Aura Renew Acq Regulatory News (ARA)

31 Jan 2006 07:01

Ardana PLC31 January 2006 ARDANA'S NOVEL TESTOSTERONE CREAM REMAINS ON TRACK FOR Q4 2007 LAUNCH FOLLOWING PRE-IND MEETING WITH US FDA. - - Company completes Phase II dose-finding study enrolment - - Edinburgh, UK, 31 January 2006; Ardana plc (LSE:ARA) the emergingpharmaceutical company focused on improving human reproductive health, todayreports on a pre-Investigational New Drug (IND) meeting with the US Food andDrug Administration (FDA) to discuss the development of its novel cream fortestosterone replacement in male hypogonadism. Agreement was reached on the next steps in development of the product, whichshould allow Ardana to meet its registration timelines and previously announcedlaunch target of end of 2007. Ardana is planning to submit an IND to the FDAwithin a few months and expects to commence a Phase III pivotal registrationtrial in the US at the end of H1 2006. Additionally, Ardana announces that enrolment to a Phase II dose finding studyin the target patient population has now been completed. A Phase IIdose-titration study in support of the registration of Ardana's testosteronecream is also on track to commence in H1 2006. Dr Maureen Lindsay, Ardana's CEO, said: "We are very encouraged by the feedbackfrom the FDA and by the progress of development of this novel testosteronecream, which complements our current and planned portfolio. We believe that thedelivery technology has broad application and we are assessing additionalcompounds which could be developed using this platform." In 2004, the testosterone replacement market in Europe and in the US wasestimated to be worth approximately $600 million. The US market is by far themost attractive with a growth rate of 40% by value and sales of $537 million(IMS Health). For more information contact: Ardana Financial DynamicsMaureen 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: • StriantTM SR, a testosterone replacement therapy for which Ardana has marketing rights in Europe, has already been launched by Ardana through its own sales force in the UK as a treatment for men with confirmed hypogonadism • Teverelix LA, in development for three initial indications: prostate cancer and benign prostatic hyperplasia (both indications are at the phase II stage), and endometriosis (currently in phase I) • Testo Cream, a transdermal testosterone delivery system in phase II for the treatment of male hypogonadism • Invicorp(R), an injectable combination drug treatment for erectile dysfunction, already approved in Denmark and for which Ardana has marketing and manufacturing rights in Europe. Launch is expected in H2 2006 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£21 million. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange