ARDANA ANNOUNCES POSITIVE PHASE I RESULTS AND STARTS PHASE II TRIALS FOR NOVEL TESTOSTERONE CREAM

Edinburgh, UK, 31 October 2005;  Ardana plc (LSE:ARA), today announces positive results in a second  Phase I study of its testosterone cream which is being developed as a treatment for testosterone deficiency in male hypogonadism.

The testosterone is being delivered using Ardana’s proprietary delivery technology and Ardana is expecting the launch of the product in the EU and US at the end of 2007.

Ardana’s testosterone cream is expected to have high patient acceptability. The cream is fast drying, has low alcohol content, and only requires application to a small area of the body.

Today’s announcement relates to a second Phase I pilot study in healthy female subjects to provide a control group equivalent to hypogonadal men with low testosterone levels. The study not only provided proof of concept on the delivery technology but also clear evidence that testosterone can be effectively delivered through the skin to bring testosterone levels to within the normal range observed in healthy males, using this cream. A Phase II dose-finding study in hypogonadal men has just been initiated. Other therapies for male hypogonadism include injectable formulations of testosterone, oral preparations, transdermal patches, topical gels and sub-cutaneous implants.

Dr Maureen Lindsay, CEO Ardana, said:

“We are very encouraged by these results. This new formulation of testosterone as a cream complements our current portfolio which includes Striant™SR, a buccal tablet testosterone replacement therapy, and will offer additional choice for the patient. Also, based upon the knowledge we have gained on the technology, Ardana can develop not only additional compounds to market ourselves but also offer this to other companies and thereby generate licensing  income.”

In 2004, the testosterone replacement market in Europe and in the US was estimated to be approximately $600 million. The US market is by far the most attractive with a growth rate of 40% (cash) and sales of $537million, of which $422 million were sales of testosterone gels (IMS Health).

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