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Biotech / Medical : Sepracor-Looks very promising

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From: Icebrg	8/1/2007 2:14:39 AM
	of 10280

Sepracor: wakes up to EU and Japan markets with Lunesta 30th July 2007 By Henry Wheeler Sepracor has announced plans to progress Lunesta beyond its core US market into Europe and Japan Sepracor's submission of a marketing authorization application in Europe for insomnia drug Lunesta and the potential for fast tracking the drug directly to Phase III in Japan looks promising. However, Datamonitor predicts the combined value of the EU and Japanese markets to be 3.6 times less than that of the US in 2007 and Sepracor should not expect Lunesta to attain blockbuster status here. Content Lunesta (eszopiclone) was submitted to the EMEA under the brand name Lunivar after two six-month placebo controlled studies. Sepracor has also reported the initiation of Phase I studies in Japan, where the possibility of fast tracking Lunesta to Phase III utilizing existing clinical trial data (potentially 35 clinical trials) appears to be strong. Sleep is essential for mental and physical restoration. Insomnia is the most pervasive of the sleep disorders and is defined as the perception or complaint of inadequate or poor quality sleep due to one or more of the following: difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up at early hours and un-refreshing sleep (even after sleeping seven to eight hours a night). Sepracor was founded in 1984 and is a research-based company located in the US that seeks for reformulations of current products. Sepracor's main areas of interest are respiratory and CNS disorders. Sepracor entered the insomnia market in April 2005, with the introduction of Lunesta in the US. The leader in the insomnia market is Sanofi-Aventis' Ambien, with over half the market share worldwide in 2006. Datamonitor predicts the insomnia market to be worth nearly $3.8 billion in 2007, for which Lunesta will account for about 22% sales of the US market. Lunesta is expected to reach blockbuster status in 2008. In contrast, Datamonitor forecasts the EU and Japan insomnia markets to total $586 million and $473 million respectively in 2007. Eisai has acquired the rights for Lunesta in Japan and will continue its development. Sepracor's move into the EU and Japanese insomnia markets is questionable as Datamonitor forecasts these sectors to be worth a mere 24% of worldwide sales by 2016, while US sales are predicted to account for over $5.19 billion out of the predicted $6.8 billion market. pharmaceutical-business-review.com

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