ARDANA ACCELERATES ANTICIPATED LAUNCH OF TEVERELIX LONG ACTING (LA) IN BENIGN PROSTATIC HYPERPLASIA FOLLOWING PRE-IND MEETING WITH THE US FDA

Edinburgh, UK, 21 September 2005: Ardana plc (LSE:ARA), today reports that the launch of its lead compound, the GnRH antagonist Teverelix Long Acting (LA) in benign prostatic hyperplasia (BPH), could be advanced by up to two years, following a pre-Investigational New Drug (IND) application meeting with the FDA at which consensus on the company’s development plan for the therapy was reached.  It was previously expected that Teverelix in BPH could reach the market in 2012.

In a recent Phase II study in patients with BPH, Teverelix LA demonstrated a statistically significant improvement in symptoms of BPH as measured by the International Prostate Symptom Score (IPSS). The FDA has confirmed that improvements in symptoms according to IPSS can serve as a single endpoint for therapeutic and regulatory success. 

Ardana is planning to submit its first study under this IND to the FDA within the next few months.  Another European  Phase II study in patients with BPH is expected to commence before the end of 2005.  If all future development goes to plan, the company anticipates that Teverelix LA may now be launched up to two years earlier than previously anticipated.

Dr Maureen Lindsay, Chief Executive Officer of Ardana, said “We are very encouraged by the feedback we have had from the FDA, which follows the positive view we recently received at a pre-IND meeting for Teverelix LA in prostate cancer.  The opportunity to bring forward the launch date for BPH is very exciting for ourselves and potential partners.  We look forward to announcing further progress with the Teverelix programme including a third indication of Endometriosis.”

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