9 December 2004 ASX / MEDIA ANNOUNCEMENT Peptech launches...

9 December 2004 ASX / MEDIA ANNOUNCEMENT Peptech launches world-first pet contraceptive Peptech Animal Health, a wholly owned subsidiary of Australian biotechnology company, Peptech Limited, today announced that its patented dog contraceptive, Suprelorin®, is now available in commercial quantities. Peptech Animal Health manufactures Suprelorin® in its North Ryde, Sydney facility. An Australian innovation and world first, the patented mechanism in Suprelorin® allows the slow release of the active ingredient, deslorelin, a gonadotropin-releasing hormone similar to those used to treat human prostate cancer. The low, continuous dose of deslorelin prevents production of the sex hormones, causing a reduction in testosterone levels to zero, leading to loss of reproductive function. An important benefit of the product is that it is reversible. The drug is inserted under the skin between the dog’s shoulders, using an implanter similar to those used for microchipping for identification. The biocompatible implant disappears over time. In addition to controlling fertility and treating testosterone-related behavioural problems in dogs, Suprelorin® is also registered for use in treating benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate, which is common in older dogs that have not been castrated. Peptech Animal Health is investing in an integrated communication campaign incorporating direct mail, advertising, media relations, wholesaler support materials and a toll-free information number for animal health professionals to establish the product in the local market. The company has also employed a full-time product manager to liaise directly with veterinarians. “Castration is widely recommended in Australia and New Zealand, for good health and behavioural reasons,” said Dr Tim Trigg, Managing Director, Peptech Animal Health. “Suprelorin® provides the advantages of castration, without resorting to surgery.” There are currently four million pet dogs in Australia, which has the highest per capita household ownership of pets in the world. It is estimated that more than 400,000 puppies are born in Australia every year. The product has also been approved for sale and export to New Zealand. “Marketing success in Australia will assist us to launch the product in the USA and Europe, which have 56 million and 30 million pet dogs respectively,” Dr Trigg said. Peptech’s Executive Chairman, Mr Mel Bridges, confirmed that Suprelorin® will be manufactured and distributed worldwide from the company’s Sydney facility. B/3423111/1
“By taking the product through regulatory approval in the Northern hemisphere, Peptech will be able to take maximum profit advantage from sales of this patented device,” Mr Bridges said. “Unlike our current TNF licences, the company will have full control over the international market release, and retain ownership of the intellectual property. “We are confident we have the manufacturing ability to meet global demand for the product and, in doing so, direct maximum future profit to the company,” he added. Peptech was the first Australian biotechnology company to take a product from development through local manufacture to subsequent successful FDA approval in the USA, with its original animal health product, Ovuplant®. “Given our experience, we are positioned perfectly to launch Suprelorin® and I have a very high degree of confidence in gaining FDA and European approval,” Mr Bridges said. Peptech Animal Health has met with regulatory authorities in the USA and Europe to enable the registration process to begin as soon as possible. In some European countries, castration is illegal and in many more the practice is taboo, so there is strong potential for a non-surgical means of sterilisation to control dog numbers, and aggressive behaviour or wandering. The first release of Suprelorin® is effective for at least six months. Final registration trials of a 12-month version are due for completion in January 2005. Trials of up to five consecutive treatments over three years have shown that fertility returns when treatment is stopped. Dr Trigg said there are many cases where Australian owners will also welcome a non-surgical alternative to castrating their dogs and that Suprelorin® provides an option. “Some male owners, particularly those with ‘macho’ breeds of dogs, are not keen to castrate their pets. A quick and easy implant gives them a more humane, cost-effective choice that leaves their dogs intact but is equally efficacious,” said Dr Trigg. “The same benefits apply to dogs being shown, of course.” Dr Trigg said the reversible aspect of Suprelorin® is a major bonus for breeders and owners of show dogs, particularly if dogs are having behavioural problems in their first few years. In relation to treating BPH, the implant provides a more cost-effective, convenient option for owners over current treatments. Claims for Suprelorin® are also being expanded to cover use in females, use for other indications such as incontinenence in spayed bitches, and use in other animal species. Successful trials of Superlorin® as a population control measure have involved elephants, lions, cheetahs, monkeys, dolphins and seals, as well as several Australian marsupials. Peptech Animal Health also announced this week that it had been awarded, in conjunction with several universities and State Government wildlife agencies, a $1.4 million Australian Research Council Linkage Grant to investigate the application of Suprelorin® in the control of problematic populations of native animals including koalas and kangaroos. For commercial enquiries about Suprelorin®, telephone: 1300 365 174. B/3423111/1
About Peptech Animal Health: Peptech Animal Health is a wholly owned subsidiary of Australian biotechnology company Peptech Limited. The company’s other product is Ovuplant®, a controlled-release drug that stimulates an ovulation in brood mares with great precision and is used widely by horse breeders in an increasing number of worldwide markets. Background: Peptech Limited focuses on the research and development of peptides and proteins in the areas of human pharmaceuticals and animal health. The company is positioned to become a globally recognised leader in biopharmaceutical development. Further information: Dr Timothy Trigg Dr Paul Schober Managing Director Investor Relations Peptech Animal Health Peptech Limited Tel: + 61 2 9870 8788 Tel: + 61 2 9870 8788