H. Lundbeck A/S (LUN) rose the most in six months after saying an experimental antidepressant showed statistically significant results in three late-stage studies that will support regulatory filings in the U.S. and Europe.
The shares gained 8.8 percent, the biggest gain since Nov. 11, to 118.60 kroner in Copenhagen, where the company is based. The drugmaker is developing the product with Japanese partner Takeda Pharmaceutical Co. (4502)
Data from the three studies showed LU AA21004 reduced depression symptoms in a dose range from 10 milligrams to 20 milligrams, compared with placebo, the company said in a statement today. Lundbeck, the Nordic region’s second-largest drugmaker, needs new products to replace lost revenue from antidepressant Lexapro, which goes off-patent in Europe in mid-2014. It plans to submit applications for approval of LU AA21004 in the U.S. and Europe this year. Annual sales for the drug may reach as much as $2 billion, the company has said.
Out of 10 large, placebo-controlled trials trials completed in patients, eight have shown that the drug is effective for depression, Lundbeck said. The most common side effects were nausea, headache, diarrhea and vomiting. Further analysis of the data is expected to be presented at upcoming medical conferences, the company said.
(A conference call will be held tomorrow at 9 a.m. Copenhagen time. Investors will be able to listen in via a link on www.lundbeck.com, which can be found under ‘Investors.’)
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