Sigma Pharmaceuticals (Sigma) and Neurim Pharmaceuticals (Neurim) have entered into a Licensing Agreement for Circadin, a prolonged release melatonin for primary insomnia, in Australia.
Circadin, currently approved for use in 33 countries, is a sleep aid indicated for the 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 showed that there are no signs of development of dependency.
Sigma is expected to launch Circadin in Australia in 2010. As per the agreement, Neurim receives an upfront payment and an ongoing share of revenues. Neurim will be responsible for manufacturing Circadin.
Eran Schenker, medical director at Neurim, said: “Circadin, an IP protected formulation which essentially mimics the normal nocturnal melatonin profile, improves sleep quality and morning alertness and facilitates sleep onset, is a valuable alternative to traditional sedative hypnotics. Most other sleep aids share a number of drawbacks, such as dependency, amnesia and residual drowsiness, unlike Circadin.”
Elmo de Alwis, managing director of Sigma, said: “We are pleased to license Circadin and introduce a new class treatment for insomnia into Australia and New Zealand. We are confident that Sigma, the first Asia Pacific partner to Neurim, will be able to realise the full potential of Circadin for the benefit of Australian patients.”