Aura Renew Acq Regulatory News (ARA)

31 Oct 2005 07:00

Ardana PLC31 October 2005 ARDANA ANNOUNCES POSITIVE PHASE I RESULTS AND STARTS PHASE II TRIALS FOR NOVEL TESTOSTERONE CREAM Edinburgh, UK, 31 October 2005; Ardana plc (LSE:ARA), the emergingpharmaceutical company focused on improving human reproductive health, todayannounces positive results in a second Phase I study of its testosterone creamwhich is being developed as a treatment for testosterone deficiency in malehypogonadism. The testosterone is being delivered using Ardana's proprietary deliverytechnology and Ardana is expecting the launch of the product in the EU and US atthe end of 2007. Ardana's testosterone cream is expected to have high patient acceptability. Thecream is fast drying, has low alcohol content, and only requires application toa small area of the body. Today's announcement relates to a second Phase I pilot study in healthy femalesubjects to provide a control group equivalent to hypogonadal men with lowtestosterone levels. The study not only provided proof of concept on thedelivery technology but also clear evidence that testosterone can be effectivelydelivered through the skin to bring testosterone levels to within the normalrange observed in healthy males, using this cream. A Phase II dose-finding studyin hypogonadal men has just been initiated. Other therapies for malehypogonadism include injectable formulations of testosterone, oral preparations,transdermal patches, topical gels and sub-cutaneous implants. Dr Maureen Lindsay, CEO Ardana, said: "We are very encouraged by these results. This new formulation of testosteroneas a cream complements our current portfolio which includes Striant(TM) SR, abuccal tablet testosterone replacement therapy, and will offer additional choicefor the patient. Also, based upon the knowledge we have gained on thetechnology, Ardana can develop not only additional compounds to market ourselvesbut also offer this to other companies and thereby generate licensing income." In 2004, the testosterone replacement market in Europe and in the US wasestimated to be approximately $600 million. The US market is by far the mostattractive with a growth rate of 40% (cash) and sales of $537million, of which$422 million were sales of testosterone gels (IMS Health). For more information contact: Ardana Financial DynamicsMaureen Lindsay (corporate/financial media relations)Tel: + 44 (0) 131 226 8550 Julia Phillips/Davina Langdale Tel: +44 (0)20 7831 3113 NB Public Relations (trade/technical media relations) Nicki Brimicombe Tel: + 44 (0)1883 732353 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: • Striant(TM) SR, a testosterone replacement therapy that has already been launched by Ardana through its own sales force in the UK as a treatment for men with hypogonadism and for which Ardana has marketing rights in Europe; • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • Testosterone cream, a trans dermal testosterone delivery system in development for the treatment of male hypogonadism, has now commenced Phase II trials; • Invicorp, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe. In addition, Ardana has a strong portfolio of follow-on products in development. Ardana completed its IPO on the London Stock Exchange in March 2005 raising £21million. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange