ARDANA ANNOUNCES POSITIVE PRELIMINARY
PHASE II RESULTS FOR ITS NOVEL TESTOSTERONE CREAM

Edinburgh, UK: 11 September 2006:  Ardana plc (LSE:ARA) today announces preliminary results of its testosterone cream in a Phase II study in hypogonadal men.  A preliminary analysis of the data confirms that Ardana’s testosterone cream is effective in restoring testosterone levels to the normal range in hypogonadal men when administered as a single dose of 2.25g or 4.5g on a daily basis.

The open-label, randomised study involved 16 patients diagnosed with male hypogonadism i.e. testosterone deficiency.  Over a period of 28 days, two groups, each of 8 patients, were randomised to receive a daily single application of Ardana’s testosterone cream at a dose of either 2.25g or 4.5g.  Serum testosterone concentrations at steady state were measured over a period of 24 hours at the end of the study, Day 28.

The preliminary analysis shows that 80% of patients on the low dose (2.25g) had average testosterone concentrations within normal range at Day 28. The average concentration of testosterone for the low dose on Day 28 was 4.74 ng/ml (normal range 3-10 ng/ml). This preliminary analysis of an initial dose of 2.25g indicates that only a small proportion of patients may require an upward dose titration to adequately replace testosterone to within the normal range.  Furthermore, the data indicates that even before dose titration the low dose should meet efficacy criteria set by the FDA.   

A Phase II long-term dose-titration study in hypogonadal men is currently ongoing.  Also a Phase I study, conducted in the US under an IND, is ongoing, investigating the effect of showering on the absorption of testosterone.

A pivotal Phase III registration study in the US is currently being prepared.

Dr Maureen Lindsay, Ardana’s CEO said “We are very encouraged by the progress in the development of Ardana’s novel testosterone cream. The preliminary data from this study meets our expectations for the product and we look forward to moving into Phase III.”

Ardana’s testosterone cream consisting of both an oil and water-based phase together with the active ingredient, testosterone.  Because of its reduced surface area requirement, Ardana’s testosterone cream appears to deliver testosterone more efficiently than existing gel-based testosterone products and also has a low alcohol content.  Alternative therapies for male hypogonadism include injectable formulations of testosterone, oral preparations, transdermal patches, topical gels and subcutaneous implants.

The male hypogonadism market has experience rapid growth over the last five years, driven by novel gel formulations which now make up 78% of the US market by value.  The US market size is estimated to be $470 million [IMS MAT Feb 06].

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