Aura Renew Acq Regulatory News (ARA)

18 Mar 2008 07:01

Ardana PLC18 March 2008 ARDANA ANNOUNCES POSITIVE RESULTS FROM A PHASE I STUDY OF TESTOSTERONE CREAM IN FEMALE SUBJECTS Edinburgh, UK, 18 March 2008 - Ardana plc (LSE:ARA) the pharmaceutical companyspecialising in improving human reproductive health, today announces positiveresults of its Testosterone Cream in a Phase I study to evaluate the absorptionof testosterone in women from their unique cream formulation . This Phase Idose-finding study provided clear evidence of the effectiveness of Ardana'scream in the transdermal delivery of testosterone in females. Among other potential uses, Testosterone Cream could be developed as an androgensupplementation in the management of Female Sexual Dysfunction (FSD) andspecifically Hypoactive Sexual Desire Disorder (HSDD). FSD is believed to be arelatively common condition, with an estimated prevalence within the generalpopulation of between 19% and 43%1. The double-blind, randomised, placebo-controlled study was conducted by DrShalendar Bhasin at Boston University in the USA and involved 9 surgicallymenopausal women between 18 and 55 years of age. These subjects received inrandom order a single application of Testosterone Cream at a dose of 0.2g, 0.4gand 0.6g, or a placebo cream. Both placebo and active cream were applied to oneupper arm only. Preliminary analysis of the data show that the three doses, 0.2g, 0.4g, 0.6g,resulted in an increase in the average concentrations of testosterone over 24hours of 10.6, 16.2 and 20.0 ng/dL respectively. The maximal concentrationswere 36.6, 47.2 and 48.9 ng/dL respectively. Ardana's Testosterone Cream, which is also in Phase III clinical development forhypogonadal men in the USA, is a novel, patented method of deliveringtestosterone. Because of its reduced surface area requirement, Ardana'sTestosterone Cream appears to deliver testosterone more efficiently thanexisting gel-based testosterone products. The cosmetic-like cream consistencyand low alcohol content contribute to a potentially user-friendly preparation.The Company recently announced positive results of a differentiation study whichshowed that the dermal tolerability of Testosterone Cream was comparable tonormal saline. Commenting on today's announcement, Dr. Huw Jones, Ardana's CEO, said: "We arevery encouraged by these preliminary data for our novel Testosterone Cream as apotentially beneficial product for women. Testosterone is naturally present inwomen and restoration of testosterone deficiency has the potential to treatassociated conditions such as Hypoactive Sexual Desire Disorder." 1.JAMA. 1999 Feb 10;281(6):537-44. For more information contact: Ardana plc Financial DynamicsDr. Huw Jones. Chief Executive Officer Julia PhillipsTel: + 44 (0) 131 226 8550 Emma Thompson Tel: +44 (0)20 7831 3113 Ardana plc (LSE: ARA) is an emerging pharmaceutical company focused on thediscovery, development and marketing of innovative products to improve humanreproductive health, a $25.5 billion market. 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; • Striant(TM) 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; and • Invicorp(TM), an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange