Ardana PLC 12 May 2005 ARDANA ANNOUNCES SUCCESSFUL RESULTS IN SECOND PHASE II STUDY OF TEVERELIX LA IN PROSTATE CANCER Edinburgh, UK, 12 May 2005; Ardana plc (LSE:ARA) the emerging pharmaceutical company focused on improving human reproductive health, today announces successful results of a second Phase II study of the Gonadotrophin Releasing Antagonist (GnRH), Teverelix LA (Long Acting), in patients with advanced prostate cancer. The progression of prostate cancer is usually driven by male sex hormones (androgens) such as testosterone. It is widely accepted that reducing levels of these hormones in advanced disease can help slow the growth of the cancer and prolong survival. The production of testosterone can be reduced either surgically, with the removal of the testicles, or through drugs that affect production of testosterone. This study confirmed that Teverelix LA can attain and maintain suppression of testosterone to castration levels in patients with advanced prostate cancer. In previous clinical studies Teverelix has been shown to reduce testosterone levels rapidly to castration levels. In this trial Teverelix LA was tested at a lower dose and administered via a different route (intramuscularly) compared to the first Phase II study reported on 17 February 2005. In this second Phase II trial, 14 patients with advanced prostate cancer each received two 90 mg doses of Teverelix LA. Each dose was administered as a single intramuscular injection on Day 1 and Day 8 of the study. After the first injection, suppression of testosterone to castration levels (<0.5 ng/ml) was achieved as early as Day 3 in 11 out of the 14 patients. Two days after the second injection, suppression of testosterone to castration levels was achieved in all patients and this was maintained in all but one patient for between 4 and 8 weeks. In one patient, testosterone levels were only suppressed up to Day 23. Teverelix LA was also shown to rapidly reduce and normalise PSA (Prostate Specific Antigen) levels, a biological marker that is elevated in most patients with prostate cancer. This clinical trial, like the previous Phase II study, confirmed that Teverelix LA was generally well tolerated with no signs of allergic reactions. Dr. Maureen Lindsay, Chief Executive of Ardana, said: "This study gives Ardana further insight into how Teverelix LA should be used to achieve the optimal clinical effect. We believe that this compound has considerable potential in the treatment of advanced prostate cancer and in the management of several other diseases." After skin cancer, prostate cancer is the most common type of cancer diagnosed in men in the US and is the fourth most common cause of cancer related deaths in men in northern Europe. It is estimated that the prostate cancer market was worth $3,716 million in 2004, and is expected to rise to $3,934 million in 2008. In addition, Teverelix LA is currently in clinical development for other indications such as Benign Prostatic Hyperplasia (BPH) and Endometriosis. Data from an on-going Phase II study in patients with BPH is expected by mid 2005. . It is one of a number of important products in the portfolio which position Ardana to become a future leader in reproductive health. 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 outlicensing to maintain a robust pipeline. Ardana's four lead products are summarised below: • StriantTM 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, BPH 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