Yondelis Experience Highlights EMEA Issues

 
• By Hazel Dawson

The European regulators' rejection of PharmaMar's lead anti-cancer drug Yondelis in November 2003 was a significant setback for Spain's flagship biotech. But the decision was close; some experts still feel the drug should have been approved. Indeed, although critics claim PharmaMar could have done more to ensure its trial design was satisfactory, the experience highlights weaknesses in Europe's centralized drug approvals procedure of which other firms should be aware. All the more so since the centralized route will likely soon be compulsory not only for biologics, but also for all products in cancer, HIV/AIDS, neurodegenerative disease and diabetes, and all designated orphan drugs.

When Zeltia SA 's biotechnology subsidiary PharmaMar SA filed its marketing authorization application for anti-cancer agent trabectedin (Yondelis) at the European Agency for the Evaluation of Medicinal Products (EMEA) in November 2001 it hoped to become one of the few biotechs in Europe—and certainly the only one in Spain—to have brought to market an in-house developed drug.

The company extracted cytotoxic Yondelis from a sea squirt native to the Mediterranean and Caribbean. (See "PharmaMar: Angling for Success,"...

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