Aura Renew Acq Regulatory News (ARA)

5 Oct 2005 07:00

Ardana PLC05 October 2005 ARDANA ANNOUNCES GERMAN LAUNCH OF STRIANT(TM) SR THROUGH CYTOCHEMIA AG Edinburgh, UK, 5th October 2005; Ardana plc (LSE:ARA), the emergingpharmaceutical company focused on improving human reproductive health, announcesthat its partner, Cytochemia AG, has commenced marketing of Striant(TM) SR,Ardana's testosterone replacement therapy for male hypogonadism, in Germany. The German launch of Striant(TM) SR was announced at the 57th Congress of theGerman Society of Urology meeting in Dusseldorf, which was attended byapproximately 3,000 urologists. Striant(TM) SR is now available on prescriptionin Germany which, with an estimated size of €15.2 million per annum*, is thelargest market for testosterone replacement therapies in Europe. Cytochemia AGwill target all 3,500 urologists plus andrologists in the country. This follows the announcement of Ardana's German sales and marketing agreementwith Cytochemia on Striant(TM) SR on 16th June 2005. Financial terms of theGerman distribution partnership were not disclosed but Ardana received anupfront payment and will have ongoing revenues for the supply of Striant(TM) SRto Cytochemia. In addition, Ardana also announces today that Mode Medical has been appointedsales and marketing agent, responsible for promoting Striant(TM) SR toendocrinology consultants in Ireland. With an estimated size of €0.25 millionand a growth rate of 42% per annum, the Irish market is small but fast growing. Striant(TM) SR is a mucoadhesive buccal (gum surface) tablet containing 30mg oftestosterone and is indicated as a replacement therapy for male hypogonadismwhen deficiency of testosterone has been confirmed. Striant(TM) SR is thefirst-to-market buccal adhesive tablet and is marketed by Ardana's own salesforce in the UK, to urologists and endocrinologists. Other therapies for malehypogonadism include injectable formulations of testosterone, oral preparations,transdermal patches, topical gels and sub-cutaneous implants. Dr. Maureen Lindsay, Chief Executive of Ardana, said: "Today's announcement demonstrates Ardana's commitment to expand in key Europeanmarkets and underlines its determination to introduce novel therapies forindications where there are unmet patient needs. " *Source: MAT June 2005, IMS data For more information contact: Ardana Financial Dynamics Maureen 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: • Striant(TM) 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 Cytochemia Cytochemia is an independent pharmaceutical company based in Germanyspecializing in immuno-therapeutics from either their own product development orexclusive licence agreements. The target group for Cytochemia's therapeuticsconsists of gynaecologists, oncologists and urologists. The company is primarilyactive in the German market but in 2000 the company founded another branch ofthe business in Switzerland. Cytochemia has considerable experience in Germany selling to the samespecialists as Ardana through their targeted sales force which has a strongtrack record in the education of physicians on product usage. Cytochemia has astrong complementary portfolio to Ardana and its product ImmuCyst, which hasbeen on the market for 13 years, is an established agent for the treatment andprevention of superficial bladder cancer. Striant(TM) SR presents an excellentstrategic fit with Cytochemia's product portfolio and will be an importantaddition. This information is provided by RNS The company news service from the London Stock Exchange