H. Lundbeck A/S and Neurim Pharmaceuticals Ltd. today announced that
Lundbeck has obtained expanded 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.
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 Løkke 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.
About Circadin®
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.
The content of this release will not affect the Lundbeck Group's
guidance for revenue or EBIT for 2008. Lundbeck expects revenue of
DKK 11-11.5 billion and an EBIT of DKK 2.8-2.9 billion in 2008.
Lundbeck is adjusting its guidance for investments to DKK 575 million
including in-licensing payments.
Neurim Pharmaceuticals contacts
Dr. Eran Schenker
Corporate Business Development
+972 52 6689944
Lundbeck contacts
Investors: Media:
Jacob Tolstrup Jens Højbjerg
Director Media Relations Manager
+45 36 43 30 79 +45 36 43 28 33
Palle Holm Olesen
Head of Investor Relations
+45 36 43 24 26
Stock Exchange Release No 338 - 30 April 2008
About Neurim
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
About Lundbeck
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
