Aura Renew Acq Regulatory News (ARA)

19 Apr 2005 07:01

Ardana PLC19 April 2005 ARDANA ANNOUNCES POSITIVE RESULTS IN PHASE I STUDY OF ORAL GROWTH HORMONE SECRETAGOGUE Edinburgh, UK, 19 April 2005; Ardana plc (LSE:ARA) the emerging pharmaceuticalcompany focused on the discovery, development and marketing of innovativeproducts to improve human reproductive health, today announces positive resultsin a Phase I study of its oral Growth Hormone Secretagogue (GHS), EP1572. EP1572 is a novel synthetic compound that is orally active and stimulates thesecretion of growth hormone (GH) from the patient's pituitary gland for thetreatment of growth hormone disorders (GHD). Ardana licensed the compound withexclusive worldwide rights, including the right to sub-licence, from AeternaZentaris (TSX:AEZ; NASDAQ: AEZS) in 2002. The Phase I study provides clear evidence that EP1572 is able to induce a risein growth hormone levels. The open, randomised, placebo-controlleddose-escalation study involved a total of 36 healthy male volunteers, dividedinto three groups of 12 volunteers. Nine subjects in each group received asingle oral dose of EP1572 - 0.005 mg/kg in the first group, 0.05 mg/kg in thesecond group and 0.5 mg/kg in the third group - with the other three subjects ineach group receiving a placebo. All subjects had been initially checked fortheir ability to release growth hormone by the intravenous administration ofanother hormone, growth hormone releasing hormone (GHRH). The data show that between 1-2 hours after drug administration there was a largeincrease in the levels of growth hormone in the blood without any effect onother hormones with the mean GH value being 79.12 ng/ml at the highest dose ofEP1572 (p = 0.009), compared to 52.62 ng/ml with GHRH and 3.58 ng/ml forplacebo. In all cases, EP1572 was well-tolerated and no adverse events werereported. EP1572 is the only orally active growth hormone in development and this presentsa major competitive advantage in terms of ease and convenience of delivery,particularly in the treatment of children. Current treatment is only viainjectable delivery. Additional studies are on-going and in-line with the company's businessstrategy, Ardana intends to seek a partner to accelerate development of EP1572for GHD and the more significant marketing opportunity of cachexia (musclewasting) associated with chronic disease, maintaining its focus on reproductivehealth. In 2004 the global growth hormone market was estimated to be worth $2.3billion (source: Wood Mackenzie's ProductView December 2004). Enquiries Ardana plc +44 (0)131 226 8550Maureen Lindsay, Chief Executive Officer Financial Dynamics +44 (0)20 7831 3113Julia PhillipsDavina Langdale 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 andoutlicensing 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; • *\* Teverelix LA, in development for three initial indications (prostate cancer, BPH 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 of drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe. *In-licensed products ** Acquired by Ardana 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