Business
Research Update
Research Update.
About this update from Aura Renewable Acquisitions Plc
[{"type":"text","content":"\n RNS Number : 2579U Ardana PLC 13 May 2008 \n\nARDANA ANNOUNCES A PRELIMINARY EVALUATION OF ITS TESTOSTERONE CREAM PIVOTAL STUDY AND PROVIDES AN UPDATE ON VARIOUS STRATEGIC OPTIONS \n\n\nEdinburgh, UK: 13 May 2008: Ardana plc ('the Company') (LSE:ARA) the pharmaceutical company specialising in improving human reproductive health, today announces a preliminary evaluation of its Testosterone Cream in a Phase III study in hypogonadal men and provides an update on the progress of the various strategic options currently being pursued by the Company.\n\nTestosterone Cream\n\nBoth the enhanced business development activity and the M&A process being undertaken since the Company's strategic review in November 2007 have revealed that there is considerable interest in Ardana's Testosterone Cream product both as an important part of the rationale for potential M&A and as a licensing opportunity in its own right. As part of their due diligence enquiries a number of potential licensing partners recently requested an update on the multi-centre open label Phase III study. \nBased on correspondence with the US Food and Drug Administration ('FDA') the expected target for patients in the eugonadal range is 75%. Whilst a substantial proportion of men who have completed the study to date have achieved average testosterone levels (Cavg) in the eugonadal range, having examined the data as part of the potential licensing of this product the Company now believes that it is unlikely that this target will be met in the current study. There was good consistency in the average testosterone levels achieved and excluding a probable protocol violator, there were no patients with excessively high average testosterone levels. The Company believes that the titration stage of the study protocol was the most likely reason that a lower than expected proportion of men were in the eugonadal range, allowing patients who should have been titrated to a higher dose to remain at lower doses. \n\nThis evaluation provides valuable input into further work for Ardana's Testosterone Cream and discussions with potential partners continue on the planning of further analyses and studies. Correspondence received from the FDA since the start of the trial has also been valuable in planning further work to clarify the optimum titration regime. The...