ALLIANCE REPORTS DATA ON SLEEP DRUG; EMEA REQUESTS MORE TRIALS

Alliance Pharma has announced preliminary results from the Phase III trials of Posidorm, the company's melatonin product for sleep disorders. The results are from pilot phases involving shift workers and elderly patients.

These results indicate a significant improvement in sleep duration compared with placebo when using the objective measure of actigraphy, a sleep-measuring device. Additionally, in the shift worker group, performance measurements during the night showed improvements for trial participants on Posidorm. In both groups, Posidorm was well tolerated with no difference in the incidence of reported side effects compared with placebo.

While the pilot trials have been successful, the company has been advised by the European Medicines Agency (EMEA) that additional safety and dose confirmation studies will be required. The original plan for Posidorm's development was based on discussions with the UK's Medicines and Healthcare products Regulatory Agency, which took into account the extensive medical and scientific literature on melatonin. That plan envisaged UK registration first, followed by registration in other European countries.

The pan-European registration routes that now have to be followed take less account of the accumulated knowledge about melatonin, according to the company. The effect of this change in regulatory approach will delay the anticipated completion of development the end of this year to the end of 2009 and will involve extra cost.

"While the additional guidance on Posidorm from the EMEA involves further time and cost, it does give a clear pathway through the registration process and allows an optimized pan-European product launch. We are currently looking at various options, including co-development, for bringing Posidorm to market in the quickest possible time," John Dawson, Alliance Pharma's chief executive, said.