Shares in Spain’s Zeltia have soared after the firm said that it plans to seek regulatory approval for expanded use of its cancer agent Yondelis.
The stock has hit its highest levels since 2001 after the Madrid-based drugmaker said it will submit data on the use of Yondelis (trabectedin) against ovarian cancer from a Phase III trial. Yondelis was approved a year ago by the European Commission for the treatment of soft tissue sarcoma.
The positive results from the study have been jointly reviewed and corroborated by Zeltia unit Pharma Mar and its US marketing partner Johnson & Johnson. The latter’s Ortho Biotech unit will make a regulatory filing in the USA for Yondelis in the new indication in the last quarter of the year, and Zeltia will do likewise in Europe at the same time.
The news comes a week after Zeltia said that first-half losses narrowed 40% to 12.4 million euros, while sales rose 21% to 54.2 million euros. Yondelis sales reached 13.5 million euros, 35% above company forecasts and Zeltia maintained its full-year sales target for the drug of 30 million euros.
