PTD unknown

new patent!!!!!!!!!!!!!!!! ***********************

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    25 August 2004
    ASX / MEDIA ANNOUNCEMENT
    Peptech Awarded Protective U.S. Patent for Dog Contraceptive
    Peptech Animal Health, a wholly-owned subsidiary of Australian biotechnology company
    Peptech Limited (ASX code: PTD), today announced it had been awarded an additional U.S.
    patent to further cement protection of the intellectual property in its peptide-based dog
    contraceptive implant, Suprelorin..
    U.S. Patent Number 6,777,386 is a continuation of protection for the formulation of
    Suprelorin., the core patent for which was granted in 2002. Peptech was awarded an initial
    patent in 1999 to cover its unique slow-release mechanism that allows the key active drug
    ingredient to be slowly released. The drug remains effective for 6 months, and on recent
    indications, for up to 12 months and more.
    Suprelorin. is protected until 2020 by patents in Australia, New Zealand, the United States and
    Europe, with patents pending in other countries.
    The issue of this most recent patent consolidates Peptech’s position as a world leader in slow
    release implantable technology for veterinary applications.
    The six-month version of Suprelorin. is scheduled for launch in Australia and New Zealand in
    the fourth quarter of this year, supported by a launch campaign to veterinary practices and dog
    owners. Final registration trials for the 12-month version of the implant will be complete in
    January 2005. Successful completion of these trials will validate the 12 month product, and these
    trials are on track.
    Peptech will increase the scale of its manufacturing facility at North Ryde (Sydney) to produce
    Suprelorin. in commercial quantities. Executive Chairman, Mel Bridges stressed that the scaleup
    in manufacturing was well within original cost estimates and presented no foreseable
    challenges to the company.
    Suprelorin. is a contraceptive hormone for male dogs that is administered by vets to provide a
    safe, effective fertility-control alternative to castration. Because it stops production of
    testosterone, Suprelorin. achieves reversible sterilisation as well as behaviour modification, and
    has been shown to be effective in treating benign prostrate hyperplasia. Without testosterone, the

    painful conditions associated with non-cancerous prostate tumours (common in older dogs that
    have not been castrated) are prevented.
    Mr Bridges said the latest U.S. patent further strengthened protection for Suprelorin. at a time
    when there is an increasing global demand for a non-surgical, humane way to sterilise
    companion animals.
    “Castration is not always the best option for male dogs for a variety of reasons, and in some
    cultures, including many in Europe, it’s becoming increasingly unpopular. In some regions the
    practice of castration for dogs is now illegal,” said Mr Bridges.
    Suprelorin. gives vets and dog owners a more humane, but equally efficacious and costeffective
    alternative – it provides a choice.
    Mr Bridges said sales of Suprelorin. in Ausralian and New Zealand will provide the guidance
    on the product’s international earnings potential, as Peptech Animal Health continues discussions
    with global pharmaceutical companies about the commercialisation and ongoing development of
    the product in major international markets. The company has an established reputation in
    veterinary markets through its other main veterinary product, Ovuplant., which stimulates
    ovulation in broodmares and is used widely by horse breeders worldwide.
    “Suprelorin. has enormous potential, beyond the reversible sterilisation of male dogs, to
    improve the health of many species of animals on a number of fronts,” said Dr. Tim Trigg,
    Managing Director, Peptech Animal Health. “For instance, our latest tests show that it is also
    effective in treating incontinence in spayed bitches, giving dog owners a convenient six-monthly
    implant option over the current requirement for administration of a daily pill.
    “Our immediate goal, however, is to promote the product internationally as an alternative to
    castration. On a recent trip to international veterinary conferences in the USA and Brazil, the
    product was very well received, both for its approved contraceptive use and for the other exciting
    applications we are working on,” Dr. Trigg said.
    Patent applications are being expanded to cover repeat usage, extended duration, use in females,
    use for other indications and for other animal species.
    Suprelorin. is already being tested in wildlife parks and zoos for population control on a number
    of different species including lions, cheetahs, monkeys, dolphins, seals and a variety of other
    mammals.
    There is a high-volume sales outlook for Suprelorin. both domestically and internationally.
    Australia has the highest per capita rate of pet ownership in the world, with 37 per cent of
    households owning nearly 4 million dogs. There are 56 million pet dogs in the United States, 30
    million in Europe and 10 million in Japan.
    To seize this market opportunity, Peptech is proceeding with clinical trials in Europe and the
    United States, followed by registration applications to the Federal Drug Administration (FDA)
    and European regulatory authorities.

    Key facts about Suprelorin.:
    The active agent in Suprelorin. is a synthetic hormone which releases a hormone agonist
    (LHRH) that stops the pituitary gland sending chemical messages to the gonads to produce the
    steroid hormones. The drug delivery platform for Suprelorin. - a subcutaneous, slow-release,
    lecithin-based, biocompatible implant - is unique in the market and has wide potential
    applications. Peptech is a world leader in this type of slow-release implantable technology.
    Suprelorin. is administered as a 2.3mm x 12mm cylindrical dose inserted between the dog’s
    shoulders. The disposable implanter is no larger than that used to implant microchips in dogs and
    is a highly cost-effective way to deliver the drug. No anaesthetic is required and there is no
    discomfort, recovery or scarring as would be associated with surgery. Trials of up to five
    consecutive treatments over three years have shown that fertility returns when treatment is
    stopped, making the treatment reversible – this is a major bonus for breeders.
    About Peptech:
    Peptech Limited focuses on the research and development of peptides and proteins in
    the areas of human pharmaceuticals and animal health. The company is positioning
    itself to become a globally recognised leader in biopharmaceutical development.
    For more information, visit:
    www.peptech.com
    Further information:
    Mel Bridges
    Executive Chairman
    Peptech Limited
    Tel: 02 9870 8788
    Mobile: 0413 051 600
    Media inquiries:
    Rachel Harris
    Phillips Group
    Tel: 02 9233 4499
    Mobile: 0401 134 147
    Email: [email protected]
 
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