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Lundbeck seeks European approval of antidepressant, plans US filing in Q4

3:29 am by | 0 Comments

COPENHAGEN (Reuters) - Danish drugmaker Lundbeck A/S has filed for regulatory approval in Europe of its antidepressant vortioxetine, the first filing of a non-copy antidepressant in Europe in five years.

Lundbeck said in a statement the European filing would be followed by filing for regulatory approval in Canada in the second half of this year, in the United States in the fourth quarter and in Japan next year.

"I am very pleased that we now have filed vortioxetine in Europe as many people suffering from major depression still struggle to find an effective treatment," Head of Research and Development Anders Gersel Pedersen said in the statement on Thursday.

Major depression is a leading cause of disability, Lundbeck said in the statement, adding that the World Health Organisation (WHO) has predicted that depression will become the leading cause of disability by 2030.

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Deutsche Bank said in a research note in May that vortioxetine could be worth up to 55 crowns per Lundbeck share, the price of which rose 0.6 percent to 103.90 by 0711 GMT against a slightly negative Copenhagen bourse benchmark index.

The company is working to find replacements for its key anti-depressant Cipralex - sold as Lexapro in the United States and Japan - as it comes off patent protection, and has warned earnings will stall until 2015 due to cheap generic competition.

New product launches are therefore vital to secure future revenue growth.

Lundbeck would file the vortioxetine application in Canada itself and would file in co-operation with its Japanese partner Takeda Pharmaceutical Co in the United States and Japan, it said.

(Reporting by Mette Fraende; Editing by David Holmes)

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