Aura Renew Acq Regulatory News (ARA)

21 May 2007 07:01

Ardana PLC21 May 2007 ARDANA'S ORAL GROWTH HORMONE SECRETAGOGUE GAINS ORPHAN DRUG STATUS Edinburgh, UK, 21 May 2007; Ardana plc (LSE:ARA) today announces that the USFood and Drug Administration (FDA) has granted Orphan Drug status for ARD-07,its oral Growth Hormone Secretagogue (GHS), which Ardana is developing as adiagnostic for growth hormone deficiency in adults. The granting of Orphan Drug status in the USA confers a number of advantagessuch as eligibility to apply for FDA grants towards clinical development, thewaiving of the User Registration Fee of $896,200 and other registration feesmoving forward. GHS is a novel synthetic small molecule sized peptidomimetic agent that isorally active and stimulates the secretion of Growth Hormone (GH) from thepatient's pituitary gland and/or indirectly via stimulation of Growth HormoneReleasing Hormone (GHRH) from the hypothalamus. Initial phase I studies have indicated that GHS stimulates growth hormonesecretion in a dose dependent manner following oral and intraduodenaladministration in healthy male subjects. No apparent adverse effects of GHS onother hormones such as ACTH, cortisol, ghrelin, insulin and glucose secretionwere observed. Following meetings with the FDA consensus has been reached that the successfuloutcome from one pivotal clinical trial will allow registration of GHS as adiagnostic for growth hormone deficiency in adults. The diagnostic clinical development and toxicology programmes are ongoing and,subject to clinical outcome, the Company anticipates filing for registration atthe end of the year with a possible launch in 2008. Ardana believes that GHS'oral formulation will give clinicians a simpler and more effective test forgrowth hormone deficiency. Dr. Maureen Lindsay, Ardana's CEO, said: "We are delighted and very encouragedthat the FDA have granted Orphan Drug status for GHS. We believe that GHS couldplay a very important role in providing clinicians with a convenient, reliableand effective diagnostic test for growth hormone deficiency." In addition to its possible use as a diagnostic, Ardana intends to undertakeclinical trials to support registration of GHS in a number of adult therapeuticindications. For more information contact: Ardana Financial DynamicsMaureen Lindsay (corporate/financial media relations)Tel: + 44 (0) 131 226 8550 Julia Phillips/John Gilbert Tel: +44 (0)20 7831 3113 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 built a broad and balanced portfolio to managerisk and actively pursues product and technology in-licensing and outlicensingto 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, for which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • ARD-07 a growth hormone secretagogue in late stage development for the diagnosis of growth hormone deficiency • 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; • Testosterone Cream, a trans dermal testosterone delivery system in development (Phase II trials) for the treatment of male hypogonadism; • InvicorpTM, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. 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 This information is provided by RNS The company news service from the London Stock Exchange