Under the terms of the agreement Neurim will receive an upfront payment and a share of revenue. The upfront payment will be deducted from the share of revenue in the first three years of commercialization. Neurim is responsible for manufacturing.
Circadin®, a novel sleep aid, was approved by the European Commission on 29 June 2007 indicated as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 and above. The approval was based on clinical trials that show positive effects on sleep induction, sleep quality, and most importantly, day-time functioning and quality of life. The trials also show that there are no signs of development of dependency. Lundbeck expects to launch Circadin® in some 15 European markets from the first half of 2008.
"Circadin® is a unique treatment of poor sleep with a new mechanism that differs from all other approved medicines. With this new agreement we will now be able to offer this valuable alternative to traditional sedative hypnotics in a number of markets worldwide to the benefit of the many patients suffering from sleep disorder problems," says Executive Vice President Stig LÃ¸kke Pedersen, head of Commercial Operations.
"Lundbeck's expanded rights for Circadin® in the major Asian and Latin American markets position Circadin® as a new global non-sedative and non-hypnotic alternative for patients with sleep disorders, who can benefit from the improvement in sleep quality as well as morning alertness provided by Circadin®," says Director Dr. Eran Schenker, Corporate Business Development at Neurim Pharmaceuticals Ltd.
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 and above.
Neurim Pharmaceuticals Ltd. (1991) 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 2007, the company's revenue was DKK 11 billion (approximately EUR 1.5 billion or USD 2.0 billion). The number of employees is approximately 5,300 globally. For further information, please visit www.lundbeck.com.