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Circadin(R) - Prolonged Release Melatonin for Primary Insomnia is Licensed to Sigma Pharmaceuticals for Australia Markets

Tuesday, December 15, 2009 Drug News
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TEL AVIV, Israel, December 14 Sigma Pharmaceuticals Ltd.and Neurim Pharmaceuticals Ltd. announce Licensing Agreement for Circadin(R)- prolonged release melatonin for primary insomnia in Australia.
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Circadin(R), currently approved for use in 33 countries, is a novel sleepaid indicated for treatment of primary insomnia. The latest approval inAustralia by the TGA, was based on clinical studies showing positive effectson both sleep induction, sleep quality, and most importantly,day-time-functioning as well as quality of life. The trials also show thatthere are no signs of development of dependency.
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Sigma Pharmaceuticals Ltd. will launch Circadin(R) in Australia in 2010.Under the terms of the agreement, Neurim receives an upfront payment and anongoing share of revenues. Neurim will be responsible for manufacturingCircadin(R).

"Circadin(R) is the first and only approved melatonin based ethical drug"says Prof. Nava Zisapel, Chief Scientific Officer of Neurim PharmaceuticalsLtd. Melatonin is a naturally occurring hormone produced by the pineal glandand it has a pivotal role in the regulation of circadian rhythms and sleep.Endogenous melatonin levels decrease with age and may contribute to thecommon complaint of poor sleep quality seen amongst the middle aged andelderly.

"Circadin(R), an IP protected formulation which essentially mimics thenormal nocturnal melatonin profile, improves sleep quality and morningalertness and facilitates sleep onset, is a very valuable alternative totraditional sedative hypnotics. Most other sleep aids share a number ofdrawbacks, such as dependency, amnesia and residual drowsiness, unlikeCircadin(R)," says Dr. Eran Schenker, Medical Director at NeurimPharmaceuticals.

"We are pleased to license Circadin(R) and introduce a new classtreatment for insomnia into Australia and New Zealand," says Elmo de Alwis,Sigma Pharmaceuticals Managing Director. "We are confident that Sigma, thefirst Asia Pacific partner to Neurim, will be able to realise the fullpotential of Circadin(R) for the benefit of Australian patients."

There are plans in place to register Circadin(R) in the New Zealand, US,Asia-Pacific and Latin America, and Neurim Pharmaceuticals is currentlyseeking strategic partners for marketing and distributors for additionalmarkets around the globe.

About Circadin(R)

Circadin(R) (http://www.Circadin.info) is the first and only IP-protectedprolonged-release melatonin and the first and only melatonin product to beapproved as an ethical drug by health authorities. In clinical trialsinvolving thousand of patients with primary insomnia, it has beendemonstrated that administration of Circadin(R) improves sleep quality andmorning alertness and facilitates sleep onset in patients aged 55 or over.Currently approved for commercialization in 33 countries, Circadin(R) isundergoing plans for registration in New Zealand, the US, Asia-Pacific andLatin American markets.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals (http://www.neurim.com) is based in Israel withoffices in Switzerland and the UK. The company was founded in 1991 and isfocused on drug discovery and development of treatments for age-relateddisorders, primarily in the central nervous system (CNS). NeurimPharmaceuticals is seeking strategic partners.

About Sigma Pharmaceuticals

Sigma Pharmaceuticals Limited (ASX:SIP) is a leading Australianmanufacturer, wholesaler and distributor of prescription, over-the-counterand generic pharmaceutical products to pharmacies throughout Australia. Sigmawas originally founded by two Melbourne pharmacists in 1912 and merged withArrow Pharmaceuticals in December 2005. In 2008, Sigma acquired OrphanAustralia which is dedicated to providing highly specialised pharmaceuticalsfor the treatment of serious or life threatening conditions in Australia.For More information: Eran Schenker, MD Medical Director & Corporate Business Development Neurim Pharmaceuticals Ltd. Tel: +972-3-7684914 ; Cell: +972-52-6689944 [email protected] OR Elmo de Alwis Managing Director Sigma Pharmaceuticals Limited Tel: +61-(0)3-9839-2820 [email protected]

SOURCE Neurim Pharmaceuticals LTD
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