Aura Renew Acq Regulatory News (ARA)

11 Sep 2006 07:01

Ardana PLC11 September 2006 ARDANA ANNOUNCES POSITIVE PRELIMINARY PHASE II RESULTS FOR ITS NOVEL TESTOSTERONE CREAM Edinburgh, UK: 11 September 2006: Ardana plc (LSE:ARA) today announcespreliminary results of its testosterone cream in a Phase II study in hypogonadalmen. A preliminary analysis of the data confirms that Ardana's testosteronecream is effective in restoring testosterone levels to the normal range inhypogonadal men when administered as a single dose of 2.25g or 4.5g on a dailybasis. The open-label, randomised study involved 16 patients diagnosed with malehypogonadism i.e. testosterone deficiency. Over a period of 28 days, twogroups, each of 8 patients, were randomised to receive a daily singleapplication 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 of24 hours at the end of the study, Day 28. The preliminary analysis shows that 80% of patients on the low dose (2.25g) hadaverage testosterone concentrations within normal range at Day 28. The averageconcentration of testosterone for the low dose on Day 28 was 4.74 ng/ml (normalrange 3-10 ng/ml). This preliminary analysis of an initial dose of 2.25gindicates that only a small proportion of patients may require an upward dosetitration to adequately replace testosterone to within the normal range.Furthermore, the data indicates that even before dose titration the low doseshould meet efficacy criteria set by the FDA. A Phase II long-term dose-titration study in hypogonadal men is currentlyongoing. 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 inthe development of Ardana's novel testosterone cream. The preliminary data fromthis study meets our expectations for the product and we look forward to movinginto Phase III." Ardana's testosterone cream consisting of both an oil and water-based phasetogether with the active ingredient, testosterone. Because of its reducedsurface area requirement, Ardana's testosterone cream appears to delivertestosterone more efficiently than existing gel-based testosterone products andalso has a low alcohol content. Alternative therapies for male hypogonadisminclude injectable formulations of testosterone, oral preparations, transdermalpatches, topical gels and subcutaneous implants. The male hypogonadism market has experience rapid growth over the last fiveyears, driven by novel gel formulations which now make up 78% of the US marketby value. The US market size is estimated to be $470 million (IMS MAT Feb 06). For more information contact:Ardana Financial DynamicsMaureen 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 andmarketing of innovative products to improve human reproductive health, a $25.5billion market. Since its foundation, Ardana has maintained a broad and balanced portfolio tomanage risk and actively pursues product and technology in-licensing andoutlicensing 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