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www.fdanews.com/articles/98301-gsk-sepracor-ink-deal-to-commercialize-lunivia

GSK, Sepracor Ink Deal to Commercialize Lunivia

September 11, 2007

UK drugmaker GlaxoSmithKline (GSK) and Sepracor signed an agreement for the commercialization of Lunivia, a treatment for insomnia, for markets outside the U.S., Canada, Mexico and Japan.

Lunivia (eszopiclone) is currently under EMEA review for marketing approval under the centralized procedure. The European marketing authorization application contained results from 122 preclinical and 35 clinical studies.

Under the agreement, Sepracor said it is entitled to receive an initial payment of $20 million plus subsequent payments upon accomplishment of various milestones. If all milestones are met, GSK will be obligated to pay Sepracor $155 million in aggregate license and milestone payments, the company added.

Lunivia is marketed in the U.S. by Sepracor as Lunesta.