Research Update

Ardana PLC 12 April 2006 ARDANA ANNOUNCES POSITIVE PHASE II RESULTS FOR TESTOSTERONE CREAM -- Company announces Phase II results-- Edinburgh, UK: 12 April 2006: Ardana plc (LSE:ARA) today announces positive results of its testosterone cream in a Phase II study in Hypogonadal Men. This Phase II dose-finding study provided clear evidence of the effectiveness of Ardana's bi-gel technology for the transdermal delivery of testosterone. The double-blind, randomised, placebo-controlled study involved 42 patients diagnosed with confirmed male hypogonadism, i.e. testosterone deficiency. Three groups, each of 14 patients, received in random order a single application of the testosterone cream at a dose of 1.5g, 2.25g or 3.0g, or a placebo cream. Both placebo and active cream were applied to one upper arm only. The data show that maximal serum concentration was achieved between 10 and 12 hours after the application. For the three doses, 1.5, 2.25 and 3.0g, the average concentrations of testosterone over 24 hours were 2.06, 2.13 and 2.63 ng /ml and the maximal concentrations were 3.35, 3.53 and 5.66 ng/ml respectively. This observed data is consistent with data reported previously. Pharmacokinetic modelling of the data from this study predicts that testosterone can be fully restored in hypogonadal men, to within normal range with one of the following two doses; 1.5g or 2.25g, or combinations thereof; when administered on a daily basis (i.e. at steady state). Ardana has also initiated a further one month Phase II study in hypogonadal men. In this study, steady state conditions of testosterone and longer-term tolerability are being evaluated. A pivotal Phase III registration study is expected to be completed by end 2006. Ardana's testosterone cream, which is in Phase II of clinical development in Europe, is a stable 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. Dr. Maureen Lindsay, Ardana's CEO, said 'We are very encouraged by the data and development progress of this novel testosterone cream, which we see as complementary to StriantTMSR, our buccal testosterone tablet already on the market for men with hypogonadism.' The male hypogonadism market has experienced rapid growth over the last five years, driven by novel gel formulations which now make up 76% of the market by value. The current US market size is estimated to be $473 million (IMS MAT Nov 05). For more information contact: Ardana plc Financial Dynamics Maureen Lindsay (corporate/financial media relations) Tel: + 44 (0) 131 226 8550 David Yates 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 $23.8 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 out-licensing to maintain a robust pipeline. Ardana's four lead products are summarised below: • StriantTM SR, a testosterone replacement therapy for which Ardana has marketing rights in Europe, has already been launched by Ardana through its own sales force in the UK as a treatment for men with confirmed hypogonadism • Teverelix LA, in development for three initial indications (prostate cancer in Phase II, benign prostatic hyperplasia in Phase II and endometriosis in Phase I) • Testosterone Cream, a transdermal testosterone delivery system in Phase II for the treatment of male hypogonadism • Invicorp(R), an injectable combination drug treatment for erectile dysfunction, already approved in Denmark and for which Ardana has marketing and manufacturing rights in Europe. Launch is expected in H2 2006 In addition, Ardana has a strong portfolio of follow-on products in development. Ardana has been listed on the main board of the London Stock Exchange since March 2005 (ARA.L). For further information please see www.ardana.co.uk -- ENDS -- This information is provided by RNS The company news service from the London Stock Exchange
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