Novel Testosterone Cream On Track for Q4 2007 Launch

Filed in archive Drugs, Vaccines and Therapeutics on February 2, 2006

Ardana, a Scotland-based firm focusing on reproductive health, announced that, during its pre-Investigational New Drug (IND) meeting with the US FDA, an agreement has been reached on the next steps in the developments of its novel cream for testosterone replacement therapy for the treatment of male hypogonadism.

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."

Enrolment to a Phase II dose finding study in the target patient population has now been completed, while a Phase II dose-titration study in support of the registration of Ardana's testosterone cream is also on track to commence this year. Ardana approximates the treatment available for launch towards the last quarter of 2007.

Ardana