Zeltia's Yondelis approved for sale in 10 new countries

Pharma Mar, a subsidiary of Spain’s Grupo Zeltia (ZEL: MC), says it has been advised by its licensee Janssen Product, part of the Johnson & Johnson (NYSE: JNJ) group, that regulatory authorities in 10 countries have granted 14 new authorizations to sell the cancer drug Yondelis (trabectedin, developed by Zeltia’s PharmaMar unit): 10 for treating relapsed platinum-sensitive ovarian cancer (ROC), in combination with Caelyx (pegylated liposomal doxorubicin), and four as monotherapy for treating soft tissue sarcoma (STS).

The 10 countries that have approved Yondelis for ROC are, Bahrain, Costa Rica, the Dominican Republic, Jamaica, Jordan, Nepal, Oman, Panama, Vietnam and Qatar. The four countries that authorized the drug for STS are Bahrain, the Dominican Republic, Jordan and Nepal.

As a result, Yondelis is now approved in 73 countries, 30 of which are in the European Economic Area (EEA). Yondelis generated gross revenues up 12% to 80.6 million euros ($104.8 million) for Zeltia in 2011, up 12% on the previous year. The European Commission approved the sale of Yondelis in combination with pegylated liposomal doxorubicin for relapsed platinum-sensitive ovarian cancer at the end of 2009. Since then, the drug has been approved and commenced sale in other territories. The European Commission approved Yondelis® for soft tissue sarcoma in 2007.