Lundbeck introduces insomnia drug in Europe

Circadin, the first melatonin agent approved by the European Medicines Agency (EMEA), is now available for the treatment of primary insomnia and is said to be the first approved sleep treatment to work by ensuring melatonin coverage all through the night. According to the company, Circadin, a sustained-release melatonin, provides natural sleep by increasing the body’s own level of this naturally occurring hormone throughout the night.

Circadin is the approved trade name in the whole EU. Lundbeck holds commercialization rights to Spain, Germany, UK, Italy, France, Ireland, Portugal, Poland, Hungary, Romania, Czech Republic, Slovak Republic, Slovenia, Bulgaria, Cyprus, Malta and Liechtenstein, representing 75% of the market potential in Europe.

Lundbeck also holds exclusive rights to commercialize Circadin in Asia, Latin America and other major markets such as Australia and Turkey. Following regulatory filing and approval Lundbeck expects to market Circadin in the first markets outside of Europe in 2009. Nycomed holds the commercialization rights to the remaining markets in Europe.