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FDA Update
FDA Update.
About this update from Aura Renewable Acquisitions Plc
[{"type":"text","content":"\n Ardana PLC\n31 January 2006\n\n\nARDANA'S NOVEL TESTOSTERONE CREAM REMAINS ON TRACK FOR Q4 2007 LAUNCH FOLLOWING\n PRE-IND MEETING WITH US FDA.\n\n - - Company completes Phase II dose-finding study enrolment - -\n\n\nEdinburgh, UK, 31 January 2006; Ardana plc (LSE:ARA) the emerging\npharmaceutical company focused on improving human reproductive health, today\nreports on a pre-Investigational New Drug (IND) meeting with the US Food and\nDrug Administration (FDA) to discuss the development of its novel cream for\ntestosterone replacement in male hypogonadism.\n\nAgreement was reached on the next steps in development of the product, which\nshould allow Ardana to meet its registration timelines and previously announced\nlaunch target of end of 2007. Ardana is planning to submit an IND to the FDA\nwithin a few months and expects to commence a Phase III pivotal registration\ntrial in the US at the end of H1 2006.\n\nAdditionally, Ardana announces that enrolment to a Phase II dose finding study\nin the target patient population has now been completed. A Phase II\ndose-titration study in support of the registration of Ardana's testosterone\ncream is also on track to commence in H1 2006.\n\nDr Maureen Lindsay, Ardana's CEO, said: 'We are very encouraged by the feedback\nfrom the FDA and by the progress of development of this novel testosterone\ncream, which complements our current and planned portfolio. We believe that the\ndelivery technology has broad application and we are assessing additional\ncompounds which could be developed using this platform.'\n\nIn 2004, the testosterone replacement market in Europe and in the US was\nestimated to be worth approximately $600 million. The US market is by far the\nmost attractive with a growth rate of 40% by value and sales of $537 million\n(IMS Health).\n\n\nFor more information contact:\n\nArdana Financial Dynamics\nMaureen Lindsay (corporate/financial media relations)\nTel: + 44 (0) 131 226 8550 Julia Phillips/Davina Langdale\n Tel: +44 (0)20 7831 3113\n\n NB Public Relations\n (trade/technical media relations)\n Nicki Brimicombe\n Tel: + 44 (0)1883 732353\n\n\n\nAbout Ardana\n\nArdana plc is a pharmaceutical company focused on the discovery, development and\nmarketing of innovative products to improve human reproductive health, a $23.8\nbillion market.\n\nSince its foundation, Ardana has ...