TEL AVIV, Israel, December 14 /PRNewswire/ -- Sigma Pharmaceuticals Ltd. and Neurim Pharmaceuticals Ltd. announce Licensing Agreement for Circadin(R) - prolonged release melatonin for primary insomnia in Australia.

Circadin(R), 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 TGA, 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.

Sigma Pharmaceuticals Ltd. will launch Circadin(R) 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(R).

"Circadin(R) is the first and only approved melatonin based ethical drug" says Prof. Nava Zisapel, Chief Scientific Officer of Neurim Pharmaceuticals Ltd. 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(R), an IP 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(R)," says Dr. Eran Schenker, Medical Director at Neurim Pharmaceuticals.

"We are pleased to license Circadin(R) and introduce a new class treatment for insomnia into Australia and New Zealand," says Elmo de Alwis, Sigma Pharmaceuticals Managing Director. "We are confident that Sigma, the first Asia Pacific partner to Neurim, will be able to realise the full potential 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 currently seeking strategic partners for marketing and distributors for additional markets around the globe.

About Circadin(R)

Circadin(R) (http://www.Circadin.info) is the first and only IP-protected prolonged-release melatonin and the first and only melatonin product to be approved as an ethical drug by health authorities. In clinical trials involving thousand of patients with primary insomnia, it has been demonstrated that administration of Circadin(R) improves sleep quality and morning alertness and facilitates sleep onset in patients aged 55 or over. Currently approved for commercialization in 33 countries, Circadin(R) is undergoing plans for registration in New Zealand, the US, Asia-Pacific and Latin American markets.

About Neurim Pharmaceuticals

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

About Sigma Pharmaceuticals

Sigma Pharmaceuticals Limited (ASX:SIP) is a leading Australian manufacturer, wholesaler and distributor of prescription, over-the-counter and generic pharmaceutical products to pharmacies throughout Australia. Sigma was originally founded by two Melbourne pharmacists in 1912 and merged with Arrow Pharmaceuticals in December 2005. In 2008, Sigma acquired Orphan Australia which is dedicated to providing highly specialised pharmaceuticals for 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
    EranS@Neurim.com

    OR

    Elmo de Alwis
    Managing Director
    Sigma Pharmaceuticals Limited
    Tel: +61-(0)3-9839-2820
    Elmo.dealwis@signet.com.au

SOURCE Neurim Pharmaceuticals LTD

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