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Reloading in a hurry

H. Lundbeck A/S has had a trying year, with the loss of two major late-stage CNS programs that had been expected to compensate for the loss of revenues when its top-selling CNS drugs go off patent between 2012 and 2014. Consequently the company has been forced to accelerate the development of its new generation of anti-depressants by planning to run more studies of more compounds simultaneously. To fund this, it has partnered them earlier than it otherwise would have, while also saying it would more aggressively search for late-stage compounds to replace the ones it lost.

At the start of 2007, Lundbeck (CSE:LUN, Copenhagen, Denmark) looked like it was on course to maintain its strategic objectives: maintaining a leadership position in the CNS arena; building a physical presence in the U.S. and Japanese markets, which account for two-thirds of global CNS drug sales; and together with partners completing Phase III trials of its two lead compounds, gaboxadol for sleep disorders and desmoteplase for stroke.

By June all that had changed.

The first blow was the March termination of development of the GABA-A agonist gaboxadol after LUN saw unpleasant, although not dangerous, psychiatric side effects in a subsegment of patients in Phase III trials(see BioCentury, April 2). Not only did the news remove a potentially lucrative revenue generator, it also put the brakes on LUN's ambitions to expand its own presence in the U.S. and Japan.

After in-licensing the compound from Garching Innovation GmbH (Munich, Germany), LUN established a co-development and co-marketing partnership with Merck & Co. Inc. (MRK, Whitehouse Station, N.J.), firstly for the U.S. market and then in a subsequent deal extension for the

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