Lundbeck soars on PhIII success for blockbuster hopeful

Lundbeck shares spiked 9% this morning on the news that three late-stage studies of its new depression drug had delivered the data needed to support upcoming regulatory filings. The developer badly needs new therapeutics to replace Lexapro, an antidepressant that now faces generic competition.

"Lu AA21004 statistically significantly reduced depression symptoms in patients with (major depression) compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale," the company reported. "In total, out of the ten large, placebo-controlled studies of Lu AA21004 completed in patients with MDD, eight have shown effect of Lu AA21004. Further analysis of the data is ongoing and data are expected to be presented at upcoming medical conferences." 

Lundbeck and its partner, Takeda, now plan to jointly file for an approval in the U.S. in the second half of the year, while Lundbeck will push ahead on its own in Europe and Canada. Bloomberg notes that Lundbeck has estimated potential annual revenue from the drug at about $2 billion.

It's standard operating procedure to mount a series of clinical studies for any new depression drug, as high placebo responses have been known to torpedo studies. Takeda and Lundbeck plan to jointly continue studies examining the drug's impact on cognitive dysfunction in depression.

- here's the press release
- read the Bloomberg piece