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UPDATE 2-Zeltia's Yondelis gets first OK for ovarian cancer

Published 07/10/2009, 03:54 AM
Updated 07/10/2009, 03:56 AM

* First time the drug approved for ovarian cancer treatment

* Shares up 5 percent after Philippines green light

* U.S. panel to review drug July 15

(Adds analyst quote, detail)

MADRID, July 10 (Reuters) - Spain's Zeltia said on Friday its Yondelis drug had been approved for the treatment of recurrent ovarian cancer in the Philippines, ahead of a hoped-for green light in the key U.S. market next week.

The news sent Zeltia shares, which are notoriously volatile, up 5 percent to 5.48 euros at 0720 GMT.

The Philippine decision comes ahead of a meeting of a Food and Drug Administration (FDA) expert panel on July 15 at which the use of Yondelis for ovarian cancer in the United States will be discussed.

"This is the first approval in the world for use in this kind of cancer, and although it may not be indicative of further approvals, it certainly helps," said Elena Fernandez, analyst at brokerage Ahorro Corporacion Financiera, who has a fair value share price for Zeltia of 7.20 euros.

"In any case, we expect a positive report next week for Yondelis (from the FDA)," she said.

Yondelis, made by Zeltia's PharmaMar unit, was also given the green light for the treatment of advanced soft tissue sarcoma in adults in the Philippines.

Soft tissue sarcoma, the initial disorder for which Yondelis is approved in Europe, is a relatively a rare disease. Winning approval to sell the medicine for ovarian cancer, which is more common, would open up a much bigger sales opportunity.

Zeltia is developing the drug in the United States with Johnson & Johnson. (Reporting by Elisabeth O'Leary and Ben Hirschler in London; Editing by Dan Lalor)

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