Research Update

Ardana PLC 11 September 2006 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). For more information contact: Ardana Financial Dynamics Maureen Lindsay (corporate/financial media relations) Tel: + 44 (0) 131 226 8550 Julia Phillips/John Gilbert Tel: +44 (0)20 7831 3113 About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development and marketing of innovative products to improve human reproductive health, a $25.5 billion market. Since its foundation, Ardana has maintained a broad and balanced portfolio to manage risk and actively pursues product and technology in-licensing and outlicensing to maintain a robust pipeline. Ardana's four lead products are summarised below: • StriantTM SR, a testosterone replacement therapy that has been launched by Ardana through its own sales force in the UK and through marketing partners in certain European countries, as a treatment for men with hypogonadism; • Teverelix LA, in development for three initial indications (prostate cancer, BPH and endometriosis); • Testosterone Cream, a trans dermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase II trials; • Invicorp, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe. In addition, Ardana has a strong portfolio of follow-on products in development. Ardana is listed on the Main Market of the London Stock Exchange. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange
UK 100

Latest directors dealings