Bloomberg , 23 September 2010 .By Manuel Baigorri and Paul Tobin 2:45 PM GMT+0200 Zeltia Chairman Sees FDA Approving Yondelis for Cancer Next Year .
Zeltia SA, the Spanish developer of cancer drugs from sea creatures, expects its Yondelis drug to be approved in the U.S. next year to treat relapsed ovarian cancer.
Centocor Ortho Biotech Products LP, Zeltia’s U.S. partner, is close to completing the collection of patient survival data the Food and Drug Administration demanded last year, Zeltia Chairman Jose Maria Fernandez Sousa-Faro said in a telephone interview. Centocor is a unit of Johnson & Johnson.
Zeltia has suffered more delays on its leading product as price negotiations with individual countries in Europe, where Yondelis did win clearance for ovarian cancer, deferred sales. The unprofitable company said Sept. 21 revenue this year may be as much as 20 percent below the 189 million euros ($252 million) it forecast in March.
“We are moderately optimistic about what we will find once we have all the data” on whether Yondelis helps patients live longer, Fernandez Sousa-Faro said. Patient survival is a key measure of efficacy regulators use for cancer medicines. The studies European regulators relied on to clear Yondelis for ovarian cancer showed it extended patients’ lives by about three months, according to Fernandez Sousa-Faro.
Yondelis, based on a chemical found in sea squirts, first went on sale in 2007 to treat soft-tissue sarcoma, a cancer that develops in connective tissue.
“We based our predictions betting on a schedule for price agreements similar to what we had with sarcoma, but with ovarian cancer we are suffering delays,” Fernandez Sousa-Faro said. “It’s hard to know what’s behind the delays though it could be related to budget restrictions.”
Zeltia still aims to reach breakeven in full-year profit before interest, tax, depreciation and amortization this year, Fernandez Sousa-Faro said. The Madrid-based company’s cost cutting won’t come at the expense of clinical trials, he said.
Johnson & Johnson, based in New Brunswick, New Jersey, owns the marketing rights for Yondelis outside Europe and Japan and helps fund research.
To contact the reporter on this story: Manuel Baigorri in Madrid at mbaigorri@bloomberg.net Paul Tobin in Madrid at ptobin@bloomberg.net
To contact the editor responsible for this story: Angela Cullen at acullen8@bloomberg.net.
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