapies which specifically target the underlying mechanism of diabetes complications.

Protemix has developed a detailed understanding of potential mechanisms underlying the complications associated with diabetes diabetic and microvascular disease. This has led Protemix to develop a number of new therapies with significant potential to address the huge and rapidly growing markets for diabetes and cardiovascular disease.

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