Aura Renew Acq Regulatory News (ARA)

12 Apr 2006 07:01

Ardana PLC12 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 positiveresults of its testosterone cream in a Phase II study in Hypogonadal Men. ThisPhase II dose-finding study provided clear evidence of the effectiveness ofArdana's bi-gel technology for the transdermal delivery of testosterone. The double-blind, randomised, placebo-controlled study involved 42 patientsdiagnosed with confirmed male hypogonadism, i.e. testosterone deficiency. Threegroups, each of 14 patients, received in random order a single application ofthe 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 12hours after the application. For the three doses, 1.5, 2.25 and 3.0g, theaverage 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. Pharmacokineticmodelling of the data from this study predicts that testosterone can be fullyrestored in hypogonadal men, to within normal range with one of the followingtwo doses; 1.5g or 2.25g, or combinations thereof; when administered on a dailybasis (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-termtolerability are being evaluated. A pivotal Phase III registration study isexpected to be completed by end 2006. Ardana's testosterone cream, which is in Phase II of clinical development inEurope, is a stable 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. Dr. Maureen Lindsay, Ardana's CEO, said "We are very encouraged by the data anddevelopment progress of this novel testosterone cream, which we see ascomplementary to StriantTMSR, our buccal testosterone tablet already on themarket for men with hypogonadism." The male hypogonadism market has experienced rapid growth over the last fiveyears, driven by novel gel formulations which now make up 76% of the market byvalue. The current US market size is estimated to be $473 million (IMS MAT Nov05). For more information contact: Ardana plc Financial DynamicsMaureen 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 andmarketing of innovative products to improve human reproductive health, a $23.8billion market. Since its foundation, Ardana has maintained a broad and balanced portfolio tomanage risk and actively pursues product and technology in-licensing andout-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 sinceMarch 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