Aura Renew Acq Regulatory News (ARA)

19 Dec 2006 07:01

Ardana PLC19 December 2006 ARDANA ANNOUNCES PRELIMINARY RESULTS IN A PHASE II STUDY OF TEVERELIX LA IN BENIGN PROSTATIC HYPERPLASIA Edinburgh, UK, 19 December 2006; Ardana plc (LSE:ARA) today announcespreliminary results from a Phase II study of its lead development compound, theGnRH antagonist Teverelix Long Acting (LA) in benign prostatic hyperplasia(BPH). Teverelix LA, administered as a single subcutaneous injection, demonstratedsymptomatic improvement from as early as week two and the duration of the effectappears to be in the order of 8 weeks based upon a preliminary analysis of therelevant clinical endpoint, the International Prostate Symptom Score (IPSS). The study was a Phase II, randomised, double-blind, placebo-controlled studyinvestigating the effects and safety of two different doses of Teverelix LA whenadministered as a single subcutaneous injection to treatment naive patients withBPH (total number of patients was 84). The findings in this study confirm theeffects of Teverelix LA on symptoms of BPH as previously reported. Furtheranalysis of data is ongoing. In previous clinical studies, Teverelix LA has been shown to decreasetestosterone and subsequently dihydrotestosterone (DHT) in a dose-dependentmanner ie reducing testosterone levels to the low end of the normal range, whichshould help to avoid a chemical castration and its related symptoms. In anearlier Phase II study in patients with BPH, Teverelix LA demonstrated astatistically significant improvement in symptoms of BPH as measured by theIPSS. BPH is a common benign disease occurring primarily in men over the age of 50,and increases in prevalence with age. BPH is characterised by an enlargement ofthe prostate gland, which results in urinary flow problems such as hesitancy,weak or interrupted stream, urgency and more frequent urination, especially atnight. The growth of prostatic tissue is driven by male sex hormones (known asandrogens), primarily testosterone and its more potent metabolite DHT. Reducinglevels of these hormones can reduce the size and growth of the prostate. Current treatment options for patients with BPH include watchful waiting,surgical or endoscopic treatment or medical treatment with 5-alpha reductaseinhibitors or alpha blockers. The BPH pharmaceutical market is estimated to beworth US$4.9 billion in 2005 (Source: Wood Mackenzie's Product View April 2006). Enquiries For more information contact: Maureen Lindsay + 44 (0) 131 226 8550Ardana Julia Phillips/John Gilbert +44 (0) 20 7831 3113Financial Dynamics(corporate and financial media relations) About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development andmarketing of innovative products to improve human reproductive health, a $25.5billion 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: • Emselex(R), a once a day treatment for the symptoms of overactive bladder which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis Pharmaceuticals UK Limited; • StriantTM SR, a testosterone replacement therapy that has been launched by Ardana through its own sales force in the UK and through marketing partners in certain European countries, as a treatment for men with confirmed hypogonadism; • Invicorp, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe; • Teverelix LA, in development for three initial indications (prostate cancer, BPH and endometriosis); • Testosterone Cream, a transdermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase II trials; and • Oral GHS (EP01572) a oral growth hormone secretagogue in late stage development in the first indication for the diagnosis of growth hormone deficiency and in early stage development in a second indication. In addition, Ardana has a strong portfolio of follow-on products in development. Ardana is listed on the Main Market of the London Stock Exchange. For further information please see www.ardana.co.uk *Source: IMS Retail Drug Monitor November 2005. Statements contained within this press release may contain forward-lookingcomments which involve risks and uncertainties that may cause actual results tovary from those contained in the forward-looking statements. In some cases, youcan identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions andforward-looking references in this press release are subject to the satisfactoryprogress of research which is, by nature, unpredictable. Forward projectionsreflect management's best estimates based on information available at the timeof issue. This information is provided by RNS The company news service from the London Stock Exchange