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 : 31 January 2006 : Ardana plc (LSE:ARA) today reports on a pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA) to discuss the development of its novel cream for testosterone replacement in male hypogonadism.

Agreement was reached on the next steps in development of the product, which should allow Ardana to meet its registration timelines and previously announced launch target of end of 2007.  Ardana is planning to submit an IND to the FDA within a few months and expects to commence a Phase III pivotal registration trial in the US at the end of H1 2006.

Additionally, Ardana announces that enrolment to a Phase II dose finding study in the target patient population has now been completed.  A Phase II dose-titration study in support of the registration of Ardana’s testosterone cream is also on track to commence in H1 2006.

Dr Maureen Lindsay, Ardana’s CEO, said: “We are very encouraged by the feedback from the FDA and by the progress of development of this novel testosterone cream, which complements our current and planned portfolio.  We believe that the delivery technology has broad application and we are assessing additional compounds which could be developed using this platform.”

In 2004, the testosterone replacement market in Europe and in the US was estimated to be worth approximately $600 million.  The US market is by far the most attractive with a growth rate of 40% by value and sales of $537 million (IMS Health).

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