Zeltia sees Yondelis on sale by year-end
MADRID, July 20 (Reuters) - Zeltia's (ZEL.MC) cancer drug Yondelis should be available to treat soft tissue sarcomas by the end of the year after it was recommended for approval in Europe on Thursday, the Spanish firm said on Friday.
On Thursday, the European Medicines Agency (EMEA) recommended Yondelis be approved by the European Commission, a process which usually takes a couple of months.
"This is excellent news," Zeltia Chairman Jose Maria Fernandez Sousa said in a statement.
"Under the expected timeframe, many European patients may have access to Yondelis before the end of the year," added Zeltia.
It gave no estimate of what financial difference Yondelis would make to Zeltia, which earns most of its money from selling paints and varnishes and whose PharmaMar biotechnology unit is researching marine organisms for medical use.
EMEA's recommendation of Yondelis is a landmark for Zeltia and its most important product, which was rejected by EU regulators in 2003.
That move meant Zeltia had to conduct new clinical trials on Yondelis, which is based on a tiny organism first found on the roots of mangrove trees in the Caribbean.
Zeltia said the new trials had shown Yondelis reduced the progression of tumours by 27 percent. More than 60 percent of patients taking the drug were still alive a year after starting the treatment, Zeltia added.
Yondelis was given orphan drug status to be used on soft tissue sarcoma -- a rare and usually fatal form of cancer that attacks muscles, fat or blood vessels -- in 2001 by European authorities and in 2004 by the U.S. Food and Drug Agency.
It was given the same status for use on ovarian cancer in 2003 in Europe and 2005 in the United States. Yondelis is now in Phase III trials on ovarian cancer and Phase II on ovarian and testicular cancer.
Yondelis will be sold by Zeltia's PharmaMar unit in Europe. It has a licensing agreement with U.S. group Johnson & Johnson (JNJ.N) for Yondelis outside Europe.
((Reporting by Jane Barrett; editing by Paul Bolding; Reuters Messaging: jane.barrett.reuters.com@reuters.net; email: jane.barrett@reuters.com; Tel: +34 91 585 8340)) Keywords: ZELTIA YONDELIS/
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