Zeltia gets final EU okay for Yondelis drug

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MADRID | Mon Nov 2, 2009 4:14am EST

MADRID Nov 2 (Reuters) - Spanish biotechnology firm Zeltia (ZEL.MC) won final European approval on Monday for its Yondelis drug to treat ovarian cancer, sending its shares higher. The authorisation from the European Commission, clearing the product for sale, had been expected after it was recommended for approval by the European Medicines Agency in September.

The sale of Yondelis for ovarian cancer will begin in Britain, Germany, Austria, Denmark, Sweden, Finland and Norway, where it is not necessary to negotiate prices with local health authorities, Zeltia said.

By 0914 GMT, Zeltia's shares were up 7.7 percent at 4.34 euros.

The loss-making drug company is targeting 300 million euros of annual sales from Yondelis for ovarian cancer in Europe, that could help it to break even or make a small profit by the end of 2010.

Zeltia has been developing Yondelis for use in combination with Johnson & Johnson's (JNJ.N) Doxil for the treatment of ovarian cancer, but has so far failed to win a green light for the medicine in the United States.

(Reporting by Tracy Rucinski; Editing by Erica Billingham)

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