Research Update

Ardana PLC 08 August 2007 ARDANA COMMENCES PHASE III REGISTRATION TRIAL FOR ITS ORAL GROWTH HORMONE SECRETAGOGUE DIAGNOSTIC Edinburgh, UK: 8 August 2007 : Ardana plc (LSE:ARA) today announces the commencement in the USA of a planned pivotal registration study of its oral growth hormone secretagogue (GHS) ARD-07 which is in development for the diagnosis of growth hormone deficiency in adults. The first patient has now been enrolled in the study. Results from the study are expected in the second half of 2007 and the Company anticipates filing for registration at the end of the year with a possible launch in 2008. Ardana believes that GHS' oral formulation has the potential to give clinicians a simpler and more effective test for growth hormone deficiency. This phase III study is a multi-centre, randomized, cross-over study investigating the safety and effectiveness of oral GHS as a Growth Hormone (GH) stimulation test compared to intravenous L-Arginine (L-ARG) plus Growth Hormone Releasing Hormone (GHRH). The study will be conducted under an Investigational New Drug (IND) application accepted by the U.S. Food & Drug Administration (FDA) in 10 centres in the USA with 80 subjects. Half of the subjects will be patients with proven GH deficiency and the other half will be matched controls (healthy subjects). GHS is a novel synthetic small molecule sized peptidomimetic agent that is orally active and stimulates the secretion of GH from the patient's pituitary gland and/or indirectly via stimulation of GHRH from the hypothalamus. Initial phase I studies have indicated that GHS stimulates growth hormone secretion in a dose dependent manner following oral and intraduodenal administration in healthy male subjects. No apparent adverse effects of GHS on other hormones (eg ACTH, cortisol, ghrelin, insulin) or on glucose secretion were observed. GHS is being developed under an exclusive worldwide licence from AEterna Zentaris Inc. (TSX: AEZ, NASDAQ: AEZS) who will receive an undisclosed milestone payment for the initiation of this trial. As previously announced, the FDA granted Orphan Drug status for GHS in May 2007. Dr Maureen Lindsay, Ardana's CEO said 'This trial is an important step forward in the development of GHS, which we believe could play a pivotal role in the diagnosis of growth hormone deficiency by providing clinicians with a convenient, reliable and effective diagnostic test.' For more information contact: Ardana Financial Dynamics Maureen Lindsay Julia Phillips Tel: + 44 (0) 131 226 8550 John Gilbert Tel: +44 (0)20 7831 3113 About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development and marketing of innovative products to improve human reproductive health, a $25.5 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 lead products are summarised below: • Emselex(R), a once a day treatment for the symptoms of overactive bladder syndrome which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • Striant(TM) 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; • Teverelix LA, in phase II development for two initial indications (prostate cancer and benign prostatic hyperplasia) and phase I development for endometriosis; • Testosterone Cream, a trans dermal testosterone delivery system in phase III development for the treatment of male hypogonadism and phase I development for a female indication; • Invicorp(TM), an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe. • ARD-07 an oral growth hormone secretagogue in late stage development for the diagnosis of hormone deficiency. 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 with ticker symbol ARA-L. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange
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