Aura Renew Acq Regulatory News (ARA)

21 Nov 2007 07:01

Ardana PLC21 November 2007 ARDANA ANNOUNCES POSITIVE RESULTS OF A SUPPLEMENTARY STUDY CONFIRMING THE HIGH DERMAL TOLERABILITY OF TESTOSTERONE CREAM Edinburgh, UK, 21 November 2007: Ardana plc (LSE:ARA) today announces that in arecently completed supplementary clinical trial, treatment with TestosteroneCream for the transdermal delivery of testosterone, has shown that it does notact as an irritant on skin. Testosterone Cream is in late-stage development formale hypogonadism. The study evaluated the dermal tolerability of Testosterone Cream on intact skinin subjects with healthy skin. Topical application of Testosterone Cream, aswell as negative and positive controls, was undertaken once daily during a21-day treatment period for an approximate duration of 23 hours per day. 40male volunteers were included in the study and all subjects received alltreatments i.e. Testosterone Cream, active-ingredient-free vehicle toTestosterone Cream (placebo), 0.9% sodium chloride in water (negative control)and 0.1% sodium dodecyl sulphate in water (positive control). Dermal reactionswere clinically assessed on study days 2-22 using an erythema score (range 0 to4 with 0 being no reaction and 4 being severe erythema reaction with infiltrateand/or dermal defect e.g. blisters/blebs/erosion). No statistically significant differences were found between Testosterone Cream,the placebo and the negative control whereas clear and significant irritationwas seen for the positive control with severe reactions observed in all subjectsby the end of the study. Several formulations for the delivery of testosterone to hypogonadal men aremarketed globally. Transdermal formulations are increasingly popular as theyavoid the inevitable "roller-coaster" effect experienced with earlierformulations such as injectables and implants. However, a significantdisadvantage of the currently available transdermal formulations is the skinreactions observed at the application site e.g. erythema, acne and dry skin atan incidence of up to 10%. Dr Huw Jones, Ardana's CEO said: "Testosterone Cream represents a very importantnear term opportunity for Ardana. The data from this study add low irritatantpotential to the other user-friendly properties of our formulation." Ardana has previously reported data from a Phase II dose-finding clinical trialshowing clear evidence of the efficacy and tolerability of Testosterone Cream.These data facilitated a Phase III pivotal registration study in men withconfirmed hypogonadism (testosterone deficiency), a study that is ongoing in theUSA. For more information contact: Ardana Financial DynamicsDr 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