Aura Renew Acq Regulatory News (ARA)

26 Nov 2007 07:00

Ardana PLC26 November 2007 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 pharmaceuticalcompany focused on improving human reproductive health, today announces positivepreliminary results from a differentiation study of its Testosterone Cream forthe treatment of testosterone deficiency in men. The preliminary results from this study demonstrate a potential differentiationof Ardana's Testosterone Cream from currently marketed gel preparations, in thatshowering as early as one hour after application of the cream does not appear tohave a negative effect on the absorption of testosterone. With existingtestosterone gels the advice given to patients is to delay showering for atleast 2-6 hours after application. This open label, randomised, cross-over study in 12 male patients withtestosterone deficiency (male hypogonadism) was conducted in a single centre inthe 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 ofTestosterone Cream (2.25g) daily for 14 days after which the study experimentwas repeated with a shower two hours after the last application. The preliminary analysis shows that there is no detrimental effect on theabsorption of testosterone if a patient showers as early as one hour after drugapplication when compared to drug application with no subsequent showering. Commenting on today's announcement, Dr Huw Jones, CEO of Ardana, said: "We arevery encouraged by these positive results as they indicate a potential advantagefor our Testosterone Cream by allowing patients the convenient option ofshowering much sooner after application than is currently recommended fortestosterone gels." A pivotal Phase III registration study in men with confirmed hypogonadism in theUnited States is currently in the active recruitment phase. For more information contact:Ardana Financial Dynamics Dr Huw Jones (corporate/financial media relations) Tel: + 44 (0) 131 226 8550 Julia Phillips/Emma Thompson 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 built a broad and balanced portfolio to managerisk and actively pursues product and technology in-licensing and outlicensingto maintain a robust pipeline. Ardana's lead products are summarised below: • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • ARD-0705 a growth hormone secretagogue in Phase III for the diagnosis of growth hormone deficiency in adults • Testosterone Cream, a transdermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase III trials; • Emselex(R), a once a day treatment for the symptoms of overactive bladder syndrome, which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • 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 confirmed hypogonadism; • InvicorpTM, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. In addition, Ardana has a strong portfolio of follow-on products in research.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