ARDANA ANNOUNCES POSITIVE PRELIMINARY RESULTS FROM A DIFFERENTIATION STUDY OF ITS TESTOSTERONE CREAM IN MALE HYPOGONADISM

Edinburgh, UK, November 26 2007: Ardana Plc (LSE:ARA), the pharmaceutical company focused on improving human reproductive health, today announces positive preliminary results from a differentiation study of its Testosterone Cream for the treatment of testosterone deficiency in men.

The preliminary results from this study demonstrate a potential differentiation of Ardana’s Testosterone Cream from currently marketed gel preparations, in that showering as early as one hour after application of the cream does not appear to have a negative effect on the absorption of testosterone.  With existing testosterone gels the advice given to patients is to delay showering for at least 2-6 hours after application.

This open label, randomised, cross-over study in 12 male patients with testosterone deficiency (male hypogonadism) was conducted in a single centre in the United States under the existing IND.  All 12 patients received a single, low dose (2.25g) of Ardana’s Testosterone Cream on four different study days.  In random order the patients had a shower after 1, 2 and 6 hours or not at all.  After this first part of the study all patients applied a single dose of Testosterone Cream (2.25g) daily for 14 days after which the study experiment was repeated with a shower two hours after the last application.

The preliminary analysis shows that there is no detrimental effect on the absorption of testosterone if a patient showers as early as one hour after drug application when compared to drug application with no subsequent showering.

Commenting on today’s announcement, Dr Huw Jones,  CEO of Ardana, said:  “We are very encouraged by these positive results as they indicate a potential advantage for our Testosterone Cream by allowing patients the convenient option of showering much sooner after application than is currently recommended for testosterone gels.”

A pivotal Phase III registration study in men with confirmed hypogonadism in the United States is currently in the active recruitment phase.

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