Circadin® (Prolonged-Release Melatonin) For Primary Insomnia Recommended For Approval In The EU

Neurim Pharmaceuticals Ltd today announced that the Committee for Medicinal Products in Human use (CHMP) of the European Medicines Agency (EMEA) has issued an approval recommendation for Circadin 2 mg (prolonged-release melatonin) as monotherapy for the short-term treatment of Primary Insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

The marketing authorisation application for Circadin was submitted by Neurim Pharmaceuticals to EMEA on October 2005. The adoption of a positive recommendation is the last step in the European regulatory approval process prior to the granting of marketing authorisation by the European Commission.

Neurim anticipates that the Commission will ratify the CHMP opinion and issue marketing authorisation in the third quarter of 2007. If granted, the EU marketing authorisation will be valid in all 27-member states of the European Union.

“We are extremely pleased to have received the Committee’s positive recommendation, which is a significant step towards Circadin becoming an important new treatment option in the EU for patients aged 55 or over suffering from Primary Insomnia,” said Prof. Nava Zisapel, CSO of Neurim “Circadin was found effective in improving quality of sleep and sleep latency while also improving morning alertness and quality of life.