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Apollo develops needle-free topical vaccine

SYDNEY, April 30, 2007-Australian bio-discovery company Apollo Life Sciences has released results of preliminary trials of its patented needle-free vaccine technology, which delivers tetanus vaccine transdermally (through the skin) without the need for an injection.

According to Apollo CEO John Priest, the research points the way to the possibility that flu injections may soon be a thing of the past.

"With the winter months fast approaching, people around Australia are considering getting their flu shots, so progress being made by Apollo in developing needle-less vaccines may soon spell the end of the dreaded jab," said Mr Priest.

Mr Priest said the current market for vaccines is worth over US$9 billion annually and - with more than half a billion immunisations given each year by injections - the potential market for needle-free technology is huge.

"The stress of giving vaccines in a needle, particularly to children, and the risk of needle-stick injuries and the re-use of needles in poorer countries can hinder the safe delivery of vaccines. Our needle-free vaccine technology corresponds to a goal of the World Health Organisation to encourage research into safer and simpler forms of vaccination," Mr Priest said.

The trials showed that the Apollo technology can successfully deliver tetanus toxoid vaccine directly through the skin of mice, without needles. The technology has the potential to be applied in the delivery of influenza and measles-mumps-rubella vaccines that are given to Australian children.

Apollo expects to begin human trials of the technology later this year.

"The early tests show great promise for immunisation without needles. Trials show a better antibody (immune) response from our needle-less vaccine than the injected vaccine. Our technology allows simple application without needles, patches, abrasion or ultrasound, which all disrupt the skin," added Dr Greg Russell-Jones, Apollo's Science Director.

Apollo's needle-free vaccines would provide a better alternative to injections by:

* Removing the stress of needles - particularly for children;

* Reducing the risk and incidence of needle-stick injuries;

* Reducing the cost of immunisation as the vaccines could be delivered conveniently and easily without medical intervention;

* Being cheaper to store and easier to deploy than injectable vaccines which require refrigeration; and

* Cutting re-use of needles in developing countries, reducing the spread of disease.

Apollo will continue with trials to optimise the tetanus vaccination, and will also investigate the potential of other vaccines.

Apollo has also used its technology to find new ways to deliver other injectable medicines. Last year, the company had notable success with trials on a lotion version of an injected drug for psoriasis.

"We are looking at all the different ways our technology can be used - from anti-inflammatory medicines to the more universal market of vaccines. The tetanus vaccination results pave the way for today's injected vaccines to be rubbed on in the future," said Mr Priest.

Apollo Life Sciences (ASX: AOP) is a bio-discovery company that has made major breakthroughs in the areas of drug delivery and expression of proteins from human cells. Apollo's combined technologies are expected to lead to more effective and lower cost therapeutics, compared to first generation protein-based drugs.

Fact Sheet

30 April 2007

The importance of needle-free vaccines

* The World Health Organization (WHO) estimates that 12 billion injections are given annually, and that 5% of these are immunisations[1]

* The development of needle-free delivery systems for vaccines has been named one of the Grand Challenges in Global Health[2]

* Needles are associated with an increased risk of infection, especially in developing countries, where there are problems with needles being reused and issues with waste management and disposal[3]

* Needle free delivery systems would make vaccines easier to deliver[4]

* Compliance would be significantly improved, with people more likely to avoid an injected vaccine because of fear and pain associated with the needle[5]

* Topical vaccines are cheaper and easier to transport and store non-injected medicines, increasing access to vaccines[6]

* Needle stick injuries are a significant problem in both developed and developing countries. It is estimated that 5 in every 100 injections worldwide result in a needle-stick accident. The introduction of needle-less vaccines would significantly reduce the risk to health care workers[7]

* Some progress has been made with oral polio, cholera and rotavirus vaccines. But diphtheria, tetanus, pertussis, varicella, measles, mumps, rubella, tuberculosis and yellow fever are all still injectable vaccines[8]

* The current market for vaccines is worth approximately $9 billion globally with a 10-12% annual growth rate[9]

* Apollo Life Science is trialling transdermal delivery of different vaccines, and has had success with initial pre-clinical trials of a needle-free tetanus vaccination

Emily Staniforth Wilkinson Media Pty Ltd

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[1] Immunization without needles: reviews, Nature Reviews, Immunology, Volume 5, December 2005, page 905

[2] Grand Challenges in Global Health website

[3] Grand Challenges in Global Health website

[4] Grand Challenges in Global Health website

[5] Grand Challenges in Global Health website

[6] Grand Challenges in Global Health website

[7] Immunization without needles: reviews, Nature Reviews, Immunology, Volume 5, December 2005, page 905

[8] Immunization without needles: reviews, Nature Reviews, Immunology, Volume 5, December 2005, page 905

[9] www.kaloramainformation.com/biotechnology-market-c57p3/ <http://www.kaloramainformation.com/biotechnology-market-c57p3/> accessed 24 April 2007

Posted: April 2007

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