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With FDA drug app in, Lundbeck gets much-needed good news

Lundbeck facing tough year as it waits for FDA drug decision
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There was a glimmer of good news today for Lundbeck, which has been slashing its payroll and its earnings projections as it wrestles with the patent loss of blockbuster Lexapro.

The FDA has accepted an application from Lundbeck and partner Takeda for a new antidepressant that it hopes will fill the shoes of its key product. But the Danish drugmaker faces a tough year while it waits for the application to run its course. Reuters reports that it should be considered by the FDA by Oct. 2, 2013.

In June, it whacked 600 jobs, mostly in Europe, where government austerity also dealt another blow to the drugmaker's fortunes. Earlier this year, it told investors not to expect earnings growth again until 2015 as sales of Lexapro, marketed as Cipralex outside the U.S., start to fall off in a number of countries. The company figures that it will lose about 80% of its Lexapro sales to generic competition this year and 90% next year. The loss of the patent has also been dramatic for Forest Laboratories ($FRX), which licensed the drug. It was Forest's largest seller as well.

Lundbeck has high hopes for a Cipralex successor. Initially, getting the application accepted nets it a $50 million milestone payment from Takeda. Lundbeck also has other products that can help fill the gap, such as Sabril, a seizure drug, and Xenazine, which treats chorea in Huntington's disease patients. And the company will plow more money into R&D this year than it ever has, as it tries to regain its financial footing.

- read the Reuters story

Special Report: Lexapro - 10 Largest U.S. Patent Losses

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