Tel-Aviv, Israel, April 27, 2007
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 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 please to have received the Committee’s positive recommendation, which is a significant step towads 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. At the same time Circadin does not impair vigilance, driving performance and memory and has no discernible withdrawal symptoms. These are considered to be of special importance in patients aged 55 years and over who suffer from Primary Insomnia”.
Neurim Pharmaceuticals will launch, market and distribute Circadin through strategic alliances with reputable marketing and distribution partners. Neurim is actively seeking strategic alliances for the major European markets.
Circadin is a prolonged-release melatonin formulation. Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin. Melatonin has a pivotal role in the regulation of circadian rhythms and sleep. The activity of melatonin at the MT1 MT2 and MT3 receptors is believed to contribute to its sleep-promoting and phase-resetting properties. Endogenous melatonin levels decrease with age and may contribute to the common complaint of poor sleep quality seen amongst the middle ages and elderly. Administration of Circadin which essentially mimics the nocturnal melatonin profile, improve sleep quality and morning alertness and facilitates sleep onset in patients aged 55 or over.
About Primary Insomnia
Insomnia is a subjective complaint encompassing delay in onset, insufficient duration and/or poor quality of sleep. Not all three symptoms need to be present for the diagnosis of insomnia.
Importantly, most insomnia people feel tired or distressed during the day.
The primary sleep disturbance is not associated with another medical disorder such as major depression and not sure to the effects of a substance, for example caffeine, or a general medical condition, for example arthritis leading to pain. Insomnia is an extremely common condition with an overall prevalence of 27% (range 8% to 43%) among primary care attendees. The prevalence of sleep problems rises from about 15% in 20-54 year olds, to 30% in the over-55 year olds. Women are 1.5 times more likely than men to have this sleep disorder. Insomnia is associated with negative consequences for health-related quality of life, daytime well-being and has economic implications.
Neurim Pharmaceuticals Ltd. (1991) headquartered in Israel with a business development unit in Switzerland, is a drug discovery and development company founded in 1991. Neurim is focused on age-related disorders, primarily in the central nervous system (CNS). The mail goal is to improve the quality of life in the older patient population. Circadin is the company’s first product reaching marketing approval. Other products are at various stages of preclinical and clinical development.