Today Nycomed announced that its partner Neurim Pharmaceuticals EEC, the EU subsidiary of Neurim Pharmaceuticals Ltd has received a European Marketing Authorisation for Circadin® 2 mg (prolonged release melatonin). Circadin® 2 mg is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Studies in primary insomnia show that Circadin® 2 mg is effective in improving quality of sleep and morning alertness as well as quality of life. At the same time Circadin® 2 mg does not impair vigilance, driving performance or memory.
The European Commission’s decision to grant the authorisation follows the Agency for the Evaluation of Medicinal Products’ (EMEA) announcement of a positive scientific assessment for Circadin® 2 mg on 26 April 2007.
Nycomed will be marketing Circadin® in Belgium, Netherlands, Austria, Greece, the Baltic States, Norway, Sweden, Finland, Denmark, Iceland, Switzerland, Luxembourg and Russia-CIS. The first launch is expected during fourth quarter 2007.
Dick Söderberg, Executive Vice President Marketing, Nycomed, said, “This is a very positive result of our on-going collaboration with Neurim Pharmaceuticals. We have great expectations for Circadin®, which is a first-in-class product for sleep disorders.”
Circadin® is a prolonged-release melatonin formulation. Melatonin, which is a naturally occurring hormone produced by the pineal gland primarily during night time, has a pivotal role in the regulation of circadian rhythms and sleep.
Endogenous melatonin levels decrease with age and may contribute to the common complaint of poor sleep quality seen amongst patients aged 55 and above. 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 with 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. Primary insomnia is not attributable to any other known mental disorder such as depression or caused by the effects of a substance, for example caffeine, or a general medical condition, for example arthritis leading to pain.
Insomnia overall is a common condition with a high 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.
About Neurim Pharmaceuticals
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 main 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.
Nycomed provides products for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.
The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.
Privately owned, the combined group had non-audited estimated annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results).
For more information visit www.nycomed.com
For further information
Christoffer Jensen, VP Communications
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Susanne Hof, Head of External Communications
Phone +49 7531 84 30 59
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