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UPDATE 2-EU agency backs Zeltia drug for ovarian cancer

Published 09/25/2009, 08:29 AM

* European Medicines Agency gives positive opinion

* Drug Yondelis' European sales seen at 300 million eur

* News is shot in the arm for EU biotech industry

* Zeltia shares soar more than 30 percent (Adds shares, chairman, byline)

By Robert Hetz and Jonathan Gleave

MADRID, Sept 25 (Reuters) - Shares in Spain's Zeltia soared on Friday after advisors to European regulators recommended the loss-making pharmaceutical firm's Yondelis drug for use in the treatment of ovarian cancer.

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

By 1210 GMT, Zeltia the shares were up 34 percent compared with a 0.2 percent fall in the Madrid bourse's benchmark Ibex. Trading in the shares had been suspended prior to news of the recommendation.

Zeltia Chairman Jose Maria Fernandez Sousa-Faro reiterated forecasts that sales from Yondelis could be 300 million euros ($440.5 million) a year in Europe and that the company could break even or make a small profit by the end of 2010.

Sousa-Faro said Zeltia may call on shareholders to boost capital by two percent. "We're going to study it, but if we need to, we'll go right ahead," he told a news conference.

Zeltia expected other countries to follow the lead shown by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The committee's recommendations are normally endorsed by the European Commission within a couple of months.

"It's highly probable that other countries will now approve Yondelis and that within a few months the only country which hasn't approved it will be the United States," said Luis Mora, managing director for Zeltia's PharmaMar biotech unit.

The news is a fillip for the European biotechnology sector, which has lagged well behind the United States in getting new drugs to market.

The European decision contrasts with the verdict of the U.S. Food and Drug Administration, whose experts were concerned that risks of heart and liver toxicity outweighed the limited ability of Yondelis to keep disease in check.

Yondelis, known chemically as trabectedin, is already sold in Europe as a treatment for soft tissue sarcoma, a relatively rare disease affecting soft tissues such as muscle, fat and tissue around joints.

The medicine is unusual in that it is a synthetic version of a compound isolated from a type of sea squirt, a tubular marine animal. It works by binding to the DNA of cancer cells and blocking their ability to multiply.

(Additional reporting by Ben Hirschler in London)

(Writing by Martin Roberts; editing by John Stonestreet) (martin.roberts@thomsonreuters.com; +34 91 585 2130; Reuters Messaging: martin.roberts1.reuters.com@reuters.net)) ($1=.6810 Euro)

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