Neurim licenses sleep-promoter Circadin to Sigma for Australia Markets; seeks more distributors

Israel's Neurim Pharmaceuticals has licensed it Circadin, a prolonged release melatonin for primary insomnia, in Australia to local firm Sigma Pharmaceuticals.

Circadin, currently approved for use in 33 countries, is a novel sleep aid indicated for treatment of primary insomnia. The latest approval in Australia by the Therapeutic Goods Administration was based on clinical studies showing positive effects on 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.

Sigma will launch Circadin in Australia in 2010. Under the terms of the agreement, Neurim receives an upfront payment and an ongoing share of revenues. Neurim will be responsible for manufacturing Circadin. Further financial terms of the deal were not disclosed.

"Circadin is the first and only approved melatonin based ethical drug," says Prof Nava Isabel, chief scientific officer of Neurim. Melatonin is a naturally occurring hormone produced by the pineal gland and 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 the middle aged and elderly.

"Circadin, an IP [intellectual property] protected formulation which essentially mimics the normal nocturnal melatonin profile, improves sleep quality and morning alertness and facilitates sleep onset, is a very valuable alternative to traditional sedative hypnotics. Most other sleep aids share a number of drawbacks, such as dependency, amnesia and residual drowsiness, unlike Circadin," added the Israeli company's medical director, Earn Schemer.

More registrations planned, partners sought

There are plans in place to register Circadin in the New Zealand, the USA, Asia-Pacific and Latin America, and Neurim currently seeking strategic partners for marketing and distributors for additional markets around the globe.