CHMP gives nod to Vidaza and Lunivia, while Astellas withdraws telavancin MAA

3 November 2008

At its late October meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for insomnia drug Lunivia (eszopiclone) from the USA's Sepracor Pharmaceuticals.

Last year (Marketletter September 17, 2007), UK drug giant GlaxoSmithKline licensed the agent for all markets worldwide, excluding the USA, Canada, Mexico and Japan in a deal worth up to $155.0 million in aggregate license and milestone fees.

On the day of the MAA approval, October 24, shares in Sepracor dipped 3.3% to $12.73, against a backdrop of much bigger declines in the wider market.

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