Aura Renew Acq Regulatory News (ARA)

21 Sep 2005 07:00

Ardana PLC21 September 2005 ARDANA ACCELERATES ANTICIPATED LAUNCH OF TEVERELIX LONG ACTING (LA) IN BENIGNPROSTATIC HYPERPLASIA FOLLOWING PRE-IND MEETING WITH THE US FDA Edinburgh, UK, 21 September 2005: Ardana plc (LSE:ARA), the emergingpharmaceutical company focused on improving human reproductive health, todayreports that the launch of its lead compound, the GnRH antagonist Teverelix LongActing (LA) in benign prostatic hyperplasia (BPH), could be advanced by up totwo years, following a pre-Investigational New Drug (IND) application meetingwith the FDA at which consensus on the company's development plan for thetherapy was reached. It was previously expected that Teverelix in BPH couldreach the market in 2012. In a recent Phase II study in patients with BPH, Teverelix LA demonstrated astatistically significant improvement in symptoms of BPH as measured by theInternational Prostate Symptom Score (IPSS). The FDA has confirmed thatimprovements in symptoms according to IPSS can serve as a single endpoint fortherapeutic and regulatory success. Ardana is planning to submit its first study under this IND to the FDA withinthe next few months. Another European Phase II study in patients with BPH isexpected to commence before the end of 2005. If all future development goes toplan, the company anticipates that Teverelix LA may now be launched up to twoyears earlier than previously anticipated. Dr Maureen Lindsay, Chief Executive Officer of Ardana, said "We are veryencouraged by the feedback we have had from the FDA, which follows the positiveview we recently received at a pre-IND meeting for Teverelix LA in prostatecancer. The opportunity to bring forward the launch date for BPH is veryexciting for ourselves and potential partners. We look forward to announcingfurther progress with the Teverelix programme including a third indication ofEndometriosis." 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: • 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, 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 £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