Circadin®, a novel sleep aid, was approved by the European Commission 29 June 2007 indicated 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 approval was based on clinical studies showing positive effects on both sleep induction, sleep quality, and most importantly, day-time-functioning as well as quality of life. The trials also show that there are no signs of development of dependency. Lundbeck expects to launch Circadin® in the first markets during 2008.
Under the terms of the agreement Neurim receives an upfront payment and a share of revenue. Neurim is responsible for manufacturing.
"We are delighted to have licensed Circadin® to a company with a strong track record within the research, development, marketing and sales of medicines for the treatment of central nervous system disorders", says Prof. Nava Zisapel, CSO of Neurim Pharmaceuticals. "We are confident that with Lundbeck as our partner we will be able to realize the full potential of Circadin® to the benefit of patients."
"Circadin® has shown to be a unique treatment of poor sleep with a new mechanism different from all other approved medicines. Circadin® mimics the physiological profile of the body's own melatonin secretion and will be a very valuable alternative to traditional sedative hypnotics, which share a number of drawbacks, such as dependency and residual drowsiness" says Executive Vice President Stig LÃ¸kke Pedersen, head of Commercial Operations.
Circadin® is the first and only IP-protected prolonged-release, melatonin containing ethical drug approved in the EU. Melatonin is a naturally occurring hormone produced by the pineal gland; it 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 those in middle age and in the elderly. Administration of Circadin®, which essentially mimics the normal nocturnal melatonin profile, improves sleep quality and morning alertness and facilitates sleep onset in patients aged 55 or over.
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. For further information, please visit www.neurim.com
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2006, the company's revenue was DKK 9.2 billion (approximately EUR 1.2 billion or USD 1.6 billion). The number of employees is approximately 5,300 globally. For further information, please visit www.lundbeck.com