Ardana PLC 07 September 2005 CLINICAL DEVELOPMENT OF ARDANA'S TEVERELIX LONG ACTING (LA) IN PROSTATE CANCER CONTINUES ON TRACK FOLLOWING PRE-IND APPLICATION MEETING WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) Edinburgh, UK, 7 September 2005; Ardana plc (LSE:ARA) the emerging pharmaceutical company focused on improving human reproductive health, today announces that the company has had a pre-Investigational New Drug (IND) application meeting with the FDA to discuss the development for prostate cancer of its lead compound Teverelix LA, a GnRH antagonist. Recent results from two Phase II studies in patients with prostate cancer have been detailed in previous press releases. In these studies Teverelix LA successfully suppressed serum testosterone to the required levels for treatment. An additional Phase II study outside the USA is expected to commence within the coming month and results from this study should be available in the first half of 2006. The FDA has confirmed that serum testosterone levels can serve as a reliable surrogate marker for efficacy in the treatment of prostate cancer. The meeting reached agreement on the path forward for the development of Teverelix LA for the treatment of prostate cancer, which will allow Ardana to meet its registration timelines and previously announced launch target of the end of 2009. Ardana is planning to submit to the FDA its first study to be performed under an IND in the pursuit of this indication within the next few months. Dr Maureen Lindsay, CEO Ardana, said "We are very encouraged by the feedback we have had from the FDA. The clinical development and launch for prostate cancer is on track according to our original schedule. Teverelix LA is also being developed for the treatment of Benign Prostatic Hyperplasia (BPH) and Endometriosis. We expect to be reporting shortly on a further meeting with the FDA about BPH. " For more information contact: Ardana Financial Dynamics Maureen 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 and marketing of innovative products to improve human reproductive health, a $23.8 billion market. Since its foundation, Ardana has maintained a broad and balanced portfolio to manage risk and actively pursues product and technology in-licensing and out-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); • Testo Bi-gel, a trans dermal testosterone delivery system in development for the treatment of male hypogonadism, shortly to enter 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 £21 million. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange