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UPDATE 1-Australian regulator rejects Zeltia cancer drug

By Robert Hetz MADRID, Nov 12 (Reuters) - Spanish drug company Zeltia's application to register its key Yondelis anti-cancer drug in Australia has been rejected, the country's Advisory Committee on Prescription Medicines (APCM) said in a report. Australia's APCM decided not to recommend Yondelis for soft tissue sarcoma and ovarian cancer arguing that the health risks posed by the drug outweigh its potential effectiveness, acccording to the report, dated Nov. 9. "The ACPM supported the delegate's assessment that the overall risk benefit profile remains unfavourable in view of the significant toxicity and toxicity related deaths," the report said. Yondelis has been approved to treat soft tissue sarcoma, tumours which affect fat, muscle and blood vessels, in several countries including the United Kingdom and was approved for ovarian cancer treatment by the European Union in November 2009. Zeltia's partner in marketing Yondelis, Johnson and Johnson is planning to submit the request to sell Yondelis in Australia with clinical data from current trials following the rejection, Zeltia said in a separate statement on Friday. At 1035 GMT, Zeltia shares were down 3.30 percent at 2.93 euros. Madrid's IBEX-35 index was down 0.07 percent. (Reporting by Robert Hetz; writing by Jonathan Gleave; Editing by Hans Peters) Keywords: ZELTIA REJECTION/ (jonathan.gleave@thomsonreuters.com; +34 91 585 2159; Reuters Messaging: jonathan.gleave.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved.

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